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Constellation of physical finding and symptoms Bladder Function UI & VD Sexual Function POP Bowel Function FI & DD R. Keith Huffaker, M.D. ETSU Center for Pelvic Surgery and Urogynecology East Tennessee State University Quillen College of Medicine Prevalence of POP or PFD in Noninstitutionalized U.S. Pop Pelvic floor disorders affect a substantial proportion of women 25 Pelvic Floor Disorders Prevalence of POP or PFD in Noninstitutionalized U.S. Pop, Impact of Age PFD N = 1,961, > 20 y/o, sample ’05-06 NHANES UI FI POP 50 N =1,961 20 40 15 30 % % 20 10 10 5 0 0 20-39 PFD UI FI 40-59 60-79 >80 POP Age, years Nygaard et.al. Pelvic Floor Disorders Network. JAMA. 2008 Sep 17;300(11):1311-6 Nygaard et.al. Pelvic Floor Disorders Network. JAMA. 2008 Sep 17;300(11):1311-6 1 Surgery for POP and UI Prevalence of > 1 PFD in Noninstitutionalized U.S. Pop., Impact of Weight 12 Cumulativ ve Incidence (%) 30 N = 1,961, > 20 y/o, sample ’05-06 NHANES 25 20 % 15 10 10 5 0 8 6 4 2 0 20-29 Normal Overweight 30-39 Obese 40-49 50-59 60-69 70-79 Age Range (years) Weight Olson et al, Obstet Gynecol 1997;89:501 Nygaard et.al. Pelvic Floor Disorders Network. JAMA. 2008 Sep 17;300(11):1311-6 PFDs Significantly Impact QoL Impact of POP/PFDs Qol Indicator Impact y >200,00 surgeries performed for POP or UI each year in the U.S. y Projected 45% increase in next 30 years •Physical Limited activities •Social Isolation •Sexual Avoidance y Cost exceeds 1 billion dollars/y •Psychological Depression, Loss of self esteem y Untreated symptomatic POP/PFD have a significant negative impact on QoL •Occupational Decreased nonsurgical treatments productivity Majority of surgical and of demonstrate significant •Domestic PFD’sPersonal hygiene improvement in QoL 2 Urinary Incontinence Prevalence Rates by Age and Gender Urinary Incontinence 18% 16% y A condition that affects more than 10 million Americans. 14% Prevalence y Involuntary leakage y Less than 50% of incontinent women seek care— under‐reported. y Direct financial costs of over $15 billion. Male Female 12% 10% 8% 6% 4% y Only a fraction spent for diagnosis and treatment. 2% 0% 5-14 15-24 25-34 35-44 45-54 55-64 65-74 75-84 >85 Total Age (Years) Thomas TM, et al. Br Med J. 1980;281(6250):1243-1245. hh1 Urinary Incontinence Is More Prevalent than Other Chronic Conditions in Women Prevalence in Women 40% 35 25 20 20% 10% 0% Predispose Gender Race Neurologic Muscular Anatomic Collagen Family UI not life-threatening, but QoL issue 30% Risk Factors for Urinary Incontinence 8 Incontinence1 Hypertension2 1. Hampel C, et al. Urology. 1997;50(suppl 6A):4-14. 2. American Heart Association. Electronic Citation; 2001. 3. American Family Physician. Electronic Citation; 2001. 4. NIDDK. Electronic Citation; 2001. Depression3 Diabetes4 Incite Childbirth Hysterectomy Vaginal surgery Radical pelvic surgery Radiation Injury Abnormal Intervene Behavioral Pharmacological Devices Surgical Stress Function Normal Promote Obesity Lung disease Smoking Menopause Constipation Recreation Occupation Medications M di ti Infection Decompensate Aging Dementia Debility Disease Environment Medications Bump RC, Norton PA. Obstet Gynecol Clin North Am. 1998;25(4):723-746. 3 Slide 12 hh1 black outs with video of woman; gender, race hhubbard, 6/6/2002 Office Evaluation of Urinary Incontinence (History) Urologic Symptoms Stress incontinence Urgency Urge incontinence Frequency Nocturia Enuresis Dysuria Difficulty voiding Post‐void fullness Post‐void dribbling Hematuria Stress Incontinence OverActiveBladder Consultation for Evaluation of Lower Urinary Tract Dysfunction Frequency (7/day) Nocturia Nocturnal enuresis y Persistent UTI following tx y Small bladder capacity y Abnormal neurologic function y Fistula Coital incontinence y Signs of voiding dysfunction or retention y Absent sensation y Large bladder capacity y Elevated post‐void residual y Failure of response to treatment for incontinence Severity Infection Obstruction Detrusor dysfunction y Urethral diverticula Walters MD et al J Am Board Fam Pract 1992;5:289 4 Other Causes of Accidental Urine Loss Urinary Incontinence Symptoms/Dx Symptom/Dx Symptoms: Description y Overflow Leakage with physical exertion or on sneezing or coughing y Functional y Ectopic ureter Ectopic ureter* Continuous & Insensitive Urge Leakage with a strong and urgent desire to void y Fistula* high volume UI Mixed Combination of stress and urge y Urethral diverticulum* Post void dribbling & dyspareunia Stress Frequency & Urge Inc *less common. Voiding Diary Verses Fluid Intake / Output Diary Q‐tip Test Hypermobile > 30 degrees 5 Cystometry •Pressure‐volume relationship of the bladder to filling •Main diagnostic value to assess stress incontinence and detrusor overactivity •Improvement of sensitivity p y with: •Maximum capacity •Patient standing •Detrusor‐provoking maneuvers Terminology Technique Fill with ith normall saline li Detrusor overactivity Bladder pressure (Pves) monitored Standing patient valsalvas Pves at which leakage occurs = aLPP Variables: catheter size, volume, patient position, vaginal prolapse, radiographic vs. visual • “urodynamic” definition Urge incontinence • sensory • motor • hyperreflexia 6 Additional tests Additional tests Uroflow • Depicts urinary flow rate and pattern Pressure flow study • Identifies bladder outlet obstruction • Pdet = Pabd - Pves • No diagnostic cut off to identify obstruction in women (?Pdet < 40 cm water, max flow rate >15) Sphincter EMG • Evaluates sphincter control and coordination (DSD) • Does not identify neuropathy Video urodynamics • • • • DSD Vesicoureteral reflux Outlet obstruction Associated pathology Pelvic Floor Muscle Training Treatment Options for SUI y Nonsurgical y Weight reduction if obese y Pelvic Floor Muscle Training* y Incontinence Pessary I i P y SRI (Duloxetine)? Electrical Stimulation Home H Biofeedback Vaginal Weights y Surgical* y Minimally invasive outpatient procedures y y TVT/TOT Urethral bulking *most accepted Rx modalities 1. Experienced Pelvic Floor Physical Therapist 2. Motivated Patient Pelvometer 7 SUI Pessaries FemsoftTM Urethral Inserts Management of OAB 1ST TIER BEHAVIORAL Rx Fluid & caffeine modulation Bladder retraining/PFMT 1. MEDICAL MANAGEMENT = 2. Anticholinergics* 1. only 10-15% continue >1yr 2. nongenerics expensive 3. similar efficacies & side-effects 2nd TIER INTRAVESICAL BOTOX 3rd TIER AUGMENTATION CYSTOPLASTY NEUROMODULATION 1. Sacral N. 2. Peripheral N. URINARY CONDUIT OR CONTINENT DIVERSION *significant placebo effect in trials Medical Management of OAB What are the anti‐cholinergic side‐ effects? Improve tolerability : y Anticholinergics/Antimuscarinics y Dry mouth* y Constipation* y Results: y 70 ‐ 90% improvement in symptoms y 20 ‐ 40% completely continent y Blurred vision y Anhidrosis 1. Dry Mouth = “sign of effectiveness” & use of gum or hard candy for Rx p 2. MOM or Miralax for constipation y Elderly – confusion, sleep disturbance, dizziness & increase risk of fall y Flexible dosing regimens and side‐effects *Most common 8 Contraindications for Anticholinergic Rx of OAB Long Term Use of Anticholinergics given for Urge Incontinence y Uncontrolled narrow angle glaucoma y ~50% patients don’t refill original script y Significant PVR (unless supplemented with CISC) y ~10 – 15% try different preparation y Gastric retention y Only 10 – 15% persist with Rx for 1 yr y Adherence rates in practice much lower than in studies y Perception of lack of efficacy, side‐effects, polypharmacy, & costs y Importance of patient counseling and coordinated management plan y Hypersensitiviy to any of formulations y Caution in patients with renal or hepatic impairment Eur J Clin Pharmacol. 2009 Mar;65(3):309-14. J. Manag Care Pharm. 2008 April 14(3):309-11. BJU Int. 2008 Sep;102(7):774-9. Botox Mechanism of Action Intravesical Botox Injection y Indicated for Refactory OAB (unresponsive to anticholinergics and behavioral RX) y Both Neurogenic and idiopathic OAB respond to BTxA (J Urol. 2005 Sep;174(3):984‐9) y Efficacy lasts for ~ 6 ‐12 mths Efficacy lasts for 6 12 mths (BJU Int. 2005 Oct;96(6):848‐52) (BJU I t O t 6(6) 8 8 ) y Improves QoL, effect sustained after repeat injections (over 5 yrs), need for CISC ~47% (J Urol. 2009 Apr;181(4):1773‐8.) y Not covered by Medicare and many private insurers 9 Sacral Neuromodulation Sacral Neuromodulation y ~65‐90% maintain efficacy over 3‐5 yrs y ~1/3 require repeat procedure (lead migration, pain, g p technical difficulties) y Expensive y Intractable OAB, failed nonsurgical Rx y ~50% test pts demonstrate >50% improvement in symptoms by diary y FDA approval 1997 (InterStimR, Medtronic) y Lead & stimulator $10K y Hosp/Surg fees $10‐20K Urology. 2006 Mar;67(3):550-3. J Urol. 2000 Apr;163(4):1219-22. Eur Urol. 2000 Feb;37(2):161-71. Peripheral Nerve Stimulation y # different sites evaluated y Posterior Tibial Nerve Stimulation yNeedle and percutaneous methods y30 min. weekly sessions y~2/3 patients have significant improvement y Not covered by Medicare and most private insurers Summary y UI negatively affects QoL and may lead to isolation and reduced productivity y Effective Rx exist for Rx of UI y Non‐surgical management is the mainstay of Rx for OAB/Urge Incontinence y Intravesical Botox and neuromodulation are options for OAB failing anticholinergic Rx y Surgical Rx mainstay for significant SUI 10 “Agnes…Your uterus is showing again” Risk Factors for Symptomatic POP y Increasing parity y Vaginal delivery > c‐section y Protective effect of c‐section diminishes with increasing parity and ageing y Forceps delivery >SVD y Increasing weight y Increasing strenuous work or activities y Chronic straining with constipation y Genetic factors y Increased transverse diameter of pelvis y Family Hx POP y Personal Hx hernias or stretch marks y Vaginal deliveries Signs and Symptoms Pressure (fullness, heaviness) Protrusion (“falling out”) Urinary retention Overflow incontinence Constipation V i l bl di ( l Vaginal bleeding (ulceration) ti ) y Vaginal Bulge and pressure/heaviness y “feels like insides are going to fall out” y Rarely associated with pain y Symptoms increase throughout day & resolve with lying down y Most reliable predictor of POP y Minimal symptoms until “bulge” near or past the hymen 11 Symptoms of POP Symptoms of POP y Poor correlation with anterior compartment prolapse and UI y Stronger correlation with progressive AC POP and obstructive voiding y c/o urinary hesitancy, increased throughout day c/o urinary hesitancy increased throughout day y Increased PVR and recurrent UTI y Weak association between progressive posterior compartment prolapse & defecatory dysfunction y Patients may admit to vaginal or peri‐rectal splinting y Roughly 50 – R hl 70% improvement with surgical repair % i t ith i l i y Weak association between PC prolapse and FI y Most commonly in association with anal sphincter disruption or dysfunction Pelvic Organ Prolapse Physical Examination y Anatomic support in female y Vaginal tissue y Vaginitis y Vaginal atrophy y Scarring y Neurologic examination, reflexes y Levator muscle atrophy and tone y Consider distended bladder, fecal impaction y Thorough history and physical Ancillary Physical y Standing rectovaginal exam y Stress urinary incontinence present prior to t i t prolapse/vault descent? Î urodynamic studies y Perineal descent y Fecal incontinence? Î endoanal ultrasound y Determine location of y Examine in lithotomy and standing position yQ Q‐tip test p y Rectal prolapse site‐specific defects? y Evaluate for all defects 12 Levator Ani Muscles y Neuromuscular injury allows widening of the genital hiatus and chronic direct stress to the CT attachments y Pts with POP 7x more likely to have major LA defects on MRI than controls y PFM contractile force less in POP cases Comparison of ordinal grading systems for prolapse, 1963-98 Obstet Gynecol. 2007 Feb;109(2 Pt 1):295-302. Computer Enhanced MRI image 23y/o Go 3D Fibromuscular CT Attachments: DeLancey’s Levels of Support Level I - Suspension Level II - Attachment Level III - Fusion 13 Management Options for POP Surgical Management of POP y y 1. Minimally or asymptomatic – expectant Natural Hx not well defined y y • Symptomatic y y 1. 2. 3. Keys to successful correction and durability: Recognition of the CT defects leading to POP Pessary or surgery Surgery : Reconstructive or obliterative Vaginal, abdominal (open, laparoscopic, robotic) Native tissue or augmentation • Surgeon experience 2. • • 3. Repair the defects or, Perform a compensatory procedure Repetition Versatility Most recurrences occur in the AC – failure to recognize & repair the transverse/apical defect . Recurrent POP y Historical risk of recurrent symptomatic POP requiring repeat surgery ~30% y Recurrence risk following surgical repair of AC POP ranges from ~5 – 60% y Recognition of the importance of apical loss of support increasing y NHDS Data,1979 – 1997. y rate of repairs for cystocele and rectocele ~constant 120 ‐ 140,000/y y rate of apical repairs increased by ~15 fold (1,400 to 22,000/year) y Recurrent POP (> Stage II) in 58% ‐ 1 yr FU y 71% ant. & 45% post. colporrhaphy y only 4% with concurrent apical repair Boyles, Am J Obstet Gynecol 1999 y Native tissue repairs with attention given to apical POP show recurrent POP < 15% at 4 – 5 y FU Shull, Am J Obstet Gynecol 2000 Silva, Obstet Gynecol 2006 Boyles et.al. Am J Obstet Gynecol 2003 14 Mesh Kits Better than repairs with native tissue? $$ Recurrent or persistent POP Morbidity unique to mesh use or kits AMS ElevateTM FDA 510 K Approval Process ACOG PRACTICE BULLETIN CLINICAL MANAGEMENT GUIDELINES FOR OBSTETRICIAN-GYNECOLOGISTS NUMBER 85, AUGUST 2007 Pelvic Organ Prolapse “Given the limited data and frequent changes in the marketed products…., patients should consent to surgery with an understanding of the postoperative risks and complications and lack of long-term outcomes data. .” FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence (Issued: Oct 20, 2008) National Health Service – National Institute for Health and Clinical Excellence, June 2008. •>1,000 reports from nine surgical mesh manufacturers of complications •Most frequent = erosions , infection, pain, recurrent POP, and/or incontinence leading to significant decrease in patient QoL •Recommendations to physicians included – “inform patients mesh permanent, complications may require subsequent surgery which may not correct the complication” •Encouraged reporting of adverse advents French Health Authority's Report Nov 2006 – “transvaginal mesh should be limited to clinical research” 15 Conclusion What factors influence your choice of Surgical Techniques for Rx POP? y Patient age, physical activities and co‐morbid medical conditions y Previous surgery, including failed POP Rx y Concurrent AC & PC defects, need for hysterectomy or Rx SUI Concurrent AC & PC defects need for hysterectomy or Rx SUI y Patients desires & expectations y Medical literature/research (EBM) y Surgeons training & experience y PFDs are relatively common and increase with ageing y POP may or may not be associated with alterations in bowel, bladder, or sexual function y Surgical correction of POP may enhance, maintain, or worsen enhance maintain or orsen bowel, bladder, or sexual function y Management of PFDs must be individualized to the patients complaints, findings, & expectations Female Pelvic Medicine and Reconstructive Surgery y Urinary incontinence y Incomplete bladder emptying y Pelvic organ prolapse y Fecal incontinence y Vesicovaginal fistulae y Rectovaginal fistulae y Rectal prolapse y Mesh complications y Urinary tract infections 16