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NCT00884871 Clinical Trial

Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders

Pelvic Floor Disorders Clinical Trial

Official title:
A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00884871
Other study ID # 071113
Secondary ID
Status Completed
Phase N/A
First received April 20, 2009
Last updated November 10, 2009
Start date September 2007
Est. completion date November 2009

Study information
Verified date November 2009
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• LapBand
Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders

Locations
Country Name City State
United States University of California San Diego Medical Center La Jolla California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire 12 months No
Secondary Weekly incontinence episodes and pad use ascertained by incontinence diary 12 months No
Secondary Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I) 12 months No
Secondary Sexual function ascertained by validated measure (PISQ) 12 months No
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