Clinical trial NCT03509038: BUDI (Bariatric UroDynamic Improvement)
Official title: Urodynamic Evaluation of Incontinent Obese Women Before and After Weight Reduction by Bariatric Surgery : What Urodynamic Healing Factors? BUDI (Bariatric UroDynamic Improvement)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Obesity
Urodynamics
Quality of Life
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Urodynamic changes after bariatric surgery in obese incontinent women
timeFrame: 24 months
measure: Urodynamic changes after bariatric surgery in obese incontinent women
timeFrame: 24 months
measure: Urodynamic changes after bariatric surgery in obese incontinent women
timeFrame: 24 months
measure: Urodynamic changes after bariatric surgery in obese incontinent women
timeFrame: 24 months
Secondary outcomes:
measure: Urinary incontinence symptom improvement after bariatric surgery
timeFrame: 24 months
measure: Quality of life improvement after bariatric surgery
timeFrame: 24 months
measure: Quality of life improvement after bariatric surgery
timeFrame: 24 months
measure: Quality of life improvement after bariatric surgery
timeFrame: 24 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Pizzoferato
Study officials:
affiliation: University hospital of Caen
name: Anne-Cécile Pizzoferrato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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