Urinary IncontinenceNCT02331186
Effects of Bariatric Surgery on Pelvic Floor Fonctions in Obese Women
An observational study of Urinary Incontinence and Obesity, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Urinary Incontinence, Obesity
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Dec 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: women who underwent bariatric surgery Body mass index ≥ 40 kg/m2 >18 years old
Who may be able to join
- Body mass index ≥ 40 kg/m2
- >18 years old
- participants who provided written informed consent
Who cannot join
- History of gynecologic operation time under one year
- History of pelvic physiotherapy
- Chronic obstructif lung disease
- Norologic disease
- Women in menopause
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bakirkoy Dr Sadi Konuk Training and Research Hospital
Istanbul, Bakirkoy, 34140
hediye dagdeviren, md, 5079872463, hediyedagdeviren@gmail.com
huseyin cengiz, md
- Recruiting
Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
Istanbul, Istanbul, 34147
hediye dağdeviren, MD, +905536161385, hediyedagdeviren@gmail.com
Huseyin cengiz, MD, +905325950454, obstetrik@gmail.com
About this study
Official title: Effects of Bariatric Surgery on Pelvic Floor in Obese Women
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.
Read the 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.
- Conditions
- Urinary Incontinence, Obesity
- Being tested
- bariatric surgery
- Keywords
- Obesity, Bariatric surgery, Urinary incontinence, Pelvic floor
- Medical subject headings
- Urinary Incontinence, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
bariatric surgery for obese women
| Study group | Role | What they receive |
|---|---|---|
| obese women who underwent bariatric surgery | obese women who underwent bariatric surgery Receives: Procedure: bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
urodynamic parameters
effect of bariatric surgery on urodynamic parameters in obese women
Measured: after six month
Secondary outcomes (3)
Urinary incontinence
effect of bariatric surgery on urinary incontinance in obese women
Measured: after six month
oxford scales
effect of bariatric surgery on oxford scales in obese women
Measured: after six month
health quality scores
effect of bariatric surgery on health quality scores in obese women
Measured: after six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hediye Dagdeviren, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331186
- Sponsor's protocol ID
- 2014/11/01
- Status last verified
- Jan 2015
- First submitted
- 21 Dec 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on Pelvic Floor in Obese Women
- ClinicalTrials.gov ID
- NCT02331186
- Acronym / sponsor ID
- 2014/11/01
- Conditions
- Urinary Incontinence, Obesity
- Keywords
- Obesity, Bariatric surgery, Urinary incontinence, Pelvic floor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese women who underwent bariatric surgery | – | Procedure: bariatric surgeryobese women who underwent bariatric surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women who underwent bariatric surgery Body mass index ≥ 40 kg/m2 >18 years old
Key inclusion criteria (3 listed)
- Body mass index ≥ 40 kg/m2
- >18 years old
- participants who provided written informed consent
Key exclusion criteria (5 listed)
- History of gynecologic operation time under one year
- History of pelvic physiotherapy
- Chronic obstructif lung disease
- Norologic disease
- Women in menopause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgerybariatric surgery for obese women | Procedure or surgery | obese women who underwent bariatric surgery |
Primary outcome
urodynamic parameters
Time frame: after six month
effect of bariatric surgery on urodynamic parameters in obese women
3 secondary outcomes
Urinary incontinence
Time frame: after six month
oxford scales
Time frame: after six month
health quality scores
Time frame: after six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Obesity, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hediye dağdeviren (05536161385, hediyedagdeviren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urodynamic parameters (time frame: after six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.