At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 383 enrolled
Drug / intervention
OnabotulinumtoxinA and Hydrogel admixture +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.
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-treatment, 2-stage, Dose-finding Study Evaluating the Efficacy and Safety of BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
In Brief
A Phase 2 clinical trial evaluating OnabotulinumtoxinA and Hydrogel admixture and Placebo and Hydrogel admixture for Urinary Incontinence and Overactive Bladder With Urinary Incontinence. Completed, enrolled 383 participants across 63 sites in 2 countries.
Detailed Summary
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedOct 2017
Primary CompletionJul 2020
TodayJul 2026
First PostedOct 25, 2017
Enrollment StartOct 4, 2017
Primary CompletionJul 21, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.7 years ago
Interventions
OnabotulinumtoxinA and Hydrogel admixturedrug
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Placebo and Hydrogel admixturedrug
Placebo and Hydrogel admixture administered as a single intravesical instillation