Effects of Bariatric Surgery on Pelvic Floor Fonctions in Obese Women

• Conditions: Obesity; Urinary Incontinence
• Interventions: Procedure: bariatric surgery

• Registration Number: NCT02331186
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-21
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-02
• Last Update Submitted: 2015-01-02
• Study First Posted: 2015-01-06
• Last Update Posted: 2015-01-06
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese women who underwent bariatric surgery	bariatric surgery	obese women who underwent bariatric surgery

Primary Outcome Measures

Name	Time	Method
urodynamic parameters	after six month	effect of bariatric surgery on urodynamic parameters in obese women

Secondary Outcome Measures

Name	Time	Method
Urinary incontinence	after six month	effect of bariatric surgery on urinary incontinance in obese women
oxford scales	after six month	effect of bariatric surgery on oxford scales in obese women
health quality scores	after six month	effect of bariatric surgery on health quality scores in obese women

Trial Locations

Locations (2)

Bakirkoy Dr Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Bakirkoy, Turkey

Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital; 🇹🇷 Istanbul, Turkey