Pelvic Floor Disorders
Conditions
Keywords
pelvic floor disorders, weight loss
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.
Interventions
PROCEDURELapBand
Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders
Sponsors
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed