Clinical Trial: Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders
Brief Summary: The specific aim of this study is to evaluate the effect of surgically-induced weight reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and pelvic organ prolapse in severely, morbidly and super-obese women using a prospective, observational study design.
Detailed Summary:
Sponsor: University of California, San Diego
Current Primary Outcome: Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Weekly incontinence episodes and pad use ascertained by incontinence diary [ Time Frame: 12 months ]
- Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I) [ Time Frame: 12 months ]
- Sexual function ascertained by validated measure (PISQ) [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: University of California, San Diego
Dates:
Date Received: April 20, 2009
Date Started: September 2007
Date Completion:
Last Updated: November 10, 2009
Last Verified: November 2009
