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Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders

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ClinicalTrials.gov Identifier: NCT00884871
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : November 11, 2009
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Study Description
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.

Condition or disease Intervention/treatment
Pelvic Floor Disorders Procedure: LapBand

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders
Study Start Date : September 2007
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Laparoscopic adjustable gastric banding
100 obese women undergoing laparoscopic adjustable gastric banding
Procedure: LapBand
Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders

Outcome Measures

Primary Outcome Measures :
  1. Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Weekly incontinence episodes and pad use ascertained by incontinence diary [ Time Frame: 12 months ]
  2. Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I) [ Time Frame: 12 months ]
  3. Sexual function ascertained by validated measure (PISQ) [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 obese women who have met surgical eligibility for laparoscopic adjustable gastric banding at the Center for the Treatment of Obesity at UCSD

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884871

United States, California
University of California San Diego Medical Center
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Emily L Whitcomb, M.D. University of California, San Diego
More Information

Responsible Party: Emily L. Whitcomb, University of California San Diego
ClinicalTrials.gov Identifier: NCT00884871     History of Changes
Other Study ID Numbers: 071113
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009

Keywords provided by University of California, San Diego:
pelvic floor disorders
weight loss

Additional relevant MeSH terms:
Weight Loss
Pelvic Floor Disorders
Pathologic Processes
Body Weight Changes
Body Weight
Signs and Symptoms
Pregnancy Complications