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BUDI (Bariatric UroDynamic Improvement)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03509038
Acronym
BUDI
Enrollment
25
Registered
2018-04-26
Start date
2018-03-13
Completion date
2023-01-31
Last updated
2021-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Quality of Life, Urinary Incontinence, Urodynamics

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.

Interventions

OTHERExploratory pathophysiology Study

Urodynamic tests before and after bariatric surgery in obese incontinent women before and after bariatric surgery

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Urodynamic changes after bariatric surgery in obese incontinent women24 monthsto highlight the changes in urodynamic vesical pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery

Secondary

MeasureTime frameDescription
Urinary incontinence symptom improvement after bariatric surgery24 monthsChanges 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
Quality of life improvement after bariatric surgery24 monthsMeasuring 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

Countries

France

Contacts

Primary ContactAnne-Cécile Pizzoferrato, MD, PhD
pizzoferrato-ac@chu-caen.fr+33682176675
Backup ContactAnne Villot, MD
villot-a@chu-caen.fr+33689529077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026