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

April 7, 2010 updated by: Watson Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States
    • New York
      • Bronx, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Oxybutynin transdermal system
3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration
Other Names:
  • Oxytrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Number of Catheterizations Without Leaking Per Day
Time Frame: 8 weeks
Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patch Adhesion
Time Frame: 8 weeks
8 weeks
Urodynamic Measurements
Time Frame: 8 weeks
8 weeks
Urinary Leakage and Catheterization Data
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Gary Hoel, RPh, PhD, Watson Laboratories, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 30, 2010

Last Update Submitted That Met QC Criteria

April 7, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXY0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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