Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns

CompletedPhase 4Relapsing MSNCT01930799

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Systematic Screening and Education Regimen

Results by group

Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores

Baseline, Month 6

GroupValueIntervalNumber analysed
All Enrolled Patients39.7 Scores on a Scale23.1 (Standard Deviation)112
All Enrolled Patients2.5 Scores on a Scale22.3 (Standard Deviation)112
All Enrolled Patients60.7 Scores on a Scale23.8 (Standard Deviation)112
All Enrolled Patients1.2 Scores on a Scale24.2 (Standard Deviation)112
All Enrolled Patients43.8 Scores on a Scale29.6 (Standard Deviation)112
All Enrolled Patients-6.9 Scores on a Scale27.5 (Standard Deviation)112
All Enrolled Patients45.3 Scores on a Scale28 (Standard Deviation)112
All Enrolled Patients-9.8 Scores on a Scale26.3 (Standard Deviation)112
All Enrolled Patients31.7 Scores on a Scale28.6 (Standard Deviation)112
All Enrolled Patients-9.0 Scores on a Scale24.5 (Standard Deviation)112
All Enrolled Patients25.9 Scores on a Scale30.3 (Standard Deviation)112
All Enrolled Patients-9.0 Scores on a Scale24.9 (Standard Deviation)112
All Enrolled Patients35.7 Scores on a Scale28.4 (Standard Deviation)112
All Enrolled Patients-9.0 Scores on a Scale21.8 (Standard Deviation)112
All Enrolled Patients41.7 Scores on a Scale27.8 (Standard Deviation)112
All Enrolled Patients-8.2 Scores on a Scale25.1 (Standard Deviation)112
All Enrolled Patients46.9 Scores on a Scale23.7 (Standard Deviation)112
All Enrolled Patients-5.7 Scores on a Scale17.7 (Standard Deviation)112

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
All Enrolled Patients00

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores

    Baseline, Month 6

    Bladder, bowel and sexual functionMood and sleepQuality of life (reported by participants)

Other measures (1)

  • Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire

    Baseline

    Bladder, bowel and sexual function

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion criteria

* Diagnosis of relapsing-remitting multiple sclerosis and currently being treated by study doctor

Exclusion criteria

* Diagnosis of primary-progressive, secondary-progressive, or progressive-relapsing multiple sclerosis

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study will assess the impact of a systematic bladder health screening and disease education regimen as well as the implementation of a referral process on the quality of life of multiple sclerosis patients with bladder dysfunction.

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History

    1. Started

      Aug 2013

    2. Main results due

      Mar 2015

    3. Finished

      Mar 2015

    4. Results posted

      May 2016

    Assembled by software from public sources.