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A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition

Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Detrusor Hyperreflexia

Intervention: Oxybutynin transdermal system (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Watson Pharmaceuticals

Official(s) and/or principal investigator(s):
Gary Hoel, RPh, PhD, Study Director, Affiliation: Watson Laboratories, Inc.


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Average Number of Catheterizations Without Leaking Per Day

Secondary outcome:

Patch Adhesion

Urodynamic Measurements

Urinary Leakage and Catheterization Data

Detailed description: The Dose Titration Period began with a 3. 9 mg/day or 7. 8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3. 9 mg/day, 7. 8 mg/day, 9. 1 mg/day, and 11. 7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3. 9 mg/day dose group, 3 were in the 7. 8 mg/day dose group, 8 were in the 9. 1 mg/day dose group, and 11 were in the 11. 7 mg/day dose group.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.

Locations and Contacts

Atlanta, Georgia, United States

Bronx, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

Additional Information

Starting date: December 2004
Last updated: April 7, 2010

Page last updated: August 23, 2015

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