BUDI (Bariatric UroDynamic Improvement)

NCT03509038 | Unknown

• 1 other identifier: 2017-A02121-52
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Obesity; Urodynamics; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Urodynamic changes after bariatric surgery in obese incontinent women

  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

  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

  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

  to highlight the changes in urodynamic maximum urethral cloture pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery

  24 months

Secondary Outcomes (4)

• Urinary incontinence symptom improvement after bariatric surgery

  24 months

• Quality of life improvement after bariatric surgery

  24 months

• Quality of life improvement after bariatric surgery

  24 months

• Quality of life improvement after bariatric surgery

  24 months

Study Arms (1)

Urinary incontinence before bariatric surgery

EXPERIMENTAL

All patients with urinary incontinence before bariatric surgery will be addressed for a urodynamic exam

Other: Exploratory pathophysiology Study

Interventions

Exploratory pathophysiology Study OTHER

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

Urinary incontinence before bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Pizzoferato

Caen, 14000, France

RECRUITING

Related Publications (24)

• 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.

  PMID: 11857671 BACKGROUND

• 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.

  PMID: 22516035 BACKGROUND

• 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.

  PMID: 8120507 BACKGROUND

• 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.

  PMID: 19846133 BACKGROUND

• 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.

  PMID: 11795637 BACKGROUND

• Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.

  PMID: 16985863 BACKGROUND

• Neels JG, Olefsky JM. Inflamed fat: what starts the fire? J Clin Invest. 2006 Jan;116(1):33-5. doi: 10.1172/JCI27280.

  PMID: 16395402 BACKGROUND

• 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.

  PMID: 20924556 BACKGROUND

• 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.

  PMID: 4039373 BACKGROUND

• 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.

  PMID: 11494188 BACKGROUND

• 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.

  PMID: 18843937 BACKGROUND

• 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.

  PMID: 24415577 BACKGROUND

• 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.

  PMID: 19136310 RESULT

• 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.

  PMID: 26678846 RESULT

• 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.

  PMID: 17950043 RESULT

• 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.

  PMID: 17978117 RESULT

• 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.

  PMID: 20018326 RESULT

• 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.

  PMID: 18679560 RESULT

• 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.

  PMID: 1564575 RESULT

• 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.

  PMID: 1497041 RESULT

• 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.

  PMID: 26686304 RESULT

• 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.

  PMID: 15592060 RESULT

• 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.

  PMID: 18379564 RESULT

• 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.

  PMID: 17905093 RESULT

MeSH Terms

Conditions

Urinary Incontinence; Obesity

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Anne-Cécile Pizzoferrato, MD, PhD

  University hospital of Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Cécile Pizzoferrato, MD, PhD

CONTACT

+33682176675; pizzoferrato-ac@chu-caen.fr

Anne Villot, MD

CONTACT

+33689529077; villot-a@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 26, 2018
• Study Start: March 13, 2018
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

FR (1)