Trial record 2 of 317 for:    Open Studies | "Urinary Bladder Diseases"

Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01930799
First received: August 26, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Urinary Bladder Diseases
Behavioral: Systematic Screening and Education Regimen
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in the King's Health Questionnaire (KHQ) Score [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Post-Video Questionnaire Score on a 5-Point Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: August 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930799

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
United States, California
Recruiting
Fresno, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01930799     History of Changes
Other Study ID Numbers: GMA-NDO-112
Study First Received: August 26, 2013
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder Diseases
Multiple Sclerosis
Sclerosis
Urologic Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014