At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 254 enrolled
Drug / intervention
onabotulinumtoxinA +1 morebiological
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.
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
In Brief
A Phase 4 clinical trial evaluating onabotulinumtoxinA and Normal saline for Overactive Bladder. Completed, enrolled 254 participants across 40 sites.
Detailed Summary
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartOct 2013
Primary CompletionMay 2016
Study CompletionJan 2017
TodayJul 2026
First PostedSep 18, 2013
Enrollment StartOct 28, 2013
Primary CompletionMay 24, 2016
Study CompletionJan 5, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.8 years ago
Interventions
onabotulinumtoxinAbiological
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Normal salinedrug
Normal saline (placebo) injected into the detrusor.