BUDI (Bariatric UroDynamic Improvement)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Urinary incontinence before bariatric surgery All patients with urinary incontinence before bariatric surgery will be addressed for a urodynamic exam |
Other: Exploratory pathophysiology Study
Urodynamic tests before and after bariatric surgery in obese incontinent women before and after bariatric surgery
|
Outcome Measures
Primary Outcome Measures
- Urodynamic changes after bariatric surgery in obese incontinent women [24 months]
to highlight the changes in urodynamic vesical pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery
- Urodynamic changes after bariatric surgery in obese incontinent women [24 months]
to highlight the changes in urodynamic vesical sensations (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery
- Urodynamic changes after bariatric surgery in obese incontinent women [24 months]
to highlight the changes in urodynamic bladder-to-urethra pressure transmission (%) with cough associated with the improvement of urinary incontinence after bariatric surgery
- 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
- 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
- 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 : activity of daily life
- 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 : self-image and emotional impact and sexuality)
- 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
Eligibility Criteria
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:
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minors under the age of 18
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pregnant or lactating women
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women not speaking French (important to understand and respond to questionnaires)
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women who have not given their written consent
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neurological diseases,
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pizzoferato | Caen | France | 14000 |
Sponsors and Collaborators
- University Hospital, Caen
Investigators
- Principal Investigator: Anne-Cécile Pizzoferrato, MD, PhD, University hospital of Caen
Study Documents (Full-Text)
None provided.More Information
Publications
- Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78.
- Agur W, Rizk DE. Obesity and urinary incontinence in women: is the black box becoming grayer? Int Urogynecol J. 2011 Mar;22(3):257-8. doi: 10.1007/s00192-010-1293-z. Epub 2010 Oct 6.
- Banerjea R, Findley PA, Sambamoorthi U. Disparities in preventive care by body mass index categories among women. Women Health. 2008;47(4):1-17. doi: 10.1080/03630240802099261.
- Elia G, Dye TD, Scariati PD. Body mass index and urinary symptoms in women. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):366-9.
- Elliott V, de Bruin ED, Dumoulin C. Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Neurourol Urodyn. 2015 Mar;34(3):236-43. doi: 10.1002/nau.22553. Epub 2014 Jan 10.
- Legendre G, Fritel X, Capmas P, Pourcelot AG, Fernandez H. [Urinary incontinence and obesity]. J Gynecol Obstet Biol Reprod (Paris). 2012 Jun;41(4):318-23. doi: 10.1016/j.jgyn.2012.02.007. Epub 2012 Apr 17. Review. French.
- Lose G, Tanko A, Colstrup H, Andersen JT. Urethral sphincter electromyography with vaginal surface electrodes: a comparison with sphincter electromyography recorded via periurethral coaxial, anal sphincter needle and perianal surface electrodes. J Urol. 1985 May;133(5):815-8.
- Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3:S3-9.
- Neels JG, Olefsky JM. Inflamed fat: what starts the fire? J Clin Invest. 2006 Jan;116(1):33-5.
- Sandvik H, Hunskaar S, Seim A, Hermstad R, Vanvik A, Bratt H. Validation of a severity index in female urinary incontinence and its implementation in an epidemiological survey. J Epidemiol Community Health. 1993 Dec;47(6):497-9.
- Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8.
- Subak LL, Richter HE, Hunskaar S. Obesity and urinary incontinence: epidemiology and clinical research update. J Urol. 2009 Dec;182(6 Suppl):S2-7. doi: 10.1016/j.juro.2009.08.071. Review.
- 2017-A02121-52