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

Detrusor Hyperreflexia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224029
• Other study ID #: OXY0401
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 7, 2010
• Start date: December 2004
• Est. completion date: May 2008

Study information

• Verified date: April 2010
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Detrusor Hyperreflexia
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Number of Catheterizations Without Leaking Per Day	Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.	8 weeks	No
Secondary	Patch Adhesion		8 weeks	No
Secondary	Urodynamic Measurements		8 weeks	No
Secondary	Urinary Leakage and Catheterization Data		8 weeks	No