DUKE UNINARY CONTINENCE TREATMENT CENTER

Duke University, Durham NC

Investigators

Abstract

A woman's lifetime risk of surgery for genuine stress incontinence (GSI) or pelvic organ prolapse (POP) is 11 %, with nearly 1/3 of surgery being performed for recurrenCes. Most GSI results from bladder neck hypermobility (BNHM) with inefficient transmission of pressure to the urethra so that bladder pressure exceeds urethral pressure at the instant of a physical stress. Most women with GSI also have decreased intrinsic urethral resistance. If this deficit reaches critical levels and is a major cause of GSI, the condition is termed intrinsic sphincteric deficiency (ISD). BNHM and ISD can coexist and be masked by POP. A number of procedures have been developed to correct BNHM and augment urethral resistance as part of GSI and POP surgery. Most of the literature describing the results of these procedures does not meet contemporary standards for outcomes analysis. The 1996 update of the AHCPR Urinary Incontinence Clinical Practice Guideline concluded that the surgical literature is deficient in standards "for describing the patient population, the type of incontinence, the methods for accurate diagnosis, the techniques of the surgical procedure, or the outcome in different domains". The broad, long-term objectives of this proposal are to develop such standards and use them to describe and compare outcomes of several procedures performed to correct GSI or prevent GSI in women undergoing POP surgery. Specific aims are to 1) validate standard urodynamic diagnostic and severity criteria for GSI to be used for inclusion and stratification and as one measure of outcome assessment; 2) validate standard diagnostic criteria for assessing and staging POP; 3) develop a standard instmment to assess for significant co-morbidities that could affect the success or complication rates of surgery; 4) establish standard and validated outcome assessment instruments in multiple domains (including physiologic measurements, anatomic assessment, patient recorded symptom diaries, fluid loss quantitation tests, and general and condition specific quality of life instruments) to evaluate both cure of stress incontinence and development of new symptoms, conditions, or anatom,ic defects; 5) establish a manual of standard operative techniques; 6) develop instmments to assess acute morbidity of the surgery; 7) develop cost tracking strategies to assess the cost effectiveness of various procedures from multiple perspectives; and 8) use all of these measures to describe and compare the effectiveness of (i) donor fascia lata sling and retropubic urethropexy for BNHM GSI without SD, (ii) donor and autologous fascia lata sling for ISD, with and without co-existent BNHM, and (iii) vaginal surgery with plication of bladder neck endopelvic fascia and abdominal surgery with retropubic urethropexy for stage III or IV POP with BNHM. Patients undergoing such surgery in one year on the Urology and Urogynecology services at Duke University Medical Center will be evaluated in a standard fashion at baseline and every 6 months for 2.5 to 3.5 years following surgery. 9) Pelvic muscle exercises as an adjuvant to surgery and empiric anticholinergic drug therapy versus urodynamically directed therapy as salvage treatment for postoperative incontinence will also be evaluated.