Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders
Completed
- Conditions
- Pelvic Floor Disorders
- 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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link surgically-induced weight loss to pelvic floor disorder improvement in obese women?
How does laparoscopic gastric banding compare to sleeve gastrectomy in treating pelvic organ prolapse and stress urinary incontinence?
Are there specific biomarkers that predict response to weight loss interventions for overactive bladder and anal incontinence?
What are the potential adverse events associated with bariatric surgery in patients with pelvic floor disorders and how are they managed?
How do combination approaches of bariatric surgery with pelvic floor physical therapy impact outcomes in super-obese women with pelvic organ prolapse?
Trial Locations
- Locations (1)
University of California San Diego Medical Center
🇺🇸La Jolla, California, United States
University of California San Diego Medical Center🇺🇸La Jolla, California, United States