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BUDI (Bariatric UroDynamic Improvement) (BUDI)

Primary Purpose

Urinary Incontinence, Obesity, Urodynamics

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Exploratory pathophysiology Study

About this trial

This is an interventional diagnostic trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

PizzoferatoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urinary incontinence before bariatric surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

Urinary incontinence symptom improvement after bariatric surgery

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

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

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

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

Full Information

NCT ID

NCT03509038

First Posted

March 14, 2018

Last Updated

August 30, 2021

Sponsor

University Hospital, Caen

1. Study Identification

Unique Protocol Identification Number

NCT03509038

Brief Title

BUDI (Bariatric UroDynamic Improvement)

Acronym

BUDI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 13, 2018 (Actual)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence, Obesity, Urodynamics, Quality of Life

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Urinary incontinence before bariatric surgery

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Exploratory pathophysiology Study

Intervention Description

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

Primary Outcome Measure Information:

Title

Urodynamic changes after bariatric surgery in obese incontinent women

Description

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

Time Frame

24 months

Title

Urodynamic changes after bariatric surgery in obese incontinent women

Description

to highlight the changes in urodynamic vesical sensations (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery

Time Frame

24 months

Title

Urodynamic changes after bariatric surgery in obese incontinent women

Description

to highlight the changes in urodynamic bladder-to-urethra pressure transmission (%) with cough associated with the improvement of urinary incontinence after bariatric surgery

Time Frame

24 months

Title

Urodynamic changes after bariatric surgery in obese incontinent women

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Urinary incontinence symptom improvement after bariatric surgery

Description

Time Frame

24 months

Title

Quality of life improvement after bariatric surgery

Description

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

Time Frame

24 months

Title

Quality of life improvement after bariatric surgery

Description

Time Frame

24 months

Title

Quality of life improvement after bariatric surgery

Description

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

Time Frame

24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne-Cécile Pizzoferrato, MD, PhD

Phone

+33682176675

pizzoferrato-ac@chu-caen.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Villot, MD

Phone

+33689529077

villot-a@chu-caen.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne-Cécile Pizzoferrato, MD, PhD

Organizational Affiliation

University hospital of Caen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pizzoferato

City

Caen

ZIP/Postal Code

14000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Cecile Pizzoferrato, MD

Phone

+33231272336

pizzoferrato-ac@chu-caen.fr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

study protocol statistical analysis plan informed consent form analytic code clinical study report

Citations:

PubMed Identifier

11857671

Citation

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.

Results Reference

background

PubMed Identifier

22516035

Citation

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.

Results Reference

background

PubMed Identifier

8120507

Citation

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.

Results Reference

background

PubMed Identifier

19846133

Citation

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.

Results Reference

background

PubMed Identifier

11795637

Citation

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.

Results Reference

background

PubMed Identifier

16985863

Citation

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

Results Reference

background

PubMed Identifier

16395402

Citation

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

Results Reference

background

PubMed Identifier

20924556

Citation

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.

Results Reference

background

PubMed Identifier

4039373

Citation

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.

Results Reference

background

PubMed Identifier

11494188

Citation

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.

Results Reference

background

PubMed Identifier

18843937

Citation

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.

Results Reference

background

PubMed Identifier

24415577

Citation

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.

Results Reference

background

PubMed Identifier

19136310

Citation

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.

Results Reference

result

PubMed Identifier

26678846

Citation

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.

Results Reference

result

PubMed Identifier

17950043

Citation

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.

Results Reference

result

PubMed Identifier

17978117

Citation

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.

Results Reference

result

PubMed Identifier

20018326

Citation

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.

Results Reference

result

PubMed Identifier

18679560

Citation

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.

Results Reference

result

PubMed Identifier

1564575

Citation

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.

Results Reference

result

PubMed Identifier

1497041

Citation

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.

Results Reference

result

PubMed Identifier

26686304

Citation

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.

Results Reference

result

PubMed Identifier

15592060

Citation

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.

Results Reference

result

PubMed Identifier

18379564

Citation

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.

Results Reference

result

PubMed Identifier

17905093

Citation

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.

Results Reference

result

Learn more about this trial

BUDI (Bariatric UroDynamic Improvement)

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