Stress Urinary Incontinence in Women With Multiple Sclerosis (UROSEP)

November 2, 2017 updated by: Lille Catholic University

Prevalence and Risk Factors of Stress Urinary Incontinence in Women With Multiple Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

363

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stress urinary incontinence
Time Frame: at inclusion
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Cecile Donzé, MD, GHICL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

January 31, 2016

Study Completion (ACTUAL)

March 31, 2016

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (ACTUAL)

November 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBS-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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