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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2013 |
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Main ID: |
NCT00439140 |
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Date of registration:
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21/02/2007 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
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Scientific title:
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Date of first enrolment:
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June 2007 |
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Target sample size:
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41 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00439140 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Brazil
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Canada
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France
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Germany
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India
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Netherlands
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United Kingdom
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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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.
- Neurological respiratory impairment and abnormal pulmonary function test results
Exclusion Criteria:
- History or evidence of pelvic or urologic abnormality
- Previous or current diagnosis of bladder or prostate cancer
- Symptomatic or untreated urinary tract infection at time of enrollment
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overactive Bladder
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Intervention(s)
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Biological: botulinum toxin Type A 200U
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Biological: botulinum toxin Type A 300U
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Drug: Normal Saline (Placebo)
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Primary Outcome(s)
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Forced Expiratory Volume
[Time Frame: Week 2]
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Forced Vital Capacity
[Time Frame: Week 2]
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Secondary Outcome(s)
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Maximum cystometric capacity (urodynamics)
[Time Frame: 52 Weeks]
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Number of episodes of urinary incontinence (urodynamics)
[Time Frame: 52 Weeks]
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Peak (amplitude) detrusor pressure (urodynamics)
[Time Frame: 52 Weeks]
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Pulmonary function
[Time Frame: 52 Weeks]
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Secondary ID(s)
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191622-082
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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