Official Title: “A Multi-Center, Open-Label, Dose-Titration Pilot Study Evaluating the Efficacy and Safety of Oxybutynin Transdermal Systems in Patients With Neurogenic Bladder Resulting From Spinal Cord Injury”

This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Oxybutynin

Primary Measures

• Measures of incontinence and leakage

Secondary Measures

• Safety, patch adhesion.

Inclusion Criteria:

• At least 18 years of age at day of consent;
• Is a male, or is a non-pregnant non-lactating female who is either of non-child-bearing potential, or is using adequate means of birth control;
• Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury etiology;
• Has impairment based on the American Spinal Injury Association (ASIA);
• Use clean intermittent catheterization;
• Has urinary incontinence between scheduled catheterization;
• Capable of understanding and complying with the protocol.

Exclusion Criteria:

• Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency;
• Have any medical condition that precludes their participation in the study, or may confound the outcome of the study;
• History of major lower urinary tract surgery, procedures;
• Has an active skin disorder, affecting TDS application site areas;
• Hypersensitivity to the investigational drug;
• Has participated in any study involving administration of an investigational compound within 30 days before this study.

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

Lead Sponsor: Watson Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Gary Hoel, RPh, PhD  Watson Laboratories, Inc.  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00224029

Study ID Number: OXY0401

ClinicalTrials.gov Identifier: NCT00224029

Health Authority: United States: Food and Drug Administration