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

NCT ID: NCT00224146

Last Updated: 2011-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-05-31

Brief Summary

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

Detailed Description

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Conditions

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Overactive Bladder Urinary Incontinence Quality of Life

Keywords

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Oxytrol(r) transdermal oxybutynin overactive bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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oxybutynin transdermal delivery system (Oxytrol(r))

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naomi V. Dahl, PharmD

Role: STUDY_DIRECTOR

Watson Laboratories, Inc.

Locations

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Mobile, Alabama, United States

Site Status

Tucson, Arizona, United States

Site Status

Torrance, California, United States

Site Status

Rocky Hill, Connecticut, United States

Site Status

Valdosta, Georgia, United States

Site Status

Gretna, Louisiana, United States

Site Status

Bloomfield Hills, Michigan, United States

Site Status

Poughkeepsie, New York, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Tomball, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17187655 (View on PubMed)

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.

Reference Type RESULT
PMID: 17132474 (View on PubMed)

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.

Reference Type RESULT
PMID: 17983434 (View on PubMed)

Other Identifiers

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MATRIX

Identifier Type: -

Identifier Source: secondary_id

OXY0402

Identifier Type: -

Identifier Source: org_study_id