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Stress Urinary Incontinence in Women With Multiple Sclerosis (UROSEP)

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ClinicalTrials.gov Identifier: NCT03332654
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:
Objective: To report the prevalence and risk factors of stress urinary incontinence (SUI) and the prevalence of intrinsic sphincter deficiency in women with multiple sclerosis (MS). Methods: A retrospective study was conducted among Female patients with MS, followed for lower urinary tract symptoms (LUTS) during a 15-year period. Demographic data, MS history, expanded disability status scale (EDSS) score at the urodynamic visit, obstetrical past, birth weight, LUTS, and urodynamic findings were collected. SUI was defined as incontinence during cough, or any effort. A maximum urethral closure pressure less than 30 cm H2O defined intrinsic sphincter deficiency. Results: In total 363 women with a mean age of 46.7±10.8 years and a mean disease duration of 12.9±8.7 years were included. The incidence of relapsing remitting MS, a secondary progressive form, and a primary progressive form was 60.6%, 32.8%, and 6.6%, respectively. The prevalence of SUI was 31.4%. The prevalence of intrinsic sphincter deficiency was 1.4% and 0.8% of these patients had a SUI (P=0.300). In a multivariate analysis, women with a SUI had significantly higher birth weight (P=0.030), a pelvic organ prolapse (P=0.021), urgent urinary incontinence (P=0.006), a lower EDSS score (P=0.019), and a weaker containing effort (P<0.001). Conclusions: The prevalence of SUI in women with MS was 31.4%. This symptom could affect the quality of life of women with MS.

Condition or disease Intervention/treatment
Urinary Incontinence, Stress Multiple Sclerosis Other: Determine prevalence of stress urinary incontinence

Study Type : Observational
Actual Enrollment : 363 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence and Risk Factors of Stress Urinary Incontinence in Women With Multiple Sclerosis
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : January 31, 2016
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Multiple sclerosis
Prevalence and risk factor of stress urinary incontinence in women with multiple sclerosis and included in the database over 15 years from December 1999 to June 2014, who had undergone a urodynamic test
Other: Determine prevalence of stress urinary incontinence



Primary Outcome Measures :
  1. Stress urinary incontinence [ Time Frame: at inclusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All women aged >18 years with multiple sclerosis, who had undergone a urodynamic test for lower urinary tract symptoms were included
Criteria

Inclusion Criteria:

  • Women aged >18 years
  • Multiple sclerosis
  • Urodynamic test for lower urinary tract symptoms
  • Followed in Saint Philibert Hospital between December 1999 to June 2014

Exclusion Criteria:

  • Non confirmation of diagnosis of Multiple sclerosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332654


Sponsors and Collaborators
Lille Catholic University
Investigators
Principal Investigator: Cecile Donzé, MD GHICL

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03332654     History of Changes
Other Study ID Numbers: OBS-019
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lille Catholic University:
Urinary Incontinence, Stress
Multiple Sclerosis
Lower Urinary Tract Symptoms

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Sclerosis
Multiple Sclerosis
Enuresis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders