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

This study has been completed.

Sponsored by:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00224029

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	Phase IV

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Oxybutynin Oxybutynin chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Measures of incontinence and leakage

Secondary Outcome Measures:

Safety, patch adhesion.

Estimated Enrollment:	30
Study Start Date:	November 2004
Estimated Study Completion Date:	February 2006

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

Charlotte, North Carolina, United States

Chapel Hill, North Carolina, United States
United States, Texas

Houston, Texas, United States

Dallas, Texas, United States

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators

Investigator:

Gary Hoel, RPh, PhD

Watson Laboratories, Inc.

More Information

Study ID Numbers:	OXY0401
Study First Received:	September 13, 2005
Last Updated:	March 10, 2006
ClinicalTrials.gov Identifier:	NCT00224029
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Oxybutynin
Urinary Bladder, Neurogenic
Signs and Symptoms
Urinary Bladder, Overactive
Spinal Cord Injuries

Cystocele
Urologic Diseases
Urinary Bladder Diseases
Neurologic Manifestations
Reflex, Abnormal

Additional relevant MeSH terms:

Muscarinic Antagonists
Parasympatholytics
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists

Autonomic Agents
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009