Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
Primary Purpose
Multiple Sclerosis, Urinary Bladder Diseases
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Systematic Screening and Education Regimen
Sponsored by
About this trial
This is an interventional health services research trial for Multiple Sclerosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All Enrolled Patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
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
Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01930799
Brief Title
Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Urinary Bladder Diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Enrolled Patients
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Systematic Screening and Education Regimen
Intervention Description
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 Measure Information:
Title
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Description
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.
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Fresno
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
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