BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence

Purpose

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

Conditions

  • Urinary Incontinence
  • Overactive Bladder With Urinary Incontinence

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
Completed
Sponsor
Allergan

Study Contact