Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns

Phase 4

Completed

• Conditions: Urinary Bladder Diseases; Multiple Sclerosis
• Interventions: Behavioral: Systematic Screening and Education Regimen

• Registration Number: NCT01930799
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-03-07
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Results First Posted: 2016-05-27
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Enrolled Patients	Systematic Screening and Education Regimen	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores	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 Outcome Measures

Name	Time	Method
Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire	Baseline	The Patient Post-Video Questionnaire was based on 5 individual questions assessing the patient's perception of the utility of the video in helping them 1) understand how MS can affect the bladder, 2) how to recognize bladder symptoms, 3) understand various treatment options, 4) understand self-help strategies, and 5) better manage their bladder problems. Percentages represent the proportion of patients who "agree/completely agree" with each question. Patients viewed the video at the Baseline visit, then completed the Patient Post-Video Questionnaire immediately after viewing the video at the Baseline visit.