Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00311376

Purpose

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.

Condition	Intervention	Phase
Overactive Bladder	Biological: botulinum toxin Type A (200U) Biological: botulinum toxin Type A (300U) Other: Normal Saline (Placebo); botulinum toxin Type A (200U) Other: Normal Saline (Placebo); botulinum toxin Type A (300U)	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

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change From Baseline in Number of Weekly Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

Secondary Outcome Measures:

Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.
Change From Baseline in Maximum Detrusor Pressure (MDP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.
Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). A positive change from baseline represents an improvement

Enrollment:	416
Study Start Date:	August 2006
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 botulinum toxin Type A (200U)	Biological: botulinum toxin Type A (200U) botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval Other Name: BOTOX®
Experimental: 2 botulinum toxin Type A (300U)	Biological: botulinum toxin Type A (300U) botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval Other Name: BOTOX®
3 placebo; botulinum toxin Type A (200U)	Other: Normal Saline (Placebo); botulinum toxin Type A (200U) Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval Other Name: BOTOX®
4 placebo; botulinum toxin Type A (300U)	Other: Normal Saline (Placebo); botulinum toxin Type A (300U) Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval Other Name: BOTOX®

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

History of evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer
Urinary tract infection at time of enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311376

Locations

United States, Michigan

Royal Oak, Michigan, United States
Australia, New South Wales

Randwick, New South Wales, Australia
Austria

Innsbruck, Austria
Belgium

Gent, Belgium
Canada

Sherbrooke, Canada
Czech Republic

Ostrava, Czech Republic
France

Garches, France
Germany

Halle (Saale), Germany
New Zealand

Christchurch, New Zealand
Poland

Wroclaw, Poland
Russian Federation

Moscow, Russian Federation
Slovakia

Martin, Slovakia
Ukraine

Lviv, Ukraine
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:	NCT00311376 History of Changes
Other Study ID Numbers:	191622-515
Study First Received:	April 4, 2006
Results First Received:	September 9, 2011
Last Updated:	September 9, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
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