Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns

April 21, 2016 updated by: Allergan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-NDO-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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