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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00224146
First Posted: September 22, 2005
Last Update Posted: November 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Watson Pharmaceuticals
  Purpose
This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)

Condition Intervention Phase
Overactive Bladder Urinary Incontinence Quality of Life Drug: oxybutynin transdermal delivery system (Oxytrol(r)) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX)

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

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

Enrollment: 2878
Study Start Date: May 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224146


Locations
United States, Alabama
Mobile, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Torrance, California, United States
United States, Connecticut
Rocky Hill, Connecticut, United States
United States, Georgia
Valdosta, Georgia, United States
United States, Louisiana
Gretna, Louisiana, United States
United States, Michigan
Bloomfield Hills, Michigan, United States
United States, New York
Poughkeepsie, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Texas
Tomball, Texas, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Naomi V. Dahl, PharmD Watson Laboratories, Inc.
  More Information

Publications:
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224146     History of Changes
Other Study ID Numbers: OXY0402
MATRIX
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: November 30, 2011
Last Verified: November 2011

Keywords provided by Watson Pharmaceuticals:
Oxytrol(r)
transdermal oxybutynin
overactive bladder

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Oxybutynin
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents