BUDI (Bariatric UroDynamic Improvement)

Not Applicable

• Conditions: Urodynamics; Obesity; Quality of Life; Urinary Incontinence
• Interventions: Other: Exploratory pathophysiology Study

• Registration Number: NCT03509038
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-13
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2022-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urinary incontinence before bariatric surgery	Exploratory pathophysiology Study	All patients with urinary incontinence before bariatric surgery will be addressed for a urodynamic exam

Primary Outcome Measures

Name	Time	Method
Urodynamic changes after bariatric surgery in obese incontinent women	24 months	to highlight the changes in urodynamic maximum urethral cloture pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery

Secondary Outcome Measures

Name	Time	Method
Quality of life improvement after bariatric surgery	24 months	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
Urinary incontinence symptom improvement after bariatric surgery	24 months	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

Trial Locations

Locations (1)

Pizzoferato; 🇫🇷 Caen, France