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

NCT ID: NCT00224029

Last Updated: 2010-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2008-05-31

Brief 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.

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.

Conditions

Detrusor Hyperreflexia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxybutynin transdermal system

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

Group Type: EXPERIMENTAL

Oxybutynin transdermal system

Intervention Type: DRUG

3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration

Interventions

Oxybutynin transdermal system

3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration

Intervention Type: DRUG

Other Intervention Names

Oxytrol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Watson Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Watson Laboratories, Inc

Principal Investigators

Gary Hoel, RPh, PhD

Role: STUDY_DIRECTOR

Watson Laboratories, Inc.

Locations

Atlanta, Georgia, United States

The Bronx, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

Countries

United States

References

Kennelly MJ, Lemack GE, Foote JE, Trop CS. Efficacy and safety of oxybutynin transdermal system in spinal cord injury patients with neurogenic detrusor overactivity and incontinence: an open-label, dose-titration study. Urology. 2009 Oct;74(4):741-5. doi: 10.1016/j.urology.2009.05.008. Epub 2009 Jul 22.

Reference Type: RESULT

PMID: 19628264 (View on PubMed)

Other Identifiers

OXY0401

Identifier Type: -

Identifier Source: org_study_id