At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 313 enrolled
Drug / intervention
botulinum toxin Type A +1 morebiological
Likely dose
Botulinum toxin Type A injected into detrusor on Day 1AI-extracted
Key inclusion· 5
- ✓Age 18-85 years
- ✓Diagnosed with overactive bladder at least 6 months ago
- ✓Weight at least 50 kg (110 lbs)
- ✓Willing and able to maintain a bladder diary for the study
Key exclusion· 2
- ✕Currently using catheterization for incontinence management
- ✕Prior use of botulinum toxin Type A or any other botulinum toxin for any condition
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Research Study for Patients With Overactive Bladder
In Brief
A Phase 2 clinical trial evaluating botulinum toxin Type A and Placebo for Overactive Bladder and Urinary Incontinence. Completed, enrolled 313 participants across 6 sites in 6 countries.
Detailed Summary
The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder, Urinary Incontinence
CountriesBelgium, Canada, Germany, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedSep 2005
Primary CompletionJan 2008
Study CompletionJun 2008
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartJul 1, 2005
Primary CompletionJan 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.8 years ago
Interventions
botulinum toxin Type Abiological
botulinum toxin Type A injected into detrusor on Day 1
Placebodrug
Placebo (normal saline) injected into detrusor on Day 1