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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-treatment, 2-stage, Dose-finding Study Evaluating the Efficacy and Safety of BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Overactive Bladder With Urinary Incontinence
• Intervention / Treatment: Drug: OnabotulinumtoxinA and Hydrogel admixture; Drug: Placebo and Hydrogel admixture

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc., an AMR company
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Urological Assoc. of South AZ
  • California
    • Canoga Park, California, United States, 91303
      • HOPE Clinical Research
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates Medical Group
    • San Diego, California, United States, 92120
      • San Diego Clinical Trials
    • San Diego, California, United States, 92108
      • Wr-McCr, Llc
    • Vacaville, California, United States, 95688
      • Sutter Institute for Medical Health
    • Whittier, California, United States, 90603
      • West Coast Urology
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
    • Englewood, Colorado, United States, 80113
      • Urology Associates, P.C
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Adult and Pediatric Urology
    • Farmington, Connecticut, United States, 06032
      • Women's Health Specialty Care
    • Middlebury, Connecticut, United States, 06762
      • CT Clinical Research Center/Urologist Specialist
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Aventura, Florida, United States, 33180
      • Innovative Medical Research of South FL, Inc.
    • Bradenton, Florida, United States, 34205
      • Manatee Medical Research Institute
    • Lauderdale Lakes, Florida, United States, 33319
      • Sunrise Medical Research
    • Miramar, Florida, United States, 33029
      • Urological Research Network
    • N. Redington Beach, Florida, United States, 33708
      • Florida Urology Partners
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center Of Florida
    • Saint Petersburg, Florida, United States, 33710
      • Pinellas Urology, Inc.
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Urology
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institute
  • Illinois
    • Lake Barrington, Illinois, United States, 60010
      • Comprehensive Urological Care
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Urogynecology Associates, PC
    • Jeffersonville, Indiana, United States, 47130
      • First Urology,PSC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research, LLC
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology Associates
    • Owings Mills, Maryland, United States, 21117
      • Chesapeake Urology
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Women's Health Care Specialists
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult Pediatric Urology & Urogynecology
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Premier Urology Group
    • Mount Laurel, New Jersey, United States, 08043
      • Delaware Valley Urology
  • New York
    • Cheektowaga, New York, United States, 14225
      • Western New York Urology Associates
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • Garden City, New York, United States, 11530
      • Urological Surgeons of Long Island
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice PLLC
    • Plainview, New York, United States, 11803
      • Urology Institute of Long Island
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals- Urology
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • American Health Research
    • Fayetteville, North Carolina, United States, 28304
      • Carolina Institute for Clinical Research
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions, LLC
  • Oregon
    • Gresham, Oregon, United States, 97030
      • The Center for Men's & Women's Urology
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of SE PA
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia Urology
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia
  • Washington
    • Kirkland, Washington, United States, 98034
      • Washington Urology and Urogynecology Associates
    • Tacoma, Washington, United States, 98405
      • MultiCare Allenmore Hospital
  • Wisconsin
    • West Allis, Wisconsin, United States, 53227
      • Aurora Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day	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.	Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period	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.	Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day	The participant recorded the number of micturition (urination in toilet or catherization) episodes per day in a 3-day bladder diary. The average number of micturition episodes 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. ANCOVA model was used for analyses.	Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Stage 2: Change From Baseline in the Average Volume Voided Per Micturition	Volume voided per micturition was recorded over one 24-hour period during the 3-day bladder diary. The volume voided during each 24-hour period was divided by the number of micturitions during the period. The average volume voided per micturition 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. ANCOVA model was used for analyses.	Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2017
• Primary Completion (Actual): July 21, 2020
• Study Completion (Actual): July 21, 2020

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Enuresis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 1839-201-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

• Phase II or III trials completed after 2008
• Listed on clinicaltrials.gov or EudraCT
• Have received regulatory approval in the United States and/or European Union (depending on registration plans) in a given indication
• Primary manuscript(s) from the trial have been published

Access to data is contingent upon the following:

• Researcher signs a data use agreement from Allergan
• Data is to be used for non-commercial purposes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No