Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00884871

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

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Surgery Urinary Incontinence Weight Control

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
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (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

Contacts

Contact: Emily L Whitcomb, M.D.	619-977-6512	ewhitcomb@ucsd.edu
Contact: Emily S Lukacz, M.D.	858-657-8435	elukacz@ucsd.edu

Locations

United States, California
University of California San Diego Medical Center	Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Emily L Whitcomb, M.D.

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

Keywords provided by University of California, San Diego:

pelvic floor disorders
weight loss

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Weight Loss
Body Weight Changes

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Pathologic Processes

Disease
Weight Loss
Body Weight Changes

ClinicalTrials.gov processed this record on August 24, 2009