Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders

NCT ID: NCT00884871

Last Updated: 2009-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Floor Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic adjustable gastric banding

100 obese women undergoing laparoscopic adjustable gastric banding

LapBand

Intervention Type PROCEDURE

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

Interventions

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LapBand

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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University of California San Diego

Principal Investigators

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Emily L Whitcomb, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California San Diego Medical Center

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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071113

Identifier Type: -

Identifier Source: org_study_id

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