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Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder (MATRIX)

Primary Purpose

Overactive Bladder, Urinary Incontinence, Quality of Life

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
oxybutynin transdermal delivery system (Oxytrol(r))
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Oxytrol(r), transdermal oxybutynin, overactive bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency Exclusion Criteria: Patients for whom Oxytrol(r) is contraindicated. Patients treated with Oxytrol(r) prior to participation in this study. Patients residing in long-term care facilities or nursing homes.

Sites / Locations

Outcomes

Primary Outcome Measures

Change in health-related quality of life

Secondary Outcome Measures

Change in other outcomes such as:
depression
work productivity
participant satisfaction
effect of enhanced patient education on any of the above outcomes

Full Information

First Posted
September 14, 2005
Last Updated
November 29, 2011
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00224146
Brief Title
Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder
Acronym
MATRIX
Official Title
Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Incontinence, Quality of Life
Keywords
Oxytrol(r), transdermal oxybutynin, overactive bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2878 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxybutynin transdermal delivery system (Oxytrol(r))
Primary Outcome Measure Information:
Title
Change in health-related quality of life
Secondary Outcome Measure Information:
Title
Change in other outcomes such as:
Title
depression
Title
work productivity
Title
participant satisfaction
Title
effect of enhanced patient education on any of the above outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency Exclusion Criteria: Patients for whom Oxytrol(r) is contraindicated. Patients treated with Oxytrol(r) prior to participation in this study. Patients residing in long-term care facilities or nursing homes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi V. Dahl, PharmD
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Rocky Hill
State/Province
Connecticut
Country
United States
City
Valdosta
State/Province
Georgia
Country
United States
City
Gretna
State/Province
Louisiana
Country
United States
City
Bloomfield Hills
State/Province
Michigan
Country
United States
City
Poughkeepsie
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Tomball
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17187655
Citation
Sand P, Zinner N, Newman D, Lucente V, Dmochowski R, Kelleher C, Dahl NV. Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community-based, randomized study. BJU Int. 2007 Apr;99(4):836-44. doi: 10.1111/j.1464-410X.2006.06658.x. Epub 2006 Dec 20.
Results Reference
result
PubMed Identifier
17132474
Citation
Sand PK, Goldberg RP, Dmochowski RR, McIlwain M, Dahl NV. The impact of the overactive bladder syndrome on sexual function: a preliminary report from the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin trial. Am J Obstet Gynecol. 2006 Dec;195(6):1730-5. doi: 10.1016/j.ajog.2006.08.013.
Results Reference
result
PubMed Identifier
17983434
Citation
Staskin DR, Rosenberg MT, Dahl NV, Polishuk PV, Zinner NR. Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions. Int J Clin Pract. 2008 Jan;62(1):27-38. doi: 10.1111/j.1742-1241.2007.01625.x. Epub 2007 Nov 15.
Results Reference
result

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Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder

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