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Clinical Trials/NCT02331186
NCT02331186
Unknown
Not Applicable

Effects of Bariatric Surgery on Pelvic Floor in Obese Women

Bakirkoy Dr. Sadi Konuk Research and Training Hospital2 sites in 1 country60 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Enrollment
60
Locations
2
Primary Endpoint
urodynamic parameters
Last Updated
11 years ago

Overview

Brief Summary

Urinary incontinence is well documented as a comorbidity of obesity. Studies demonstrate improvement of incontinency after weight loss. However, the mechanisms are still not clear. Aim of our study to analyze the effects of bariatric surgery on pelvic floor function in women.

Detailed Description

Obesity is considered an important public health problem, both in developed and developing countries. Obese people are at a higher risk for developing various comorbidities: type II diabetes, dyslipidemia, cardiovascular and cerebrovascular diseases, coagulation disorders, degenerative joint disease, some types of cancer, sleep apnea and urinary incontinence Women suffering from obesity are more likely to develop urinary incontinence, especially when related to stress. Excess weight is a modifiable risk factor. It is believed that weight reduction may be an effective treatment for urinary incontinence. The aim of this study is to analyze the effects of weight loss induced by bariatric surgery on pelvic floor function. Taking into account that modest weight loss (5% to 10%) already brings benefits to women with obesity and incontinence, one may assume even more marked improvement owing to the massive loss of weight by surgical means.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2015
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hediye Dagdeviren

M.D.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Eligibility Criteria

Inclusion Criteria

  • Body mass index ≥ 40 kg/m2
  • \>18 years old
  • participants who provided written informed consent

Exclusion Criteria

  • History of gynecologic operation time under one year
  • History of pelvic physiotherapy
  • Chronic obstructif lung disease
  • Norologic disease
  • Women in menopause

Outcomes

Primary Outcomes

urodynamic parameters

Time Frame: after six month

effect of bariatric surgery on urodynamic parameters in obese women

Secondary Outcomes

  • Urinary incontinence(after six month)
  • oxford scales(after six month)
  • health quality scores(after six month)

Study Sites (2)

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