At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 116 enrolled
Drug / intervention
OnabotulinumtoxinA 100 UNT [Botox]drug
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.
Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial
In Brief
A Phase 4 clinical trial evaluating OnabotulinumtoxinA 100 UNT [Botox] for Overactive Bladder and 6 related conditions. Completed, enrolled 116 participants across 1 site.
Detailed Summary
Patients with either overactive bladder (OAB) or urgency urinary incontinence (UUI) with be randomized (like a flip of a coin) to receive 100 units of bladder Botox® at either one injection site or ten injection sites. Efficacy and patient satisfaction will be measured by questionnaires.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder, Urinary Urge Incontinence, Overactive Bladder Syndrome, Urinary Incontinence, Urge, Urge Incontinence, Urinary Urgency, Urinary Frequency
CountriesUnited States
CollaboratorsKaiser Permanente, St. Joseph Hospital of Orange
Timeline
Phase 4CompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartMay 2022
Primary CompletionDec 2023
Study CompletionMar 2024
TodayJul 2026
First PostedApr 4, 2022
Enrollment StartMay 1, 2022
Primary CompletionDec 31, 2023
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.2 years ago
Interventions
OnabotulinumtoxinA 100 UNT [Botox]drug
Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites