Completed
PHASE2
INTERVENTIONAL
NCT03320850
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
Interventions
Name:
OnabotulinumtoxinA and Hydrogel admixture
Type:
DRUG
Description:
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Name:
Placebo and Hydrogel admixture
Type:
DRUG
Description:
Placebo and Hydrogel admixture administered as a single intravesical instillation
Primary Outcomes
Measure:
Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day
TimeFrame:
Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Description:
The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.
Measure:
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period
TimeFrame:
Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)
Description:
An adverse event (AE) is any untoward medical occurrence in a participants or clinical study investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.
Trial Information
NCT ID
NCT03320850
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Allergan
Last Updated
December 15, 2025