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

Sponsor:	Allergan
Information provided by:	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: placebo/botulinum toxin Type A Biological: botulinum toxin Type A Biological: Botulinum toxin Type A	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Botox

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 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 ]

Enrollment:	74
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 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

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-518
Study First Received:	December 13, 2007
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00575016 History of Changes
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
Anti-Dyskinesia Agents
Urinary Bladder Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions
Urological Manifestations

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

ClinicalTrials.gov processed this record on November 30, 2009