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

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.

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.

Intervention(s) in this Clinical Trial

• Drug: Oxybutynin transdermal system
  • 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Oxybutynin transdermal system
  • Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing

Primary Measures

• Average Number of Catheterizations Without Leaking Per Day
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Patch Adhesion
  • Time Frame: 8 weeks
    Safety Issue?: No
• Urodynamic Measurements
  • Time Frame: 8 weeks
    Safety Issue?: No
• Urinary Leakage and Catheterization Data
  • Time Frame: 8 weeks
    Safety Issue?: No

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 Investigator: Watson Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Gary Hoel, RPh, PhD Study Director Watson Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

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