Urinary incontinence is a major problem with significant medical, psychological, social and financial consequences. Surgical management of stress urinary incontinence (SUI) is effective, with 5-year cure rates of 80-90%, however, significant short- and long-term postoperative bladder and voiding dysfunction is associated with most surgical procedures for incontinence. Behavioral interventions have been used successfully to resolve urge incontinence and bladder dysfunction unrelated to surgery. Theoretically, such interventions could be an effective adjunct to surgery. The primary purpose of the proposed prospective randomized trial is to test the effects of a perioperative behavioral training program versus usual care on the occurrence of postoperative bladder and voiding dysfunction. Approximately 500 patients planning to undergo a Burch retropubic urethropexy or pubovaginal sling procedure for the treatment of SUI will be randomized to a perioperative biofeedback-assisted behavioral training program or usual care. Perioperative behavioral intervention will be implemented 2-4 weeks preoperatively, approximately 2 days postoperatively and at the 4week postoperative clinic visit. Subsequent evaluation at 3 months and 12 months postop will include a urodynamic evaluation to determine the occurrence of detrusor instability, voiding dysfunction and effectiveness of surgery, as well as a 7-day bladder diary (to determine symptoms of urgency, urinary frequency and changes in the frequency of incontinence episodes), 24- hour pad tests (to assess changes in volume of incontinence) and three quality of life instruments, the Incontinence Impact Questionnaire, the Urogenital Distress Inventory and the SF-36 Health Survey.
The second aim i s to identify preoperative variables that may be predictive of postoperative bladder and voiding dysfunction. These will include such variables as age, estrogen status, body mass index, duration of incontinence, and urodynamic parameters. Perioperative behavioral training may help to prevent significant postoperative bladder and voiding dysfunction. Furthermore, the identification of risk factors for postoperative bladder or voiding dysfunction will allow physicians to more effectively counsel and treat their incontinent female patients to further enhance long term quality of life.
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