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

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224029
First received: September 13, 2005
Last updated: April 7, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Detrusor Hyperreflexia
Drug: Oxybutynin transdermal system
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Average Number of Catheterizations Without Leaking Per Day [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.


Secondary Outcome Measures:
  • Patch Adhesion [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Urodynamic Measurements [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Urinary Leakage and Catheterization Data [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2004
Study Completion Date: May 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Oxytrol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224029

Locations
United States, Georgia
Atlanta, Georgia, United States
United States, New York
Bronx, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Gary Hoel, RPh, PhD Watson Laboratories, Inc.
  More Information

Publications:
Responsible Party: Gary Hoel, RPh, PhD, Watson Laboratories, Inc
ClinicalTrials.gov Identifier: NCT00224029     History of Changes
Other Study ID Numbers: OXY0401
Study First Received: September 13, 2005
Results First Received: November 13, 2009
Last Updated: April 7, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Cord Injuries
Reflex, Abnormal
Urinary Bladder, Overactive
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014