Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
All Enrolled Patients
Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
Intervention: Systematic Screening and Education Regimen (Behavioral)
Outcomes
Primary Outcomes
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Time Frame: Baseline, Month 6
The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.
Secondary Outcomes
- Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire(Baseline)