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Office Evaluation and Urinary Incontinence and Pelvic Organ Prolapse Brian J. Flynn, MD Director Office Evaluation and Urinary Incontinence and Pelvic Organ Prolapse Brian J. Flynn, MD Director of Reconstructive Urology, Urogynecology and Urodynamics Associate Professor of Urology/Surgery University of Colorado Health Sciences Center Denver, CO Primary Care 2008

Primary Care 2008 Primary Care 2008

Office Evaluation of Incontinence and Prolapse I. History and Physical II. Diagnostic Tests III. Office Evaluation of Incontinence and Prolapse I. History and Physical II. Diagnostic Tests III. Office Management - Behavioral - Medical - Procedural Primary Care 2008

Objectives Voiding Dysfunction Defined as a failure to store or empty urine · Understand Objectives Voiding Dysfunction Defined as a failure to store or empty urine · Understand the current management of · office evaluation of voiding dysfunction · over active bladder (OAB) Primary Care 2008

Urinary Incontinence and Pelvic Organ Prolapse Epidemiology Urinary incontinence * · 10 -20%, aged Urinary Incontinence and Pelvic Organ Prolapse Epidemiology Urinary incontinence * · 10 -20%, aged 15 -64 years · 30 -40%, > 60 years · 50%, long-term care facility Pelvic Organ Prolapse † ‡ 50%, > 50 years of age · 30 -50%, lifetime prevalence · 354, 962 operations/year, US data (1997) · Females patients comprise 40% of a general urology practice Iselin, CE and Webster, GD: Urol Clin N Amer 1998 Samuelsson, EC, et al. : Am J Obstset Gyencol 1999 ‡ Suback, LL, et al. : Obstet Gynecol 2001 * † Primary Care 2008

How Many People Have Incontinence? · 13 million Americans of all ages suffer from How Many People Have Incontinence? · 13 million Americans of all ages suffer from urinary incontinence Women account for nearly 85% Primary Care 2008

What Is Incontinence? Incontinence is the unintentional release of urine · Embarrassing; unpredictable condition; What Is Incontinence? Incontinence is the unintentional release of urine · Embarrassing; unpredictable condition; it can cause women to: · Avoid an active lifestyle • Shy away from social situations • Constantly search for the nearest bathroom • Become too embarrassed to talk to their doctor • Primary Care 2008

Urinary Incontinence A Hidden Condition * Two-thirds of patients are symptomatic for 2 years Urinary Incontinence A Hidden Condition * Two-thirds of patients are symptomatic for 2 years before seeking treatment · 30% of patients who seek treatment receive no assessment · Nearly 80% are not examined · Patients self-manage by voiding frequently, reducing fluid intake and wearing pads Primary Care 2008 * Survey conducted by Gallup Group (European Study)

Urinary Incontinence Barriers to Treatment · Patient misconceptions and fears “Normal part of aging” Urinary Incontinence Barriers to Treatment · Patient misconceptions and fears “Normal part of aging” “Not severe or frequent enough to treat” “Too embarrassing to discuss” “Treatment won't help” Primary Care 2008

Are There Different Types of Incontinence? · 4 Types Overflow • Urge • Stress Are There Different Types of Incontinence? · 4 Types Overflow • Urge • Stress • Mixed • Primary Care 2008

Classification of Incontinence Symptom Categories * · Stress incontinence · Urge incontinence · Unconscious Classification of Incontinence Symptom Categories * · Stress incontinence · Urge incontinence · Unconscious incontinence · Continuous leakage · Nocturnal enuresis · Post-void dribble · Extra-urethral incontinence · Geriatric incontinence * Romanzi and Blaivis, Urol Clin North Am 1995 Primary Care 2008

Office Evaluation of UI and POP Goals * • • • Nature of incontinence Office Evaluation of UI and POP Goals * • • • Nature of incontinence Duration of incontinence Degree of interference with lifestyle/activities Predisposing medical/surgical conditions Prior medical/surgical therapies for incontinence Presence of pelvic floor relaxation Direct appropriate and effective therapy Primary Care 2008

Office Evaluation of UI and POP Female Bladder Questionnaire INITIAL HISTORY AND PHYSICAL FEMALE Office Evaluation of UI and POP Female Bladder Questionnaire INITIAL HISTORY AND PHYSICAL FEMALE University of Colorado Hospital (This section to be completed by patient) DIVISION OF UROLOGY Patient Name__________________ Medical Record # __________ Date________________ Age____ Phone_________________ Chief Complaint (Why you want to see the doctor today? ): ________________________________________________________________________________________ Bladder SYMPTOM QUESTIONNAIRE (circle symptoms that are present now) (Please be sure to complete the bladder diary you were sent) How often do you urinate: during the day? __________ during the night? Is the amount of urine you usually pass : Large Average Small Do you have difficulty starting your urinary flow? Yes No Do you strain to void your urine? Yes No Is your urine flow (circle one) Strong Weak Dribbling Intermittent Do you feel that you empty your bladder completely? Yes No Do you notice dribbling of urine after voiding? Yes No Do you have to assume abnormal positions to urinate? Yes No Primary Care 2008

Screening and Diagnosis of Overactive Bladder “Do you have bladder problems that are troublesome Screening and Diagnosis of Overactive Bladder “Do you have bladder problems that are troublesome or do you ever leak urine? ” YES · Assess history, symptoms, and test results · Establish a diagnosis Primary Care 2008

Office Evaluation of UI and POP Past History · Medical History • • • Office Evaluation of UI and POP Past History · Medical History • • • Diabetes mellitus GI complaints/Constipation Neurological disorders – Prior CVA – Multiple sclerosis – Parkinson’s disease · Surgical • • Incontinence and prolapse surgery, hysterectomy Radical pelvic surgery (prostatectomy, APR) Spinal surgery Bladder outlet procedures Primary Care 2008

Office Evaluation of UI and POP Obstetrical/Gynecological · Number of children (vaginal or cesarean) Office Evaluation of UI and POP Obstetrical/Gynecological · Number of children (vaginal or cesarean) · Vaginal deliveries • Number Large birth weight • Forceps delivery • · Menopausal status • Estrogen replacement Primary Care 2008

Office Evaluation of UI and POP SUI Subjective Data · Precipitating events • Minimal Office Evaluation of UI and POP SUI Subjective Data · Precipitating events • Minimal provocation: quiet walking, bending • Moderate provocation: coughing, sneezing • Significant provocation: strenuous exercise · Magnitude of stress incontinence • • • Drops v. complete void Frequency of episodes Type of pads used: liners, maxipads or diapers – How many used daily – Changed when wet, damp or dry (changed by habit) Primary Care 2008

Office Evaluation Urge Incontinence · Triggers • • • “Key in the door”, hand Office Evaluation Urge Incontinence · Triggers • • • “Key in the door”, hand washing Rising from the seated position Coughing, walking, jumping ·“Urge Syndrome” symptoms • • Frequency Nocturia Urgency Urge incontinence Primary Care 2008

OAB and Stress Incontinence Differential Diagnosis History and Physical Examination Symptom Assessment Overactive bladder OAB and Stress Incontinence Differential Diagnosis History and Physical Examination Symptom Assessment Overactive bladder Yes Stress incontinence 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 Ability to reach the toilet in time following an urge to void Waking to pass urine at night Large (if present) Small Often no Yes Usually Seldom Symptoms Urgency (strong, sudden desire to void) Abrams P, Wein AJ. The Overactive Primary Care 2008 Bladder: A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998. No

Urinary Incontinence Differential Diagnosis * Stress Urge · Condition · · Urethral hypermobility ISD Urinary Incontinence Differential Diagnosis * Stress Urge · Condition · · Urethral hypermobility ISD · Causes • · Causes • · Pelvic floor relaxation Prior pelvic surgery · Neurogenic • · Detrusor overactivity • Idiopathic Neurogenic • • * UTI Bladder cancer Outlet obstruction Romanzi and Blaivis, Urol Clin North Am 1995 Primary Care 2008

Office Evaluation of UI and POP Physical Examination · Neurological · Abdominal • • Office Evaluation of UI and POP Physical Examination · Neurological · Abdominal • • • · Back/Spine • skeletal deformities scars from trauma/surgery • tuft of hair, skin dimple • Primary Care 2008 · mental status sensory function motor function · prior surgical scars distended bladder obesity reflex integrity · ·

Office Evaluation of UI and POP Pelvic Examination · Moderately full bladder · Components Office Evaluation of UI and POP Pelvic Examination · Moderately full bladder · Components • • Visual inspection Speculum exam Assessment of pelvic floor strength Bimanual exam Primary Care 2008

Office Evaluation of UI and POP Pelvic Examination · Inspection • Labia • • Office Evaluation of UI and POP Pelvic Examination · Inspection • Labia • • Introitus • • • Signs of estrogenization Atrophy/stenosis Posterior injury from childbirth Perineum • Wide perineum or posteriorly displaced anus may indicate weakened perineal body/pelvic muscle atrophy Primary Care 2008

Office Evaluation of UI and POP Speculum Examination · Systematic • • • Anterior Office Evaluation of UI and POP Speculum Examination · Systematic • • • Anterior vaginal wall and urethra Vaginal apex Posterior vaginal wall · Valsalva/strain or cough · Stage • Baden-Walker (halfway down v. POPQ) Primary Care 2008

Office Evaluation of UI and POP Anterior Compartment · Urethral or bladder decent · Office Evaluation of UI and POP Anterior Compartment · Urethral or bladder decent · +/- Q-tip test · Incontinence (Quantity relative to valsalva) · Cystocele · Lateral defect • Corrected by replacing the lateral fornices to the sidewall (using ring forceps) · Central defect • Smooth surfaced (loss of rugae) herniation not corrected by lateral replacement Primary Care 2008

Office Evaluation of UI and POP Vaginal Apex and Posterior Compartment · Position of Office Evaluation of UI and POP Vaginal Apex and Posterior Compartment · Position of cervix or vaginal cuff • • Cervical descent with straining Cervical mucosal appearance · Rectocele · · · Bulge close to the introitus generally Confirm with simultaneous DRE Graded similar to cystocele · Enterocele · · Bulge generally higher in vault Bidigital rectovaginal exam essential Primary Care 2008

Office Evaluation of UI and POP Objective Data • • • Voiding diary Pad Office Evaluation of UI and POP Objective Data • • • Voiding diary Pad weight test Laboratory tests Cystourethroscopy Urodynamics • Eyeball urodynamics • Multichannel urodynamics Primary Care 2008

Office Evaluation Voiding Diary (3 -5 days) · Date, time and volume of each Office Evaluation Voiding Diary (3 -5 days) · Date, time and volume of each void · Record of each incontinent episode • time amount • precipitating cause of leakage • Poor correlation between patient’s recalled history of nature/ volume/frequency of incontinent events and voiding diary Primary Care 2008

Office Evaluation of UI and POP Pad Weight Test · Only truly objective measure Office Evaluation of UI and POP Pad Weight Test · Only truly objective measure of incontinence · 1 ml urine roughly equals 1 gm · Weight of wet pad minus sample dry pad · 24 -hour test best for urge and stress incontinence · 1 -hour pad test standardized by ICS good measure of SUI Primary Care 2008

Office Evaluation of UI and POP Laboratory Evaluation · Urine analysis and culture · Office Evaluation of UI and POP Laboratory Evaluation · Urine analysis and culture · BUN and creatinine · Hematuria • Cytology • Upper tract evaluation (IVP or CT) • Cystoscopy Primary Care 2008

Office Evaluation of UI and POP Cystoscopy · Urethra • • Urethritis (shaggy, erythematous, Office Evaluation of UI and POP Cystoscopy · Urethra • • Urethritis (shaggy, erythematous, painful mucosa), atrophy (pale), diverticulum, FB Stricture · Bladder • • • Outlet (contracture, BPH) Neoplasia Ureteral orifice (location and number) Diverticuli Calculi and foreign bodies Not usually required in most patients, but generally helpful in patients with prior surgery Primary Care 2008

Office Evaluation of UI and POP Urodynamics * Not generally required in most patients Office Evaluation of UI and POP Urodynamics * Not generally required in most patients with uncomplicated incontinence In neurologically intact patients, one can proceed with noninvasive empiric therapy if history, physical and urinalysis do not suggest serious pathology * Erickson and Davies, AUA update series, 1999 (11) Primary Care 2008

Office Evaluation of UI and POP Urodynamics * · Indications • • • * Office Evaluation of UI and POP Urodynamics * · Indications • • • * Iselin Initial tests inconclusive Prior corrective surgery for incontinence Prior radical pelvic surgery or radiotherapy Neurologic disorder Mixed stress/urge with unclear relative contribution and Webster, Urol Clin N Amer 1998 Primary Care 2008

Behavioral Management Primary Care 2008 Behavioral Management Primary Care 2008

Management of Urinary Incontinence Behavioral Modifications Timed Voiding Education Pelvic Floor Exercises Behavioral Modification Management of Urinary Incontinence Behavioral Modifications Timed Voiding Education Pelvic Floor Exercises Behavioral Modification Reinforcement Primary Care 2008 Delayed Voiding

Office Treatment of Urinary Incontinence Behavioral Therapy “Force the patient to store larger volumes Office Treatment of Urinary Incontinence Behavioral Therapy “Force the patient to store larger volumes of urine under conditions of physical activity and urgency by using the pelvic floor to maintain continence and to inhibit the detrusor” • • • Fluid and dietary modification Bladder retraining Pelvic floor reeducation Iselin and Webster, Urol Clin N Amer 1998 Primary Care 2008

Office Treatment of Urinary Incontinence Fluid and Dietary Modification · Fluid restriction often practiced Office Treatment of Urinary Incontinence Fluid and Dietary Modification · Fluid restriction often practiced and often counterproductive • • Concentrated urine, irritating, increased odor Increased urgency and frequency · Drink small amounts often, usually before 7 pm · Increase intake in hot weather or exercise · Avoid bladder irritants • Coffee and tea, carbonated beverages, chocolate, spicy and tomato based foods · Avoid constipation, which contributes to urgency • Increased fiber and fluid intake Primary Care 2008

Management of Urinary Incontinence Biofeedback · Monitoring instruments to detect and amplify internal unconscious Management of Urinary Incontinence Biofeedback · Monitoring instruments to detect and amplify internal unconscious functions · EMG v. manometric devices · Can significantly improve success rates to 50% with reeducation alone, to 90% with biofeedback Primary Care 2008

Pharmacologic Management of OAB Primary Care 2008 Pharmacologic Management of OAB Primary Care 2008

Management of OAB ICS Definition Urgency, with or without incontinence, usually with frequency and Management of OAB ICS Definition Urgency, with or without incontinence, usually with frequency and nocturia In the absence of a pathologic or metabolic condition that might explain these symptoms International Continence Society: 2002 Primary Care 2008

Office Evaluation Urge Incontinence · Rule-out neurological disorders • • • Radicular pain Paresthesias Office Evaluation Urge Incontinence · Rule-out neurological disorders • • • Radicular pain Paresthesias Muscle weakness Diminished sensation Ocular symptoms (MS) · Bladder outlet obstruction · Risk factors for TCC of the bladder Primary Care 2008

Distribution of Muscarinic Receptors Muscarinic receptors are Abrams P, Wein AJ. The Overactive Bladder—A Distribution of Muscarinic Receptors Muscarinic receptors are Abrams P, Wein AJ. The Overactive Bladder—A Widespread and Treatable Condition. 1998. also located in the CNS. Primary Care 2008

Management of OAB Pharmacologic Therapy Antimuscarinic agents are the mainstay · OAB symptoms relieved Management of OAB Pharmacologic Therapy Antimuscarinic agents are the mainstay · OAB symptoms relieved by · inhibition of involuntary bladder contractions • increased bladder capacity • · Treatment limited by side effects dry mouth • dry eyes, blurred vision • constipation, GERD • CNS effects • Primary Care 2008

Anticholinergic Agents Oxybutynin Immediate Release (OXY-IR) · It is a tertiary amine that is Anticholinergic Agents Oxybutynin Immediate Release (OXY-IR) · It is a tertiary amine that is smooth muscle relaxant that facilitates bladder storage · Pharmacodynamic properties • Extensive first-pass hepatic metabolism by cytochrome P 450 enzyme (CYP 3 A 4) into many active metabolites • The primary active metabolite is N-desethyloxybutynin (N-DEO) has been implicated as the cause of side effects • Side effects • dry mouth, dry eyes, constipation, CNS impairment · Contraindicated in patients with glaucoma · Oxy-IR 2. 5 -5 mg po TID Primary Care 2008

Anticholinergic Agents Oxybutynin Extended release (XL) • • • OXY-ER is designed to pass Anticholinergic Agents Oxybutynin Extended release (XL) • • • OXY-ER is designed to pass through the upper GI tract OXY-ER is metabolized primarily in the colon This delays absorption and reduces first-pass effect Results in reduced N-DEO levels compared to OXY-IR OXY-ER has equivalent efficacy to OXY-IR, improved dosing and side-effect profile Extended 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

Anticholinergic Agents Oxybutynin Transdermal Delivery System (OXY-TDS) • Rationale • Oral bioavailability is low Anticholinergic Agents Oxybutynin Transdermal Delivery System (OXY-TDS) • Rationale • Oral bioavailability is low • OXY-TDS avoids first-pass gastric and hepatic metabolism • Effective OXY-TDS dose is 3. 9 mg/day Results • OXY-TDS maintains a consistent delivery of OXY over a 96 -hours with marked reduction in the plasma concentrations of N-DEO • OXY-TDS has equivalent efficacy to OXY-IR and lower AEs • Primary AE is application site reaction (9% discontinuation) Dmochowski RR, et al. : J Urol 2002 Primary Care 2008 Diokno AC, et al. : OPERA Trial, Urology 2003

Anticholinergic Agents Tolterodine (Detrol) · · It is a tertiary amine that is less Anticholinergic Agents Tolterodine (Detrol) · · It is a tertiary amine that is less lipid soluble then oxybutynin and has a limited capacity to cross the blood-brain barrier Pharmacodynamic properties • Extensively metabolized by cytochrome P 450 enzyme (CYP 2 D 6) and has a major active metabolite similar to parent compound • Non selective muscarinic receptor antagonist • Decreased frequency of voids • Decreased urge incontinence episodes Similar efficacy to oxybutynin-IR with better tolerance and fewer drop outs Continuation rates higher than with oxybutynin IR • • Tolterodine IR 2 mg po BID Tolterodine long acting (Detrol LA) 4 mg po QD Van Kerrebroeck P, et al. : Urology 2001 Primary Care 2008

Anticholinergic Agents Tropsium (Sanctura) It is a quaternary amine that is less lipid soluble Anticholinergic Agents Tropsium (Sanctura) It is a quaternary amine that is less lipid soluble then oxybutynin and does not cross the blood-brain barrier to the same extent · Pharmacodynamic properties • Competitive antagonist of ACh at postsynaptic binding sites • Only anticholinergic that is not metabolized by cytochrome P 450 rather it is excreted unchanged in the urine by tubular secretion • Comparable selectivity for M 1 -M 5 Efficacy • Decreased frequency of voids • Decreased urge incontinence episodes • Onset within one week · Low GI absorption/low bioavailability • <10% is absorbed; bioavailability is low at 9. 6% • Tropsium (Sanctura) 20 -40 mg po BID · Fusgen I, et al. : Int J Clin Pharmacol Ther 2000 Zinner 2008 Primary Care. N, et al. : J Urol 2004

Anticholinergic Agents Darifenacin (Enablex) Pharmacodynamic properties • Metabolized by P 450 isoforms CYP 3 Anticholinergic Agents Darifenacin (Enablex) Pharmacodynamic properties • Metabolized by P 450 isoforms CYP 3 A 4 and CYP 2 D 6 • Dose adjusted in patients taking potent CYP 3 A 4 inhibitors • Darifenacin has the greatest M 3 affinity • Decreased frequency of voids • Decreased urge incontinence episodes • M 3 receptors are involved in contraction of the bladder, GI smooth muscle, heart and saliva production · Darifenacin 7. 5 -15 mg po QD · Haab F, et al. : Eur Urol 2004 Chapple CR. J Urol 2004 Primary Care 2008

Anticholinergic Agents Solifenacin (VESIcare) · · A tertiary amine that is well absorbed by Anticholinergic Agents Solifenacin (VESIcare) · · A tertiary amine that is well absorbed by the GI tract Pharmacodynamic properties • Muscarinic antagonist with some M 3 selectivity (10 fold) • Metabolized by P 450 isoform CYP 3 A 4 • Elimination half-life following chronic dosing is approximately 45 to 68 hours Efficacy, safety and tolerability documented in phase III trials • Significant reduction in frequency, urgency and urge incontinence episodes Solifenacin 5 -10 po QD Chapple CR, et al. : BJU Int 2004 a Chapple CR, et al. : BJU Int 2004 b Primary Care 2008

Management of Refractory OAB Primary Care 2008 Management of Refractory OAB Primary Care 2008

Management of Refractory OAB/PBS · Endoscopic procedures • • • · · Urethral dilation Management of Refractory OAB/PBS · Endoscopic procedures • • • · · Urethral dilation Direct ulcer injection Endoscopic resection Laser therapy Hydrodistention Botox injection Ingelman-Sundberg • Transvesical phenol injection • Cystoloysis • Sacral rhizotomy • · Electrical stimulation • • Denervation Cystoplasty Autoaugmentation • Enterocystoplasty • Perc neuromodulation Afferent nerve stimulator · Urinary diversion Mitrofanoff • Conduit • Continent diversion • Stepwise approach in most instances from least invasive to most invasive Primary Care 2008

Management of Refractory OAB Intravesical Botilinum Toxin (botox) Botox is derived from the organism Management of Refractory OAB Intravesical Botilinum Toxin (botox) Botox is derived from the organism C. botulinum · Inhibits the vesicular neuronal blockade up to 9 mos · Increasing data on the benefits of botox in patients with • Non-neurogenic DO • Neurogenic DO • DSD • Interstitial cystitis? · Schurch B, et al. : J Urol 2000 Smith CP and Chancellor MB: J Urol 2004 Primary Care 2008

Management of Refractory OAB Intravesical Botilinum Toxin Type-A (botox) · Technique Urethra • 100 Management of Refractory OAB Intravesical Botilinum Toxin Type-A (botox) · Technique Urethra • 100 units in 2 -3 ml of NS Collagen needle used to inject 3, 6, 9 and 12 o’clock positions in striated sphincter · Bladder • 200 -300 units in 30 ml of NS • Inject 30 -40 sites within the detrusor, targeting the trigone, base of the bladder and lateral walls • Schurch B, et al. : J Urol 2000 Primary Care 2008 Smith CP and Chancellor MB: J Urol 2004

Management of Refractory OAB Interstim™ has evolved from a large cut-down procedure over the Management of Refractory OAB Interstim™ has evolved from a large cut-down procedure over the Primary Care 2008 sacrum to a less invasive percutaneous tined lead approach

Management of SUI Primary Care 2008 Management of SUI Primary Care 2008

What Causes SUI? Pelvic muscle strain · Childbirth · Pelvic muscle tone loss · What Causes SUI? Pelvic muscle strain · Childbirth · Pelvic muscle tone loss · Estrogen loss/menopause · Primary Care 2008

More About SUI · Most prevalent type of incontinence You are not alone! • More About SUI · Most prevalent type of incontinence You are not alone! • 8 million women have SUI • · Affects women of all ages, young mothers, premenopausal women, seniors • · Average of onset: 48 Treatable condition Primary Care 2008

The Impact of SUI 70% of women with SUI surveyed said they worry about The Impact of SUI 70% of women with SUI surveyed said they worry about coughing, sneezing and even laughing in public for fear of having an accident · 35% report changing their activities to accommodate the condition including avoiding exercise, traveling less frequently and avoiding sex · 62% waited a year or longer before even discussing their condition with a doctor · * Gallup Survey, April 2002 63

There is Treatment for SUI! Self management · Medication · Biofeedback, electrical stimulation · There is Treatment for SUI! Self management · Medication · Biofeedback, electrical stimulation · Minimally invasive procedures · Primary Care 2008

Minimally Invasive Procedures · Common SUI surgical procedures Bladder neck suspensions • Needle suspensions Minimally Invasive Procedures · Common SUI surgical procedures Bladder neck suspensions • Needle suspensions • Conventional sling procedures • · Most treatments are Invasive • Involve general anesthesia • Require hospital stay • Require extended recovery time (up to six weeks) • Primary Care 2008

TVT How Does It Work? · Restores your body’s ability to control urine loss TVT How Does It Work? · Restores your body’s ability to control urine loss Surgeon provides support to the urethra by placing a "sling" or mesh tape beneath it • The tape supports the urethra during sudden movements, such as a cough or sneeze, keeping the urethra closed and preventing the involuntary loss of urine. • Primary Care 2008

Benefits • Completed in 30 minutes • Patient may be able to return home Benefits • 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 Treatment · Effective 86% cured, • 11% report improvement • Follow-up studies Simple, Proven Treatment · Effective 86% cured, • 11% report improvement • Follow-up studies show that even years later women stay dry • · More than 500, 000 women worldwide have been treated Primary Care 2008

What Are The Potential Risks? All medical procedures contain some risk · Hemorrhage/hematoma · What Are The Potential Risks? All medical procedures contain some risk · Hemorrhage/hematoma · Injury to blood vessels, bladder or bowel · Difficulty with urination Primary Care 2008

TVT-Obturator Convalescence • • • Results Mean operative time 28 minutes All patients discharged TVT-Obturator Convalescence • • • Results Mean operative time 28 minutes All patients discharged same day without catheter All patients returned to normal activity, with the exception of heavy lifting, in < 7 days Intra-Operative Complications There were no to bladder, bowel or neural injury • 1 intra-operative urethral injury was repaired and TVT-O completed • Mean EBL 43 (0 -300) ml • no patient required a blood transfusion • Flynn BJ and Myers J: 2008 Primary Care SC AUA 2005

TVT-Obturator Continence Outcome Results Mean follow-up 13. 5 (2 -23) months 76 of 82 TVT-Obturator Continence Outcome Results Mean follow-up 13. 5 (2 -23) months 76 of 82 (92. 6%) patients cured • 66 patients required 0 pads • 10 patients averaged 1 ppd • 6 of 82 (7. 4%) patients were considered failures • 5 patients with persistent/recurrent SUI (> 1 ppd) • • Complications 4 case of bladder incomplete emptying or de novo urgency required urethrolysis in 2 • 1 vaginal mesh extrusion noted at 6 weeks • Multi-layer closure performed, no recurrent extrusion • Flynn BJ and Myers J: SC AUA 2005 Primary Care 2008

Tension-Free Vaginal Tape Secur (TVT-S™) The Next Generation * Gynecare Inc. , Summerville, NJ Tension-Free Vaginal Tape Secur (TVT-S™) The Next Generation * Gynecare Inc. , Summerville, NJ 1. 1 x 8 cm of laser cut polypropylene mesh tape placed through a small vaginal incision under the mid-urethra with no exit site Can be placed as a ‘U” or “hammock” · Unique tension-free fixation mechanism · Primary Care 2008

Tension-Free Vaginal Tape Secur (TVT-S™) Proposed Advantages Can be done under local anesthesia, outpatient, Tension-Free Vaginal Tape Secur (TVT-S™) Proposed Advantages Can be done under local anesthesia, outpatient, no catheter, ability to do cough test · · · · Less invasive Less dissection Less pain Less complicated Less bleeding Eliminate risk of bowel, Lower risk of retention ureteral injury and de novo urgency Primary Care 2008

Management of POP Primary Care 2008 Management of POP Primary Care 2008

Etiology of Pelvic Organ Prolapse Childbirth · Estrogen deficiency · Chronic intra-abdominal pressure · Etiology of Pelvic Organ Prolapse Childbirth · Estrogen deficiency · Chronic intra-abdominal pressure · Pulmonary disease • Heavy lifting • Chronic straining • · Neuropraxia affecting the pelvic floor Primary Care 2008

Pelvic Organ Prolapse Prevalence POP in > 50% of women over 501 · Lifetime Pelvic Organ Prolapse Prevalence POP in > 50% of women over 501 · Lifetime prevalence of 30 -50%1 · Women > 65 is the fastest growing segment of the US population 2 · Demand for services expected to double in the next 30 years 3 · 1 2 3 Subak et al. Obstet Gynecol 2001; 98: 646 -651 US Census Bureau 2000 Int data base Luber et al. Am J Obstet Gynecol 2001; 184: 1496 -1501 Primary Care 2008

POP Procedural Demand 11% risk of surgical intervention by age 801 226, 000 procedures POP Procedural Demand 11% risk of surgical intervention by age 801 226, 000 procedures performed in 19972 Cost > $1 billion 3 Estimated number in 2030 is 7 million 4 Represents a small subset of symptomatic patients · · · 1 2 3 4 Olsen et al. Obstet Gynecol 1997; 89: 501 -506 Brown et al. Am J Ob Gyn 2002; 186: 712 -716 Subak et al. Obstet Gynecol 2001; 98: 646 -651 Shull. Am J Ob Gyn 1999; 181: 6 -11 Primary Care 2008

Management of Level I Defects · Expectant management • When is it appropriate? Pessary Management of Level I Defects · Expectant management • When is it appropriate? Pessary placement · Surgical Correction · Vaginal • Abdominal • Combined • Laparoscopic • Primary Care 2008

Nonsurgical Management of Vaginal Vault Prolapse Kegel exercises · Reduce intrabdominal pressure/straining • Bowel Nonsurgical Management of Vaginal Vault Prolapse Kegel exercises · Reduce intrabdominal pressure/straining • Bowel regimen • Weight reduction • Eliminate heavy lifting · Pessary · Primary Care 2008

How are we doing with our current surgical procedures? · · 11. 1% lifetime How are we doing with our current surgical procedures? · · 11. 1% lifetime risk of surgery 29 -40% patients require reoperation within 3 years 1, 2 60% of the recurrences are at the same site 3 32. 5% of the recurrences are at a different site 3 Olson et al. Obstet and Gynecol 1997; 89: 501 -506 Marchionni et al. J Reproduct Med 1999; 44; 679 -684 3 Clark et al. Am J Obstet and Gynecol 2003; 189: 1261 -1267 1 2 Primary Care 2008

PROLIFT System: Early Outcome Data 1, 2 Author Groenen MJC et. al. (Netherlands)1 # PROLIFT System: Early Outcome Data 1, 2 Author Groenen MJC et. al. (Netherlands)1 # Mean Pts Age Site 26 A-6 P-10 T-10 61 Perscheler M et. al. (Austria)1 80 N/A Rivera JM et. al. (USA)2 82 63 Compiled Data 1 IUGA 549 64 Complications Vd. dysfcn-5 Exposure 1 (3. 8%) S=N/A Cystotomy-2 Hematomas-2 8 (10%) S=5 (50%) P-19 T-63 Hematoma-1 Hemmorrhage-1 7 (11. 7%) S=N/A A-109 P-85 T-256 Cystotomy- 1. 7% Rectal perf- 0. 4% Hemorrhagic 1. 3% Void dysfcn- 6. 7% 34 (6. 2%) S=12 (2. 6%) Length of Follow Up “Success” (< Stage II) 2 mo. 26 (100%) N/A 3 mo. Not well defined 6 mo. 81. 4 -100% – Fatton - 2006 Abstracts all. Primary Care in: Int Urogynecol J 2006; 17(S. 2): S 212 published 2008 2006 Abstract published in: Int Urogyn J 2006; 17(S. 3): S 460 2 AUGS

Polypropylene mesh reinforced pelvic floor repair and vaginal vault suspension (Prolift) Operative Technique Anterior Polypropylene mesh reinforced pelvic floor repair and vaginal vault suspension (Prolift) Operative Technique Anterior Mesh Implant Primary Care 2008

Resources Where you can find more information: · www. nafc. org (National Association for Resources Where you can find more information: · www. nafc. org (National Association for Continence) · www. simonfoundation. org · www. niddk. nih. gov (National Kidney and Urologic Diseases Information Clearinghouse) Primary Care 2008