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

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: placebo/botulinum toxin Type A Biological: botulinum toxin Type A Biological: Botulinum toxin Type A	Phase II

MedlinePlus related topics:

Botox

ChemIDplus related topics:

Sodium chloride Clostridium botulinum toxin

U.S. FDA Resources

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

Further study details as provided by Allergan:

Primary Outcome Measures:

Number of episodes of urinary incontinence [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum cystometric capacity (urodynamics) [ Time Frame: Weeks 6 - 24 ] [ Designated as safety issue: No ]
Peak detrusor pressure (urodynamics) [ Time Frame: Weeks 6 - 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
2: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
3: Experimental	Biological: Botulinum toxin Type A botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
4 Placebo followed by experimental	Biological: placebo/botulinum toxin Type A Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor

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

Contacts


Contact: Allergan Inc		clinicaltrials@allergan.com

Locations


Serbia and Montenegro
		Recruiting
	Belgrade, Serbia and Montenegro

Sponsors and Collaborators

Allergan

Investigators


Study Director:	Medical Director	Allergan

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-518
First Received:	December 13, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00575016
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Signs and Symptoms

Urinary Bladder, Overactive

Botulinum Toxins

Urologic Diseases

Urinary Bladder Diseases

Botulinum Toxin Type A

Additional relevant MeSH terms:

Urological Manifestations

Anti-Dyskinesia Agents

Therapeutic Uses

Physiological Effects of Drugs

Neuromuscular Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00575016