At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
Botox +1 moredrug
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.
Randomized Double-blind Placebo Controlled Trial of Intradetrusor Injections of Botox for the Treatment of Refractory Overactive Bladder Secondary to Benign Prostatic Obstruction-BTX0621
In Brief
A Phase 3 clinical trial evaluating Botox and Placebo for Overactive Bladder. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This is a prospective, randomized, double-blind study comparing intravesical injection of BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following treatment groups:
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedOct 2010
Primary CompletionJun 2011
Study CompletionNov 2012
TodayJul 2026
First PostedOct 14, 2010
Enrollment StartJun 1, 2009
Primary CompletionJun 1, 2011
Study CompletionNov 13, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.7 years ago
Interventions
Botoxdrug
Botox injection
Placebodrug
Placebo injection