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OpenTrials
Completed

NCT Number: NCT00884871

Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders

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.

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Key information

Conditions

Pelvic Floor Disorders Body Weight Body Weight Changes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Weight Loss

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California San Diego Medical Center

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LapBand

Procedure

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

Primary outcomes

  1. Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 21, 2009
Registry last updated
Nov 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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