Purpose

This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
  • Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB

Exclusion Criteria

  • Overactive Bladder caused by neurological condition
  • Patient has predominance of stress incontinence
  • History or evidence of pelvic or urological abnormality
  • Prior use of BOTOX for any urological condition

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
100U cohort - BOTOX® plus Hydrogel admixture
100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
  • Drug: OnabotulinumtoxinA and Hydrogel admixture
    BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
    Other names:
    • BOTOX®
    • Botulinum Toxin Type A
Placebo Comparator
100U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
  • Drug: Placebo and Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation
Experimental
300U cohort - BOTOX® plus Hydrogel admixture
300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
  • Drug: OnabotulinumtoxinA and Hydrogel admixture
    BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
    Other names:
    • BOTOX®
    • Botulinum Toxin Type A
Placebo Comparator
300U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
  • Drug: Placebo and Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation
Experimental
400U cohort - BOTOX® plus Hydrogel admixture
400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
  • Drug: OnabotulinumtoxinA and Hydrogel admixture
    BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
    Other names:
    • BOTOX®
    • Botulinum Toxin Type A
Placebo Comparator
400U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
  • Drug: Placebo and Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation
Experimental
500U cohort - BOTOX® plus Hydrogel admixture
500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
  • Drug: OnabotulinumtoxinA and Hydrogel admixture
    BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
    Other names:
    • BOTOX®
    • Botulinum Toxin Type A
Placebo Comparator
500U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
  • Drug: Placebo and Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation

More Details

Status
Active, not recruiting
Sponsor
Allergan

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.