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Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00884871
First received: April 20, 2009
Last updated: November 10, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention
Pelvic Floor Disorders
 Procedure: LapBand

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weekly incontinence episodes and pad use ascertained by incontinence diary [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sexual function ascertained by validated measure (PISQ) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884871

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

No publications provided

Responsible Party: Emily L. Whitcomb, University of California San Diego
ClinicalTrials.gov Identifier: NCT00884871     History of Changes
Other Study ID Numbers: 071113
Study First Received: April 20, 2009
Last Updated: November 10, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013