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

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00910520

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox Urinary Incontinence Urine and Urination

Drug Information available for: Botulinum toxin A 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 ]

Enrollment:	548
Study Start Date:	September 2009
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: botulinum toxin Type A botulinum toxin Type A	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 Other Name: BOTOX®
placebo/botulinum toxin Type A placebo/botulinum toxin Type A	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. Other Name: BOTOX®

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: NCT00910520

Locations

United States, California

Laguna Hills, California, United States
Belgium

Gent, Belgium
Czech Republic

Prague, Czech Republic
Germany

Tubingen, Germany
Poland

Warsaw, Poland
Russian Federation

Moscow, Russian Federation
United Kingdom

London, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00910520 History of Changes
Other Study ID Numbers:	191622-520
Study First Received:	May 28, 2009
Last Updated:	December 8, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Botulinum Toxins, Type A

Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012