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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Mandelic Acids; Oxybutynin

Criteria

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.