primary care 2008 office evaluation and urinary incontinence and pelvic organ prolapse associate...
TRANSCRIPT
Primary Care 2008
Office Evaluation and Urinary Office Evaluation and Urinary Incontinence and Pelvic Organ Incontinence and Pelvic Organ
ProlapseProlapse
Associate Professor of Urology/SurgeryAssociate Professor of Urology/Surgery
University of Colorado Health Sciences CenterUniversity of Colorado Health Sciences Center
Denver, CODenver, CO
Brian J. Flynn, MDBrian J. Flynn, MDDirector of Reconstructive Urology, Director of Reconstructive Urology, Urogynecology and UrodynamicsUrogynecology and Urodynamics
Primary Care 2008
I. History and PhysicalI. History and Physical
II. Diagnostic TestsII. Diagnostic Tests
III. Office ManagementIII. Office Management
- Behavioral- Behavioral
- Medical- Medical
- Procedural- Procedural
Office Evaluation of Incontinence Office Evaluation of Incontinence and Prolapseand Prolapse
Primary Care 2008
ObjectivesObjectivesVoiding DysfunctionVoiding Dysfunction
Understand the current management ofUnderstand the current management of office evaluation of voiding dysfunctionoffice evaluation of voiding dysfunction over active bladder (OAB)over active bladder (OAB)
Defined as a failure to store or empty urineDefined as a failure to store or empty urine
Primary Care 2008
10-20%, aged 15-64 years10-20%, aged 15-64 years
30-40%, > 60 years30-40%, > 60 years
50%, long-term care facility50%, long-term care facility
Urinary Incontinence and Pelvic Organ ProlapseUrinary Incontinence and Pelvic Organ ProlapseEpidemiologyEpidemiology
** Iselin, CE and Webster, GD: Urol Clin N Amer 1998 Iselin, CE and Webster, GD: Urol Clin N Amer 1998†† Samuelsson, EC, et al.: Am J Obstset Gyencol 1999Samuelsson, EC, et al.: Am J Obstset Gyencol 1999‡‡ Suback, LL, et al.: Obstet Gynecol 2001Suback, LL, et al.: Obstet Gynecol 2001
Females patients comprise 40% of a general Females patients comprise 40% of a general urology practiceurology practice
50%, > 50 years of age50%, > 50 years of age 30-50%, lifetime prevalence30-50%, lifetime prevalence 354,962 operations/year, US data (1997)354,962 operations/year, US data (1997)
Urinary incontinence Urinary incontinence **
Pelvic Organ Prolapse Pelvic Organ Prolapse † ‡† ‡
Primary Care 2008
How Many People Have How Many People Have Incontinence?Incontinence?
13 million Americans of all ages suffer from 13 million Americans of all ages suffer from urinary incontinenceurinary incontinence
Women account for nearly 85%Women account for nearly 85%
Primary Care 2008
What Is Incontinence?What Is Incontinence?
Incontinence is the unintentional release of urineIncontinence is the unintentional release of urine Embarrassing; unpredictable condition; it can Embarrassing; unpredictable condition; it can
cause women to:cause women to:• Avoid an active lifestyleAvoid an active lifestyle• Shy away from social situationsShy away from social situations• Constantly search for the nearest bathroomConstantly search for the nearest bathroom• Become too embarrassed to talk to their doctorBecome too embarrassed to talk to their doctor
Primary Care 2008
* Survey conducted by Gallup Group (European Study)* Survey conducted by Gallup Group (European Study)
Urinary IncontinenceUrinary IncontinenceA Hidden Condition A Hidden Condition **
Two-thirds of patients are symptomatic for 2 Two-thirds of patients are symptomatic for 2 years before seeking treatmentyears before seeking treatment
30% of patients who seek treatment receive 30% of patients who seek treatment receive no assessmentno assessment
Nearly 80% are not examined Nearly 80% are not examined
Patients self-manage by voiding frequently, Patients self-manage by voiding frequently, reducing fluid intake and wearing padsreducing fluid intake and wearing pads
Primary Care 2008
Urinary IncontinenceUrinary IncontinenceBarriers to TreatmentBarriers to Treatment
Patient misconceptions and fearsPatient misconceptions and fears
““Normal part of aging”Normal part of aging”
““Not severe or frequent enough to treat”Not severe or frequent enough to treat”
““Too embarrassing to discuss”Too embarrassing to discuss”
““Treatment won't help”Treatment won't help”
Primary Care 2008
Are There Different Types of Are There Different Types of Incontinence?Incontinence?
4 Types4 Types• OverflowOverflow• UrgeUrge• StressStress• MixedMixed
Primary Care 2008
Stress incontinenceStress incontinence Urge incontinenceUrge incontinence Unconscious incontinenceUnconscious incontinence Continuous leakageContinuous leakage Nocturnal enuresisNocturnal enuresis Post-void dribblePost-void dribble Extra-urethral incontinence Extra-urethral incontinence Geriatric incontinenceGeriatric incontinence
Classification of IncontinenceClassification of IncontinenceSymptom Categories Symptom Categories *
* Romanzi and Blaivis, Urol Clin North Am 1995 Romanzi and Blaivis, Urol Clin North Am 1995
Primary Care 2008
• Nature of incontinenceNature of incontinence• Duration of incontinenceDuration of incontinence• Degree of interference with lifestyle/activitiesDegree of interference with lifestyle/activities• Predisposing medical/surgical conditionsPredisposing medical/surgical conditions• Prior medical/surgical therapies for incontinencePrior medical/surgical therapies for incontinence• Presence of pelvic floor relaxationPresence of pelvic floor relaxation
Office Evaluation of UI and POPOffice Evaluation of UI and POPGoals Goals *
Direct appropriate and effective therapyDirect appropriate and effective therapy
Primary Care 2008
Office Evaluation of UI and POPOffice Evaluation of UI and POPFemale Bladder QuestionnaireFemale Bladder Questionnaire
INITIAL HISTORY AND PHYSICAL FEMALE University of Colorado HospitalINITIAL HISTORY AND PHYSICAL FEMALE University of Colorado Hospital(This section to be completed by patient)(This section to be completed by patient) DIVISION OF UROLOGY DIVISION OF UROLOGY
Patient NamePatient Name______________________________________________________________________ Medical Record # Medical Record # ______________________________________
DateDate_______________________________ _______________________________ AgeAge________ ________ PhonePhone____________________________________________________________________
Chief ComplaintChief Complaint (Why you want to see the doctor today?)(Why you want to see the doctor today?): : ______________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Bladder SYMPTOM QUESTIONNAIREBladder SYMPTOM QUESTIONNAIRE ( (circle symptoms that are present circle symptoms that are present nownow))
((Please be sure to complete the bladder diary you were sentPlease be sure to complete the bladder diary you were sent))
How often do you urinate: during the day? ___________________ during the night?How often do you urinate: during the day? ___________________ during the night?
Is the amount of urine you usually pass : Is the amount of urine you usually pass : Large Average SmallLarge Average Small Do you have difficulty starting your urinary flow?Do you have difficulty starting your urinary flow? YesYes NoNo
Do you strain to void your urine?Do you strain to void your urine? Yes Yes NoNo
Is your urine flow (circle one) Strong Weak Dribbling Is your urine flow (circle one) Strong Weak Dribbling IntermittentIntermittent
Do you feel that you empty your bladder completely?Do you feel that you empty your bladder completely? YesYes NoNo
Do you notice dribbling of urine after voiding?Do you notice dribbling of urine after voiding? YesYes NoNo
Do you have to assume abnormal positions to urinate?Do you have to assume abnormal positions to urinate? YesYes NoNo
Primary Care 2008
Screening and Diagnosis ofScreening and Diagnosis ofOveractive BladderOveractive Bladder
Assess history, symptoms, Assess history, symptoms, and test resultsand test results
Establish a diagnosisEstablish a diagnosis
“Do you have bladder problems Do you have bladder problems that are troublesome or do you that are troublesome or do you
ever leak urine?”ever leak urine?”
YES
Primary Care 2008
Medical HistoryMedical History
• Diabetes mellitusDiabetes mellitus
• GI complaints/ConstipationGI complaints/Constipation
• Neurological disordersNeurological disorders
– Prior CVAPrior CVA
– Multiple sclerosisMultiple sclerosis
– Parkinson’s diseaseParkinson’s disease
SurgicalSurgical
• Incontinence and prolapse surgery, hysterectomyIncontinence and prolapse surgery, hysterectomy
• Radical pelvic surgery (prostatectomy, APR)Radical pelvic surgery (prostatectomy, APR)
• Spinal surgerySpinal surgery
• Bladder outlet proceduresBladder outlet procedures
Office Evaluation of UI and POPOffice Evaluation of UI and POPPastPast HistoryHistory
Primary Care 2008
Number of children (vaginal or cesarean)Number of children (vaginal or cesarean) Vaginal deliveriesVaginal deliveries
• NumberNumber
• Large birth weightLarge birth weight
• Forceps deliveryForceps delivery
Menopausal statusMenopausal status• Estrogen replacementEstrogen replacement
Office Evaluation of UI and POPOffice Evaluation of UI and POPObstetrical/GynecologicalObstetrical/Gynecological
Primary Care 2008
Precipitating eventsPrecipitating events• Minimal provocation: quiet walking, bendingMinimal provocation: quiet walking, bending• Moderate provocation: coughing, sneezingModerate provocation: coughing, sneezing• Significant provocation: strenuous exerciseSignificant provocation: strenuous exercise
Magnitude of stress incontinenceMagnitude of stress incontinence• Drops v. complete voidDrops v. complete void• Frequency of episodesFrequency of episodes• Type of pads used: liners, maxipads or diapersType of pads used: liners, maxipads or diapers
– How many used dailyHow many used daily– Changed when wet, damp or dry (changed by habit)Changed when wet, damp or dry (changed by habit)
Office Evaluation of UI and POPOffice Evaluation of UI and POPSUISUI Subjective DataSubjective Data
Primary Care 2008
TriggersTriggers• ““Key in the door”, hand washingKey in the door”, hand washing
• Rising from the seated positionRising from the seated position
• Coughing, walking, jumpingCoughing, walking, jumping
““Urge Syndrome” symptomsUrge Syndrome” symptoms• FrequencyFrequency
• NocturiaNocturia
• UrgencyUrgency
• Urge incontinenceUrge incontinence
Office EvaluationOffice EvaluationUrge IncontinenceUrge Incontinence
Primary Care 2008
OAB and Stress IncontinenceOAB and Stress IncontinenceDifferential DiagnosisDifferential Diagnosis
Symptom Assessment
History and Physical Examination
Abrams P, Wein AJ. The Overactive Bladder: Abrams P, Wein AJ. The Overactive Bladder: A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998.A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998.
SymptomsSymptoms Overactive Overactive bladderbladder
Stress incontinenceStress incontinence
Urgency (strong, sudden desire to void)
Yes No
Frequency with urgency (>8 times/24 h)
Yes No
Leaking during physical activity; eg, coughing, sneezing, lifting
No Yes
Amount of urinary leakage with each episode of incontinence
Large (if present)
Small
Ability to reach the toilet in time
following an urge to void Often no
Yes
Waking to pass urine at night
Usually
Seldom
Primary Care 2008
ConditionCondition• Detrusor overactivityDetrusor overactivity
CausesCauses• IdiopathicIdiopathic
• NeurogenicNeurogenic
• UTIUTI
• Bladder cancerBladder cancer
• Outlet obstructionOutlet obstruction
Urinary IncontinenceUrinary IncontinenceDifferential Diagnosis Differential Diagnosis *
* Romanzi and Blaivis, Urol Clin North Am 1995 Romanzi and Blaivis, Urol Clin North Am 1995
ConditionCondition Urethral hypermobilityUrethral hypermobility ISDISD
CausesCauses Pelvic floor relaxationPelvic floor relaxation Prior pelvic surgeryPrior pelvic surgery NeurogenicNeurogenic
StressStress UrgeUrge
Primary Care 2008
AbdominalAbdominal• prior surgical scarsprior surgical scars
• distended bladderdistended bladder
• obesityobesity
Back/SpineBack/Spine• skeletal deformitiesskeletal deformities
• scars from trauma/surgeryscars from trauma/surgery
• tuft of hair, skin dimpletuft of hair, skin dimple
Office Evaluation of UI and POPOffice Evaluation of UI and POPPhysical ExaminationPhysical Examination
NeurologicalNeurological mental statusmental status sensory functionsensory function motor functionmotor function reflex integrity reflex integrity
Primary Care 2008
Moderately full bladderModerately full bladder ComponentsComponents
• Visual inspectionVisual inspection
• Speculum examSpeculum exam
• Assessment of pelvic floor strengthAssessment of pelvic floor strength
• Bimanual examBimanual exam
Office Evaluation of UI and POPOffice Evaluation of UI and POPPelvic ExaminationPelvic Examination
Primary Care 2008
InspectionInspection• LabiaLabia
• Signs of estrogenizationSigns of estrogenization
• IntroitusIntroitus• Atrophy/stenosisAtrophy/stenosis
• Posterior injury from childbirthPosterior injury from childbirth
• PerineumPerineum• Wide perineum or posteriorly displaced anus may Wide perineum or posteriorly displaced anus may
indicate weakened perineal body/pelvic muscle atrophyindicate weakened perineal body/pelvic muscle atrophy
Office Evaluation of UI and POPOffice Evaluation of UI and POPPelvic ExaminationPelvic Examination
Primary Care 2008
SystematicSystematic• Anterior vaginal wall and urethraAnterior vaginal wall and urethra
• Vaginal apexVaginal apex
• Posterior vaginal wallPosterior vaginal wall
Valsalva/strain or coughValsalva/strain or cough StageStage
• Baden-Walker (halfway down v. POPQ)Baden-Walker (halfway down v. POPQ)
Office Evaluation of UI and POPOffice Evaluation of UI and POPSpeculum ExaminationSpeculum Examination
Primary Care 2008
Urethral or bladder decentUrethral or bladder decent +/- Q-tip test+/- Q-tip test Incontinence (Quantity relative to valsalva)Incontinence (Quantity relative to valsalva) CystoceleCystocele
Office Evaluation of UI and POPOffice Evaluation of UI and POPAnterior CompartmentAnterior Compartment
Lateral defectLateral defect• Corrected by replacing the lateral fornices to the Corrected by replacing the lateral fornices to the
sidewall (using ring forceps)sidewall (using ring forceps)
Central defectCentral defect• Smooth surfaced (loss of rugae) herniation not Smooth surfaced (loss of rugae) herniation not
corrected by lateral replacementcorrected by lateral replacement
Primary Care 2008
Position of cervix or vaginal cuffPosition of cervix or vaginal cuff• Cervical descent with straining Cervical descent with straining
• Cervical mucosal appearanceCervical mucosal appearance
Office Evaluation of UI and POPOffice Evaluation of UI and POPVaginal Apex and Posterior CompartmentVaginal Apex and Posterior Compartment
RectoceleRectocele Bulge close to the introitus generallyBulge close to the introitus generally Confirm with simultaneous DREConfirm with simultaneous DRE Graded similar to cystoceleGraded similar to cystocele
EnteroceleEnterocele Bulge generally higher in vaultBulge generally higher in vault Bidigital rectovaginal exam essentialBidigital rectovaginal exam essential
Primary Care 2008
• Voiding diary Voiding diary • Pad weight testPad weight test• Laboratory testsLaboratory tests• CystourethroscopyCystourethroscopy• UrodynamicsUrodynamics
• Eyeball urodynamicsEyeball urodynamics• Multichannel urodynamicsMultichannel urodynamics
Office Evaluation of UI and POP Office Evaluation of UI and POP Objective DataObjective Data
Primary Care 2008
Date, time and volume of each voidDate, time and volume of each void Record of each incontinent episodeRecord of each incontinent episode
• timetime
• amountamount
• precipitating cause of leakageprecipitating cause of leakage
Office EvaluationOffice EvaluationVoiding Diary (3-5 days)Voiding Diary (3-5 days)
Poor correlation between patient’s recalled history of nature/ Poor correlation between patient’s recalled history of nature/ volume/frequency of incontinent events and voiding diaryvolume/frequency of incontinent events and voiding diary
Primary Care 2008
Only truly objective measure of incontinence Only truly objective measure of incontinence 1ml urine roughly equals 1gm1ml urine roughly equals 1gm Weight of wet pad minus sample dry padWeight of wet pad minus sample dry pad 24-hour test best for urge and stress 24-hour test best for urge and stress incontinenceincontinence 1-hour pad test standardized by ICS good 1-hour pad test standardized by ICS good measure of SUImeasure of SUI
Office Evaluation of UI and POPOffice Evaluation of UI and POPPad Weight TestPad Weight Test
Primary Care 2008
Urine analysis and cultureUrine analysis and culture BUN and creatinineBUN and creatinine HematuriaHematuria
• CytologyCytology
• Upper tract evaluation (IVP or CT)Upper tract evaluation (IVP or CT)
• CystoscopyCystoscopy
Office Evaluation of UI and POPOffice Evaluation of UI and POPLaboratory EvaluationLaboratory Evaluation
Primary Care 2008
UrethraUrethra• Urethritis (shaggy, erythematous, painful mucosa), Urethritis (shaggy, erythematous, painful mucosa),
atrophy (pale), diverticulum, FBatrophy (pale), diverticulum, FB
• StrictureStricture
BladderBladder• Outlet (contracture, BPH)Outlet (contracture, BPH)
• NeoplasiaNeoplasia
• Ureteral orifice (location and number)Ureteral orifice (location and number)
• DiverticuliDiverticuli
• Calculi and foreign bodiesCalculi and foreign bodies
Office Evaluation of UI and POPOffice Evaluation of UI and POPCystoscopyCystoscopy
Not usually required in most patients, but generally helpful Not usually required in most patients, but generally helpful in patients with prior surgeryin patients with prior surgery
Primary Care 2008
Not generally required in most patients with Not generally required in most patients with uncomplicated incontinenceuncomplicated incontinence
Office Evaluation of UI and POPOffice Evaluation of UI and POPUrodynamics Urodynamics **
** Erickson and Davies, AUA update series, 1999 (11)Erickson and Davies, AUA update series, 1999 (11)
In neurologically intact patients, one can proceed with In neurologically intact patients, one can proceed with noninvasive empiric therapy if history, physical and noninvasive empiric therapy if history, physical and
urinalysis do not suggest serious pathologyurinalysis do not suggest serious pathology
Primary Care 2008
IndicationsIndications• Initial tests inconclusiveInitial tests inconclusive
• Prior corrective surgery for incontinencePrior corrective surgery for incontinence
• Prior radical pelvic surgery or radiotherapyPrior radical pelvic surgery or radiotherapy
• Neurologic disorderNeurologic disorder
• Mixed stress/urge with unclear relative Mixed stress/urge with unclear relative contributioncontribution
* * Iselin and Webster, Urol Clin N Amer 1998Iselin and Webster, Urol Clin N Amer 1998
Office Evaluation of UI and POPOffice Evaluation of UI and POPUrodynamics Urodynamics **
Primary Care 2008
Behavioral ManagementBehavioral Management
Primary Care 2008
Behavioral Behavioral ModificationModification
Education
Delayed Voiding
Timed Voiding
Reinforcement
Pelvic Floor Exercises
Management of Management of Urinary IncontinenceUrinary Incontinence Behavioral ModificationsBehavioral Modifications
Primary Care 2008
““Force the patient to store larger volumes of urine Force the patient to store larger volumes of urine under conditions of physical activity and urgency by under conditions of physical activity and urgency by using the pelvic floor to maintain continence and to using the pelvic floor to maintain continence and to
inhibit the detrusor”inhibit the detrusor”
Office Treatment of Urinary IncontinenceOffice Treatment of Urinary IncontinenceBehavioral TherapyBehavioral Therapy
Iselin and Webster, Urol Clin N Amer 1998Iselin and Webster, Urol Clin N Amer 1998
• Fluid and dietary modificationFluid and dietary modification
• Bladder retrainingBladder retraining
• Pelvic floor reeducationPelvic floor reeducation
Primary Care 2008
Fluid restriction often practiced and often Fluid restriction often practiced and often counterproductivecounterproductive
• Concentrated urine, irritating, increased odorConcentrated urine, irritating, increased odor
• Increased urgency and frequencyIncreased urgency and frequency
Drink small amounts often, usually before 7pmDrink small amounts often, usually before 7pm Increase intake in hot weather or exerciseIncrease intake in hot weather or exercise Avoid bladder irritantsAvoid bladder irritants
• Coffee and tea, carbonated beverages, chocolate, spicy Coffee and tea, carbonated beverages, chocolate, spicy and tomato based foodsand tomato based foods
Avoid constipation, which contributes to urgencyAvoid constipation, which contributes to urgency• Increased fiber and fluid intakeIncreased fiber and fluid intake
Office Treatment of Urinary IncontinenceOffice Treatment of Urinary Incontinence Fluid and Dietary ModificationFluid and Dietary Modification
Primary Care 2008
Monitoring instruments to Monitoring instruments to detect and amplify detect and amplify internal unconscious internal unconscious functionsfunctions
EMG v. manometric devicesEMG v. manometric devices Can significantly improve Can significantly improve
success rates to 50% success rates to 50% with reeducation with reeducation
alone, to 90% with alone, to 90% with biofeedbackbiofeedback
Management of Management of Urinary IncontinenceUrinary Incontinence BiofeedbackBiofeedback
Primary Care 2008
Pharmacologic Management of Pharmacologic Management of OABOAB
Primary Care 2008
Management of OABManagement of OABICS DefinitionICS Definition
Urgency, with or without incontinence, Urgency, with or without incontinence, usually with frequency and nocturiausually with frequency and nocturia
In the absence of a pathologic or metabolic In the absence of a pathologic or metabolic condition that might explain these symptomscondition that might explain these symptoms
International Continence Society: 2002International Continence Society: 2002
Primary Care 2008
Rule-out neurological disordersRule-out neurological disorders• Radicular painRadicular pain
• ParesthesiasParesthesias
• Muscle weaknessMuscle weakness
• Diminished sensationDiminished sensation
• Ocular symptoms (MS)Ocular symptoms (MS)
Bladder outlet obstructionBladder outlet obstruction Risk factors for TCC of the bladderRisk factors for TCC of the bladder
Office EvaluationOffice EvaluationUrge IncontinenceUrge Incontinence
Primary Care 2008
Distribution of Muscarinic Receptors Distribution of Muscarinic Receptors
Muscarinic receptors are also located in the CNS.
Abrams P, Wein AJ. The Overactive Bladder—A Widespread and Treatable Condition. 1998.
Primary Care 2008
Management of OABManagement of OABPharmacologic TherapyPharmacologic Therapy
Antimuscarinic agents are the mainstayAntimuscarinic agents are the mainstay OAB symptoms relieved byOAB symptoms relieved by
• inhibition of involuntary bladder contractionsinhibition of involuntary bladder contractions• increased bladder capacityincreased bladder capacity
Treatment limited by side effects Treatment limited by side effects • dry mouthdry mouth• dry eyes, blurred visiondry eyes, blurred vision• constipation, GERDconstipation, GERD• CNS effectsCNS effects
Primary Care 2008
Anticholinergic Agents Anticholinergic Agents Oxybutynin Immediate Release (OXY-IR)Oxybutynin Immediate Release (OXY-IR)
It is a tertiary amine that is smooth muscle relaxant that facilitates It is a tertiary amine that is smooth muscle relaxant that facilitates bladder storagebladder storage Pharmacodynamic propertiesPharmacodynamic properties
• Extensive first-pass hepatic metabolism by cytochrome P450 Extensive first-pass hepatic metabolism by cytochrome P450 enzyme (CYP3A4) into many active metabolitesenzyme (CYP3A4) into many active metabolites
• The primary active metabolite is N-desethyloxybutynin The primary active metabolite is N-desethyloxybutynin (N-DEO) has been implicated as the cause of side effects(N-DEO) has been implicated as the cause of side effects
• Side effectsSide effects
• dry mouth, dry eyes, constipation, CNS impairmentdry mouth, dry eyes, constipation, CNS impairment Contraindicated in patients with glaucomaContraindicated in patients with glaucoma Oxy-IR 2.5-5 mg po TIDOxy-IR 2.5-5 mg po TID
Primary Care 2008
Anticholinergic Agents Anticholinergic Agents Oxybutynin Extended release (XL)Oxybutynin Extended release (XL)
• OXY-ER is designed to pass through the upper GI tract OXY-ER is designed to pass through the upper GI tract • OXY-ER is metabolized primarily in the colonOXY-ER is metabolized primarily in the colon• This delays absorption and reduces first-pass effectThis delays absorption and reduces first-pass effect• Results in reduced N-DEO levels compared to OXY-IRResults in reduced N-DEO levels compared to OXY-IR• OXY-ER has equivalent efficacy to OXY-IR, improved dosing and OXY-ER has equivalent efficacy to OXY-IR, improved dosing and
side-effect profileside-effect profile• Extended release (XL) 5-10 mg po QDExtended release (XL) 5-10 mg po QD
Appel RA, et al.: OBJECT Study, Mayo Clin Proc 2001
Diokno AC, et al.: OPERA Trial, Urology 2003
Primary Care 2008
• RationaleRationale
• Oral bioavailability is lowOral bioavailability is low
• OXY-TDS avoids first-pass gastric and hepatic metabolismOXY-TDS avoids first-pass gastric and hepatic metabolism
• Effective OXY-TDS dose is 3.9 mg/dayEffective OXY-TDS dose is 3.9 mg/day
Anticholinergic Agents Anticholinergic Agents Oxybutynin Transdermal Delivery System (OXY-TDS)Oxybutynin Transdermal Delivery System (OXY-TDS)
• OXY-TDS maintains a consistent delivery of OXY over a 96-hours OXY-TDS maintains a consistent delivery of OXY over a 96-hours with marked reduction in the plasma concentrations of N-DEOwith marked reduction in the plasma concentrations of N-DEO
• OXY-TDS has equivalent efficacy to OXY-IR and lower AEsOXY-TDS has equivalent efficacy to OXY-IR and lower AEs
• Primary AE is application site reaction (9% discontinuation)Primary AE is application site reaction (9% discontinuation)
ResultsResults
Dmochowski RR, et al.: J Urol 2002
Diokno AC, et al.: OPERA Trial, Urology 2003
Primary Care 2008
It is a tertiary amine that is less lipid soluble then oxybutynin It is a tertiary amine that is less lipid soluble then oxybutynin and has a limited capacity to cross the blood-brain barrierand has a limited capacity to cross the blood-brain barrier
Pharmacodynamic propertiesPharmacodynamic properties• Extensively metabolized by cytochrome P450 enzyme (CYP2D6) Extensively metabolized by cytochrome P450 enzyme (CYP2D6)
and has a major active metabolite similar to parent and has a major active metabolite similar to parent compoundcompound
• Non selective muscarinic receptor antagonistNon selective muscarinic receptor antagonist• Decreased frequency of voidsDecreased frequency of voids• Decreased urge incontinence episodesDecreased urge incontinence episodes
Similar efficacy to oxybutynin-IR with better tolerance and fewer Similar efficacy to oxybutynin-IR with better tolerance and fewer drop outsdrop outs
Continuation rates higher than with oxybutynin IRContinuation rates higher than with oxybutynin IR• Tolterodine IR 2 mg po BIDTolterodine IR 2 mg po BID• Tolterodine long acting (Detrol LA) 4 mg po QDTolterodine long acting (Detrol LA) 4 mg po QD
Anticholinergic Agents Anticholinergic Agents Tolterodine (Detrol)Tolterodine (Detrol)
Van Kerrebroeck P, et al.: Urology 2001
Primary Care 2008
It is a quaternary amine that is less lipid soluble then It is a quaternary amine that is less lipid soluble then oxybutynin and does not cross the blood-brain barrier to the oxybutynin and does not cross the blood-brain barrier to the samesame extent
Pharmacodynamic propertiesPharmacodynamic properties• Competitive antagonist of ACh at postsynaptic binding sites Competitive antagonist of ACh at postsynaptic binding sites • Only anticholinergic that is not metabolized by cytochrome P450 Only anticholinergic that is not metabolized by cytochrome P450
rather it is excreted unchanged in the urine by tubular rather it is excreted unchanged in the urine by tubular secretionsecretion
• Comparable selectivity for MComparable selectivity for M11--MM55 Efficacy Efficacy• Decreased frequency of voidsDecreased frequency of voids• Decreased urge incontinence episodesDecreased urge incontinence episodes• Onset within one weekOnset within one week
Low GI absorption/low bioavailabilityLow GI absorption/low bioavailability• <10% is absorbed; bioavailability is low at 9.6%<10% is absorbed; bioavailability is low at 9.6%• Tropsium (Sanctura) 20-40 mg po BIDTropsium (Sanctura) 20-40 mg po BID
Anticholinergic Agents Anticholinergic Agents Tropsium (Sanctura)Tropsium (Sanctura)
Fusgen I, et al.: Int J Clin Pharmacol Ther 2000Zinner N, et al.: J Urol 2004
Primary Care 2008
Anticholinergic AgentsAnticholinergic Agents Darifenacin (Enablex)Darifenacin (Enablex)
Pharmacodynamic propertiesPharmacodynamic properties• Metabolized by P450 isoforms CYP3A4 and CYP2D6Metabolized by P450 isoforms CYP3A4 and CYP2D6• Dose adjusted in patients taking potent CYP3A4 inhibitorsDose adjusted in patients taking potent CYP3A4 inhibitors
• Darifenacin has the greatest MDarifenacin has the greatest M3 3 affinityaffinity
• Decreased frequency of voidsDecreased frequency of voids• Decreased urge incontinence episodesDecreased urge incontinence episodes
• MM33 receptors are involved in contraction of the bladder, GI receptors are involved in contraction of the bladder, GI
smooth muscle, heart and saliva productionsmooth muscle, heart and saliva production Darifenacin 7.5-15 mg po QDDarifenacin 7.5-15 mg po QD
Haab F, et al.: Eur Urol 2004
Chapple CR. J Urol 2004
Primary Care 2008
Anticholinergic AgentsAnticholinergic AgentsSolifenacin (VESIcare)Solifenacin (VESIcare)
A tertiary amine that is well absorbed by the GI tractA tertiary amine that is well absorbed by the GI tract Pharmacodynamic propertiesPharmacodynamic properties
• Muscarinic antagonist with some MMuscarinic antagonist with some M33 selectivity (10 fold) selectivity (10 fold)• Metabolized by P450 isoform CYP3A4 Metabolized by P450 isoform CYP3A4 • Elimination half-life following chronic dosing is Elimination half-life following chronic dosing is
approximately 45 to 68 hoursapproximately 45 to 68 hours Efficacy, safety and tolerability documented in phase III trialsEfficacy, safety and tolerability documented in phase III trials
• Significant reduction in frequency, urgency and urge Significant reduction in frequency, urgency and urge incontinence episodesincontinence episodes
Solifenacin 5-10 po QDSolifenacin 5-10 po QD
Chapple CR, et al.: BJU Int 2004a
Chapple CR, et al.: BJU Int 2004b
Primary Care 2008
Management of Refractory Management of Refractory OABOAB
Primary Care 2008
Endoscopic proceduresEndoscopic procedures• Urethral dilationUrethral dilation• Direct ulcer injectionDirect ulcer injection• Endoscopic resectionEndoscopic resection• Laser therapyLaser therapy• HydrodistentionHydrodistention• Botox injectionBotox injection
Electrical stimulationElectrical stimulation• Perc neuromodulationPerc neuromodulation• Afferent nerve stimulatorAfferent nerve stimulator
Stepwise approach in most Stepwise approach in most instances from least invasive to instances from least invasive to
most invasivemost invasive
Management of Refractory Management of Refractory OAB/PBSOAB/PBS
DenervationDenervation• Ingelman-SundbergIngelman-Sundberg• Transvesical phenol Transvesical phenol
injectioninjection• CystoloysisCystoloysis• Sacral rhizotomySacral rhizotomy
CystoplastyCystoplasty• AutoaugmentationAutoaugmentation• EnterocystoplastyEnterocystoplasty
Urinary diversionUrinary diversion• MitrofanoffMitrofanoff• ConduitConduit• Continent diversionContinent diversion
Primary Care 2008
Management of Refractory OABManagement of Refractory OABIntravesical Botilinum Toxin (botox)Intravesical Botilinum Toxin (botox)
Botox is derived from the Botox is derived from the organism C. botulinumorganism C. botulinum
Inhibits the vesicular neuronal Inhibits the vesicular neuronal blockade up to 9 mosblockade up to 9 mos
Increasing data on the benefits of Increasing data on the benefits of botox in patients withbotox in patients with
• Non-neurogenic DONon-neurogenic DO• Neurogenic DONeurogenic DO• DSDDSD• Interstitial cystitis?Interstitial cystitis?
Schurch B, et al.: J Urol 2000Schurch B, et al.: J Urol 2000
Smith CP and Chancellor MB: J Urol 2004Smith CP and Chancellor MB: J Urol 2004
Primary Care 2008
Management of Refractory OABManagement of Refractory OABIntravesical Botilinum Toxin Type-A (botox)Intravesical Botilinum Toxin Type-A (botox)
Schurch B, et al.: J Urol 2000Schurch B, et al.: J Urol 2000
Smith CP and Chancellor MB: J Urol 2004Smith CP and Chancellor MB: J Urol 2004
TechniqueTechnique UrethraUrethra• 100 units in 2-3 ml of NS100 units in 2-3 ml of NS
• Collagen needle used to Collagen needle used to inject 3, 6, 9 and 12 inject 3, 6, 9 and 12 o’clock o’clock positions in positions in striated striated sphinctersphincter
BladderBladder• 200-300 units in 30 ml of NS200-300 units in 30 ml of NS• Inject 30-40 sites within the Inject 30-40 sites within the
detrusor, targeting the detrusor, targeting the trigone, base of the trigone, base of the bladder bladder and lateral wallsand lateral walls
Primary Care 2008
Management of Refractory OABManagement of Refractory OABInterstimInterstim
InterstimInterstim™™ has evolved from a large cut-down procedure over the has evolved from a large cut-down procedure over the sacrum to a less invasive percutaneous tined lead approachsacrum to a less invasive percutaneous tined lead approach
Primary Care 2008
Management of SUIManagement of SUI
Primary Care 2008
What Causes SUI?What Causes SUI?
Pelvic muscle strainPelvic muscle strain ChildbirthChildbirth Pelvic muscle tone lossPelvic muscle tone loss Estrogen loss/menopauseEstrogen loss/menopause
Primary Care 2008
More About SUIMore About SUI
Most prevalent type of incontinenceMost prevalent type of incontinence• You are not alone!You are not alone!• 8 million women have SUI8 million women have SUI
Affects women of all ages, young mothers, pre-Affects women of all ages, young mothers, pre-menopausal women, seniorsmenopausal women, seniors• Average age of onset: 48Average age of onset: 48
Treatable conditionTreatable condition
Primary Care 2008 63
The Impact of SUIThe Impact of SUI
70% of women with SUI surveyed 70% of women with SUI surveyed said they worry about said they worry about coughing, sneezing and even laughing in public for coughing, sneezing and even laughing in public for fear of fear of having an accidenthaving an accident
35% report changing their activities to accommodate the 35% report changing their activities to accommodate the condition including avoiding exercise, traveling less condition including avoiding exercise, traveling less frequently and avoiding sex frequently and avoiding sex
62% waited a year or longer before even discussing their 62% waited a year or longer before even discussing their condition with a doctorcondition with a doctor
Primary Care 2008
There is Treatment for SUI!There is Treatment for SUI!
Self managementSelf management MedicationMedication Biofeedback, electrical stimulationBiofeedback, electrical stimulation Minimally invasive proceduresMinimally invasive procedures
Primary Care 2008
Minimally Invasive ProceduresMinimally Invasive Procedures
Common SUI surgical proceduresCommon SUI surgical procedures• Bladder neck suspensionsBladder neck suspensions• Needle suspensionsNeedle suspensions• Conventional sling proceduresConventional sling procedures
Most treatments areMost treatments are• InvasiveInvasive• Involve general anesthesiaInvolve general anesthesia• Require hospital stayRequire hospital stay• Require extended recovery time (up to six weeks)Require extended recovery time (up to six weeks)
Primary Care 2008
TVTTVTHow Does It Work?How Does It Work?
Restores your body’s ability to control urine lossRestores your body’s ability to control urine loss• Surgeon provides support to the urethra by placing a Surgeon provides support to the urethra by placing a
"sling" or mesh tape beneath it"sling" or mesh tape beneath it• The tape supports the urethra during sudden movements, The tape supports the urethra during sudden movements,
such as a cough or sneeze, keeping the urethra such as a cough or sneeze, keeping the urethra closed closed and preventing the involuntary loss of urine.and preventing the involuntary loss of urine.
Primary Care 2008
BenefitsBenefits
•Completed in 30 minutes
•Patient may be able to return home the same day
•Reduced need for post-surgical catheterization
•Short recovery time, minimal pain
Primary Care 2008
Simple, Proven TreatmentSimple, Proven Treatment EffectiveEffective
• 86% cured,86% cured,• 11% report improvement11% report improvement• Follow-up studies show Follow-up studies show
that even years later women that even years later women stay drystay dry
More than 500,000 women More than 500,000 women worldwide have been treatedworldwide have been treated
Primary Care 2008
What Are The Potential Risks?What Are The Potential Risks?
All medical procedures contain some riskAll medical procedures contain some risk Hemorrhage/hematomaHemorrhage/hematoma Injury to blood vessels, bladder or bowelInjury to blood vessels, bladder or bowel Difficulty with urinationDifficulty with urination
Primary Care 2008
• Mean operative time 28 minutesMean operative time 28 minutes• All patients discharged same day without catheterAll patients discharged same day without catheter• All patients returned to normal activity, with the All patients returned to normal activity, with the
exception of heavy lifting, in < 7 daysexception of heavy lifting, in < 7 days
TVT-ObturatorTVT-ObturatorResultsResults
• There were no to bladder, bowel or neural injuryThere were no to bladder, bowel or neural injury• 1 intra-operative urethral injury was repaired and TVT-O 1 intra-operative urethral injury was repaired and TVT-O
completedcompleted• Mean EBL 43 (0-300) mlMean EBL 43 (0-300) ml
• no patient required a blood transfusionno patient required a blood transfusion
Intra-Operative ComplicationsIntra-Operative Complications
ConvalescenceConvalescence
Flynn BJ and Myers J: SC AUA 2005Flynn BJ and Myers J: SC AUA 2005
Primary Care 2008
TVT-ObturatorTVT-Obturator ResultsResults
• Mean follow-up 13.5 (2-23) months Mean follow-up 13.5 (2-23) months • 76 of 82 (92.6%) patients cured76 of 82 (92.6%) patients cured
• 66 patients required 0 pads66 patients required 0 pads• 10 patients averaged 1 ppd10 patients averaged 1 ppd
• 6 of 82 (7.4%) patients were considered failures6 of 82 (7.4%) patients were considered failures• 5 patients with persistent/recurrent SUI (> 1 ppd)5 patients with persistent/recurrent SUI (> 1 ppd)
ComplicationsComplications
• 4 case of bladder incomplete emptying or de novo urgency 4 case of bladder incomplete emptying or de novo urgency required urethrolysis in 2required urethrolysis in 2
• 1 vaginal mesh extrusion noted at 6 weeks1 vaginal mesh extrusion noted at 6 weeks• Multi-layer closure performed, no recurrent extrusionMulti-layer closure performed, no recurrent extrusion
Continence OutcomeContinence Outcome
Flynn BJ and Myers J: SC AUA 2005Flynn BJ and Myers J: SC AUA 2005
Primary Care 2008
Tension-Free Vaginal Tape Secur (TVT-S™)Tension-Free Vaginal Tape Secur (TVT-S™)The Next GenerationThe Next Generation
Can be placed as a ‘U” or “hammock”Can be placed as a ‘U” or “hammock” Unique tension-free fixation mechanismUnique tension-free fixation mechanism
** Gynecare Inc., Summerville, NJ Gynecare Inc., Summerville, NJ
1.1 x 8 cm1.1 x 8 cm of laser cut of laser cut polypropylenepolypropylene mesh mesh
tape placed through a tape placed through a small vaginal incision small vaginal incision under the mid-urethra under the mid-urethra
with no exit sitewith no exit site
Primary Care 2008
Tension-Free Vaginal Tape Secur (TVT-S™)Tension-Free Vaginal Tape Secur (TVT-S™)Proposed AdvantagesProposed Advantages
Less invasiveLess invasive Less dissectionLess dissection Less painLess pain Less complicatedLess complicated Less bleedingLess bleeding Eliminate risk of bowel, Eliminate risk of bowel,
ureteral injuryureteral injury Lower risk of retention Lower risk of retention and and
de novo urgencyde novo urgency
Can be done under local anesthesia, outpatient, no Can be done under local anesthesia, outpatient, no catheter, ability to do cough testcatheter, ability to do cough test
Primary Care 2008
Management of POPManagement of POP
Primary Care 2008
Etiology of Pelvic Organ ProlapseEtiology of Pelvic Organ Prolapse
ChildbirthChildbirth Estrogen deficiencyEstrogen deficiency Chronic intra-abdominal Chronic intra-abdominal
pressurepressure• Pulmonary diseasePulmonary disease• Heavy liftingHeavy lifting• Chronic strainingChronic straining
Neuropraxia affecting Neuropraxia affecting the the pelvic floorpelvic floor
Primary Care 2008
Pelvic Organ Prolapse PrevalencePelvic Organ Prolapse Prevalence
POP in > 50% of women over 50POP in > 50% of women over 5011
Lifetime prevalence of 30-50%Lifetime prevalence of 30-50%11
Women > 65 is the fastest growing segment of the Women > 65 is the fastest growing segment of the US populationUS population22
Demand for services expected to double in the next Demand for services expected to double in the next 30 years30 years33
1 1 Subak et al. Obstet Gynecol 2001;98:646-651Subak et al. Obstet Gynecol 2001;98:646-6512 2 US Census Bureau 2000 Int data baseUS Census Bureau 2000 Int data base3 3 Luber et al. Am J Obstet Gynecol 2001;184:1496-1501Luber et al. Am J Obstet Gynecol 2001;184:1496-1501
Primary Care 2008
POP Procedural DemandPOP Procedural Demand
11% risk of surgical intervention by age 8011% risk of surgical intervention by age 8011
226,000 procedures performed in 1997226,000 procedures performed in 199722
Cost > $1 billionCost > $1 billion33
Estimated number in 2030 is 7 millionEstimated number in 2030 is 7 million44
Represents a small subset of symptomatic patientsRepresents a small subset of symptomatic patients
1 1 Olsen et al. Obstet Gynecol 1997;89:501-506Olsen et al. Obstet Gynecol 1997;89:501-5062 2 Brown et al. Am J Ob Gyn 2002;186:712-716Brown et al. Am J Ob Gyn 2002;186:712-7163 3 Subak et al. Obstet Gynecol 2001;98:646-651Subak et al. Obstet Gynecol 2001;98:646-6514 4 Shull. Am J Ob Gyn 1999;181:6-11Shull. Am J Ob Gyn 1999;181:6-11
Primary Care 2008
Management of Level I DefectsManagement of Level I Defects
Expectant managementExpectant management• When is it appropriate?When is it appropriate?
Pessary placementPessary placement Surgical CorrectionSurgical Correction
• Vaginal Vaginal • Abdominal Abdominal • CombinedCombined• LaparoscopicLaparoscopic
Primary Care 2008
Nonsurgical Management of Vaginal Nonsurgical Management of Vaginal Vault ProlapseVault Prolapse
Kegel exercisesKegel exercises Reduce intrabdominal Reduce intrabdominal
pressure/strainingpressure/straining• Bowel regimenBowel regimen• Weight reductionWeight reduction• Eliminate heavy liftingEliminate heavy lifting
PessaryPessary
Primary Care 2008
1 1 Olson et al. Olson et al. Obstet and GynecolObstet and Gynecol 1997;89:501-5061997;89:501-50622 Marchionni et al. Marchionni et al. J J Reproduct MedReproduct Med 1999;44;679-6841999;44;679-68433 Clark et al. Clark et al. Am J Obstet and Gynecol 2003;189:1261-1267Am J Obstet and Gynecol 2003;189:1261-1267
How are we doing with our current How are we doing with our current surgical procedures? surgical procedures?
11.1% lifetime risk of surgery11.1% lifetime risk of surgery 29-40% patients require 29-40% patients require
reoperation within 3 yearsreoperation within 3 years1,21,2
60% of the recurrences are at 60% of the recurrences are at the same sitethe same site33
32.5% of the recurrences are at 32.5% of the recurrences are at a different sitea different site33
Primary Care 2008
PROLIFT System: Early Outcome DataPROLIFT System: Early Outcome Data1,21,2
AuthorAuthor ##PtsPts
MeaMean n AgeAge
SiteSite ComplicationsComplications ExposureExposure Length of Length of Follow UpFollow Up
““Success” Success” ((<< Stage II) Stage II)
Groenen MJC Groenen MJC et.al.et.al.
(Netherlands)(Netherlands)11
2626 6161
A-6A-6
P-10P-10
T-10T-10
Vd.dysfcn-5Vd.dysfcn-5 1 (3.8%)1 (3.8%)
S=N/AS=N/A 2 mo.2 mo. 26 (100%)26 (100%)
Perscheler M Perscheler M et.al.et.al.
(Austria)(Austria)11
8080 N/AN/A N/AN/ACystotomy-2Cystotomy-2
Hematomas-2Hematomas-2
8 (10%)8 (10%)
S=5 (50%)S=5 (50%)
N/AN/A N/AN/A
Rivera JM Rivera JM
et.al .et.al .
(USA)(USA)22
8282 6363P-19P-19
T-63T-63
Hematoma-1Hematoma-1
Hemmorrhage-1Hemmorrhage-1
7 (11.7%)7 (11.7%)
S=N/AS=N/A3 mo.3 mo.
Not wellNot well
defineddefined
1 1 IUGA – Fatton - 2006 Abstracts all published in: Int Urogynecol J 2006;17(S.2):S212IUGA – Fatton - 2006 Abstracts all published in: Int Urogynecol J 2006;17(S.2):S2122 2 AUGS 2006 Abstract published in: Int Urogyn J 2006;17(S.3):S460AUGS 2006 Abstract published in: Int Urogyn J 2006;17(S.3):S460
CompiledCompiled
DataData549549 6464
A-109A-109
P-85P-85
T-256T-256
Cystotomy- 1.7%Cystotomy- 1.7%
Rectal perf- 0.4%Rectal perf- 0.4%
Hemorrhagic- Hemorrhagic- 1.3%1.3%
Void dysfcn- 6.7%Void dysfcn- 6.7%
34 (6.2%)34 (6.2%)
S=12 S=12 (2.6%)(2.6%)
6 mo.6 mo. 81.4-100%81.4-100%
Primary Care 2008
Polypropylene mesh reinforced pelvic floor repair Polypropylene mesh reinforced pelvic floor repair and vaginal vault suspension (Prolift)and vaginal vault suspension (Prolift)
Operative TechniqueOperative TechniqueAnterior Mesh Anterior Mesh ImplantImplant
Primary Care 2008
ResourcesResources
Where you can find more information:Where you can find more information: www.nafc.orgwww.nafc.org (National Association (National Association
for Continence)for Continence) www.simonfoundation.orgwww.simonfoundation.org www.niddk.nih.govwww.niddk.nih.gov (National Kidney (National Kidney
and Urologic Diseases Information and Urologic Diseases Information Clearinghouse)Clearinghouse)