Effects of Bariatric Surgery on Pelvic Floor Fonctions in Obese Women

NCT ID: NCT02331186

Last Updated: 2015-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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obese women who underwent bariatric surgery

obese women who underwent bariatric surgery

bariatric surgery

Intervention Type PROCEDURE

bariatric surgery for obese women

Interventions

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bariatric surgery

bariatric surgery for obese women

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hediye Dagdeviren

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, Bakirkoy, Turkey (Türkiye)

Site Status RECRUITING

Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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hediye dağdeviren

Role: CONTACT

05536161385

huseyin cengiz, MD

Role: CONTACT

05325950454

Facility Contacts

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hediye dagdeviren, md

Role: primary

5079872463

hediye dağdeviren, MD

Role: primary

+905536161385

Huseyin cengiz, MD

Role: backup

+905325950454

Other Identifiers

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2014/11/01

Identifier Type: -

Identifier Source: org_study_id

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