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BUDI (Bariatric UroDynamic Improvement)

C

Caen University Hospital

Status

Unknown

Conditions

Urodynamics
Quality of Life
Obesity
Urinary Incontinence

Treatments

Other: Exploratory pathophysiology Study

Study type

Interventional

Funder types

Other

Identifiers

NCT03509038
2017-A02121-52

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Urinary incontinence before bariatric surgery
Experimental group
Description:
All patients with urinary incontinence before bariatric surgery will be addressed for a urodynamic exam
Treatment:
Other: Exploratory pathophysiology Study

Trial contacts and locations

1

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Central trial contact

Anne Villot, MD; Anne-Cécile Pizzoferrato, MD, PhD

Data sourced from clinicaltrials.gov

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