Study of Surgically-Induced Weight Loss on Pelvic Floor D... | NCT00884871

Studies
Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders

NCT00884871

Sponsor

University of California, San Diego

Status

Completed

Last Update Posted

Nov 11, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Pelvic Floor Disorders

Interventions

LapBand

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Apr 20, 2009

First Submission Date that Met QC Criteria

Apr 20, 2009

First Posted Date

Apr 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2009

Last Update Posted Date

Nov 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic adjustable gastric banding		100 obese women undergoing laparoscopic adjustable gastric banding	Procedure: LapBand

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LapBand	Procedure	Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders	Laparoscopic adjustable gastric banding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire		12 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emily L Whitcomb, M.D.	University of California, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego Medical Center		La Jolla	California	92037	United States

Condition Browse Module

MeSH Terms

ID	Term
D059952	Pelvic Floor Disorders
D015431	Weight Loss

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D011248	Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided