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Status unknownNCT03509038BUDIUpdated Aug 31, 2021

BUDI (Bariatric UroDynamic Improvement)

An interventional study of Exploratory pathophysiology Study in Urinary Incontinence, Obesity and Urodynamics, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Urinary Incontinence
  • Obesity
  • Urodynamics
  • Quality of Life
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 25 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • 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

Interventions

  • OtherExploratory pathophysiology Study

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

  2. 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

    Time frame: 24 months

  3. 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

    Time frame: 24 months

  4. 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

    Time frame: 24 months

Secondary outcomes

  1. 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

    Time frame: 24 months

  2. 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

    Time frame: 24 months

  3. 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)

    Time frame: 24 months

  4. 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

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. doi: 10.1002/nau.10052. No abstract available. PubMed 11857671 ↗
  • 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. PubMed 22516035 ↗
  • 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. PubMed 8120507 ↗
  • 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. PubMed 19846133 ↗
  • 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. PubMed 11795637 ↗
  • Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9. PubMed 16985863 ↗
  • Neels JG, Olefsky JM. Inflamed fat: what starts the fire? J Clin Invest. 2006 Jan;116(1):33-5. doi: 10.1172/JCI27280. PubMed 16395402 ↗
  • 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. PubMed 20924556 ↗
  • 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. PubMed 4039373 ↗
  • 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. PubMed 11494188 ↗
  • 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. PubMed 18843937 ↗
  • 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. PubMed 24415577 ↗
  • 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. PubMed 19136310 ↗
  • 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. PubMed 26678846 ↗
  • 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. PubMed 17950043 ↗
  • 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. PubMed 17978117 ↗
  • 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. PubMed 20018326 ↗
  • 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. PubMed 18679560 ↗
  • 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. PubMed 1564575 ↗
  • 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. PubMed 1497041 ↗
  • 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. PubMed 26686304 ↗
  • 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. PubMed 15592060 ↗
  • 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. PubMed 18379564 ↗
  • 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. PubMed 17905093 ↗

Individual participant data

Plan to share: Undecided — study protocol statistical analysis plan informed consent form analytic code clinical study report

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03509038
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Apr 26, 2018
Start date
Mar 13, 2018
Primary completion
Jan 2022 (estimated)
Completion
Jan 2023 (estimated)
Last update
Aug 31, 2021

Study contacts

Anne-Cécile Pizzoferrato, MD, PhD
Contact
pizzoferrato-ac@chu-caen.fr
+33682176675
Anne Villot, MD
Contact
villot-a@chu-caen.fr
+33689529077
Anne-Cécile Pizzoferrato, MD, PhD
principal investigator · University hospital of Caen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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