Urinary Incontinence, Stress Clinical Trial
Official title:
CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts
Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.
Many women have surgery for pelvic organ prolapse (cystocele, uterine prolapse, rectocele).
Women with advanced pelvic organ prolapse may experience stress urinary incontinence
following surgery to repair the prolapse. Development of incontinence is unpredictable. This
study will determine which, if any, clinical tests are useful for predicting post-operative
urinary incontinence. The study will also determine if a Burch urethropexy should be
performed routinely or selectively at the time of sacrocolpopexy in continent women.
Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to
a Burch urethropexy group or to a control group. Women in the Burch group will undergo
urethropexy at the time of prolapse repair. Assessments will include a quality of life
telephone interview, urodynamic testing, and physical examination. Follow-up evaluations
occur at 6 weeks, 3 months, and 1 and 2 years following surgery. Post-operative phone
interviews will occur at 3 months, 6 months, and 1 and 2 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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