Effects of Bariatric Surgery on Pelvic Floor Fonctions in Obese Women

Obesity Clinical Trial

Official title:

Effects of Bariatric Surgery on Pelvic Floor in Obese Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331186
• Other study ID #: 2014/11/01
• Status: Recruiting
• Phase: N/A
• First received: December 21, 2014
• Last updated: January 2, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: hediye dagdeviren
• Phone: 05536161385
• Email: hediyedagdeviren[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Urinary Incontinence

Intervention

Procedure:
• bariatric surgery
bariatric surgery for obese women

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Training and Research Hospital	Istanbul	Bakirkoy
Turkey	Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urodynamic parameters	effect of bariatric surgery on urodynamic parameters in obese women	after six month	No
Secondary	Urinary incontinence	effect of bariatric surgery on urinary incontinance in obese women	after six month	No
Secondary	oxford scales	effect of bariatric surgery on oxford scales in obese women	after six month	No
Secondary	health quality scores	effect of bariatric surgery on health quality scores in obese women	after six month	No