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

Primary Purpose

Detrusor Hyperreflexia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxybutynin transdermal system
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Detrusor Hyperreflexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxybutynin transdermal system

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patch Adhesion
Urodynamic Measurements
Urinary Leakage and Catheterization Data

Full Information

First Posted
September 13, 2005
Last Updated
April 7, 2010
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00224029
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detrusor Hyperreflexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxybutynin transdermal system
Arm Type
Experimental
Arm Description
Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing
Intervention Type
Drug
Intervention Name(s)
Oxybutynin transdermal system
Other Intervention Name(s)
Oxytrol
Intervention Description
3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration
Primary Outcome Measure Information:
Title
Average Number of Catheterizations Without Leaking Per Day
Description
Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patch Adhesion
Time Frame
8 weeks
Title
Urodynamic Measurements
Time Frame
8 weeks
Title
Urinary Leakage and Catheterization Data
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Hoel, RPh, PhD
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Atlanta
State/Province
Georgia
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19628264
Citation
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.
Results Reference
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A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition

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