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NCT01930799 Clinical Trial

Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01930799
Other study ID # GMA-NDO-112
Secondary ID
Status Completed
Phase Phase 4
First received August 26, 2013
Last updated May 22, 2015
Start date August 2013
Est. completion date March 2015

Study information
Verified date May 2015
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in the King's Health Questionnaire (KHQ) Score Baseline, Month 6 No
Secondary Patient Post-Video Questionnaire Score on a 5-Point Scale Baseline No
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