Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
NCT ID: NCT00311376
Last Updated: 2015-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
416 participants
INTERVENTIONAL
2006-08-31
2010-05-31
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 (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval
2
botulinum toxin Type A (300U)
botulinum toxin Type A (300U)
botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at \> 12 weeks interval
3
placebo; botulinum toxin Type A (200U)
Normal Saline (Placebo); botulinum toxin Type A (200U)
Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval
4
placebo; botulinum toxin Type A (300U)
Normal Saline (Placebo); botulinum toxin Type A (300U)
Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at \> 12 weeks interval
Interventions
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botulinum toxin Type A (200U)
botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval
botulinum toxin Type A (300U)
botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at \> 12 weeks interval
Normal Saline (Placebo); botulinum toxin Type A (200U)
Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval
Normal Saline (Placebo); botulinum toxin Type A (300U)
Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at \> 12 weeks interval
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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Royal Oak, Michigan, United States
Randwick, New South Wales, Australia
Innsbruck, , Austria
Ghent, , Belgium
Sherbrooke, , Canada
Ostrava, , Czechia
Garches, , France
Halle, , Germany
Christchurch, , New Zealand
Wroclaw, , Poland
Moscow, , Russia
Martin, , Slovakia
Lviv, , Ukraine
London, , 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.
Chancellor MB, Patel V, Leng WW, Shenot PJ, Lam W, Globe DR, Loeb AL, Chapple CR. OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity. Neurology. 2013 Aug 27;81(9):841-8. doi: 10.1212/WNL.0b013e3182a2ca4d. Epub 2013 Jul 26.
Ginsberg D, Gousse A, Keppenne V, Sievert KD, Thompson C, Lam W, Brin MF, Jenkins B, Haag-Molkenteller C. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. J Urol. 2012 Jun;187(6):2131-9. doi: 10.1016/j.juro.2012.01.125. Epub 2012 Apr 12.
Other Identifiers
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191622-515
Identifier Type: -
Identifier Source: org_study_id