CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 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.

Search/NCT03052764
NCT03052764Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)

Allergan·interventional·Posted Feb 14, 2017·Updated Dec 24, 2019

In Brief

A Phase 4 clinical trial evaluating onabotulinumtoxinA and Placebo (saline) for Urinary Bladder, Overactive and Urinary Incontinence. Completed, enrolled 120 participants across 31 sites.

Detailed Summary

This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with an anticholinergic.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder, Overactive, Urinary Incontinence
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 14, 2017
Enrollment StartDec 12, 2016
Primary CompletionDec 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.4 years ago

Interventions

onabotulinumtoxinAbiological

OnabotulinumtoxinA (BOTOX®) injection into the bladder.

Placebo (saline)drug

Placebo (saline) injection into the bladder.