Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
NCT ID: NCT00461292
Last Updated: 2015-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
275 participants
INTERVENTIONAL
2007-05-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
botulinum toxin Type A (200U)
botulinum toxin Type A (200U)
botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection \> Week 12; injections into detrusor
2
botulinum toxin Type A (300U)
botulinum toxin Type A (300U)
botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor
3
placebo; botulinum toxin Type A (200U)
Normal saline (Placebo); botulinum toxin Type A (200U)
Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection \> 12 weeks; injections into detrusor
4
placebo; botulinum toxin Type A (300U)
Normal saline (Placebo); botulinum toxin Type A (300U)
Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor
Interventions
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botulinum toxin Type A (200U)
botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection \> Week 12; injections into detrusor
botulinum toxin Type A (300U)
botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor
Normal saline (Placebo); botulinum toxin Type A (200U)
Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection \> 12 weeks; injections into detrusor
Normal saline (Placebo); botulinum toxin Type A (300U)
Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria
* Previous or current diagnosis of bladder or prostate cancer
* Urinary tract infection at time of enrollment
18 Years
80 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Middlebury, Connecticut, United States
Rio de Janeiro, , Brazil
Victoria, British Columbia, Canada
Salouël, , France
Milan, , Italy
Amsterdam, , Netherlands
Porto, , Portugal
Singapore, , Singapore
Pretoria, , South Africa
Santa Cruz de Tenerife, , Spain
Hualien City, , Taiwan
Scunthorpe, , United Kingdom
Countries
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References
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Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.
Sussman D, Patel V, Del Popolo G, Lam W, Globe D, Pommerville P. Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Neurourol Urodyn. 2013 Mar;32(3):242-9. doi: 10.1002/nau.22293. Epub 2012 Sep 10.
Cruz F, Herschorn S, Aliotta P, Brin M, Thompson C, Lam W, Daniell G, Heesakkers J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011 Oct;60(4):742-50. doi: 10.1016/j.eururo.2011.07.002. Epub 2011 Jul 13.
Other Identifiers
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191622-516
Identifier Type: -
Identifier Source: org_study_id
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