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

Quality of Life Clinical Trial

— MATRIX  

Official title:

Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224146
• Other study ID #: OXY0402
• Secondary ID: MATRIX
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: November 29, 2011
• Start date: May 2004
• Est. completion date: May 2005

Study information

• Verified date: November 2011
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2878
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Quality of Life
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• oxybutynin transdermal delivery system (Oxytrol(r))

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub — View 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 Obste — View 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. Epub 2007 Nov — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health-related quality of life			No
Secondary	Change in other outcomes such as:			No
Secondary	depression			No
Secondary	work productivity			No
Secondary	participant satisfaction			No
Secondary	effect of enhanced patient education on any of the above outcomes			No