Urinary incontinence is a common, distressing complication of radical prostatectomy that often, but not always, resolves within days to weeks after surgery. For men with post-prostatectomy incontinence persisting beyond six months, biofeedback-assisted behavioral training has been shown to be effective for the reduction of stress, urge, or mixed incontinence. The primary purpose of the proposed project is to test whether this training, if performed prior to surgery, would be an effective prevention strategy for reducing the duration or severity of incontinence in the six months following surgery. This project will be a randomized clinical trial comparing the effects of pre operative biofeedback- assisted behavioral training against a """"""""usual care"""""""" control condition in which subjects receive only verbal instructions for pelvic muscle exercise after surgery (Specific Aim #1). Approximately 132 men who plan to undergo radical prostatectomy will be enrolled in the study with the expectation that 106 will complete the protocol. Stratified and blocked randomization procedures will be used to assign subjects to the prevention condition (pre-operative biofeedback-assisted behavioral training plus daily exercise) or the control condition (""""""""usual care"""""""" consisting of post-operative verbal instructions to interrupt the urinary stream during voiding). Bladder diaries, completed by subjects in the six-month post-operative period, will be used to calculate the primary outcome measures: 1) duration of post-operative incontinence; 2) severity of incontinence (number of accidents) at four time points: one week, sex weeks, three months, and six months following surgery; and 3) number of absorbent pads used at each follow up.
The second aim of the study is to assess the impact of the prevention strategy on quality of life in the six months following radical prostatectomy. Three aspects of quality of life will be examined. First, psychological impact will be evaluated using the Hopkins Symptom Checklist (SCL-90-R), a measure of psychological distress that includes scales for depression and anxiety. Second, the Incontinence Impact Questionnaire will be modified for men and used to measure impact of incontinence on psychosocial functioning including activities of daily living, social interactions, and self-perception. Third, the SF-36 Health Survey will be used to access changes in general health-related quality of life, including the impact of health on physical activities, social activities and mood (Specific Aim #2).
| Burgio, Kathryn L; Goode, Patricia S; Urban, Donald A et al. (2006) Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial. J Urol 175:196-201; discussion 201 |
