Wich sling for wich patient?

Prof. Paulo Palma

UNICAMP, SP, Brazil

HIPOCRATES 375 A CHIPOCRATES 375 A C

Minimally invasiveMinimally invasive

PessariesPessaries

““The gold standard”The gold standard”

AUA STRESS INCONTINENCE GUIDELINE COMMITTEE:

META-ANALYSIS OF THE LITERATURE:

SLINGS ARE MORE DURABLE AND HAVE A HIGHER SUCCES RATEBUT A HIGHER INCIDENCE OF VOIDING DYSFUNCTION

Evidence based analysisEvidence based analysis“efficacy”“efficacy”

• interview / questionnaire / chart / examination / UDS

• accuracy and reliability of the survey instrument

• accuracy and reliability (bias) of patient or interviewer

• “moment in time” : info obtained vs. published

• follow-up: time (minimum / average / range) & dropouts

•

• Quality of life: SF – 36• Bristol• King’s College• SEAPI• others

Evidence based analysis“quality of life”

• what is the complication rate?• is the symptom persistent, exacerbated, or new?• how bothersome to the patient? will it resolve?• if not, what is the nature of the corrective treatment?• if it is medicine: will it be chronic?• if it is surgery, how difficult for the patient?

Evidence based analysisEvidence based analysis“tolerability - complications”“tolerability - complications”

• what is the “gold standard” / does it exist?• is the old or new technique reproducible?• how is one operation compared to another?• retrospective vs prospective? randomized?• who is doing the procedure? individual or group?• is there a learning curve? • are the complications similar?

Evidence based analysis“comparisons of operations”

Evidence Based AnalysisEvidence Based Analysis

• Follow-up “drop-outs” “exclusions” “intent to tx”

• Patients lost to follow-up may have > complication rate•• Complaints that are omitted because of insufficient data

• Patients who refuse surgery may bias outcome

• How does the patient know the alternative treatment ?

SUBURETHRAL SLINGSSUBURETHRAL SLINGS

• +/- complete, partial or patch

• +/- penetration of urogenital diaphram

• +/- objectifying appropriate tension

• +/- autologous / bio-graft / artificial

• +/- bladder neck or mid-urethral

• 1907 Von Giordano• 1978 McGuire & Lytton Combined Approach• 1993 Petros

IVS/TVT• 2001 Delorme TOT • 2002 Palma Readjustment (bi-directional) SAFYRE t • 2003 Marques-Queimadelos Unidirectional

Readjustment - Remeex

A BRIEF HISTORY OF TIME

A BRIEF HISTORY OF TIMEFIRST PARADIGM SHIFT

• 1978: autologous pubovaginal sling *

1. Aponeurotic free graft

2. Combines approach

3. Tension-free

4. ISC

*1978 McGuire & Lytton

PubourethralPubourethralLigamentLigament

PubiPubiss

BladderBladder

RationaleRationale

Utero-sacral Utero-sacral LigamentLigament

BladderBladder

UterusUterus

PP

Tendinous ArcTendinous Arc

pubourethral pubourethral LigamentLigament

SacrumSacrum

Vag.Vag.

A BRIEF HISTORY OF TIMESECOND PARADIGM SHIFTPetros

&Ulmste

n

uretropelvicuretropelvicLigamentLigament

A BRIEF HISTORY OF TIMETOT:THIRD PARADIGM SHIFT A BRIEF HISTORY OF TIMETOT:THIRD PARADIGM SHIFT

Emmanuel Delorme 2001Emmanuel Delorme 2001

Cystoscopy not mandatory

Avoids Retzius space

Less irritative symptoms

Less visceral and vascular

trauma

RATIONALERATIONALE

pubourethral pubourethral ligamentligament

urethropelvicurethropelvicligamentligament

Transobturator SlingTransobturator Sling

Pubovaginal SlingPubovaginal Sling

92

55 54 53

42

0

10

20

30

40

50

60

70

80

90

100

Cirurgias Eletivas Mais RealizadasQuadro Geral Jan-Jun 2003

HC-UNICAMP

Colecistectomia

Sling

Marcapasso

Revasc.MiocárdioMamoplastia

U N ICA M PU N ICA M P

55

2117 17 17

0

10

20

30

40

50

60

Cirurgias Urológicas Eletivas mais realizadas Janeiro a Julho/03

HC-UNICAMP

Sling

RTU Próstata

Prostatectomiaradical

Varicocelectomia

RTU Bexiga

U N ICA M PU N ICA M P

What is the ideal sling?What is the ideal sling?

Non adjustablesNon adjustables

• AutologousAutologous• AutologousAutologous

• Minimally invasiveMinimally invasive• Minimally invasiveMinimally invasive

Non AdjustableNon Adjustable

AutologousAutologous

EfficacyEfficacy

GraftGraft

Hospital stayHospital stay

ComplicationsComplications

Non AdjustableNon Adjustable

ObstructionObstruction• 436 slings• 20 urethrolysis

• Autologous: 18/210 8.5%

• Adjustable synthetic: 2/226 0.8%

Autologous: more obstructiveAutologous: more obstructive

Urethrolysis instead of adjustmentUrethrolysis instead of adjustment

Autologous: more obstructiveAutologous: more obstructive

Urethrolysis instead of adjustmentUrethrolysis instead of adjustment

Palma et al. Eur Urol (A) 2005

A Randomised Trial of A Randomised Trial of Colposuspension and TVTColposuspension and TVT

• Prospective randomized 14 center study• 344 patients 15 month period, ending Aug. 1999

• Methodology - meas. questionnaire; freq. / vol. chart, filling / voiding cystometry, urethral pressure profilometry, ICS 1hr. Pad test, SF-36, EuroQol, Bristol FLUTS questionnaire.

• Measures - Pre-Op, 6 mo., 12 months, 24 month

• Evaluable Patients at 24 mo. - 137 TVT vs. 108 Burch

Karen Ward - Paul Hilton

A Randomised Trial of A Randomised Trial of Colposuspension and TVT Colposuspension and TVT

• Cure rates and quality of life changes

• TVT remained comparable with colposuspension at 24 months

• Economic considerations Surgery details show TVT to be less expensive

due to shorter time and duration of treatment anesthetic room, OR time, recovery room, hospital stay, and hemoglobin during the operation

TVTTVT

Complication US Ex-US TotalVascular Injury 3 25 28Vaginal Mesh Exposure 19 2 21 Urethral Erosion 12 0 12Bowel Perforation 8 6 14Nerve Injury 1 0 1

* As of April 15, 2002, 5 deaths have been reported to GYNECARE that are associated with TVT..

Most Serious Reported Complications* (based on over 200,000 patients treated world-wide)

The Relationship of TVT Insertion to the Vascular Anatomy of the Retropubic Space and the Anterior Abdominal Wall

• Study performed on 10 fresh cadavers • Measured distance from the needle to vessel• • Results: All vessels were lateral to the needle

• Conclusion: “If the TVT needle is laterally directed or externally rotated in the course of insertion, major vascular injury may result”

T.W. Muir, , et al. Paper presentation, 22nd Annual Meeting, AUGS, Oct. 2001.

PubocervicalFascia

TVT Needle

External IliacVein

AccessoryObturatorVein

ObturatorNerve

Pubic Ramus

Pubic Symphysis

TVT Needle

Bowel

Anterior Abdominal Wall

TVTTVT

Rezapour, Ulmsten U. Tension-Free vaginal tape (TVT) in stress incontinent women with intrinsic sphincter deficiency (ISD)-a long-term follow-up.

• 49 patients (3- 5 years F/U)

... ... oldeolderr patients (>70 years) with a very patients (>70 years) with a very low low resting resting urethral pressure and an urethral pressure and an immobileimmobile urethra seem to urethra seem to constitute a risk group where TVT surgery is less constitute a risk group where TVT surgery is less successful...successful...

Int Urogynecol J. 2001, 12 Suppl 2:S12-14.

TVTTVT

Neuman M. Trans vaginal tape readjustment after unsuccessful tension-free vaginal tape (TVT) operation.

• 334 patients• 4 adjustaments • Cure: 3• Failure: 1

There are no reports with others TVT- like slings There are no reports with others TVT- like slings

Neurourol Urodyn 2004;23(3):282-3.

Non Adjustable TOTNon Adjustable TOT

Ozel B Ozel B et. al.et. al. Treatment of Treatment of

voiding dysfunction after voiding dysfunction after

transobturator tape transobturator tape

procedure.procedure.

Urology 2004, 64(5):1030.

• 2 patients (PO 17 / PO 18)• Successful loosening of the mesh

What is the ideal sling?What is the ideal sling?

Adjustable sling: rationaleAdjustable sling: rationale

1. There is a 10-15% failure rate2. Complicated subset of patients

ISDDetrusor hypocontractibilityOrthotopic neobladderObesityChronic pulmonary diseasesOthers

Adjustable slingsAdjustable slings

2.Reemex2.Reemex1.1. SafyreSafyre

SAFYRESAFYRE

FeaturesFeatures

• Hybrid & versatileHybrid & versatile

• Universal approachUniversal approach

SAFYRESAFYRE

• Re-adjustabilityFeaturesFeatures

• Hybrid & versatileHybrid & versatile

• Universal approachUniversal approach

Adjustable slingAdjustable sling

The Ibero-American experience with a re-adjustable minimally invasive sling.

• 126 patients126 patients

• PVR > 100 mlPVR > 100 ml 4 patients (3%) 4 patients (3%)

• 4 successful4 successful readjustments readjustments

Palma et al. BJU Int 2005, 95:341-5.

Palma & Netto, Illustrated Urogynecology , 2005

TRANSVAGINAL x TRANSOBTURATOR

• 226 patients226 patients• 226 patients226 patients

126 vs (mean age 63)126 vs (mean age 63)

F/U 18 monthsF/U 18 months

75 (59%) previous surgery75 (59%) previous surgery

100 t (mean age 61)100 t (mean age 61)

F/U 14 monthsF/U 14 months

65 (65%) previous surgery65 (65%) previous surgery

SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS

Palma et al. Int Urogynecol J. 2005

SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS

Cure (p>0,05)Cure (p>0,05)

VS: 92,1%VS: 92,1%

T : 94 %T : 94 %

Improvement (p>0,05)Improvement (p>0,05)

VS: 2,4%VS: 2,4%

T : 2%T : 2%

Palma et al. Int Urogynecol J. 2005

RESULTSRESULTSRESULTSRESULTS

Student’s t testStudent’s t test

Mean operative time (p<0,05)Mean operative time (p<0,05)

VS: 25 minVS: 25 min

T : 15 minT : 15 min

Transient Voiding symptoms Transient Voiding symptoms (p<0,05)(p<0,05)

VS: 20.6 %VS: 20.6 %T : 10 %T : 10 %

Palma et al. Int Urogynecol J. 2005

SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS

RESULTSRESULTSRESULTSRESULTS

Mesh infection (p>0,05)VS: 4 (3,1%)T : 1 (1%)

Mesh infection (p>0,05)VS: 4 (3,1%)T : 1 (1%)

Bladder injury (p<0,05%)Bladder injury (p<0,05%)

VS: 12 (10%)VS: 12 (10%)

T : 0T : 0

Palma et al. Int Urogynecol J. 2005

SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS

COMPLICATIONSCOMPLICATIONSCOMPLICATIONSCOMPLICATIONS

• SAFYRE T IS AS EFFECTIVE AS SAFYRE VS

• SAFYRE T LESS OPERATIVE TIME

• SAFYRE T NO VASCULAR OR VISCERAL

TRAUMA

• READJUSTABILITY IMPROVES OUTCOME

Palma et al. Int Urogynecol J. 2005

SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS

HypermobilityHypermobility

Intrinsic Sphincter

Deficiency

Intrinsic Sphincter

Deficiency

PurePure

Are all the patients the same?

Good Mild Bad

ISDISD

Perspective: Crossover TOTPerspective: Crossover TOT

WHAT WHAT SHOULDSHOULD BE EVALUATED ? BE EVALUATED ?

MAJORMAJOR MINORMINOR

EfficacyEfficacy

SafetySafety CostsCosts

EBMEBM

AdjustAdjust

OutpatientOutpatient

Op timeOp time

Sick leaveSick leave

LearningLearning

ComplicationsComplications

New devicesNew devices

Where the past meets the presentWhere the past meets the present Where the past meets the presentWhere the past meets the present

SoranusSoranus

Primum non nocerePrimum non nocereMinimally invasive Maximally effective

Thank you