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Clinical Practice Guidelines

The American Urological AssociationFemale Stress Urinary IncontinenceClinical Guidelines Panel

The Surgical Management of Female Stress UrinaryIncontinence

The Surgical Management of Female Stress UrinaryIncontinence

Gary E. Leach, M.D.(Panel Chairman)Director, Tower Urology Institute for

ContinenceAssociate Clinical Professor of UrologyUniversity of California, Los AngelesLos Angeles, California

Roger R. Dmochowski, M.D.,(Panel Facilitator)Associate ProfessorDepartment of UrologyUniversity of Tennessee Medical CenterMemphis, Tennessee

Rodney A. Appell, M.D.Head, Section of Voiding Dysfunction

and Female UrologyDepartment of UrologyCleveland Clinic FoundationCleveland, Ohio

Jerry G. Blaivas, M.D.Clinical Professor of Urology and

Attending SurgeonNew York Hospital/Cornell Medical CenterNew York, New York

Female Stress Urinary IncontinenceClinical Guidelines Panel Members and Consultants

The Female Stress Urinary Incontinence Clinical Guidelines Panel consists of board-certifiedurologists and a urogynecologist who are experts in female stress urinary incontinence. ThisReport on the Surgical Management of Female Stress Urinary Incontinencewas extensivelyreviewed by over 50 physicians throughout the country in November 1996. The Panel finalizedits recommendations for the American Urological Association (AUA) Practice Parameters,Guidelines and Standards Committee, chaired by Joseph W. Segura, MD, in March 1997. TheAUA Board of Directors approved these practice guidelines in April 1997.

The Summary Report also underwent independent scrutiny by the Editorial Board of theJournal of Urology, was accepted for publication in March 1997, and appeared in its September1997 issue. A Doctor’s Guide for Patientsand Evidence Working Papershave also been devel-oped; both are available from the AUA.

The AUA expresses its gratitude for the dedication and leadership demonstrated by the mem-bers of the Female Stress Urinary Incontinence Clinical Guidelines Panel in producing thisguideline.

Members Consultants

Claus G. Roehrborn, M.D.(Facilitator/Coordinator)Assistant Professor of UrologyDepartment of UrologyThe University of TexasSouthwestern Medical CenterDallas, Texas

Hanan S. Bell, PhD(Consultant in Methodology)Seattle, Washington

Patrick M. Florer(Database Design and Coordination)Dallas, Texas

Curtis Colby(Editor)Washington, D.C.

Jeffrey Csiszar, M.D.Jill Gerspach, M.D.Steven Kurtz, M.D.Susan Martins-Levy, M.D.Hetal Patel, M.D.Lisa Stout, M.D.

Residents (Data Extraction)

H. Roger Hadley, M.D.Professor and Chairman,Urology DepartmentLoma Linda University Medical CenterLoma Linda, California

Karl M. Luber, M.D.Director of Section of UrogynecologySouthern California Permanente

Medical GroupSan Diego, California

Jacek L. Mostwin, M.D.Associate ProfessorBrady Urological InstituteJohns Hopkins HospitalBaltimore, Maryland

Pat D. O’Donnell, M.D.Clinical Professor of UrologyUniversity of ArkansasFayetteville, Arkansas

ISBN 0-9649702-3-6

Page iCopyright © 1997 American Urological Association, Inc.

For women with stress urinary incontinence (SUI)—characterized symptomati-cally by the involuntary loss of urine during activities such as coughing, laughing andpositional changes—a number of treatments are available. Patient options includeboth surgical and nonsurgical therapies.

However, a detailed analysis of surgical procedures is missing from previouslypublished clinical practice guidelines such as the one developed by the Agency forHealth Care Policy and Research (AHCPR) (Fantl, Newman, Colling, et al., 1996).Guidelines like the AHCPR guideline are directed mainly toward primary careproviders and take a broad-based approach covering a range of different types of uri-nary incontinence in both men and women as well as a wide range of different treat-ment methods.

To provide more detailed information specifically regarding the surgical treatmentof SUI in women, the American Urological Association (AUA) convened the FemaleStress Urinary Incontinence Clinical Guidelines Panel. The panel conducted a com-prehensive review and in-depth analysis of published outcomes data pertaining solelyto surgical procedures for treating female stress urinary incontinence. This report isthe result of that effort.

The focus of the report is relatively narrow. The target patient, termed the indexpatient, is defined as an otherwise healthy woman with stress urinary incontinence,either untreated or previously treated (surgically or nonsurgically), without significantpelvic organ prolapse, who has decided to seek surgical treatment. The index patientmay have either urethral hypermobility or intrinsic sphincteric deficiency or a combi-nation of both.

The report provides the following:• A descriptive discussion of incontinence diagnostic procedures (without formal

data review and analysis);• Descriptions of surgical procedures for treating SUI;• A summary discussion of the methodology employed by the panel in develop-

ing recommendations for choosing a surgical procedure;• Displays of evidence extracted from published outcomes data; and• Recommendations, insofar as the evidence permits, of practice policies for sur-

gical management of SUI in the index patient.As noted above, the panel did not formally review and analyze data on diagnostic

procedures since diagnostic evaluation is not the focus of this report; but because apreoperative evaluation is crucial for selection of a treatment option, the panel didmake recommendations based on expert opinion regarding the components of a pre-operative evaluation.

Also included in the report are: (1) discussion of limitations in the literature hin-dering the development of evidence-based recommendations; (2) detailed suggestionsfor minimal standards to be used in clinical trials for assessing the efficacy of urinaryincontinence therapies; and (3) recommendations for future research.

A Doctor’s Guide for Patientsis available from the AUA upon request. Also avail-able is a technical supplement, Evidence Working Papers.

Introduction

Page iiiCopyright © 1997 American Urological Association, Inc.

Table of Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iExecutive Summary – Report on the surgical management of female stress

urinary incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1Diagnostic evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1Nonsurgical therapies for stress incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Surgical treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Treatment outcomes analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Treatment recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6Research recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Chapter 1 – Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Literature search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9Article review and data extraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9Data combination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Chapter 2 – Female stress urinary incontinence and its management . . . . . . . . . . . . .13Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Diagnostic evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Therapy for stress incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Chapter 3 – Outcomes analysis: Surgical alternatives for treating female stressurinary incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18The outcomes tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Analysis of outcomes categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Chapter 4 – Treatment recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Flexibility of panel recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26The index patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Recommendations: Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Recommendation : Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Chapter 5 – Literature limitations, recommended standards of efficacy forevaluation of treatment outcomes and recommendations for future research . . . .29Limitations in the literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29Standards of efficacy for clinical trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Posttreatment evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Research recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32Appendix A – Data presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40Appendix B – Comparative outcomes tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61Appendix C – Descriptive analysis of urodynamic testing . . . . . . . . . . . . . . . . . . . . . .68Appendix D – Data extraction form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71

Production and layout by:Suzanne Boland Pope

Julie BowersJoyce BrownLisa EmmonsTracy Kiely

Betty Wagner

Copyright © 1997American Urological Association, Inc.

Executive Summary Page 1Copyright © 1997 American Urological Association, Inc.

To develop recommendations for surgical treat-ment of female stress urinary incontinence (SUI),the Female Stress Urinary Incontinence ClinicalGuidelines Panel reviewed the SUI surgical treat-ment literature to January 1994 and extracted andmeta-analyzed all relevant data to estimate as accu-rately as possible both desirable and undesirableoutcomes of the various surgical procedures. Thepanel followed an explicit approach to the develop-ment of practice policy recommendations (Eddy,1992). This approach emphasizes the use of scien-tific evidence in estimating outcomes. If the evi-dence has limitations, the limitations are clearlystated. When panel opinion is necessary, the expli-cit approach calls for an explanation of why it isnecessary and/or discussion of the factors consid-ered. For a full description of the methodology, seeChapter 1.

This Report on the Surgical Management ofFemale Stress Urinary Incontinencefocuses on sur-gical treatment of stress urinary incontinence in theotherwise healthy female. The panel did not con-sider for analysis either incontinence associatedwith neurologic disease or incontinence associatedwith significant pelvic organ prolapse (large cysto-cele, enterocele, rectocele, uterine or vault pro-lapse).

SUI is the involuntary loss of urine related toincreases in abdominal pressure resulting fromactivities such as coughing, laughing, lifting andpositional changes. Spontaneous urinary inconti-nence may also occur when a woman is eitherseated or standing. Gravitational loss of urine (lossof urine with postural change) occurs in the mostsevere cases.

SUI may coexist with urgency and/or urgeincontinence. Urgency is characterized by a strong,sudden, uncomfortable need to void. Urge inconti-nence is characterized by the precipitate loss ofurine accompanied by urgency. Stress incontinenceaccompanied by urge incontinence is termed mixedincontinence.

An estimated 30-65 percent of women with SUIpresent with mixed incontinence (McGuire andSavastano, 1985). The components vary in theircontribution to the presenting symptom complex.In some cases, urgency or urge-related incontinencemay be the predominant symptom. When urgencyand/or urge incontinence is a symptom, coexistentinfection, bladder stones, cancer, obstruction andneurologic disease are excluded during the diag-nostic evaluation.

Essential to the management of SUI is an accu-rate diagnosis. The diagnostic evaluation includes athorough history and physical examination supple-mented by urinalysis and other appropriate labora-tory studies.

There are two basic factors to be evaluated: ure-thral hypermobility and/or intrinsic sphinctericdeficiency (ISD). The two may coexist.

Hypermobility, present in the majority of womenwith SUI, is the rotational descent of the proximalurethra and bladder neck into the vagina, associatedwith increases in abdominal pressure that occurwith such activities as coughing. Hypermobilitycan be observed visually or radiographically. Itspresence, however, does not necessarily indicateSUI; many women have urethral hypermobilitywithout SUI. If incontinence does occur, an ele-ment of sphincteric weakness is present.

The second factor, ISD, also represents a signifi-cant component of incontinence in women. Theprevalence of ISD is not fully known, but in the

Diagnostic evaluation

Overview

Methodology

Executive Summary – Report on the surgical management of female stress urinary incontinence

Executive Summary Copyright © 1997 American Urological Association, Inc.

panel’s expert opinion it is present in a significantpercentage of women with stress incontinence. ISDrefers to a deficiency in the urethral sphincter func-tion, which is unrelated to urethral support. Themost common reasons for loss of this urethral func-tion are prior incontinence surgery, prior pelvicsurgery (radical hysterectomy, abdominoperinealresection of rectum), neurologic disorders (spinabifida), urethral mucosal atrophy and, in rare cases,radiation exposure. The result is poor urethralmucosal coaptation and incontinence with minimalstress activities.

The selection of a surgical procedure shouldreflect the relative contributions of these two condi-tions, which as noted previously may coexist.

Management of SUI includes the option of non-surgical therapies. Chief among them are behav-ioral management techniques such as timed void-ing, pelvic floor exercises, biofeedback, insertdevices, functional electrical stimulation and phar-macologic therapy. The panel did not review non-surgical therapies because they are outside thescope of this report.

Surgical approaches to SUI are diverse. Groupedwithin four major categories of procedures aremany individual procedures and modifications ofprocedures. The four major groupings are retropu-bic suspensions, transvaginal suspensions, anteriorrepairs and sling procedures. Insufficient data pre-cluded panel analysis of artificial sphincters andinjectable agents.

Historically, surgical procedures to treat SUIwere designed to elevate/suspend and repositionthe urethra. The current goal, in the panel’s opin-ion, is to stabilize the proximal urethra and bladderneck (i.e., prevent their descent). Suspension proce-dures and pubovaginal slings may be used fordemonstrable proximal urethral hypermobility inthe presence of intact sphincteric function.

The goal of surgery for ISD is recreation of ure-thral coaptation, either by external bolstering (slingor artificial sphincter) or by internal bulking(injectable agents).

All four of the major procedure categoriesreviewed—retropubic suspensions, transvaginalsuspensions, anterior repairs and sling proce-dures—may be considered for demonstrable proxi-mal urethral hypermobility in the presence of intactsphincteric function. However, when sphinctericfunction is poor, a procedure such as a sling, aninjectable agent or an artificial urinary sphinctershould be considered. Pubovaginal slings are alsoan option in those patients with SUI due to com-bined hypermobility and poor urethral coaptation.

The comparative outcomes tables on pages 19and 20 (Tables 1 and 2) display probability esti-mates for the four major procedure categories:retropubic suspensions, transvaginal suspensions,anterior repairs and pubovaginal sling procedures.All outcome probability estimates were developedby combining outcomes data for the various indi-vidual procedures that make up each of the fourmajor procedure categories. For example, in thefirst cell of Table 1, under the “Retropubic Suspen-sions” heading, the median probability estimate forcure/dry at 12-23 months is 84 percent. This esti-mate was derived from combined cure/dry data forBurch, Marshall-Marchetti-Krantz and variousother individual retropubic suspension procedures.The other probability estimates in the “RetropubicSuspensions” column, including estimates of poten-tial complications, were also derived from com-bined outcomes data for the various individual pro-cedures that make up the retropubic suspensiongrouping. Similarly, the estimates in the “Trans-vaginal Suspensions” column were derived fromcombined outcomes data for Pereyra/modifiedPereyra, Stamey, Gittes and other types of individ-ual transvaginal suspension procedures. The panelfound no significant differences between individualprocedures within each of the four major categor-ies.

After analyzing cure/dry data variously reportedin the literature at time points 12-120 months, thepanel defined the three discrete time frames in

Treatment outcomesanalysis

Surgical treatment

Nonsurgical therapiesfor stress incontinence


Table 1: 12-23 months follow-up (short term), 24-47 months follow-up (intermediate) and follow-upof 48 months and longer (long term).

The rates indicate that after 48 months, retropu-bic suspensions and slings appear to be more effi-cacious than transvaginal suspensions and anteriorrepairs. For anterior repairs, however, the ratesafter 24 months are anomalous—with a sharpincrease in cure/dry status at 24-47 months (from68% to 85%), then a sharp decline after 48 months(to 61%). These rates are believed by the panel torepresent an aberrancy of data reporting rather thantrue outcomes. Such results occur because not allstudies report outcomes at all time points.

For ISD therapy, cure/dry results are incom-pletely reported in the literature because recogni-tion of ISD as a diagnostic entity is relatively new.In the panel’s opinion, sling procedures are themost effective type of treatment for ISD patients.However, the available data are insufficient todetermine whether other types of procedures mightbe equally effective.

The panel also attempted to determine from theliterature the degree to which factors such aspatient age and prior surgery have an impact oncure/dry outcomes. Factors the panel evaluatedinclude the following: prior incontinence surgery,subjective urgency, urodynamically proven detrusorinstability (DI), menopausal status, parity, priorhysterectomy and age. Because of incomplete dataand varying definitions within the data, the panelcould make no determinations regarding the effectsof these variables on cure/dry rates.

Cure/dry rates alone do not fully represent allpotential treatment benefits. Many patients, even ifnot completely cured of their SUI problem, reportvery substantial improvement and consider thesurgery successful. For this reason, the panelincluded a “Cure/Dry/Improved” category in Table1 (cure/dry plus improved). As would be expected,cure/dry/improved rates are higher than cure/dryrates alone for all treatment types across all threetime frames. Both cure/dry rates and cure/dry/im-proved rates are displayed graphically on page 21as well as in Table 1 on page 19.

Cure/dry/improved data are variously reported inthe literature. Some reports clearly specify an“improved” rate as well as a “cure/dry” rate. Otherreports do not specify a “cure/dry” rate, but classifypatients as “cured/improved,” “improved” or“failed.” Still other reports omit “improved” andclassify patients as either “cure/dry” or “failed.”

For these reports, the panel inferred an “improved”rate of 0 percent.

Probability estimates for treatment complicationsare displayed in Tables 1 and 2 beginning with esti-mates of postoperative urgency, which are dis-played in Table 1 relative to patients’ preoperativestatus. Analysis of the four patient subgroups listedunder the “Postoperative Urgency” heading reveal-ed no major statistical differences between trans-vaginal suspensions, sling procedures and retropu-bic suspensions with regard to postoperativeurgency. Insufficient data exist to evaluate anteriorrepairs for this outcome. In general, if urgency andDI are present preoperatively, there is significantrisk of these symptoms persisting postoperatively.If either is absent, the risk of postoperative urgencyis reduced. However, no accurate statistical state-ments can be made regarding these tendenciesbecause of small total sample sizes.

The panel determined that two time periodsshould be reported for urinary retention: (1) reten-tion greater than four weeks and (2) permanentretention. For temporary retention, the panel recog-nized that the data for less than four weeks reflectvarying practice patterns and changes in hospital-ization practices and medical management over thetime frame of the literature reviewed. The data can-not be meaningfully combined because of differinglengths of hospital stay and different studies mea-suring retention at different points in time.

The estimated probability of temporary urinaryretention lasting longer than four weeks is 5 per-cent for both retropubic and transvaginal suspen-sions and 8 percent for sling procedures. For ante-rior repairs, the retention data were insufficient togenerate a probability estimate.

For permanent retention, there are no accuratedata to date. In the panel’s opinion, the risk issomewhat higher for sling procedures than forother procedures. However, for all procedures,panel opinion is that the risk of permanent reten-tion generally does not exceed 5 percent.

Days in the hospital, as reported in the literature,again reflect practice patterns that in the panel’sopinion are no longer current. Assuming an uncom-plicated stay, based on current practice, the paneldetermined that length of hospital stay for eachtreatment type ranges from 0 to 5 days, with theshortest length of stay for transvaginal suspensionsand anterior repairs.

The panel attempted to analyze obstruction diag-nosed by urodynamics and pelvic prolapse as well


as urinary retention and other possible complica-tions of surgery. However, the obstruction datawere variable and incomplete, with differing defini-tions and a lack of objective data.

Also, there was insufficient information to esti-mate incidence for the following complications:large bowel injury, peripheral nerve injury and vas-cular injury. For UTI, the diagnoses were variableand reflected different definitions and reportingbiases in the urologic as contrasted to the gyneco-logic literature. In general, UTI was more com-monly reported in the gynecologic literature.

Death rate as an outcome was a difficult variableto assess based on explicit evaluation of the avail-able literature. Because death as a complication ofsurgery for SUI is so rare, it is seldom mentioned.Therefore, when considering death rate values, thepanel attempted to estimate a reasonable rate for allprocedures and agreed upon a death rate of approx-imately 5 per 10,000 procedures. This is consistentwith rates for hysterectomy, a pelvic procedure forwhich defined mortality rates are available (Wingo,Huezo, Rubin, et al., 1985).

For considering other complications, six generalcategories were developed. The six categories are:transfusions, general medical complications, intra-operative complications, perioperative complica-tions, subjective complications and those complica-tions requiring surgery. Table 1 displays summaryprobability estimates for these categories, andTable 2 displays subcategories by type of reportedcomplications. The significant and nonsignificantcomplications in three of the categories in Table 1were determined for summary purposes by panelopinion.

In evaluating the complications in each of thesix categories in Table 1, the panel noted no majordifferences in complication rates across the fourprocedure types (retropubic suspensions, transvagi-nal suspensions, anterior repairs and sling proce-dures). Transfusion rates range only from 3 to 5percent (median values) across all four proceduretypes. No complication rate in any of the six cate-gories exceeds 16 percent, and most rates are under10 percent.

With regard to synthetic materials used forslings, the literature suggests higher complicationrates when using such materials—as shown inTable 3 on page 25, which compares synthetic withautologous and homologous materials for specificcomplications.

The panel generated treatment recommendationsbased on outcomes estimates derived from datareported in the literature, to the extent the data per-mitted. Where reported data were insufficient, thepanel added its expert opinion in making recom-mendations. The methodology is described inChapter 1.

Overall, after a thorough review of the literatureand rigorous analysis of the reported data, the panelfound sufficient acceptable long-term outcomesdata (48 months and longer) to conclude that surgi-cal treatment of female stress urinary incontinenceis effective, offering a long-term cure in a signifi-cant percentage of women. The evidence supportssurgery as an initial therapy and as a secondaryform of therapy after failure of other treatments forSUI.

As explained in Chapter 1 (Methodology), panelrecommendations were graded according to threelevels of flexibility based on strength of evidenceand the panel’s assessment of patient needs andpreferences. These three levels—standards, guide-lines and options—are defined on pages 9-10 inChapter 1. Standards have the least flexibility.Guidelines have considerably more flexibility, andoptions are the most flexible.

In this report, none of the panel’s recommenda-tions fits the definition of a guideline on page 10.Two recommendations are labeled standards andone an option. The labels indicate the strength ofthe recommendations. Recommendations werelabeled standards if the panel concluded that theyshould be followed by virtually all health careproviders for virtually all patients. The recommen-dation labeled an option was given this label, indi-cating considerable implementation flexibility,because outcomes evidence in the literature wasinsufficient for a stronger recommendation andbecause of significant trade-offs (such as a higherlong-term cure/dry rate but also higher complica-tion rates for a particular procedure) that couldresult in divided patient preferences.

The type of patient to whom the panel’s recom-mendations apply is termed the index patient. Thispatient is defined as an otherwise healthy womanwith stress urinary incontinence, either untreated orpreviously treated (surgically or nonsurgically),without significant pelvic organ prolapse, who hasdecided to seek surgical treatment. The index

Treatment recommendations

(Continued on page 6)


Recommendations

Standard

Based on the panel’s expert opinion, the preoperative evaluation ofwomen with symptoms of stress urinary incontinence should comprise thefollowing components:

● History, including impact of symptoms on lifestyle;

● Physical examination: objective demonstration of stress inconti-nence;

● Urinalysis;

● Other appropriate diagnostic studies designed to assess the following:

◆ Symptom causes—in particular, consideration of the relative con-tributions of urethral hypermobility, intrinsic sphincteric defi-ciency and detrusor dysfunction;

◆ Frequency and severity of incontinent episodes;

◆ Patient’s expectations from treatment.

Standard

● The index patient should be informed of the available surgical alter-natives. Patients should also be informed, for each procedure, of esti-mated benefits and risks. The choice of treatment should be madebetween the surgeon and patient, taking into consideration patientpreferences and the experience and judgment of the surgeon.

Option

● Although the four major types of procedure groupings—retropubicsuspensions, transvaginal suspensions, anterior repairs and sling pro-cedures—have important differences in their outcomes, all four areoptions for the index patient.


patient may have urethral hypermobility, ISD or acombination of both.

The panel’s recommendations assume that thesurgeon is proficient in diagnostic and therapeutictechniques including the broad categories of surgi-cal procedures described in Chapter 2 of thisreport.

It is assumed also that the index patient has beencounseled regarding nonsurgical treatment alterna-tives. The surgeon may review these alternatives aspart of informed consent.

Recommendations: StandardsBased on the panel’s expert opinion, the preop-

erative evaluation of women with symptoms ofstress urinary incontinence should comprise the fol-lowing components:

Although components of diagnostic evaluationare not the main focus of this document, the panelcreated the above standard because an accurate pre-operative evaluation is obviously indispensable forselection of a treatment option. As indicated in thelist of recommended evaluation components, theessential goals are: (1) to ascertain the impact of apatient’s incontinence on her quality of life; (2) toobjectively demonstrate stress urinary inconti-nence; (3) to identify the etiologic factors con-tributing to incontinence; and (4) to identify prog-nostic indicators.

In particular, on the basis of the preoperativeevaluation, the surgeon should understand the rela-tive contributions and underlying causes of urethralhypermobility, intrinsic sphincteric deficiency anddetrusor dysfunction. Although urethral hypermo-bility is associated with stress urinary incontinencein the majority of women, hypermobility oftencoexists with ISD. The panel believes that recogni-tion of this coexistence is crucial to the success ofsubsequent surgical intervention. Also, in thepanel’s opinion, the presence of detrusor dysfunc-tion (urgency/urge incontinence, detrusor instabil-ity, impaired detrusor contractility, poor bladdercompliance) can have a deleterious effect on proce-dure outcomes.

A thorough history and physical examinationmay be sufficient to achieve the goals stated above.However, as noted in Chapter 2 (page 15), furtherevaluation may be necessary—including, for exam-ple, a voiding diary, pad tests and urodynamic test-ing. Urinalysis, of course, is necessary to excludeurinary tract infection and hematuria.

With regard to patient expectations from treat-ment, she should be accurately informed about thesignificant risks of either continued or de novourgency after any operation for stress incontinence,and that these symptoms tend to persist for a longertime after a sling procedure. Continued or de novourgency is a major cause for patient dissatisfactionfollowing surgery.

In weighing the potential benefits and harms ofeach surgical alternative, the surgeon and patientshould discuss not only cure/dry and cure/dry/im-proved rates, but such issues as length of operation,length of hospital stay and possible complications.Patients should be informed especially of the possi-ble occurrence of common complications, withinformation on how they would be treated if theyoccur.

● The index patient should be informed of theavailable surgical alternatives. Patientsshould also be informed, for each procedure,of estimated benefits and risks. The choiceof treatment should be made between thesurgeon and patient, taking into considera-tion patient preferences and the experienceand judgment of the surgeon.

● History, including impact of symptoms onlifestyle;

● Physical examination: objective demonstra-tion of stress incontinence;

● Urinalysis;● Other appropriate diagnostic studies

designed to assess the following:◆ Symptom causes—in particular, consid-

eration of the relative contributions ofurethral hypermobility, intrinsic sphinc-teric deficiency and detrusor dysfunction;

◆ Frequency and severity of incontinentepisodes;


Recommendations


If a surgical treatment is a relatively short proce-dure, with low risk of short-term morbidity, apatient may choose this treatment even though ithas a lower estimated long-term cure/dry rate thanan alternative treatment that requires more time andposes a higher risk of complications. On the otherhand, a patient may be willing to accept a longeroperation, with greater likelihood of complicationsand short-term morbidity, if there is also greaterlikelihood of long-term success.

The estimates displayed in the comparative out-comes tables (Table 1 on page 19 and Table 2 onpage 20) are averages based upon evidence fromthe literature. However, these outcome estimatesmay differ for individual patients. The patientshould be informed of how the estimates will beaffected by her specific diagnostic condition (i.e.,ISD or detrusor dysfunction). In addition, individ-ual surgeons may have different outcomes depend-ing on prior training and level of experience with aparticular procedure.

Recommendation: Option

Based upon evidence from the literature as indi-cated by the probability estimates in Table 1 onpage 19, and upon expert opinion, retropubic sus-pensions and slings are the most efficacious pro-cedures for long-term success (based on cure/dryrates).

However, in the panel’s opinion, retropubic sus-pensions and sling procedures are associated withslightly higher complication rates, including post-operative voiding dysfunction, and longer conva-lescence. In patients who are willing to acceptslightly higher complication risks for the sake oflong-term cure, retropubic suspensions and slingsare appropriate choices. In the patient for whom

decreased hospital stay, less likelihood of morbidityand/or earlier return to work are paramount, trans-vaginal suspensions are appropriate procedures.Anterior repairs, in the panel’s opinion, are theleast likely of the four major procedure categoriesto be efficacious in the long term.

Among the various transvaginal suspension pro-cedures, cure/dry rates are similar but complicationrates are higher with the Stamey procedure.Cure/dry and complication rates do not appear sig-nificantly different among the various retropubicsuspension procedures and among sling procedures.

The panel made a further observation regardingchoice of procedure. Not only is the range of surgi-cal options for treating SUI already extremelydiverse, but new techniques and procedure modifi-cations continue to emerge. Some of these, as inthe past, will not stand the test of experience overtime. Moreover, different surgeons may performthe same procedure quite differently. The panelbelieves that surgeons should take these considera-tions into account, together with their own areasand levels of expertise and their own previoustreatment results, when counseling patients regard-ing choice of procedure.

Research is needed to develop: (1) a standard-ized lexicon describing the types of incontinence;(2) a standardized diagnostic methodology todefine the types of incontinence; and (3) standard-ized outcome measures.

Needed as well are: (1) methods to identifyintrinsic sphincteric deficiency, particularly inpatients with concurrent hypermobility; (2) bettertechniques for management of patients with com-bined intrinsic sphincteric deficiency and hypermo-bility; (3) less obstructive techniques for the cor-rection of patients with hypermobility-associatedstress incontinence; (4) methods of systematicallyrelating preoperative indicators to treatment out-comes; and (5) better understanding of the patho-physiology underlying SUI.

Researchrecommendations

● Although the four major types of proceduregroupings—retropubic suspensions, trans-vaginal suspensions, anterior repairs andsling procedures—have important differ-ences in their outcomes, all four are optionsfor the index patient.

Copyright © 1997 American Urological Association, Inc.

The Female Stress Urinary Incontinence ClinicalGuidelines Panel developed the recommendationsin this Report on the Surgical Management ofFemale Stress Urinary Incontinenceusing anexplicit approach to the development of practicepolicies (Eddy, 1992), as opposed to an approachrelying solely on panel consensus without descrip-tion of the specific evidence considered.

The explicit approach attempts to arrive at prac-tice policy recommendations through mechanismsthat take into account the relevant factors for mak-ing selections between alternative interventions.These factors include estimated outcomes from theinterventions, patient preferences, costs of theinterventions and (when possible to assess) relativepriority of the interventions for a share of limitedhealth care resources. In estimating outcomes ofthe interventions, emphasis is placed on the use ofscientific evidence. When panel opinion is neces-sary, the explicit approach calls for explanation ofwhy it was necessary and/or discussion of the fac-tors considered.

This report focuses on surgical interventions thatmay be used to treat stress urinary incontinence inotherwise healthy females who have alreadydecided to seek surgical treatment. The purpose isto distinguish between alternative surgical proce-dures and provide estimates of the outcomes thatcan be expected with each. These outcome esti-mates are intended to help a woman and her physi-cian decide which surgical procedure is best forher.

The panel began the process of evidence review,outcomes estimation and development of practicepolicy recommendations by defining preciselywhich patients would be addressed, which alterna-tive interventions would be considered and whatoutcomes would be relevant to physician/patientdecision-making. At the beginning stage of theprocess, the panel tried to include all surgical inter-ventions and procedure modifications, even thosefor which the panel suspected little evidence wasavailable, and all the relevant outcomes. Thus, thepanel was able to determine what important infor-mation was missing as well as what data wereavailable.

The panel initially hoped to make outcome esti-mates of treatment efficacy for various categoriesof women, based on factors such as age, weight,prior pregnancies, prior surgical treatment and thepresence of urgency and/or detrusor instability.However, most of the available data were insuffi-cient to distinguish between outcomes based onsuch factors. There were some data about theeffects of preoperative urgency and detrusor insta-bility on postoperative urgency, and the resultingoutcome estimates are displayed and analyzed inChapter 3 (pages 19 and 20). For other factors thatthe panel had hoped would be useful in predictingoutcomes, the evidence was insufficient to makeseparate outcome estimates.

The review of the evidence started with a litera-ture search, extraction and validation of data asdescribed on pages 9-10. The data available in theliterature were displayed in evidence tables. Fromthese tables, with references back to the originalarticles when necessary, the panel developed esti-mates of outcomes for four major categories ofprocedures—retropubic suspensions, transvaginalsuspensions, anterior repairs, sling procedures—and for modifications of these procedures to theextent available data permitted. To develop the out-comes estimates, the panel used the FAST*PROmeta-analysis software as described on page 11 forcombining data extracted from studies that met thepanel’s selection criteria (page 10). Outcome esti-mates are arrayed in the comparative outcomestables on pages 19 and 20 of Chapter 3 and ana-lyzed on pages 22-25.

The panel generated its practice policy recom-mendations from the outcome estimates shown inthe tables and from the panel’s expert opinion. Therecommendations were graded according to threelevels of flexibility based on the strength of the evi-dence and the panel’s assessment of patient needsand preferences. Levels of flexibility are defined asfollows (Eddy, 1992; American Academy of FamilyPhysicians, 1996):

• Standard: A policy is considered a standard ifthe outcomes of the alternative interventions aresufficiently well-known to permit meaningful

Chapter 1 – Methodology


decisions and there is virtual unanimity aboutwhich intervention is preferred.

• Guideline: A policy is considered a guideline ifthe outcomes of the interventions are sufficientlywell-known to permit meaningful decisions andan appreciable but not unanimous majority agreeon which intervention is preferred.

• Option: A policy is considered an option if (1)the outcomes of the interventions are not suffi-ciently well-known to permit meaningful deci-sions, (2) preferences among the outcomes arenot known, (3) patients’ preferences are dividedamong alternative interventions, and/or (4)patients are indifferent about the alternativeinterventions.

Standards obviously have the least flexibility.Guidelines have considerably more flexibility, andoptions are the most flexible. As noted in the defin-itions, options can exist because of insufficient evi-dence or because patient preferences are divided. Inthe latter case particularly, it is important to con-sider the preferences of individual patients inselecting among alternative interventions.

In this report, none of the panel’s recommenda-tions fits the above definition of a guideline. Tworecommendations are labeled standards and one anoption (see pages 27-28). The labels indicate thestrength of the recommendations. Recommenda-tions were labeled standards if the panel concludedthat they should be followed by virtually all healthcare providers for virtually all patients. The recom-mendation labeled an option was given this label,indicating considerable implementation flexibility,because outcomes evidence in the literature wasinsufficient for a stronger recommendation andbecause of significant trade-offs (such as a higherlong-term cure/dry rate but also higher complica-tion rates for a particular procedure) that couldresult in divided patient preferences.

To extract outcomes data for surgical interven-tions to treat SUI, a literature search was performedutilizing the MEDLINE database. The databasewas searched several times up to January 1994,using the MESH subject headings “urinary inconti-nence” and “urinary incontinence, stress.” In addi-tion, the panel collected appropriate references byhand searching bibliographies of articles that were

reviewed. Some of these references predate theinception of MEDLINE (1966). All citations recov-ered were imported into a bibliographic databasesoftware system (Papyrus Bibliography System;Research Software Design, Portland, Oregon).

The panel reviewed citations and (when avail-able) abstracts for 5,322 articles on stress inconti-nence published between 1950 and December1993. Each citation (author/title/date) or abstractwas reviewed independently by at least two panelmembers. If any panel member thought that thearticle might be relevant, it was retrieved.

The great majority of citations and abstractsrecovered from the MEDLINE database, using thevery broad subject headings “urinary incontinence”and “urinary incontinence, stress,” were clearly notrelevant to surgical treatment of female SUI. Onthe basis of the panel’s citation/abstract review, 457of the 5,322 articles were retrieved for detailed arti-cle review and data extraction.

Figure A-1 in Appendix A of this report (page59) shows graphically, by year, the number of arti-cles the panel retrieved on the basis of citation/-abstract review. Evident in this graph is theincrease over time in the number of papers pub-lished on stress incontinence. Figure A-2 shows, byjournal, sources of articles from the English lan-guage literature. Also see Table A-1 of Appendix A(page 40) for a list of all individual articles fromwhich outcomes data were extracted. (Articles citedin the text of this report, for referencing points ofinformation, were not necessarily among the artic-les reviewed to extract outcomes data.)

The basic tasks of article review and extractionof outcomes data were performed by a paid staff ofreviewers selected by the panel chairman and panelfacilitator. All reviewers were residents in urologyat Kaiser Permanente Medical Center in Los Ange-les, California. They were trained by the facilitatorcoordinator for AUA clinical practice guidelines,aided by other AUA consultants and staff. Thepanel chairman and panel facilitator closely moni-tored the entire process of article review and dataextraction.

To capture as much pertinent information as pos-sible from each article, the panel chairman, panel

Article review anddata extraction

Literature search


facilitator and AUA consultants and staff devised acomprehensive data extraction form. A sample ofthe form is in Appendix D. The selected articleswere divided among the reviewers, who thenreviewed the articles and transcribed the data ontothe form. Two reviewers independently extracteddata from each article, after which they met to rec-oncile any differences. If they remained uncertain,the panel facilitator or panel chairman made thedetermination. All reconciled forms were reviewedby the panel facilitator. Data from the forms wereentered into a database by staff (who double-checked all entries). From this database, data weredisplayed in evidence tables. (As noted in the Intro-duction, a technical supplement to this report, Evi-dence Working Papers,is available from the AUA.)After detailed review and analysis by the entirepanel, the data were combined meta-analytically toproduce the outcome estimates displayed in theoutcomes tables on pages 19 and 20 (Tables 1 and2).

Over the course of the review process, allreviewers noted the general lack of consistency inthe incontinence literature in reporting outcomesdata. For example, articles often differ greatly inhow they define cures and partial cures and in howthey report the length of time patients remainedcontinent following treatment. See Chapter 5 fordetailed recommendations regarding how informa-tion should be reported in future studies.

The primary outcome the panel evaluated waswhether patients were cured and/or dry (an out-come referred to in this report as “cure/dry”). Thepanel used each author’s objective or subjectivedefinition of cure/dry for inclusion of data to com-pute values for outcomes estimates. The panel alsorecognized that “cure” does not always equal “dry.”“Cure” means being cured of stress incontinence. Apatient who was reported as cured of stress inconti-nence, but who reported incontinence due tourgency or urge-related incontinence, was consid-ered cured for purposes of data analysis.

For length of follow-up, the panel established a12-month minimum as an exclusion criterion. Anycure/dry data with reported follow-up of less than12 months were excluded from the analysis. Forarticles that reported a range of follow-up, the min-imum of the range had to be 12 months or longer.For articles reporting follow-up only as an averageor mean, that average or mean had to be at least 24months or the data were excluded. However, somearticles from which cure/dry data were excluded

because of insufficient length of follow-up did pro-vide acceptable short-term complications data.

Other selection criteria were established. Articleswere rejected if not published in a peer-reviewedpublication in the English language, if the articlewas in abstract form only, if there was concomitantprolapse surgery, if the data reported were irrele-vant to surgical management of stress incontinencein the otherwise healthy female, if primary datawere absent (as in a review article), if data asreported could not be extracted to fit the categoriesin the data extraction form or if data were updatedin a more recent article. Articles were also rejectedfor various miscellaneous reasons. For example,the panel voted to reject articles dealing withTeflon™, which was not FDA approved in theUnited States for urologic applications. Teflon™, asof 1997, is undergoing clinical trials for use in suchapplications.

Of the 457 articles retrieved for detailed reviewand data extraction on the basis of citation/abstractreview, 133 were rejected for one or more of theabove reasons during the review and data extrac-tion process. The panel, meeting as a group toreview and analyze the extracted data, rejected anadditional 42 articles for the reasons listed in TableA-2 on page 58 of Appendix A. The net result was282 articles with some type of acceptable outcomesdata.

The extracted data were combined to yield theoutcomes estimates displayed in Tables 1 and 2 onpages 19 and 20, respectively. Combining dataallows a clinical practice guidelines panel to makeestimates of outcomes based on the totality ofavailable evidence. In addition, combining evi-dence usually makes differences in treatments moreapparent since small studies may not have the sta-tistical power to elucidate the differences. By com-bining the studies, the effect is similar to havinglarger series. This results in more accurate esti-mates with smaller confidence intervals. The proba-bility of missing true differences is reduced withoutincreasing the probability of falsely detecting dif-ferences.

Specific methods are available for combiningdata, depending on the nature of the evidence. Forthe Report on the Surgical Management of FemaleStress Urinary Incontinence, the AUA elected to

Data combination


use the Confidence Profile Method (Eddy, 1989;Eddy, Hasselblad and Shachter, 1990), whichallows analysis of data from studies that are notrandomized controlled trials. The FAST*PRO com-puter software (Eddy and Hasselblad, 1992) wasused in the analysis.

Because there are few randomized controlled tri-als reporting outcomes for surgical management ofSUI, the FAST*PRO software was used to combinethe single arms from various clinical series to esti-mate outcomes for each intervention. Frequently,the series that were combined showed very differ-ent results, thus implying site-to-site variations.These variations may be caused by differences inpatient populations, differences in surgical tech-nique or differences in the skills of those perform-ing the technique. If there appeared to be signifi-cant differences and the frequency of occurrence ofa particular outcome was high enough, a randomeffects or hierarchical model was used to combinethe data. If the studies reported similar effects or ifthe frequency of occurrence was low, Bayesianmeta-analysis was used.

A random effects model assumes that for eachsite there is an underlying true rate for the outcomebeing assessed. It further assumes that this underly-ing rate varies from site to site. The site-to-sitevariation in the true rate is assumed to be normallydistributed. The method of meta-analysis used inanalyzing the incontinence surgery data attempts todetermine this underlying distribution.

The results of the Confidence Profile Methodincorporated in the FAST*PRO software are proba-bility distributions. They can be described using amedian probability estimate with a confidenceinterval. For this report, the panel used a 95-per-cent confidence interval (95% CI). The probabilityof the true value being outside the interval is 5 per-cent.

The data on stress urinary incontinence surgeryare based almost entirely on clinical series, ratherthan randomized controlled trials (RCTs). Onlythree RCTs were found in the literature. The dif-ficulty with using data from clinical series is thatsuch data are frequently not comparable, and pool-ing them can lead to large and uncharacterizablebiases. Already mentioned (page 10) is inconsis-tency in how outcomes data are reported in the lit-erature.

In addition, the studies may be dealing withpatients who differ in important ways. For exam-ple, patients who are offered sling procedures maybe more likely than patients offered anterior repairto have ISD or more severe incontinence (more fre-quent or greater volume of leakage) and to havefailed a prior surgical attempt at cure. Yet, mostreported data, as noted on page 8, are not stratifiedso that outcomes can be estimated for different cat-egories of patients based on pretreatment factorssuch as prior surgery and severity of symptoms.

Another problem is that many papers reviewedby the panel reported on procedures that weresmall variants of the procedures reported in otherpapers. The panel elected to combine such papersdespite procedural variants, based on the premisethat these variations were no more than the varia-tions in technique among individual surgeons per-forming the procedures or even the variations intechnique of one surgeon over time.

Cure/dry data as outcomes of treatment are par-ticularly difficult to meta-analyze. One reason isthat the methods of obtaining reported results vary.Methods run the gamut from simply reading thepatient’s chart to conducting a structured evaluationof the patient as recommended in Chapter 5 (pages30-31).

A major problem in meta-analyzing cure/dry andcure/dry/improved outcomes data is the impact oflosses to follow-up. For more accuracy, the lengthof time patients remain dry should be reportedactuarially, as if it were a survival statistic. It israrely treated this way in the literature. Few studiesreviewed by the panel used the types of actuarialstatistics (life tables or Kaplan-Meier) that wouldbe most appropriate, and no studies providedenough information to enable a meta-analysis ofsuch statistics. The panel was left instead to definetime intervals (12-23 months, 24-47 months, 48months and longer) and combine results of studiesthat reported dryness within those time periods. Ifmore than 50 percent of patients were lost to fol-low-up for a given time period in a study, the paneldid not use those results.

In part because of loss to follow-up, not all stud-ies reported cure/dry data within all three of thetime periods the panel defined. A study might pro-vide data for only one or two of the time periods.In order to make maximal use of available data, thepanel elected to include the data reported as long asthe study met the other selection criteria (page 10).However, the results of combining data from differ-ent studies for different time periods are not the

Limitations


same as results that would accrue from reportingdata for a single group of patients over time. Insome instances, the results of the combined dataare anomalous such as when they seem to showpatients improving over time (pages 22-23).

The data for complications of surgery presentedthe panel with fewer meta-analysis problems thandid the cure/dry data. Short-term complications aremore easily measured, and loss to follow-up is nota problem. Nevertheless, for complications data asfor cure/dry data, almost all the sources are uncon-trolled clinical series. The differences in patientpopulations, in techniques, as well as in definitionsfor a complication such as urinary tract infection,mean that the results reported in the literature arenot perfectly generalizable across studies.

Also, prior to combining the data, the panel hadto adjust for the fact that many authors do not listall complications in their results sections. Theymay list only the complications that occur. Thenonoccurrence of an uncommon complication suchas perioperative death may not be reported. Yet, ifdata are combined only from studies in whichdeath occurs, without taking into account nonoc-currence, the estimate of frequency will be artifi-cially high. Therefore, for studies not reporting anyperioperative deaths, the panel reviewed each study

to determine whether it was reasonable to infer thatthis complication had in fact not occurred. If so,the panel initially inferred a zero rate for that studyand included the data in the meta-analysis. Uponfurther consideration, however, the panel decidedinstead to assume a reasonable death rate for allprocedures of approximately 5 deaths per 10,000procedures (see page 24).

In summary, because of limitations such as thosestated above and on pages 29-30 of Chapter 5, theoutcome estimates for different types of surgicalprocedures displayed in the comparative outcomestables may be biased for cure/dry and cure/dry/im-proved outcomes and to some degree even forshort-term complications. For example, differencesin patient selection may have had more weight inyielding the results shown than the differing effectsof the various procedures. It has also been docu-mented that patients may not completely reportposttreatment symptoms, which could make reli-able measurement of treatment outcomes difficult(Korman, Sirls and Kirkemo, 1994). However, theresults displayed in the outcomes tables reflect thebest outcome estimates possible at the present timeand, notwithstanding their limitations, may providesome guidance for what to expect from differenttreatments.


This report focuses on the surgical managementof stress urinary incontinence in the otherwisehealthy female. Stress urinary incontinence (SUI) isthe involuntary loss of urine related to increases inabdominal pressure resulting from activities suchas coughing, laughing, lifting and positionalchanges. Spontaneous urinary incontinence mayalso occur either when a woman is seated or whenshe is standing. Gravitational loss of urine (loss ofurine with postural change) occurs in the mostsevere cases.

SUI has a multifactorial etiology. Major factorsinclude parturition, laxity of the pelvic floor andpossibly loss of estrogen support at menopause.Other contributing factors include prior pelvicsurgery (especially prior incontinence procedures),neurologic dysfunction and pelvic fracture.

SUI may coexist with urgency and/or urgeincontinence. Urgency is characterized by a strong,sudden, uncomfortable need to void. Urge inconti-nence is characterized by the precipitate loss ofurine accompanied by urgency. Stress incontinenceaccompanied by urge incontinence is termed mixedincontinence.

An estimated 30-65 percent of women with SUIpresent with mixed incontinence (McGuire andSavastano, 1985). The components vary in theircontribution to the presenting symptom complex.In some cases, urgency or urge-related incontinencemay be the predominant symptom. When urgencyand/or urge incontinence is a symptom, coexistentinfection, bladder stones, cancer, obstruction andneurologic disease are excluded during the diag-nostic evaluation.

Four other types of incontinence may occur,either alone or coexistent with symptomatic stressincontinence, and are identified for treatment if pre-sent during evaluation for SUI:

1. Overflow incontinence, due to bladder outletobstruction or poor detrusor contractility, occurs

when a large residual urine volume is presentand the patient is able to void only smallamounts.

2. Continuous incontinence is the loss of urine onan uninterrupted basis. It is most commonly seenwith urinary tract fistulas, but may occur withsevere intrinsic sphincteric deficiency or congen-ital abnormalities such as ectopic ureter.

3. Transient incontinence is involuntary urine lossassociated with a discretely identifiable etiologysuch as immobilization or urinary tract infection.It is often found in institutionalized individualsor the noninstitutionalized elderly.

4. Unaware incontinence is urine loss withoutpatient awareness (enuresis). It may occur in thenight or day or in both night and day.

The panel did not consider for analysis eitherincontinence associated with neurologic disease orincontinence associated with significant pelvicorgan prolapse (large cystocele, enterocele, recto-cele, uterine or vault prolapse).

Essential to the management of SUI is an accu-rate diagnosis. The panel therefore included in thisreport the following descriptive discussion of eval-uation components and diagnostic procedures, pre-ceded by a discussion of two basic factors to beevaluated: urethral hypermobility and intrinsicsphincteric deficiency.

Urethral hypermobility and intrinsicsphincteric deficiency

The patient is to be evaluated for the presence oftwo basic conditions: urethral hypermobility and/orintrinsic sphincteric deficiency (ISD). The two maycoexist.

Diagnostic evaluation

Overview

Chapter 2 – Female stress urinary incontinence and its management


Hypermobility, present in the majority of womenwith SUI, is the rotational descent of the proximalurethra and bladder neck into the vagina, associatedwith increases in abdominal pressure that occurwith such activities as coughing. Hypermobilitycan be observed visually or radiographically. Itspresence, however, does not necessarily indicateSUI; many women have urethral hypermobilitywithout SUI. If incontinence does occur, an ele-ment of sphincteric weakness is present.

The second factor, ISD, also represents a signifi-cant component of incontinence in women. Theprevalence of ISD is not fully known, but in thepanel’s expert opinion it is present in a significantpercentage of women with stress incontinence. ISDrefers to a deficiency in the urethral sphincter func-tion, which is unrelated to urethral support. Themost common reasons for loss of this urethral func-tion are prior incontinence surgery, prior pelvicsurgery (e.g., radical hysterectomy, abdominoper-ineal resection of rectum), neurologic disorders(e.g., spina bifida), urethral mucosal atrophy and, inrare cases, radiation exposure. The result is poorurethral mucosal coaptation and incontinence withminimal stress activities.

The selection of a surgical procedure shouldreflect the relative contributions of these two condi-tions, which as noted above may coexist.

History, physical examinationand laboratory testing

Diagnostic evaluation includes a thorough his-tory and physical examination supplemented byurinalysis and other appropriate laboratory studies.

History

Relevant historical information includes: symp-tomatic presentation and contribution of stress andurge-related components, pertinent obstetric his-tory, severity of incontinence (activities producingincontinence), number and type of protective padsutilized, voiding history (e.g., diurnal frequencyand nocturia), the presence of emptying symptoms(e.g., hesitancy, intermittent stream, incompleteemptying), prior surgical procedures for inconti-nence and prolapse, neurologic history and currentmedications. A voiding diary and/or pad test, whichcan help elucidate and quantitate symptom history,may be useful. The following are important toascertain during preoperative counseling: (1) theeffect of a patient’s symptoms on her daily activi-

ties and quality of life and (2) her expectations fortreatment. (See Chapter 4, page 27.)

Of concern in a patient’s medical history areneurologic diseases such as multiple sclerosis,stroke, myelodysplasia and Parkinson’s diseasewhich can affect bladder and sphincteric function.Neurologic symptoms such as weakness, doublevision, tremor, tingling or paresthesia are particu-larly important.

Prior pelvic surgery may affect either bladder orurethral function. Procedures such as radical hys-terectomy, previous incontinence surgery andabdominoperineal or low anterior resection of therectum may alter both bladder and urethral func-tion.

Medications may cause or contribute to inconti-nence. For example, alpha antagonists reduce blad-der neck tone and may cause incontinence. Para-sympatholytics and tricyclics may causediminished detrusor contraction and urinary reten-tion with overflow incontinence.

Physical examination andlaboratory testing

The goal of the physical examination is to objec-tively demonstrate urinary incontinence and toidentify etiologic and prognostic factors such asanatomic or neurologic conditions.

Neurologic evaluation may include observationof the individual’s gait and subtle abnormalities ofspeech and expression. Sacral dermatomes areassessed by testing perineal sensation, anal sphinc-ter tone (at rest and with volitional contraction) andthe bulbocavernosus reflex.

The patient’s vagina is examined in the litho-tomy position. When the patient coughs or per-forms a Valsalva maneuver, the presence of hyper-mobility of the proximal urethra and bladder neckis evaluated. This may be facilitated by use of acotton swab test (Crystle, Charme and Copeland,1971). Vaginal inspection will also define thedegree of vaginal epithelial atrophy and the coexis-tence of cystocele, enterocele, rectocele or uterineprolapse. Examination of the patient in the standingposition also may be useful.

To assess the presence and degree of inconti-nence, the patient’s bladder may be filled through aurethral catheter after the postvoid residual urinevolume has been measured. The bladder is allowedto fill by gravity, and the woman is questionedregarding bladder sensation and urgency. When the


bladder is comfortably full, the catheter is removedand the patient is asked to cough and perform theValsalva maneuver with increasing force to insti-gate incontinence. If urine loss continues after thestress maneuver has ended, the presence of detrusorinstability must be considered. If incontinenceoccurs with minimal or no hypermobility, ISDshould be considered as an etiology.

If incontinence has not been demonstrated, theexamination may be repeated with the patient inthe standing position with one foot on a stool. Thepatient is again asked to cough and perform theValsalva maneuver to demonstrate urine loss. If uri-nary loss still cannot be demonstrated, the patientmay perform a pad test.

Urinalysis and urine culture are performed toexclude hematuria and urinary tract infection.Urine cytology may also be performed in thosepatients with significant urgency symptoms.

Further evaluation may be needed to delineatethe relative contributions of urethral hypermobility,intrinsic sphincteric deficiency and detrusor dys-function as well as other compounding factors.This evaluation may include urodynamic evalua-tion, cystoscopy and other imaging studies.

Nonsurgical treatmentManagement of SUI includes the option of non-

surgical therapies. Chief among them are behav-ioral management techniques such as timed void-ing, pelvic floor exercises, biofeedback, insertdevices, functional electrical stimulation and phar-macologic therapy. The panel did not review non-surgical therapies because they are outside thescope of this report.

Surgical treatmentSurgical approaches to SUI are diverse. Grouped

within four major categories of procedures aremany individual procedures and modifications ofprocedures. The four major groupings are retropu-bic suspensions, transvaginal suspensions, anteriorrepairs and sling procedures. Insufficient data pre-

cluded panel analysis of artificial sphincters andinjectable agents.

Historically, surgical procedures to treat SUIwere designed to elevate/suspend and repositionthe urethra. The current goal, in the panel’s opin-ion, is to stabilize the proximal urethra and bladderneck (i.e., prevent their descent). Suspension proce-dures and pubovaginal slings may be used fordemonstrable proximal urethral hypermobility inthe presence of intact sphincteric function.

The goal of surgery for ISD is recreation of ure-thral coaptation, either by external bolstering suchas with a sling or artificial sphincter, or by internalbulking as with injectable agents. Pubovaginalslings are also an option in those patients with SUIdue to combined hypermobility and poor urethralcoaptation.

Retropubic suspensions

Retropubic suspensions utilize the strong com-ponents of the pelvic wall, including Cooper’s liga-ment and periosteum of the pubis, as anchoring tis-sue for sutures placed in the periurethral andperivesical tissues. The first retropubic suspensionwas reported by Williams (1947), who describedsuspension of the bladder to the symphysis pubis.Subsequently, Marshall, Marchetti and Krantz(1949) described the first true urethral suspension.This procedure utilizes four figure-of-eight suturesplaced at the midurethra and bladder neck, whichare secured to the symphysis pubis. The vaginalwall sutures do not include epithelium. Krantzaltered the procedure to include single suture place-ment at the bladder neck because of concernregarding the creation of an iatrogenic urethralobstruction from the distal sutures (Zimmern,1985). Lapides (1974) described a modification uti-lizing the placement of a transverse suture at thebladder neck.

Burch (1961) proposed the placement of fourpaired sutures in a paravesical location that incor-porated the vaginal wall and Cooper’s ligament.This procedure requires adequate vaginal mobilityand depth so that elevation can be performed.

The retropubic paravaginal repair reapproxi-mates the endopelvic fascia to the obturator inter-nus fascia with interrupted sutures placed in a par-avesical location (Richardson, Edmonds, Williams,1981). Sutures are extended into periurethral fascia.No suspension sutures are placed at the level of thebladder neck.

Therapy for stressincontinence


Complications that may occur with retropubicsuspensions include the following: urinary reten-tion; urethral obstruction; new-onset pelvic pro-lapse (especially enterocele formation); vesical,ureteral or bowel injury; persistence or develop-ment of urgency symptoms after surgery; andosteitis pubis. Persistent or new-onset detrusorinstability also can occur and can result in urgeincontinence.

Transvaginal suspensions

Pereyra described the vaginal approach for sur-gical treatment of SUI in 1959. This procedureinvolves passage of wire sutures from two vaginalincisions placed laterally at the bladder neck to amidline suprapubic incision with a trochar. Thepassage of the suture is manually guided in closeproximity to the posterior aspect of the symphysispubis. Cystoscopy is not performed as part of theprocedure. Pereyra and Lebherz (1967) modifiedthe procedure to include incision of the endopelvicfascia, to allow direct finger guidance of the trocharpassage through the retropubic space, and substi-tuted chromic suture for wire. In addition, a vaginalwall plication was performed to decrease suturepull-through. In 1982, Pereyra and Lebherz furthermodified the technique, placing the vaginal suturein a helical fashion through the endopelvic fasciaon either side of the bladder neck.

Stamey (1973) introduced the concept of aDacron pledget to anchor the fixation suture to thevaginal wall. He described passing needles fromtwo suprapubic incisions to a T-shaped vaginalincision under cystoscopic guidance without dis-ruption of the endopelvic fascia. One suture isplaced on either side of the bladder neck. Theabdominal fascia serves as anchoring tissue for thefixation sutures. Cystoscopy was added to verifysuture location and exclude bladder or ureteralinjury. Also, anchoring of these sutures directly tothe pubic tubercle may lessen the risk of postopera-tive suprapubic or groin pain (Leach and Labasky,1989).

The Cobb-Ragde technique (1978) creates a con-sistent inclusion of a 1 cm bridge of fascia by uti-lizing a double-pronged needle. To further anchorthe vaginal suture, a barrel knot is placed in thepermanent suture as it traverses the bridge of vagi-nal wall. No dissection of the endopelvic fascia isperformed.

The Raz suspension (1981) creates lateral vagi-nal incisions through which the endopelvic fascia isdissected and perforated. A monofilament nonab-sorbable suture is secured to the vaginal wall,endopelvic fascia and periurethral ligaments. A sus-pension needle is passed with fingertip guidance,and the monofilament suture is withdrawn andanchored to the fascia in the suprapubic incision.Cystoscopy is used to avoid bladder or urethralinjury.

The Gittes procedure utilizes local anesthesiaand involves a small abdominal incision throughwhich a single-pronged needle is blindly passed tothe vagina (Gittes and Loughlin, 1987). No incisionis performed in the vagina. The suspension suturesare placed on either side of the bladder neck andsecured to the vaginal wall in a helical fashion.These sutures eventually become covered withvaginal epithelium.

Concomitant prolapse procedures may also beperformed with these procedures. Complications oftransvaginal needle suspensions are similar to thosefor retropubic procedures and include possibleretention, urethral obstruction, bladder and urethralperforation, vaginal shortening, stenosis, peri-urethral fibrosis, postoperative inguinal pain andpersistent or new-onset urgency.

Anterior repairs

The primary objective of the anterior repair is torestore vaginal support to the bladder base, usingthe pubocervical fascia. Anterior repair has alsobeen used to treat SUI (Miller, 1932). Differingtechniques have employed fascial plication at theproximal urethra alone or in combination with pli-cation beneath the base of the bladder. The Kellyplication (1914) imbricates urethropelvic fascia andanterior vaginal wall to restore support to the floorof the urethra and bladder neck. The Kennedy pro-cedure (1941) continues this plication to includethe pubocervical fascia in order to restore supportto the base of the bladder. These two proceduresare often combined as a unified technique. Themost significant potential complications followinganterior repair or its modifications are urethral,bladder and ureteral injuries.

Ball (1952) described a periurethral imbricatingsuture line that corrects urethrocele. Ingelman-Sundberg (1952) incorporated pubocervical fasciaand endopelvic fascia in a sequential fashion asoverlapping layers to improve bladder base support.


Combined procedures

Combined procedures attempt to optimize resultsfrom more than one approach. The Ball-Burchtechnique (Ball, Knapp, Nathanson, et al., 1966)combines the Ball anterior repair with the Burchretropubic suspension previously described. TheCantor procedure (1971) combines the Kelly plica-tion with the Burch. Because experience with com-bined procedures is limited, and the available dataare extremely limited, the panel did not attempt toestimate outcomes for these procedures.

Sling procedures

A variety of materials has been utilized forslings, including autologous materials (e.g., rectusfascia, fascia lata, dura, skeletal muscle, vaginalwall) and synthetic materials (e.g., mersilene,Gore-Tex™, Marlex™).

The first autologous sling, described by Goebellin 1910, utilizes reflected pyramidalis muscle as abolster for the urethra. Further modificationsincluded the addition of fascia and plication of theurethra (Frangenheim, 1914; Goebell, 1910;Stoeckel, 1917). Unacceptable complication ratesled to the abandonment of this technique.

Aldridge (1942) described the use of rectus fas-cia strips based on a medial base, which are passedbeneath the urethra and sutured in place. McGuireand Lytton (1978), McGuire, Bennett, Konnak, etal. (1987) and Blaivas and Jacobs (1991) reportedthe use of free rectus slings positioned under thevesical neck and secured to the abdominal wall fas-cia with permanent suture. The strip is placedunder minimal tension and anchored to the under-side of the urethra to prevent displacement. Cys-toscopy is used to verify sling position.

Other sling materials have included fascia lata(Beck, Grove, Arnusch, et al., 1974), ox fascia(Iosif, 1987) and dura, all implanted in a similarfashion to that previously described. Syntheticmaterials have included Dacron/Marlex™, mersi-lene (i.e., gauze hammock sling), Gore-Tex™ andMarlex™ (Moir, 1968; Morgan, 1970; Williams andTelinde, 1962). The utility of these synthetic mate-

rials is limited by erosion, fistula and infectiouscomplications.

Possible complications of sling proceduresinclude prolonged retention (either permanent ornecessitating prolonged intermittent catheteriza-tion), urgency and urge-related incontinence. Thepanel observed that surgical techniques havechanged in recent years with regard to slings. Sur-geons now recognize the importance of not makingslings overly tight, because of the relationshipbetween excessive tension and complications. Inthe panel’s opinion, the incidence of complicationsis not necessarily higher with excessive tension, butcomplications that occur tend to last longer.

Artificial urinary sphincters

Another alternative in the management of ISD isthe artificial urinary sphincter. Devices have signifi-cantly improved in recent years. However, despitethe improvements, device malfunction may occurdue to component failure, cuff erosion or urethralatrophy. The panel found the available outcomesdata on artificial sphincters deficient (e.g., smallnumbers of patients and only short-term follow-up)and decided to exclude the data from the outcomestables.

Injectable agents

Periurethral injection of bulking agents repre-sents another option for increasing outlet resistancein patients with ISD. Numerous alternative agentshave been proposed for this purpose. The goal ofinjection therapy is deposition of the bulking agentwithin the submucosa of the proximal urethra andbladder neck.

Critical evaluation of all injectable agentsremains problematic due to the varied reporting ofsuccess rates, the use of subjective criteria forreporting results, nonuniform time intervalsbetween injections, nonreporting of intervalsbetween the last injection and the reported resultsand lack of long-term follow-up. The panel decidedto exclude injectable agents data from the out-comes tables.


For purposes of comparative analysis, outcomesof a therapeutic medical intervention can becategorized as either beneficial or harmful (Eddy,1990, 1992). The Female Stress Urinary Inconti-nence Clinical Guidelines Panel analyzed in detailavailable outcomes data for both the potentialbenefits and harms of alternative surgicalapproaches to treating female SUI. Results of thepanel’s analysis are summarized as probability esti-mates in the comparative outcomes tables on pages19 and 20 of this chapter. The data extraction andevidence combination processes that produced theprobability estimates are described on pages 9-11of Chapter 1. The raw data are in a technical sup-plement to this report, Evidence Working Papers,which is available from the AUA.

Outcomes tables like Table 1 on page 19 andTable 2 on page 20 list “beneficial and harmfulhealth outcomes and their magnitudes, including arange of uncertainty for each” (Eddy, 1992). Thisform of summary display, Eddy notes, allows“simultaneous consideration of all the importantoutcomes.”

The outcomes tables summarize results of confi-dence profile (FAST*PRO) meta-analyses of com-bined outcomes data from the SUI literature, asdescribed in Chapter 1. (“Median” in these tables isthe median of a probability distribution resultingfrom FAST*PRO meta-analysis, not the median ofan array of individual study results.)

For most outcomes, a 95-percent confidenceinterval (2.5-97.5%) is reported along with themedian probability. As explained in Chapter 1, a95-percent confidence interval (95% CI) is thatinterval such that the probability of the true valuebeing outside the interval is 5 percent. A wide con-fidence interval indicates considerable uncertainty,for which there may be several reasons. One com-mon reason is a limited number of patient groups

and/or a limited number of patients for whom datawere reported. Another reason is wide variability inreported results among studies.

The outcomes tables display probability esti-mates for four major procedure categories: retropu-bic suspensions, transvaginal suspensions, anteriorrepairs and pubovaginal sling procedures. The esti-mates for these four major procedure categories arelisted in parallel columns identified by headingsacross the top of each table. The G/P column foreach procedure category shows the number ofpatient groups (G) for a given outcome and thetotal number of patients (P) in those groups. Ablank cell in an outcome table means insufficientextractable data for the given outcome and that par-ticular procedure category.

All outcome probability estimates were devel-oped by combining outcomes data for the variousindividual procedures that make up each of the fourmajor procedure categories (procedure descriptionsin Chapter 2, pages 15-17). For example, in thefirst cell of Table 1 on page 19, under the “Retropu-bic Suspensions” heading, the median probabilityestimate for cure/dry at 12-23 months is 84 percent.This estimate was derived from combined cure/drydata for Burch, Marshall-Marchetti-Krantz andvarious other individual retropubic suspension pro-cedures. The other probability estimates in the“Retropubic Suspensions” column, including esti-mates of potential complications, were also derivedfrom combined outcomes data for the various indi-vidual procedures that make up the retropubic sus-pension grouping.

Similarly, the estimates in the “Transvaginal Sus-pensions” column were derived from combined out-comes data for Pereyra/modified Pereyra, Stamey,Gittes and other types of individual transvaginalsuspension procedures. Tables B-2 to B-5 in Appen-dix B display outcome probability estimates forindividual procedures in the four major categories.The panel found no significant differences betweenindividual procedures within each of the four cate-gories. However, the panel noted that some newtechniques, although described as modifications of

The outcomes tables

Chapter 3 – Outcomes analysis: Surgical alternativesfor treating female stress urinary incontinence

(Continued on page 22)


Figures 1 and 2 compare in graphic form the same cure/dry and cure/dry/improved probability estimates dis-played in Table 1 for the four major procedure categories. The graph’s horizontal axis is marked off (top and bot-tom) in gradations from 0.0 to 1.0. Down the vertical axis (left) are listed the four procedure categories, eachwith three time intervals as in Table 1. For each time interval, there is a set of two brackets representing a 95 per-cent confidence interval. The dark square on the line between the brackets represents the median probability esti-mate. For comparing procedure categories with regard to cure/dry and cure/dry/improved, note where the brack-ets and squares are located along the horizontal axis. Note also the distance between the two brackets in each set.Narrower brackets (confidence intervals) indicate greater certainty regarding the probability estimate.

Figure 1.

Figure 2.


well-known procedure types, are actually quite dif-ferent from those procedures. For example, a proce-dure called a laparoscopic Burch procedure is notthe same as a true Burch procedure. The placementof sutures is different.

The panel decided not to include in the out-comes tables two types of treatment—artificial uri-nary sphincters and injectable agents—for whichoutcomes data were extracted. Data on artificialsphincters were available for only small numbersof patients with short-term follow-up, and most ofthe available studies of injectable agents deal withTeflon™ which was not FDA approved at the timeof the panel’s analysis. Both types of treatment arediscussed briefly in Chapter 2 (page 17).

The outcomes of interest for this Report on theSurgical Management of Female Stress UrinaryIncontinenceare listed down the left side of theoutcomes tables. Beneficial outcomes are dividedinto two categories labeled “Cure/Dry” and “Cure/-Dry/Improved” (Table 1). (See below and on page23 for definitions.) Outcome estimates for thesetwo categories are also displayed graphically onpage 21. Possible undesirable or harmful outcomesare divided into several categories. These includepostoperative urgency, postoperative retentiongreater than four weeks and various categories ofpossible complications.

In some cases, surgeons may find the outcomesestimates in the tables at variance with their ownexperience. Estimated probabilities, for example,may seem overoptimistic—possibly reflecting fail-ure to report negative results in the peer-reviewedliterature and overrepresentation of data from cen-ters of excellence. Surgeons are encouraged to aug-ment the tables with their own data when counsel-ing patients.

The following analysis is by outcomes cate-gories in the order listed in Tables 1 and 2, begin-ning with the cure/dry category in Table 1.

Cure/dryCure/dry rates are the major indicators of treat-

ment efficacy, a prime concern of women choosing

a therapy for their SUI problem. The patient towhom the recommendations in this report apply isa woman who has already chosen surgery ratherthan a nonsurgical therapy. Surgical alternativesoffer her potential for either permanent cure or sat-isfactory long-term improvement.

However, determining the relative efficacy of thedifferent surgical alternatives is difficult, mainlybecause of the way in which outcomes data arereported in the incontinence literature. The principallimitations overall are discussed in Chapter 1 onpages 11-12. A particular problem for determiningcure/dry rates is that articles differ in how theydefine “cure.” Many articles are also inexact inreporting how long a treatment is effective.

To ensure as much as possible the accuracy ofthe probability estimates displayed in the outcomestables, the panel established strict criteria foraccepting cure/dry data. These criteria, such aspatient follow-up of 12 months or longer, aredetailed on page 10 of Chapter 1.

In defining “cure,” as noted in Chapter 1, thepanel recognized that “cure” does not always equal“dry.” “Cure” means being cured of stress inconti-nence. A patient who was reported as cured ofstress incontinence, but who experienced inconti-nence due to urgency or urge-related incontinence,was considered cured for purposes of data analysis.

After analyzing reported cure/dry data in the lit-erature at time points 12 months to 120 months, thepanel defined the three discrete time frames inTable 1: 12-23 months follow-up (short term), 24-47 months follow-up (intermediate) and follow-upof 48 months and longer (long term). Data for timeperiods longer than 60 months were sparse and, forthe most part, not statistically evaluable.

The panel noted during the literature reviewprocess that, for certain procedure types, thecure/dry rates reported at 24-60 months werehigher than at 12-18 months. This data aberrancyinflated somewhat the median estimates in the tablefor long-term follow-up. Careful scrutiny of the lit-erature indicated that loss of patients to follow-upand/or patient selection bias probably skewed someof the data reported. The panel believes that actuallong-term cure/dry rates may be lower than whatTable 1 shows, but estimated that any difference isat most a few percentage points. The panel, there-fore, chose to use the data as reported, with theforegoing explanation, and to display in the tablethe cure/dry rates as derived from those data. Ratesare displayed graphically as well on page 21.

Analysis of outcomescategories


With the above caveats regarding cure/dry rateslonger than 48 months, the rates in the table repre-sent cure/dry outcomes to an acceptable degree ofaccuracy for retropubic suspensions, transvaginalsuspensions and slings. The rates indicate that after48 months, retropubic suspensions and slingsappear to be more efficacious than transvaginalsuspensions and anterior repairs. For anteriorrepairs, however, the rates after 24 months areanomalous—with a sharp increase in cure/dry sta-tus at 24-47 months (from 68% to 85%), then asharp decline after 48 months (to 61%). These ratesare believed to represent an aberrancy of datareporting rather than true outcomes. Such resultsoccur because, as explained in Chapter 1 (pages 11-12), not all studies report outcomes at all timepoints.

For ISD therapy, cure/dry results are incom-pletely reported in the literature because recogni-tion of ISD as a diagnostic entity is relatively new.In the panel’s opinion, sling procedures are themost effective type of treatment for ISD patients.However, the available data are insufficient todetermine whether or not other types of proceduresmight be equally effective.

The panel also attempted to determine from theliterature the degree to which factors such aspatient age and prior surgery have an impact oncure/dry outcomes. Factors the panel evaluatedinclude the following: prior incontinence surgery,subjective urgency, urodynamically proven detrusorinstability (DI), menopausal status, parity, priorhysterectomy and age. Because of incomplete dataand varying definitions of data, the panel couldmake no determinations regarding the effects ofthese variables on cure/dry rates.

Cure/dry/improvedCure/dry rates alone do not fully represent all

potential treatment benefits. Many patients, even ifnot completely cured of their SUI problem, reportvery substantial improvement and consider thesurgery successful. For this reason, the panelincluded a “Cure/Dry/Improved” category in theoutcomes tables (cure/dry plus improved). Aswould be expected, cure/dry/improved rates arehigher than cure/dry rates alone for all treatmenttypes across all three time frames. Cure/dry/im-proved rates, together with cure/dry rates, are rep-resented graphically on page 21.

Cure/dry/improved data are variously reported inthe literature. Some reports clearly specify an

“improved” rate as well as a “cure/dry” rate. Otherreports do not specify a “cure/dry” rate, but classifypatients as “cured/improved,” “improved” or“failed.” Still other reports omit “improved” andclassify patients as either “cure/dry” or “failed.”For these reports, the panel inferred an “improved”rate of 0 percent.

Urgency/urge incontinenceProbability estimates of postoperative urgency

are displayed relative to patients’ preoperative sta-tus. Patients are divided into four subgroups withvarying combinations of urodynamically diag-nosed, preoperative symptomatic urgency anddetrusor instability (DI). In the first subgroup arepatients with urgency and DI preoperatively. In thenext subgroup are patients with urgency but no DIpreoperatively. In the third subgroup are patientswith no urgency but with DI preoperatively. Thefourth subgroup comprises patients with nourgency and no DI preoperatively. This evaluationby subgroup quantitates the percentages of persis-tent and de novo urgency.

Analysis of the four patient subgroups revealedno major statistical differences between transvagi-nal suspensions, sling procedures and retropubicsuspensions with regard to postoperative urgency.Insufficient data exist to evaluate anterior repairsfor this outcome. A tendency toward increased per-sistent urgency is apparent in the first subgroup(urgency and DI preoperatively) for retropubic sus-pensions (66%), as compared to transvaginal sus-pensions (54%) and slings (46%). In general, ifurgency and DI are present preoperatively, there issignificant risk of these symptoms persisting post-operatively. If either is absent, the risk of postoper-ative urgency is reduced. However, no accurate sta-tistical statements can be made regarding thesetendencies because of small total sample sizes.

For new-onset postoperative urgency with pre-operative DI, sling procedures show an increasedrate (20%) compared to retropubic suspensions(4%) and transvaginal suspensions (7%). Again noaccurate statistical evaluation could be performedwith these data because of small sample sizes.

RetentionThe panel determined that two time periods

should be reported for urinary retention: (1) tempo-rary retention greater than four weeks and (2) per-manent retention. For temporary retention, the


panel recognized that the data reflect varying prac-tice patterns and changes in hospitalization prac-tices and medical management over the time frameof the literature reviewed. The data cannot bemeaningfully combined because of differinglengths of hospital stay and studies measuringretention at different points in time.

The estimated probability of temporary urinaryretention lasting longer than four weeks is 5 per-cent for both retropubic and transvaginal suspen-sions and 8 percent for sling procedures. For ante-rior repairs, the retention data were insufficient togenerate a probability estimate.

For permanent retention, there are no accuratedata to date. In the panel’s opinion, the risk issomewhat higher for sling procedures than forother procedures. However, for all procedures,panel opinion is that the risk of permanent reten-tion generally does not exceed 5 percent.

Length of hospital stay and resumption of normal activities

Days in the hospital as reported in the literatureagain reflect practice patterns that in the panel’sopinion are no longer current. Assuming an uncom-plicated stay, based on current practice, the paneldetermined that length of hospital stay for eachtreatment type ranges from 0 to 5 days, with trans-vaginal suspensions and anterior repairs requiringthe shortest length of stay.

The panel considered resumption of normalphysical activity after surgery to be an importantoutcomes variable. Few data were found in the lit-erature indicating time periods for returning tobaseline activity levels. The panel agreed on sixweeks as the typical length of time before resump-tion of normal physical activities.

Obstruction and prolapseIn analyzing specific outcomes of incontinence

surgery, the panel attempted to analyze obstructiondiagnosed by urodynamics and pelvic prolapse aswell as urinary retention and other possible compli-cations of surgery. However, the obstruction datawere variable and incomplete, with differing defini-tions and a lack of objective data. Urodynamic diag-nosis of obstruction was noted to be poorly stan-dardized and often dependent on subjectivesymptoms rather than defined pressure/flow criteria.

It has been observed that surgery for SUI mayprecede the development of pelvic prolapse. Suffi-cient data could not be identified for establishing acausal relationship between incontinence surgeryand resultant de novo postoperative prolapse. Thepanel assumes that in patients with SUI and signsor symptoms of pelvic prolapse, the prolapse wouldbe appropriately evaluated preoperatively andtreated at the time the SUI is corrected.

Other complications of surgeryAlthough, overall, a significant amount of infor-

mation on complications was evaluated during theliterature review, there was insufficient informationto estimate incidence for the following complica-tions: large bowel injury, peripheral nerve injuryand vascular injury. For urinary tract infection(UTI), the diagnoses were variable and reflecteddifferent definitions and reporting biases in the uro-logic as contrasted to the gynecologic literature. Ingeneral, UTI was more commonly reported in thegynecologic literature.

Death

Death rate as an outcome was a difficult variableto assess based on explicit evaluation of the avail-able literature. Because death as a complication ofsurgery for SUI is so rare, it is seldom mentioned.Therefore, when considering death rate values, thepanel attempted to estimate a reasonable rate for allprocedures and agreed upon a death rate of approx-imately 5 per 10,000 procedures. This is consistentwith rates for hysterectomy, a pelvic procedure forwhich defined mortality rates are available (Wingo,Huezo, Rubin, et al., 1985).

Complication categories

For considering other complications, six generalcategories were developed. The six categories are:transfusions, general medical complications, intra-operative complications, perioperative complica-tions, subjective complications and those complica-tions requiring surgery. Summary probabilityestimates for the six categories are displayed inTable 1.

The significant and nonsignificant complicationsin three of the categories in Table 1 (General Med-ical, Intraoperative and Perioperative) were deter-mined for summary purposes by panel opinion.Acute cholecystitis is an example of a significant


(though uncommon) general medical abdominalcomplication, and acute gastric dilatation an exam-ple of a nonsignificant abdominal complication.Urinary tract infections and wound complications(such as wound seroma) are examples of common,usually insignificant perioperative complications. Acomplete list of both significant and nonsignificantcomplications reported in the literature is in TablesB-6 to B-8 on pages 66-67 of Appendix B.

In the six categories, the panel noted no majordifferences in complication rates between the fourprocedure types in Table 1 (retropubic suspensions,transvaginal suspensions, anterior repairs and slingprocedures). In the transfusion category, rates rangefrom 3 to 5 percent (median values) across all fourprocedure types. In the other five complication cat-egories, rates are also similar across the four proce-dure types. No complication rate in any categoryexceeds 16 percent, and most rates are under 10percent.

Further subcategorization of the complicationheadings was possible based on the kinds of com-plications reported. These probability estimates aredisplayed in Table 2. For the “General Medical”

grouping, the panel defined and was able to gener-ate probability estimates for three subgroups:abdominal, cardiovascular and pulmonary compli-cations. Under “Intraoperative Complications,” thesubgroups are bladder, ureteral and urethral compli-cations. Within the “Perioperative” group, the panelgenerated probability estimates for bleeding, UTIand wound complications. Under “Subjective Com-plications,” the subgroups are dysuria, pain andsexual dysfunction. Finally, for “ComplicationsRequiring Surgery,” fistula and stone formationconstitute the subgroups.

Complication rates for syntheticsling materials

With regard to synthetic materials used forslings, the literature suggests higher complicationrates when using such materials, as shown in Table3, which shows the number of patients who experi-enced specific complications with autologous mate-rials (e.g., rectus fascia and fascia lata), homolo-gous materials (e.g., nonsynthetic, nonself grafts;such as porcine xenografts) and synthetic materials.

Table 3. Comparative complication rates for sling materials

Autologous Materials Homologous Materials Synthetic materialsComplications (1,715 pts.) (414 pts.) (1,515 pts.)

Vaginal erosion 1 pt. (.0001) 0 10 pts. (.007)

Urethral erosion 5 pts. (.003) 0 27 pts. (.02)

Fistula 6 pts. (.003) 0 4 pts. (.002)

Wound sinus 3 pts. (.002) 0 11 pts. (.007)

Wound infection 11 pts. (.006) 9 pts. (.02) 15 pts. (.009)

Seroma 6 pts. (.003) 0 1 pt. (.0007)


The practice policy recommendations in thischapter are to help patients and physicians selectsurgical therapies for female stress urinary inconti-nence (SUI). The classic SUI symptom is involun-tary loss of urine during stress activities such ascoughing, laughing, lifting and positional changes.The two basic factors to be evaluated are urethralhypermobility and intrinsic sphincteric deficiency(ISD). Hypermobility, present in the majority ofwomen with SUI, is the rotational descent of theproximal urethra and bladder neck into the vagina,associated with increases in abdominal pressurethat occur with stress activities. ISD refers to adeficiency in the urethral sphincter function, whichis unrelated to urethral support. The result issphincteric incontinence with minimal stress activi-ties. Hypermobility and ISD may coexist; andselection of a surgical procedure, as will be empha-sized further, should reflect the relative contribu-tions of these two factors. (For a fuller discussionof SUI, as well as other types of incontinence thatmay be present, see page 13 of Chapter 2.)

The Female Stress Urinary Incontinence ClinicalGuidelines Panel generated the recommendationsin this chapter based on outcomes estimatesderived from data reported in the literature, to theextent the data permitted. Where reported datawere insufficient, the panel added its expert opin-ion in making recommendations. The methodologyis described in Chapter 1.

Overall, after thorough review of the literatureand rigorous analysis of the reported data, the panelfound sufficient acceptable long-term outcomesdata (48 months and longer) to conclude that surgi-cal treatment of female stress urinary incontinenceis effective, offering a long-term cure in a signifi-cant percentage of women. The evidence supportssurgery as an initial therapy and as a secondaryform of therapy after failure of other treatments forSUI.

As explained in Chapter 1, panel recommenda-tions were graded according to three levels of flexi-bility based on strength of evidence and the panel’sassessment of patient needs and preferences. Defin-itions and explanations of these three levels arerepeated below from Chapter 1:

● Standard: A policy is considered a standardif the outcomes of the alternative interven-tions are sufficiently well-known to permitmeaningful decisions and there is virtual una-nimity about which intervention is preferred.

● Guideline: A policy is considered a guidelineif the outcomes of the interventions are suffi-ciently well-known to permit meaningfuldecisions and an appreciable but not unani-mous majority agree on which intervention ispreferred.

● Option: A policy is considered an option if(1) the outcomes of the interventions are notsufficiently well-known to permit meaningfuldecisions, (2) preferences among the out-comes are not known, (3) patients’ prefer-ences are divided among alternative interven-tions, and/or (4) patients are indifferent aboutthe alternative interventions.

Standards obviously have the least flexibility.Guidelines have considerably more flexibility, andoptions are the most flexible. As noted in the defin-itions, options can exist because of insufficient evi-dence or because patient preferences are divided. Inthe latter case particularly, it is important to con-sider the preferences of individual patients inselecting among alternative interventions.

In this report, none of the panel’s recommenda-tions fits the above definition of a guideline. Tworecommendations are labeled standards and one anoption. The labels indicate the strength of the rec-ommendations. Recommendations were labeledstandards if the panel concluded that they shouldbe followed by virtually all health care providers

Flexibility of panelrecommendations

Overview

Chapter 4 – Treatment recommendations


for virtually all patients. The recommendationlabeled an option was given this label, indicatingconsiderable implementation flexibility, becauseoutcomes evidence in the literature was insufficientfor a stronger recommendation and because of sig-nificant trade-offs (such as a higher long-termcure/dry rate but also higher complication rates fora particular procedure) that could result in dividedpatient preferences.

The type of patient to whom the panel’s recom-mendations apply is termed the index patient. Thispatient is defined as an otherwise healthy womanwith stress urinary incontinence, either untreated orpreviously treated (surgically or nonsurgically),without significant pelvic organ prolapse, who hasdecided to seek surgical treatment. The indexpatient may have urethral hypermobility, ISD or acombination of both.

The panel’s recommendations assume that thesurgeon is proficient in diagnostic and therapeutictechniques including the broad categories of surgi-cal procedures described in Chapter 2 of thisreport.

It is assumed also that the index patient has beencounseled regarding nonsurgical treatment alterna-tives. The surgeon may review these alternatives aspart of informed consent.

Based on the panel’s expert opinion, the preop-erative evaluation of women with symptoms ofstress urinary incontinence should comprise the fol-lowing components:

Although components of diagnostic evaluationare not the main focus of this document, the panelcreated the above standard because an accurate pre-operative evaluation is obviously indispensable forselection of a treatment option. As indicated in thelist of recommended evaluation components, theessential goals are: (1) to ascertain the impact of apatient’s incontinence on her quality of life; (2) toobjectively demonstrate stress urinary inconti-nence; (3) to identify the etiologic factors con-tributing to incontinence; and (4) to identify prog-nostic indicators.

In particular, on the basis of the preoperativeevaluation, the surgeon should understand the rela-tive contributions and underlying causes of urethralhypermobility, intrinsic sphincteric deficiency anddetrusor dysfunction. Although urethral hypermo-bility is associated with stress urinary incontinencein the majority of women, hypermobility oftencoexists with ISD. The panel believes that recogni-tion of this coexistence is crucial to the success ofsubsequent surgical intervention. Also, in thepanel’s opinion, the presence of detrusor dysfunc-tion (urgency/urge incontinence, detrusor instabil-ity, impaired detrusor contractility, poor bladdercompliance) can have a deleterious effect on proce-dure outcomes.

A thorough history and physical examinationmay be sufficient to achieve the goals stated above.However, as noted in Chapter 2 (page 15), furtherevaluation may be necessary—including, for exam-ple, a voiding diary, pad tests and urodynamic test-ing. Urinalysis, of course, is necessary to excludeurinary tract infection and hematuria.

With regard to patient expectations from treat-ment, she should be accurately informed about thesignificant risks of either continued or de novourgency after any operation for stress incontinence,and that these symptoms tend to persist for a longertime after a sling procedure. Continued or de novourgency is a major cause for patient dissatisfactionfollowing surgery.

◆ Symptom causes—in particular, consid-eration of the relative contributions ofurethral hypermobility, intrinsic sphinc-teric deficiency and detrusor dysfunction;

◆ Frequency and severity of incontinentepisodes;


● History, including impact of symptoms onlifestyle;

● Physical examination: objective demonstra-tion of stress incontinence;

● Urinalysis;

● Other appropriate diagnostic studiesdesigned to assess the following:

Recommendations:Standards

The index patient


In weighing the potential benefits and harms ofeach surgical alternative, the surgeon and patientshould discuss not only cure/dry and cure/dry/im-proved rates, but such issues as length of operation,length of hospital stay and possible complications.Patients should be informed especially of the possi-ble occurrence of common complications, withinformation on how they would be treated if theyoccur.

If a surgical treatment is a relatively short proce-dure, with low risk of short-term morbidity, apatient may choose this treatment even though ithas a lower estimated long-term cure/dry rate thanan alternative treatment that requires more time andposes a higher risk of complications. On the otherhand, a patient may be willing to accept a longeroperation, with greater likelihood of complicationsand short-term morbidity, if there is also greaterlikelihood of long-term success.

The estimates displayed in the comparative out-comes tables (Table 1 on page 19 and Table 2 onpage 20) are averages based upon evidence fromthe literature. However, these outcome estimatesmay differ for individual patients. The patientshould be informed of how the estimates will beaffected by her specific diagnostic condition (i.e.,ISD or detrusor dysfunction). In addition, individ-ual surgeons may have different outcomes depend-ing on prior training and level of experience with aparticular procedure.

Based upon evidence from the literature as indi-cated by the probability estimates in Table 1 onpage 19, and upon expert opinion, retropubic sus-pensions and slings are the most efficacious proce-dures for long-term success (based on cure/dryrates).

However, in the panel’s opinion, retropubic sus-pensions and sling procedures are associated withslightly higher complication rates, including post-operative voiding dysfunction, and with longerconvalescence. In patients who are willing toaccept slightly higher complication rates for thesake of long-term cure, retropubic suspensions andslings are appropriate choices. In the patient forwhom decreased hospital stay, less likelihood ofmorbidity and/or earlier return to work are para-mount, transvaginal suspensions are appropriateprocedures. Anterior repairs, in the panel’s opinion,are the least likely of the four major proceduretypes to be efficacious in the long term.

Among the various transvaginal suspension pro-cedures, cure/dry rates are similar but complicationrates are higher with the Stamey procedure.Cure/dry and complication rates do not appear sig-nificantly different among the various retropubicsuspension procedures and among sling procedures.

The panel made a further observation regardingchoice of procedure. Not only is the range of surgi-cal options for treating SUI already extremelydiverse, but new techniques and procedure modifi-cations continue to emerge. Some of these, as inthe past, will not stand the test of experience overtime. Moreover, different surgeons may performthe same procedure quite differently. The panelbelieves that surgeons should take these considera-tions into account, together with their own areasand levels of expertise and their own previoustreatment results, when counseling patients regard-ing choice of procedure.

sling procedures—have important differ-ences in their outcomes, all four are optionsfor the index patient.

● Although the four major types of proceduregroupings—retropubic suspensions, trans-vaginal suspensions, anterior repairs and

Recommendation: Option

● The index patient should be informed of theavailable surgical alternatives. Patientsshould also be informed, for each procedure,of estimated benefits and risks. The choiceof treatment should be made between thesurgeon and patient, taking into considera-tion patient preferences and the experienceand judgment of the surgeon.


As discussed in Chapter 1 (pages 8-11), theFemale Stress Urinary Incontinence ClinicalGuidelines Panel developed its recommendationsutilizing an explicit approach (Eddy, 1992), withemphasis on scientific evidence reported in the lit-erature. As also discussed in Chapter 1 (pages 11-12), the panel encountered numerous limitations inthe literature.

Of the panel’s recommendations, two are stan-dards relating to general criteria for selecting andinforming surgery patients. However, because of adearth of studies that meet minimum criteria forgood science in conducting clinical trials andreporting the results, the panel was unable to useevidence-based data to develop either standards orguideline-level recommendations specificallyrelated to choosing surgical procedures for individ-ual patients. Only an option-level recommendationwas possible.

Chapter 5 summarizes the chief limitations inthe literature that prevented a stronger recommen-dation with regard to choices of surgical procedure,addresses these limitations by specifying minimalstandards for clinical trials and makes recommen-dations for future research. The following is a sum-mary of the limitations:

● Lack of prospective, randomized, controlledtrials. Prospective, randomized, controlled tri-als, although optimal for providing reliable data,are almost never undertaken.

● Lack of standardized diagnostic criteria. Thepanel unanimously agreed that it is conceptuallyimportant to classify the cause(s) of stress incon-tinence as urethral hypermobility, intrinsicsphincteric deficiency or both. Yet, there are nodefinitive diagnostic tools to make these distinc-

tions, and only a small number of studiesreviewed by the panel actually classified thepatients in this manner. Furthermore, the panelunanimously agreed that it is important to recordthe presence or absence of urinary urgency, urgeincontinence and detrusor instability, both pre-and posttreatment. This was rarely done in thestudies the panel reviewed.

● Lack of standardized outcomes criteria.There are no standardized methods of recordingoutcomes. Moreover, the vast majority of studiesunder panel review did not even define the meth-ods by which incontinence was assessed.

● Lack of specific time intervals over whichresults were reported. Although many studiesclaimed to have long-term follow-ups, themajority did not record the total number ofpatients treated, the number actually evaluatedand the number lost to follow-up over the fol-low-up period. Most studies had statements suchas the following: “100 women were followed for1-10 years with a mean follow-up of 5 years.”This kind of statement does not allow the draw-ing of meaningful conclusions about follow-upbeyond the first year.

● Lack of uniformity in terminology describingsurgical procedures. Many authors describedsignificant modifications of surgical techniqueunder one name, but the actual technique theyused was closer to a technique known by anothername. For example, one author used the name“Stamey bladder neck suspension” in the title ofthe paper, but the text indicated a technique thatwas almost identical to the Raz procedure.

● Failure of authors to indicate whether theirstudy population was a new or updated series.A number of authors published their results asoften as every 1-3 years, and in most instances itwas not possible to determine how many of thepatients represented follow-up and how manywere new patients.

Limitations in the literature

Chapter 5 – Literature limitations, recommended standards of efficacy for evaluation of treatment outcomes and recommendations for future research


● Failure of authors to describe the complica-tions and morbidities of the surgery. Compli-cations and morbidities are not described in theliterature in a consistent way, often making itimpossible to determine their true incidence.

The recommendations in this section wereadapted from the “Standards of Efficacy for Evalu-ation of Treatment Outcomes in Urinary Incon-tinence,” developed by a multidisciplinary commit-tee of the Urodynamics Society and approved byboth the American Urological Association and theUrodynamics Society (Blaivas, Appell, Fantl, et al.,1997). These are minimal standards to be used inclinical trials for assessing the efficacy of urinaryincontinence therapies. Widespread adoption ofthese standards would obviate many of the prob-lems the panel encountered in reviewing and ana-lyzing outcomes data, especially problems involv-ing data inconsistencies.

General recommendationsAs a general consideration, all clinical trials

should consist of pre- and posttreatment evalua-tions adhering to the specific standards recom-mended in this section. Protocols should furtherspecify the criteria by which treatment success orfailure is determined.

Posttreatment evaluation of surgical, prostheticand implantation therapies should be conducted noless often than 1, 6 and 12 months after treatment.Ideally, evaluation should be done at yearly inter-vals thereafter. With regard to surgical therapies, aminimum of five-year follow-up is highly desir-able. The following data should be clearlydescribed at each posttreatment interval: (1) thenumber of patients treated during that interval oftime; (2) the number of patients actually evaluated;and (3) the number of patients lost to follow-upand the reasons why.

Some therapies, including most of those involv-ing pharmacologic agents, exert their effects onlyduring active treatment. These should be evaluatedat intervals dictated by the expected outcome, butno less often than monthly. After a successful pilot

study, tests of all drug therapies should be double-blinded and placebo controlled.

Whenever repeated therapies are contemplated(such as periurethral injections), the indications forretreatment and the time interval over whichretreatment is instituted should be specified. Theefficacy assessments should be conducted at aspecified time interval after the last treatment.

Pretreatment evaluationThe pretreatment evaluation should consist of a

structured micturition history and/or questionnaire,structured physical examination, micturition diary,a quantitative measure of urinary loss such as a padtest, urodynamics testing and a quality-of-lifeassessment.

The history should specifically include: (1) thepatient’s age; (2) previous operations that mightaffect the results, including pelvic and/or inconti-nence surgery and abdominalperineal resection ofthe rectum; (3) previous pelvic irradiation; (4) neu-rologic conditions known to affect micturition; (5)menstrual and obstetric history; and (6) concurrentmedications known to affect micturition.

The micturition history and/or questionnaireshould include at a minimum the following ele-ments: number of micturitions per day; number ofmicturitions per night; number of incontinentepisodes per day; number of incontinent episodesper night; type of incontinence symptoms (e.g.,stress, urge, unconscious, continuous leakage);voiding symptoms; subjective evaluation of sever-ity of symptoms, such as a “bother” index; andtype and number of pads used.

The structured physical examination should beconducted with a comfortably full bladder andinclude a neurourologic and a vaginal examination.The neurourologic examination should assess peri-anal sensation, anal sphincter tone and control andbulbocavernosus reflex. It should also include abrief neurologic examination to discriminate nor-mal, paraplegic, quadriplegic, hemiplegic, demen-tia, etc. The vaginal examination should includedemonstration of urinary leakage: spontaneous/con-tinuous, synchronous with stress and after stress. Itshould detect the presence and degree of cystocele,urethrocele, uterine prolapse/vaginal vault prolapse,enterocele and rectocele. An estimate of urethralhypermobility (such as a cotton-swab test) shouldbe done.

Standards of efficacyfor clinical trials


The micturition diary, self-reported by thepatient, should include time of micturition, timeand type of incontinence and the voided volume.The pad test should be quantitative or semiquanti-tative. A quantitative pad test estimates the volumeof urine loss (for example, by weighing pads). Asemiquantitative pad test describes the amount ofloss (such as large or small). Urinary dyes such asPyridium™ may be useful for this. The specifictechnique of the pad test should be delineated.

For urodynamic evaluation, the most compre-hensive technique is videourodynamics. The mini-mum evaluation should consist of the following:cystometry (liquid) with simultaneous measure-ment of vesical and abdominal pressure for deter-mination of detrusor pressure, detrusor pressure/-uroflow study and simple uroflow. A measure, orestimate of sphincteric strength and urethral hyper-mobility, such as leak point pressure and cotton-swab test, should be performed in order to assessfor the relative contribution of urethral hypermobil-ity and intrinsic sphincteric deficiency.

The cause of incontinence should be diagnosedas urethral hypermobility, intrinsic sphincteric defi-ciency or both. How the diagnosis was madeshould be stated (e.g., examination, cotton-swabtest, cystourethrogram, ultrasound, leak point pres-sure). In addition, the presence or absence ofurgency and/or urge incontinence should be notedas well as the presence of detrusor instability. Ifdetrusor instability is present at cystometry, itshould be categorized as symptomatic or asympto-matic.

The posttreatment evaluation should consist of astructured micturition history and/or questionnaire

at each follow-up visit, a quality-of-life assessment,a structured physical examination with full bladderat appropriate intervals, micturition diary at eachfollow-up, pad test at each follow-up and measure-ment of uroflow and postvoid residual at least onceand at appropriate intervals thereafter. The exactmethod by which the data for analysis wasobtained should be specified (e.g., retrospective orprospective chart review or analysis by indepen-dent researcher). The latter is the preferred method.

Specific complications and morbidities should benoted including: (1) postoperative death; (2) uri-nary retention (e.g., incidence, duration andwhether it was an expected or unexpected out-come); and (3) incidence of postoperative urinaryfrequency, urgency and urge incontinence (each asa separate data point) and whether persistent or ade novo occurrence.

Research is needed to develop: (1) a standard-ized lexicon describing the types of incontinence;(2) a standardized diagnostic methodology todefine the types of incontinence; and (3) standard-ized outcome measures.

Needed as well are: (1) methods to identifyintrinsic sphincteric deficiency, particularly inpatients with concurrent hypermobility; (2) bettertechniques for management of patients with com-bined intrinsic sphincteric deficiency and hypermo-bility; (3) less obstructive techniques for the cor-rection of hypermobility-associated stressincontinence; (4) methods of systematically relat-ing preoperative indicators to treatment outcomes;and (5) better understanding of the pathophysiol-ogy underlying SUI.

Researchrecommendations

Posttreatmentevaluation


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American Academy of Family Physicians. AAFP positions on the clinicalaspects of medical practice. Kansas City: American Academy of FamilyPhysicians, 1996.

Andersen J, Andersen B, Christensen P. Endoscopic suspension of thebladder neck by the Stamey method for urinary incontinence. Ital J SurgSci 1989;19:387-90.

Andersen JT, Heisterberg L, Hebjørn S, Petersen K, Stampe Sørensen S,Fischer-Rasmussen W, Mølsted Pedersen L, Nielsen NC. Suprapubicversus transurethral bladder drainage after colposuspension/vaginalrepair. Acta Obstet Gynecol Scand 1985;64:139-43.

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Beck RP, Lai AR. Results in treating 88 cases of recurrent urinary stressincontinence with the Oxford fascia lata sling procedure. Am J ObstetGynecol 1982;142:649-51.

Beck RP, McCormick S. Treatment of urinary stress incontinence withanterior colporrhaphy. Obstet Gynecol 1982;59:269-74.

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Beck RP, Thomas EA, Maughan GB. Surgical results in the treatment ofpressure equalization stress incontinence. Am J Obstet Gynecol1968;100:483-9.

Beckingham IJ, Wemyss-Holden G, Lawrence WT. Long-term follow-upof women treated with perurethral Teflon injections for stress inconti-nence. Br J Urol 1992;69:580-3.

Beisland HO, Fossberg E, Sander S, Moer A. Urodynamic studies beforeand after retropubic urethropexy for stress incontinence in females. SurgGynecol Obstet 1982;155:333-6.

Benassayag E. Simple surgical procedure for urinary stress incontinence.Eur Urol 1990;18:68-70.

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Bergman A, Koonings PP, Ballard CA. Stress urinary incontinence of lowurethral pressure type: one year follow-up with the Ball-Burch proce-dure. Neurourology and Urodynamics 1989;8:335-6.

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Bergman A, Matthews L, Ballard CA, Roy S. Suprapubic versustransurethral bladder drainage after surgery for stress urinary inconti-nence. Obstet Gynecol 1987;69:546-9.

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Vierhout ME, Mulder AFP. De novo detrusor instability after Burch col-posuspension. Acta Obstet Gynecol Scand 1992;71:414-6.

Viljoen AC. The vaginal strips sling operation. An alternative procedurefor urinary incontinence. S Afr Med J 1990;77:632-4.

Vordermark JS, Brannen GE, Wettlaufer JN, Modarelli RO. Suprapubicendoscopic vesical neck suspension. J Urol 1979;122:165-7.

Walker GT, Texter JH Jr. Success and patient satisfaction following theStamey procedure for stress urinary incontinence. J Urol1992;147:1521-3.

Walter S, Hald T, Buhl J, Astrup A, Nordling J. Recurrent urinary inconti-nence treated with quite another type of prolapse operation. Eur Urol1979;5:149-50.

Walter S, Olesen KP, Hald T, Jensen HK, Pedersen PH. Urodynamic eval-uation after vaginal repair and colposuspension. Br J Urol 1982;54:377-80.

Webster GD, Kreder KJ. Voiding dysfunction following cystourethropexy:its evaluation and management. J Urol 1990;144:670-3.

Webster GD, Perez LM, Khoury JM, Timmons SL. Management of typeIII stress urinary incontinence using artificial urinary sphincter. Urology1992;39:499-503.

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Wharton LR Jr, Telinde RW. An evaluation of fascial sling operation forurinary incontinence in female patients. J Urol 1959;82:76-9.

Wheelahan JB. Long-term results of colposuspension. Br J Urol1990;65:329-32.

Wheeler JS Jr, Culkin DJ, O’Hara RJ, Canning JR. Bladder dysfunctionand neurosyphilis. J Urol 1986;136:903-5.

Wheeless CR Jr, Wharton LR, Dorsey JH, Telinde RW. The Goebell-Stoeckel operation for universal cases of urinary incontinence. Am JObstet Gynecol 1977;128:546-9.

Williams E. The discussion on stress incontinence. Proc R Soc Med1947;40:361-70.

Williams TJ, Telinde RW: The sling operation for urinary incontinenceusing mersilene ribbon. Obstet Gynecol 1962; 19:241.

Wingo PA, Huezo CM, Rubin GL, Ory HW, Peterson HB. The mortalityrisk associated with hysterectomy. Am J Obstet Gynecol 1985;152:803-8.

Winter CC. Peripubic urethropexy for urinary stress incontinence inwomen. Urology 1982;20:408-11.

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Zecchi de Souza A. Stress incontinence of urine. Int Surg 1976;61:396-402.

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App

endi

x A

– D

ata

Pre

sent

atio

n

Tabl

e A

-1

Art

icle

s ex

trac

ted

by P

apyr

us r

efer

ence

num

ber


Table A-2 Articles rejected by panel group review

Principal Reason Rejected Number Rejected

Data duplicated or updated in another report 23

Review article without primary data 1

Abstract only 9

Unconventional treatment 4

Incomplete or unintelligible information 2

Case report 1

Data irrelevant to surgical treatment of female SUI 1

Concomitant vaginal surgery 1

Total: 42


App

endi

x B

– C

ompa

rativ

e ou

tcom

es ta

bles


Ana

lysi

s of

indi

vidu

al p

roce

dure

s co

mpl

icat

ions

(Ta

bles

B-2

to

B-5

)S

ubgr

oupi

ngs

of c

ompl

icat

ions

for

the

var

ious

indi

vidu

al p

roce

dure

s un

der

each

of

the

four

maj

or p

roce

dure

gro

upin

gs a

re d

ispl

aye

d in

Tab

les

B-2

to

B-5

.U

nder

the

ret

ropu

bic

susp

ensi

on g

roup

ing

(Tab

le B

-2),

the

indi

vidu

al p

roce

dure

s ar

e: B

urch

, M

MK

, La

pide

s, P

arav

agin

al a

nd O

ther

. F

or t

rans

vagi

nal s

uspe

nsio

ns(T

able

B-3

), t

he in

divi

dual

pro

cedu

res

are:

Per

eyra

, M

odifi

ed P

erey

ra,

Sta

mey

, R

az,

Gitt

es a

nd O

ther

. F

or t

he a

nter

ior

repa

ir gr

oupi

ng (

Tabl

e B

-4),

the

Kel

ly p

li-ca

tion

and

Oth

er a

re t

he o

nly

proc

edur

es li

sted

(be

caus

e of

con

side

rabl

e va

riabi

lity

in t

ypes

of

proc

edur

es in

the

Oth

er c

ateg

ory

). F

inal

ly,

Tabl

e B

-5 s

umm

ariz

essl

ing

proc

edur

es: A

bdom

inal

Fas

cia,

Fas

cia

Lata

, Va

gina

l Wal

l, H

omol

ogou

s M

ater

ials

, S

ynth

etic

Mat

eria

ls a

nd O

ther

.T

he O

ther

cat

egor

y in

eac

h of

the

se t

able

s co

ntai

ns c

ombi

ned

proc

edur

es (

see

page

17

in C

hapt

er 2

) as

wel

l as

a va

riety

of

addi

tiona

l pro

cedu

re m

odifi

catio

ns.

Ate

chni

cal s

uppl

emen

t to

thi

s re

port

, E

vide

nce

Wor

king

Pap

ers

(ava

ilabl

e fr

om t

he A

UA

) co

ntai

ns a

ful

l lis

ting

of p

roce

dure

s in

the

Oth

er c

ateg

ory.

Rat

es o

f co

mpl

icat

ions

are

gen

eral

ly s

imila

r be

twee

n th

e ty

pes

of r

etro

pubi

c su

spen

sion

s (T

able

B-2

), w

ith s

ome

exce

ptio

ns.

For

exa

mpl

e, t

he B

urch

pro

cedu

reap

pear

s to

hav

e a

high

er U

TI

rate

(m

edia

n 24

%)

than

oth

er r

etro

pubi

c pr

oced

ures

. In

the

pan

el’s

opi

nion

, su

ch d

iffer

ence

s ar

e d

ue t

o re

port

ing

varia

nces

bet

wee

nst

udie

s an

d to

sm

all o

vera

ll sa

mpl

e si

zes.

For

tra

nsva

gina

l sus

pens

ion

proc

edur

es (

Tabl

e B

-3),

com

plic

atio

n ra

tes

are

also

gen

eral

ly s

imila

r. In

cons

iste

ncie

s ar

e du

e to

sm

all n

umbe

rs o

f pa

tient

gro

ups

and/

or p

atie

nts.

Thi

s is

tru

e of

the

tra

nsfu

sion

rat

e fo

r P

erey

ra (

17%

) an

d of

the

dys

uria

rat

e fo

r S

tam

ey (

41%

).C

ompl

icat

ion

rate

s fo

r an

terio

r re

pairs

(Ta

ble

B-4

) ar

e ge

nera

lly lo

w a

nd r

eflec

t di

ffere

nces

in r

epor

ting

and

olde

r lit

erat

ure

refe

renc

es r

athe

r th

an r

eal d

iffer

-en

ces

from

the

oth

er p

roce

dure

gro

upin

gs.

Tabl

e B

-5 d

ispl

ays

com

plic

atio

n ra

tes

for

slin

g pr

oced

ures

. D

iffer

ence

s in

dat

a re

port

ed a

re d

ue t

o sm

all s

ampl

e si

ze a

nd o

lder

lite

ratu

re.


Appendix C – Descriptive analysis of urodynamictesting

Urodynamic investigation evaluates bladder and sphincteric function. Urodynamics are helpful whenincontinence cannot be demonstrated by other techniques, in women who have undergone prior inconti-nence surgery or who have failed empiric therapies and in patients who have undergone radical pelvicsurgery or who have neurologic disorders that may affect bladder function.

Cystometry

Cystometry, the graphic representation of detrusor pressure related to bladder volume, is used to assessdetrusor sensation, capacity, compliance and activity. Water cystometry is more physiologic than gas.Incontinence is easily demonstrated with liquid media, and filling with fluid allows better estimation ofbladder volume and compliance.

Leak point pressure

The abdominal leak point pressure indicates the relationship between sphincteric function and the vesi-cal or abdominal pressure that causes leakage. The lower the leak pressure, the more profound the sphinc-teric dysfunction. Low leak point pressure implies intrinsic sphincteric dysfunction, but further validation isrequired regarding reproducibility, variables affecting leak point pressure and standardization of technique.

Leak point pressure is determined with the patient in the standing position. At a known bladder volume,the patient is asked to slowly execute the Valsalva maneuver until incontinence is documented. The leakpressure may then be repeated later in filling. Variables known to affect leak point pressures include pelvicprolapse (such as cystocele), size of catheter, bladder volume at which leak point pressure is determinedand bladder compliance.

Urethral pressure profile

Urethral function may also be evaluated with a urethral pressure profile that estimates functional urethrallength and maximum urethral closure pressure. Reproducibility and variability in values are problematicwith this testing methodology. Techniques describing pressure transmission ratios between bladder and ure-thra associated with increases in abdominal pressure have not shown applicability. There is no relationshipbetween any urethral pressure profile parameter and patient continence data (wet or dry) or type of inconti-nence (Versi, 1990).

Pressure/flow evaluation

The simultaneous measurement of bladder pressure and urinary flow rate allows the recognition of uri-nary outflow obstruction that occurs in some women after incontinence surgery.

Videourodynamics (VUDS)

Videourodynamic testing provides simultaneous functional and anatomic evaluation of the lower urinarytract. Recognition of pressure-related vesicoureteral reflux, outlet obstruction and urethral anatomy duringbladder filling are advantages of this modality.

Synchronous measurement and display of urodynamic parameters associated with radiographic visual-ization of the lower tract is the most accurate tool for evaluating dysfunction of the bladder and urethra.The status of the bladder neck and proximal urethra can be assessed at rest and with stress maneuvers, andtheir location in relation to the symphysis pubis can be determined. In obstructed patients, the location ofurethral obstruction can be visually detected and compared with pressure/flow changes.


Appendix D – Data extraction form


AAbdominal complications, 24-25Abdominoperineal resection of rectum

as cause of ISD, 2, 14, 30Acute cholecystitis, 24-25Acute gastric dilatation, 25Age of patient, 3, 8, 23, 30Aldridge procedure, 17Anterior repairs

and cure/dry rate, 3, 7, 23, 28and days in the hospital, 3, 24as option for treatment, 2, 7, 28complications of, 16description of, 16-17postoperative urgency and DI, 23

Artificial sphincters, 2, 17, 22Autologous sling materials, 4, 17, 25

BBall procedure, 16Ball-Burch procedure (combined), 17Biofeedback, 2, 15Bladder complications, 25Bladder stones, 1, 13Bleeding as complication, 25Bowel injury, as complication, 4, 16, 24Bulbocavernous reflex, 14, 30Burch procedure, 15, 22

CCantor procedure (combined), 17Cardiovascular complications, 25Cobb-Ragde technique, 16Combined surgical procedures, 16, 17Continuous incontinence, 13Cooper’s ligament, 15Cotton swab test, 14, 30, 31Cure/dry rate

and anterior repairs, 3, 7, 23, 28,and follow-up time points, 2-3, 11, 22and meta-analysis, 11,12, 22and retropubic suspensions, 3, 7, 23, 28and sling procedures, 3, 7, 23, 28and transvaginal suspensions, 3, 7, 23, 28description of, 2, 3, 4, 10, 22-23discussion of with patient, 6, 28

Cure/dry/improved rate and meta-analysis, 3, 11, 12, 22, 23,description of, 3, 23discussion of with patient, 6, 28

Cystocele, 1, 13, 14, 30Cystoscopy , 16, 17

DDacron pledget, used in Stamey procedure,

16Death, 4, 12, 24, 31Detrusor instability

in diagnosis, 5, 6, 15, 27, 31postoperative, 3, 8, 16, 23

Diagnostic evaluation, 1-2, 6, 13-15, 27, 30-31

Dysuria, as complication, 25

EEnterocele, 1, 13, 14, 16, 30Enuresis, 13Estrogen, loss of as factor in SUI, 13

FFAST*PRO meta-analysis software, 8, 11, 18Fibrosis, 16Fistulas, 25Functional electrical stimulation, 2, 15

GGittes procedure, 16Goebell procedure, 17Gravitational loss of urine, 1, 13

HHematuria, 15, 27Homologous sling materials, 4, 17, 25Hospital stay, 3, 6, 24, 28Hypermobility, see Urethral hypermobility Hysterectomy, 2, 4, 14, 23, 24

IIndex patient, definition of and criteria for, 4,

27Infection, 4, 6, 11, 13, 15, 24, 25, 27Ingelman-Sundberg procedure, 16Injectable agents, 2, 17, 22Insert devices, 2, 15Intrinsic sphincteric deficiency (ISD), 1-2, 3,

6, 13-14, 15, 17, 23, 26, 27, 31

KKelly plication, 16Kennedy procedure, 16

LLaparoscopic Burch procedure, 22Lapides procedure, 15Leak point pressure, 31

MMarshall, Marchetti and Krantz procedure, 2,

15Micturition diary, see Voiding history Mixed incontinence, 1, 13Multiple sclerosis, 14Myelodysplasia, 14

NNeurologic disorders or disease, 1, 2, 13, 14Neurologic evaluation, 14, 30Nonsurgical therapies for SUI, 2, 6, 15

OObstruction, 1, 3, 4, 15, 16, 24

Outcomesdefinition and description of, 2, 3, 10, 12,18, 22tables, 19-20

Overflow incontinence, 13

PPad test, 6, 14, 27, 30, 31Pain, as complication, 16, 25 Parkinson’s disease, 14Patient

expectations from treatment, 5, 6, 14, 27index patient, 4, 27informing of, 5, 6, 27-28treatment, 6, 7

Pelvic floor exercises, 2, 15Pelvic organ prolapse, see Prolapse; see also

Cystocele, Enterocele, Uterine prolapse,Vault prolapse

Pereyra procedure, 16 Perforation of bladder and urethral as com-

plication, 16 Peripheral nerve injury, as complication, 4,

24Pharmacologic therapy, 2, 15, 30Physical examination, 6, 14-15, 27, 30-31Postvoid residual urine volume, 14Prolapse, 1, 4, 14, 16, 24, 27, 30Pyridium™, 31

RRaz suspension, 16Rectocele, 1, 13, 14, 30Retention, see Urinary retention Retropubic suspensions

and cure/dry rate, 3, 7, 23, 28and urgency/urge incontinence, 23and urinary retention, 3, 24 as option for treatment, 7, 28complications of, 16description of, 15-16postoperative urgency and DI, 23

SSacral dermatomes, 14Seroma, as complication of sling procedures,

25Sexual dysfunction, as complication, 25 Sling procedures

and cure/dry rate, 3, 7, 23, 28 and ISD, 23and urinary retention, 3, 24as option for treatment, 2, 7, 28complications of, 17, 25description of, 17materials for, 4, 17, 25postoperative urgency and DI, 23

Stamey procedure, 7, 16, 28Stenosis, 16Stone formation, as complication, 25Stroke, 14

Index


Surgeon experience, 5, 7, 27, 28Surgical treatment

goal of, 2, 15overall effectiveness of, 4, 28prior, as factor in SUI, 2, 3, 13, 14, 23, 30

Symphysis pubis, 16Symptoms, types of incontinence, 13Synthetic sling materials, 4, 17, 25

TTeflon™, 10, 22Timed voiding, 2, 15Transfusions, as complication, 4, 24, 25Transient incontinence, 13Transvaginal suspensions

and cure/dry rate, 3, 7, 23, 28and days in the hospital, 3, 24and urinary retention, 3, 24as option for treatment, 2, 7, 28

complications of, 16description of, 16postoperative urgency and DI, 23

UUreteral complications, 16, 25Urethral erosion, 25Urethral hypermobility, 1, 6, 13-14, 15, 26,

27, 31Urethral mucosal coaptation (atrophy) as

cause of ISD, 2, 14, 15, 17Urethrocele, 16, 30Urgency, and urge incontinence, see also

specific treatment methodsas symptom, 1, 13, 31description of, 13postoperative, 3, 6, 8, 16, 17, 22, 23, 27

Urinalysis, 1, 5, 6, 15, 27Urinary retention, 3, 16, 17, 22, 23-24, 31

Urinary sphincters, artificial, 2, 17, 22Urinary tract infection (UTI) 4, 6, 11, 13, 15,

24, 25, 27Urodynamic evaluation, 6, 14-15, 31Uterine prolapse, 1, 13, 14, 30

VVaginal epithelial atrophy, 14Vaginal erosion, 25Vaginal examination as part of diagnosis, 30Vaginal shortening, as complication, 16Valsalva maneuver, 14, 15Vascular injury, as complication, 4, 16, 24Vault prolapse, 1, 13, 30Voiding history or diary, 14, 27, 30

WWound complication, 24, 25

Suzanne Boland PopeGuidelines Coordinator

Julie BowersGuidelines Assistant

Joyce BrownGuidelines Assistant

Kim HagedornHealth Policy Projects Coordinator

Robin HudsonHealth Policy Projects Assistant

American Urological Association, Inc.

This report on the Surgical Management of Female Stress Urinary Incontinencewasdeveloped by the Female Stress Urinary Incontinence Clinical Guidelines Panel of theAmerican Urological Association, Inc.

This report is intended to furnish to the skilled practitioner a consensus of clear principlesand strategies for quality patient care, based on current professional literature, clinical expe-rience, and expert opinion. It does not establish a fixed set of rules or define the legal stan-dard of care, pre-empting physician judgment in individual cases.

An attempt has been made to recommend a range of generally acceptable modalities oftreatment, taking into account variations in resources and in patient needs and preferences.It is recommended that the practitioner articulate and document the basis for any significantdeviation from these parameters.

Finally, it is recognized that conformance with these guidelines cannot ensure a success-ful result. The parameters should not stifle innovation, but will, themselves, be updated andwill change with both scientific knowledge and technological advances.

Board of Directors (1997 – 1998)

Practice Parameters, Guidelines and Standards Committee (1997 – 1998)

Health Policy Department Staff and Consultants

Roy J. Correa, Jr., MD*William R. Turner, Jr., MD*Jack W. McAninch, MDMartin I. Resnick, MD*Winston K. Mebust, MD*Brendan M. Fox, MDThomas P. Ball, Jr. MD*

Joseph W. Segura, MD, ChairIan M. Thompson, Jr., MD, Vice ChairRodney A. Appell, MDRoy J. Correa, Jr., MD, Ex OfficioRoger R. Dmochowski, MDJack S. Elder, MDThomas C. Fenter, MD, ConsultantJohn B. Forrest, MDCharles E. Hawtrey, MD, Consultant

Gerald P. Hoke, MDStuart S. Howards, MDJohn D. McConnell, MD, ConsultantWinston K. Mebust, MD, Ex OfficioSharron L. Mee, MDGlenn M. Preminger, MDMartin I. Resnick, MD, Ex OfficioClaus G. Roehrborn, MD, FacilitatorLinda D. Shortliffe, MD, Consultant

Joseph A. Smith, Jr., MD, ConsultantDatta C. Wagle, MDHanan Bell, PhD, Methodology

ConsultantCurtis Colby, Medical Editor

ConsultantPatrick M. Florer, Database

Consultant

Theresa LincolnHealth Policy Projects Clerk

Lisa EmmonsHealth Policy Manager

Tracy KielyHealth Policy Analyst

Betty WagnerHealth Policy Assistant

Megan CohenGovernment Relations Manager

Scott ReidGovernment Relations Policy Analyst

Roger WoodsGovernment Relations Assistant

Randolph B. FenningerWashington Liaison

William GlitzPublic Relations Consultant

Dennis J. Card, MD*Joseph C. Cerny, MD*Joseph N. Corriere, Jr., MDH. Logan Holtgrewe, MDLawrence W. Jones, MD*David L. McCullough, MD*Harry C. Miller, Jr., MD*

Gerald Sufrin, MD*Robert S. Waldbaum, MD*G. James GallagherMelanie H. Younger

*Voting member

American Urological Association, Inc.1000 Corporate BoulevardLinthicum, Maryland 21090

ISBN 0-9649702-3-6

June 1997R

eport on the Surgical M

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