NCT03332654

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 2, 2017

Last Update Submit

November 2, 2017

Conditions

Keywords

Urinary Incontinence, StressMultiple SclerosisLower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

  • Stress urinary incontinence

    at inclusion

Study Arms (1)

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

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Non confirmation of diagnosis of Multiple sclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, StressMultiple SclerosisLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Cecile Donzé, MD

    GHICL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 6, 2017

Study Start

February 1, 2015

Primary Completion

January 31, 2016

Study Completion

March 31, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11