Phase 4
N=120
Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
Multiple Sclerosis · Urinary Bladder Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01930799 ↗Enrolled (actual)
120
Serious AEs
—
Results posted
May 2016
Primary outcome: Primary: Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores — 39.7; 2.5; 60.7; 1.2 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Systematic Screening and Education Regimen (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores |
39.7; 2.5; 60.7; 1.2; 43.8; -6.9 | — |
| SECONDARY Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire |
94.0; 94.0; 94.0; 88.9; 81.2 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01930799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.