BUDI (Bariatric UroDynamic Improvement)

Study Overview
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Brief Summary
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In the population of obese women, the prevalence of urinary incontinence (UI) is around 70%. It was shown in the literature that weight loss by bariatric surgery allowed a significant improvement in the symptoms and impact on the quality of life of the IU. However, no prognostic factor for recovery has yet been identified and the pathophysiological mechanisms underpinning this improvement are not fully elucidated. The main objective of this study is to highlight the urodynamic changes associated with the improvement of the symptom and quality of life scores in a population of incontinent obese women before and after bariatric surgery.

Official Title
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Urodynamic Evaluation of Incontinent Obese Women Before and After Weight Reduction by Bariatric Surgery : What Urodynamic Healing Factors? BUDI (Bariatric UroDynamic Improvement)

Conditions
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Urinary Incontinence, Obesity, Urodynamics, Quality of Life

Intervention / Treatment
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* Other: Exploratory pathophysiology Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The research protocol will be proposed to all patients requiring bariatric surgery (gastric bypass or sleeve gastrectomy) and describing urinary incontinence according to the definition of the International Continence Society (ICS) Exclusion Criteria: minors under the age of 18 pregnant or lactating women women not speaking French (important to understand and respond to questionnaires) women who have not given their written consent neurological diseases, patients who have benefited from urinary incontinence surgery, prolapse treatment or pelvic surgery at risk of urodynamic modifications (extensive resection of deep endometriosis, pelvic wound surgery, pelvic radiation therapy).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urinary incontinence before bariatric surgery<br>All patients with urinary incontinence before bariatric surgery will be addressed for a urodynamic exam | Other: Exploratory pathophysiology Study<br>* Urodynamic tests before and after bariatric surgery in obese incontinent women before and after bariatric surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic changes after bariatric surgery in obese incontinent women | to highlight the changes in urodynamic vesical pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery | 24 months | 
| Urodynamic changes after bariatric surgery in obese incontinent women | to highlight the changes in urodynamic vesical sensations (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery | 24 months | 
| Urodynamic changes after bariatric surgery in obese incontinent women | to highlight the changes in urodynamic bladder-to-urethra pressure transmission (%) with cough associated with the improvement of urinary incontinence after bariatric surgery | 24 months | 
| Urodynamic changes after bariatric surgery in obese incontinent women | to highlight the changes in urodynamic maximum urethral cloture pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence symptom improvement after bariatric surgery | Changes in ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form) scores (assessing frequency and quantity of urinary loss, ranging from 0 to 21) after weight loss in incontinent obese women | 24 months | 
| Quality of life improvement after bariatric surgery | Measuring changes in Quality of life after weight loss with the Contilife questionnaire which specifically measures the impact of urinary incontinence on quality of life : activity of daily life | 24 months | 
| Quality of life improvement after bariatric surgery | Measuring changes in Quality of life after weight loss with the Contilife questionnaire which specifically measures the impact of urinary incontinence on quality of life : self-image and emotional impact and sexuality) | 24 months | 
| Quality of life improvement after bariatric surgery | Measuring changes in Quality of life after weight loss with the Contilife questionnaire which specifically measures the impact of urinary incontinence on quality of life : sexuality | 24 months |