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:	NCT00575016

Purpose

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

Condition	Intervention	Phase
Overactive Bladder	Biological: Normal saline (Placebo); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (200U)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: 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

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.

Enrollment:	74
Study Start Date:	December 2007
Study Completion Date:	July 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 botulinum toxin Type A (50U); botulinum toxin Type A (200U)	Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U) botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor Other Name: BOTOX®
Experimental: 2 botulinum toxin Type A (100U); botulinum toxin Type A (200U)	Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U) botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor Other Name: BOTOX®
Experimental: 3 botulinum toxin Type A (200U)	Biological: botulinum toxin Type A (200U) botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor Other Name: BOTOX®
4 placebo; botulinum toxin Type A (200U)	Biological: Normal saline (Placebo); botulinum toxin Type A (200U) Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor 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
Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

History or 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: NCT00575016

Locations

Egypt

Cairo, Egypt
Greece

Thessaloniki, Greece
India

Ahmadabad, India
Lebanon

Beirut, Lebanon
Serbia

Belgrade, Serbia
Turkey

Ankara, Turkey

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00575016 History of Changes
Other Study ID Numbers:	191622-518
Study First Received:	December 13, 2007
Results First Received:	September 9, 2011
Last Updated:	September 9, 2011
Health Authority:	India: Drugs Controller General, India, Directorate General of Health Services; Greece: National Drug Organization; Turkey: Turkish Republic Ministry of Health; Egypt: Ministry of Health and Population

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