Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders
A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 20, 2009
CompletedFirst Posted
Study publicly available on registry
April 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedNovember 11, 2009
November 1, 2009
2.2 years
April 20, 2009
November 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire
12 months
Secondary Outcomes (3)
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
Study Arms (1)
Laparoscopic adjustable gastric banding
100 obese women undergoing laparoscopic adjustable gastric banding
Interventions
Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders
Eligibility Criteria
100 obese women who have met surgical eligibility for laparoscopic adjustable gastric banding at the Center for the Treatment of Obesity at UCSD
You may qualify if:
- 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
You may not qualify if:
- pregnancy or planned pregnancy
- recent pregnancy or pelvic surgery
- age \< 21 years
- known neurologic disease or pelvic pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Diego Medical Center
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily L Whitcomb, M.D.
University of California, San Diego
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 20, 2009
First Posted
April 21, 2009
Study Start
September 1, 2007
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
November 11, 2009
Record last verified: 2009-11