At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 829 enrolled
Drug / intervention
botulinum toxin Type Abiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
In Brief
A Phase 3 clinical trial evaluating botulinum toxin Type A for Overactive Bladder and Urinary Incontinence. Completed, enrolled 829 participants across 8 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the long term safety and effectiveness of botulinum toxin type A in treating patients with idiopathic overactive bladder with urinary incontinence.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder, Urinary Incontinence
CountriesBelgium, Canada, Czechia, Germany, Poland, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartFeb 2010
Primary CompletionAug 2014
TodayJul 2026
First PostedJun 8, 2009
Enrollment StartFeb 1, 2010
Primary CompletionAug 5, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.1 years ago
Interventions
botulinum toxin Type Abiological
Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.