Surgical techniques for the treatment of stress incontinence (SUI) have significantly evolved over the last 100 years. The gold standard Burch urethropexy and pubovaginal sling procedures are now being performed less frequently, with the increased use of the newer minimally invasive mid-urethral sling procedures, the most common being the tension-free vaginal tape procedure (TVT). The TVT procedure is comparable in efficacy to the open Burch procedure with low morbidity and fewer complications. Because the sling is placed at the level of the mid-urethra under no tension, it was thought that the TVT would yield fewer postoperative lower urinary tract symptoms. However, a review of the literature has not borne this out, with postoperative storage symptoms reported in up to 42% of women. The primary purpose of the proposed randomized clinical trial is to test whether a perioperative behavioral/pelvic floor muscle training program can reduce the occurrence of these postoperative storage symptoms and voiding dysfunction in women undergoing a TVT procedure for SUI. Behavioral interventions are known to be effective for treating urge incontinence and voiding dysfunction unrelated to surgery, but have not been tested as a preventive adjunctive strategy. Approximately 400 subjects will be randomized to a perioperative behavioral program or usual care. The intervention will be implemented 2 weeks preoperatively, and reinforced before leaving the hospital and two weeks postoperatively. The primary outcome will be complaints of urgency, frequency, nocturia and urge incontinence using the overactive bladder questionnaire (OABq). Evaluations will be performed at 2 and 6 weeks, 3, 6, and 12 months postop, and will include the OABq, questionnaire for urinary diagnosis (QUID), urogenital distress inventory (UDI), pelvic organ prolapse/urinary incontinence sexual function questionnaire (PISQ), patient global impression of severity (PGI-S) and SF-36. Subjects will also complete a 7-day bladder diary to assess frequency of storage symptoms. Secondary aims are to determine whether this intervention reduces time to voiding and symptoms of voiding dysfunction, whether it impacts on patient satisfaction and quality of life, and to identify predictors of postoperative storage symptoms and voiding dysfunction symptoms. This type of information 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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