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

July 21, 2021 updated by: Allergan

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
383

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day
Time Frame: Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
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
Time Frame: Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day
Time Frame: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
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
Time Frame: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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