Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns

NCT01930799 | Completed Phase 4 Results

• 1 other identifier: GMA-NDO-112
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Urinary Bladder Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 6

Secondary Outcomes (1)

• Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire

  Baseline

Study Arms (1)

All Enrolled Patients

OTHER

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

Interventions

Systematic Screening and Education Regimen BEHAVIORAL

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.

All Enrolled Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of relapsing-remitting multiple sclerosis and currently being treated by study doctor

You may not qualify if:

• Diagnosis of primary-progressive, secondary-progressive, or progressive-relapsing multiple sclerosis

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Fresno, California, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 27, 2016
• Results First Posted: May 27, 2016

Record last verified: 2016-04

Locations

US (1)