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

Allergan

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder With Urinary Incontinence; Urinary Incontinence

Treatments: Drug: Placebo and Hydrogel admixture; Drug: OnabotulinumtoxinA and Hydrogel admixture

Study type: Interventional

Funder types: Industry

Identifiers

NCT03320850

1839-201-021

Details and patient eligibility

About

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

Enrollment: 383 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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383 participants in 8 patient groups, including a placebo group

100U cohort - BOTOX® plus Hydrogel admixture

Experimental group

Description:

100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1

Treatment:

Drug: OnabotulinumtoxinA and Hydrogel admixture

100U cohort - Placebo plus Hydrogel admixture

Placebo Comparator group

Description:

Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1

Treatment:

Drug: Placebo and Hydrogel admixture

300U cohort - BOTOX® plus Hydrogel admixture

Experimental group

Description:

300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1

Treatment:

Drug: OnabotulinumtoxinA and Hydrogel admixture

300U cohort - Placebo plus Hydrogel admixture

Placebo Comparator group

Description:

Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1

Treatment:

Drug: Placebo and Hydrogel admixture

400U cohort - BOTOX® plus Hydrogel admixture

Experimental group

Description:

400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1

Treatment:

Drug: OnabotulinumtoxinA and Hydrogel admixture

400U cohort - Placebo plus Hydrogel admixture

Placebo Comparator group

Description:

Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1

Treatment:

Drug: Placebo and Hydrogel admixture

500U cohort - BOTOX® plus Hydrogel admixture

Experimental group

Description:

500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1

Treatment:

Drug: OnabotulinumtoxinA and Hydrogel admixture

500U cohort - Placebo plus Hydrogel admixture

Placebo Comparator group

Description:

Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1

Treatment:

Drug: Placebo and Hydrogel admixture