Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders
Completed
- Conditions
- Pelvic Floor Disorders
- Interventions
- Procedure: LapBand
- Registration Number
- NCT00884871
- Lead Sponsor
- University of California, San Diego
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
- surgical eligibility met by Center for the Treatment Obesity criteria
- morbid obesity (BMI > 40 kg/m2) or severe obesity (BMI > 33 kg/m2) in presence of NIH co-morbidities
- willing to participate in study, including completion of self-reported questionnaires
Exclusion Criteria
- pregnancy or planned pregnancy
- recent pregnancy or pelvic surgery
- age < 21 years
- known neurologic disease or pelvic pathology
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Laparoscopic adjustable gastric banding LapBand 100 obese women undergoing laparoscopic adjustable gastric banding
- Primary Outcome Measures
Name Time Method Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire 12 months
- Secondary Outcome Measures
Name Time Method Weekly incontinence episodes and pad use ascertained by incontinence diary 12 months Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I) 12 months Sexual function ascertained by validated measure (PISQ) 12 months
Trial Locations
- Locations (1)
University of California San Diego Medical Center
🇺🇸La Jolla, California, United States