Effects of Bariatric Surgery on Pelvic Floor Fonctions in Obese Women

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02331186

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Obesity	Procedure: bariatric surgery

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Effects of Bariatric Surgery on Pelvic Floor in Obese Women

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
obese women who underwent bariatric surgery obese women who underwent bariatric surgery	Procedure: bariatric surgery bariatric surgery for obese women

Arm

Intervention/Treatment

obese women who underwent bariatric surgery

Procedure: bariatric surgery

bariatric surgery for obese women

Outcome Measures

Primary Outcome Measures

urodynamic parameters [after six month]
effect of bariatric surgery on urodynamic parameters in obese women

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakirkoy Dr Sadi Konuk Training and Research Hospital	Istanbul	Bakirkoy	Turkey	34140
2	Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital	Istanbul		Turkey	34147