The broad objective of this study is to determine the efficacy of behavioral therapy in the management of urinary incontinence in women. This clinical trial will use a randomized experimental design to investigate the comparative effectiveness of three treatments (bladder training; pelvic muscle exercise; bladder training and pelvic muscle exercise) in the management of urinary incontinent community-dwelling women ages 45 years and over. Subjects will be stratified by urodynamic subgroup 1) SI alone, and 2) DI +/- SI, and severity of incontinence 1) mild, 2) moderate, and 3) severe, and randomly assigned to a treatment group. All treatments will be conducted over six weeks involving weekly clinic visits. Bladder training will consist of scheduled voidings with progressive increases in the intervals between voidings. Pelvic muscle exercises will consist of biofeedback clinic sessions and home practice. A combination therapy will include both bladder training and pelvic muscle exercise protocols simultaneously. Follow-up will be conducted at 6, 12 and 30 (6 months) weeks post-randomization. Treatment outcome will be primarily assessed by weekly incontinent episodes. Secondary endpoints will be 1) diurnal micturition frequency, 2) nocturnal micturition frequency, 3) grams of fluid lost during a laboratory test, 4) maximal urethral closing pressure, 5) functional urethral length, 6) pressure transmission ratios, 7) maximal intravaginal pressure, and 8) intravaginal pressure over time. This study will help determine the comparative benefits of three behavioral interventions in management of different types of urinary incontinence, and will help identify the characteristics of women most likely to receive maximal benefit from each intervention.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AG005170-09
Application #
3768116
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
9
Fiscal Year
1993
Total Cost
Indirect Cost
Name
Virginia Commonwealth University
Department
Type
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298
Barber, Matthew D; Visco, Anthony G; Wyman, Jean F et al. (2002) Sexual function in women with urinary incontinence and pelvic organ prolapse. Obstet Gynecol 99:281-9
Theofrastous, J P; Wyman, J F; Bump, R C et al. (2002) Effects of pelvic floor muscle training on strength and predictors of response in the treatment of urinary incontinence. Neurourol Urodyn 21:486-90
McClish, D K; Wyman, J F; Sale, P G et al. (1999) Use and costs of incontinence pads in female study volunteers. Continence Program for Women Research Group. J Wound Ostomy Continence Nurs 26:207-8, 210-3
Bump, R C; Hurt, W G; Elser, D M et al. (1999) Understanding lower urinary tract function in women soon after bladder neck surgery. Continence Program for Women Research Group. Neurourol Urodyn 18:629-37
Elser, D M; Wyman, J F; McClish, D K et al. (1999) The effect of bladder training, pelvic floor muscle training, or combination training on urodynamic parameters in women with urinary incontinence. Continence Program for Women Research Group. Neurourol Urodyn 18:427-36
Wyman, J F; Fantl, J A; McClish, D K et al. (1998) Comparative efficacy of behavioral interventions in the management of female urinary incontinence. Continence Program for Women Research Group. Am J Obstet Gynecol 179:999-1007
Bump, R C; Hurt, W G; Addison, W A et al. (1998) Reliability and correlation of measurements during and after bladder neck surgery. The Continence Program for Women Research Group. Br J Urol 82:628-33
Theofrastous, J P; Wyman, J F; Bump, R C et al. (1997) Relationship between urethral and vaginal pressures during pelvic muscle contraction. The Continence Program for Women Research Group. Neurourol Urodyn 16:553-8
Fantl, J A; Bump, R C; Robinson, D et al. (1996) Efficacy of estrogen supplementation in the treatment of urinary incontinence. The Continence Program for Women Research Group. Obstet Gynecol 88:745-9
Bump, R C; Hurt, W G; Theofrastous, J P et al. (1996) Randomized prospective comparison of needle colposuspension versus endopelvic fascia plication for potential stress incontinence prophylaxis in women undergoing vaginal reconstruction for stage III or IV pelvic organ prolapse. The Continence Program for W Am J Obstet Gynecol 175:326-33;discussion 333-5

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