This study evaluates changes in health related quality of life outcomes in patients using...
Date First Received: September 14, 2005
Last Updated: February 4, 2008
Verified by: Watson Pharmaceuticals, February 2008
Clinical Trial Phase: Phase 4 | Start Date: May 2004
Overall Status: Completed
Estimated Enrollment: 2500
Brief Summary
Official Title: “Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX)”
Condition Keyword(s):
Intervention(s):
This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: oxybutynin transdermal delivery system (Oxytrol(r))
Outcome Measures for this Clinical Trial
Primary Measures
- Change in health-related quality of life
Secondary Measures
- Change in other outcomes such as:
- depression
- work productivity
- participant satisfaction
- effect of enhanced patient on any of the above outcomes
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Watson Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Naomi V. Dahl, PharmD Study Director Watson Laboratories, Inc.
Related Publications
Citations Reporting Results
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. 2006 Dec 20; [Epub ahead of print]
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.
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. Epub 2007 Nov 15.
Additional Information
Information obtained from ClinicalTrials.gov on August 21, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00224146
Study ID Number: OXY0402
ClinicalTrials.gov Identifier: NCT00224146
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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