Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00910845

Purpose

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating patients with idiopathic overactive bladder with urinary incontinence.

Condition	Intervention	Phase
Overactive Bladder	Biological: botulinum toxin Type A Biological: Placebo/botulinum toxin Type A	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Botox Urinary Incontinence Urine and Urination

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Number of Episodes of Urinary Incontinence [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of micturition episodes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Volume Voided per micturition [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Treatment Benefit Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
King's Health Questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Number of Urgency episodes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	534
Study Start Date:	September 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: botulinum toxin Type A Botulinum toxin Type A 100U injected into the detrusor at Day 1 , followed by a repeat injection of botulinum toxin Type A 100U after a minimum of 12 weeks has elapsed from previous treatment, if requested/qualified
2: Placebo Comparator	Biological: Placebo/botulinum toxin Type A Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after a minimum of 12 weeks has elapsed from previous treatment, if requested/qualified.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

Overactive Bladder caused by neurological condition
Patient has predominance of stress incontinence
History or evidence of pelvic or urological abnormality

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910845

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, California
	Recruiting
Newport Beach, California, United States
Canada, British Columbia
	Recruiting
Victoria, British Columbia, Canada

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-095
Study First Received:	May 28, 2009
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00910845 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Anti-Dyskinesia Agents
Urination Disorders
Urinary Bladder Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions
Urological Manifestations

Signs and Symptoms
Botulinum Toxins
Urologic Diseases
Therapeutic Uses
Urinary Incontinence
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010