- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509038
BUDI (Bariatric UroDynamic Improvement) (BUDI)
Urodynamic Evaluation of Incontinent Obese Women Before and After Weight Reduction by Bariatric Surgery : What Urodynamic Healing Factors? BUDI (Bariatric UroDynamic Improvement)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne-Cécile Pizzoferrato, MD, PhD
- Phone Number: +33682176675
- Email: pizzoferrato-ac@chu-caen.fr
Study Contact Backup
- Name: Anne Villot, MD
- Phone Number: +33689529077
- Email: villot-a@chu-caen.fr
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- Pizzoferato
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Urinary incontinence before bariatric surgery
All patients with urinary incontinence before bariatric surgery will be addressed for a urodynamic exam
|
Urodynamic tests before and after bariatric surgery in obese incontinent women before and after bariatric surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urodynamic changes after bariatric surgery in obese incontinent women
Time Frame: 24 months
|
to highlight the changes in urodynamic vesical pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery
|
24 months
|
Urodynamic changes after bariatric surgery in obese incontinent women
Time Frame: 24 months
|
to highlight the changes in urodynamic vesical sensations (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery
|
24 months
|
Urodynamic changes after bariatric surgery in obese incontinent women
Time Frame: 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
|
24 months
|
Urodynamic changes after bariatric surgery in obese incontinent women
Time Frame: 24 months
|
to highlight the changes in urodynamic maximum urethral cloture pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary incontinence symptom improvement after bariatric surgery
Time Frame: 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
|
24 months
|
Quality of life improvement after bariatric surgery
Time Frame: 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
|
24 months
|
Quality of life improvement after bariatric surgery
Time Frame: 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)
|
24 months
|
Quality of life improvement after bariatric surgery
Time Frame: 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
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne-Cécile Pizzoferrato, MD, PhD, University Hospital of Caen
Publications and helpful links
General Publications
- Richter HE, Kenton K, Huang L, Nygaard I, Kraus S, Whitcomb E, Chai TC, Lemack G, Sirls L, Dandreo KJ, Stoddard A. The impact of obesity on urinary incontinence symptoms, severity, urodynamic characteristics and quality of life. J Urol. 2010 Feb;183(2):622-8. doi: 10.1016/j.juro.2009.09.083. Epub 2009 Dec 16.
- 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. doi: 10.1002/nau.10052. No abstract available.
- 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. doi: 10.1136/jech.47.6.497.
- Neels JG, Olefsky JM. Inflamed fat: what starts the fire? J Clin Invest. 2006 Jan;116(1):33-5. doi: 10.1172/JCI27280.
- 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. French.
- 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.
- 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. doi: 10.1007/pl00004043.
- Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.
- 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. No abstract available.
- 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. doi: 10.1016/s0022-5347(17)49238-x.
- Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8. doi: 10.1053/apmr.2001.24297.
- 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.
- 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.
- Chen CC, Gatmaitan P, Koepp S, Barber MD, Chand B, Schauer PR, Brethauer SA. Obesity is associated with increased prevalence and severity of pelvic floor disorders in women considering bariatric surgery. Surg Obes Relat Dis. 2009 Jul-Aug;5(4):411-5. doi: 10.1016/j.soard.2008.10.006. Epub 2008 Oct 29.
- Knepfler T, Valero E, Triki E, Chilintseva N, Koensgen S, Rohr S. Bariatric surgery improves female pelvic floor disorders. J Visc Surg. 2016 Apr;153(2):95-9. doi: 10.1016/j.jviscsurg.2015.11.011. Epub 2015 Dec 8.
- Kuruba R, Almahmeed T, Martinez F, Torrella TA, Haines K, Nelson LG, Gallagher SF, Murr MM. Bariatric surgery improves urinary incontinence in morbidly obese individuals. Surg Obes Relat Dis. 2007 Nov-Dec;3(6):586-90; discussion 590-1. doi: 10.1016/j.soard.2007.08.007. Epub 2007 Oct 18.
- Burgio KL, Richter HE, Clements RH, Redden DT, Goode PS. Changes in urinary and fecal incontinence symptoms with weight loss surgery in morbidly obese women. Obstet Gynecol. 2007 Nov;110(5):1034-40. doi: 10.1097/01.AOG.0000285483.22898.9c.
- Richter HE, Creasman JM, Myers DL, Wheeler TL, Burgio KL, Subak LL; Program to Reduce Incontinence by Diet and Exercise (PRIDE) Research Group. Urodynamic characterization of obese women with urinary incontinence undergoing a weight loss program: the Program to Reduce Incontinence by Diet and Exercise (PRIDE) trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1653-8. doi: 10.1007/s00192-008-0694-8. Epub 2008 Aug 5.
- Nathan PA, Keniston RC, Myers LD, Meadows KD. Obesity as a risk factor for slowing of sensory conduction of the median nerve in industry. A cross-sectional and longitudinal study involving 429 workers. J Occup Med. 1992 Apr;34(4):379-83.
- Bump RC, Sugerman HJ, Fantl JA, McClish DK. Obesity and lower urinary tract function in women: effect of surgically induced weight loss. Am J Obstet Gynecol. 1992 Aug;167(2):392-7; discussion 397-9. doi: 10.1016/s0002-9378(11)91418-5.
- Romero-Talamas H, Unger CA, Aminian A, Schauer PR, Barber M, Brethauer S. Comprehensive evaluation of the effect of bariatric surgery on pelvic floor disorders. Surg Obes Relat Dis. 2016 Jan;12(1):138-43. doi: 10.1016/j.soard.2015.08.499. Epub 2015 Aug 13.
- Amarenco G, Ismael SS, Lagauche D, Raibaut P, Rene-Corail P, Wolff N, Thoumie P, Haab F. Cough anal reflex: strict relationship between intravesical pressure and pelvic floor muscle electromyographic activity during cough. Urodynamic and electrophysiological study. J Urol. 2005 Jan;173(1):149-52. doi: 10.1097/01.ju.0000147305.00443.df.
- Townsend MK, Curhan GC, Resnick NM, Grodstein F. BMI, waist circumference, and incident urinary incontinence in older women. Obesity (Silver Spring). 2008 Apr;16(4):881-6. doi: 10.1038/oby.2008.14. Epub 2008 Feb 14.
- Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8. doi: 10.1016/j.urology.2007.03.084.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A02121-52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
Clinical Trials on Exploratory pathophysiology Study
-
Central Hospital, Nancy, FranceCompleted
-
University of North Carolina, Chapel HillCompletedFrailtyUnited States
-
CHU de ReimsRecruiting
-
MetaboGen ABSkane University Hospital; Stockholm South General HospitalCompletedIntrahepatic Cholestasis of PregnancySweden
-
Egyptian Biomedical Research NetworkCompleted
-
University Hospital, Clermont-FerrandCompletedParkinson Disease | Joint Osteoarthritis | Atherosclerosis of the Distal Arteries, Without Gangrene | Chronic Obstructive Pulmonary Disease, Unspecified | Obesity, UnspecifiedFrance
-
Baylor UniversityCompletedObesity | PREG1United States
-
National Taiwan University HospitalUnknownHepatitis | Tuberculosis | hepatitisBTaiwan
-
University Hospital, Clermont-FerrandActive, not recruitingCharcot-Marie-Tooth Type 1A NeuropathyFrance
-
Cairo UniversityCompleted