Urinary IncontinencePhase 2APOLLONCT03320850
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
A Phase 2 study testing OnabotulinumtoxinA and Hydrogel admixture in people with Urinary Incontinence and Overactive Bladder With Urinary Incontinence, run by Allergan at 63 sites in 2 countries.
Trial summary
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Incontinence, Overactive Bladder With Urinary Incontinence
- What is being tested?
- OnabotulinumtoxinA and Hydrogel admixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 383 participants
- Where
- 63 sitesin 2 countries
- Study dates
- 4 Oct 2017to 21 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
63 sites in 2 countries.
63 sites in 2 countries
United States61 sites
Innovative Medical Research of South FL, Inc.
Aventura, Florida, 33180
South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Manatee Medical Research Institute
Bradenton, Florida, 34205
Adult and Pediatric Urology
Bridgeport, Connecticut, 06606
Hope Clinical Research
Canoga Park, California, 91303
Urogynecology Associates, PC
Carmel, Indiana, 46032
American Health Research
Charlotte, North Carolina, 28207
Western New York Urology Associates
Cheektowaga, New York, 14225
North Idaho Urology
Coeur d'Alene, Idaho, 83814
Urology Clinics of North Texas
Dallas, Texas, 75231
The Urology Center of Colorado
Denver, Colorado, 80211
Premier Urology Group
Edison, New Jersey, 08837
Urology Associates, P.C
Englewood, Colorado, 80113
Women's Health Specialty Care
Farmington, Connecticut, 06032
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304
AccuMed Research Associates
Garden City, New York, 11530
Urological Surgeons of Long Island
Garden City, New York, 11530
The Center for Men's & Women's Urology
Gresham, Oregon, 97030
Chesapeake Urology Associates
Hanover, Maryland, 21076
Houston Metro Urology
Houston, Texas, 77027
First Urology,PSC
Jeffersonville, Indiana, 47130
Women's Health Care Specialists
Kalamazoo, Michigan, 49009
Washington Urology and Urogynecology Associates
Kirkland, Washington, 98034
Comprehensive Urological Care
Lake Barrington, Illinois, 60010
Excel Clinical Research
Las Vegas, Nevada, 89109
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319
Idaho Urologic Institute
Meridian, Idaho, 83642
Clinical Research Solutions, LLC
Middleburg Heights, Ohio, 44130
CT Clinical Research Center/Urologist Specialist
Middlebury, Connecticut, 06762
Urological Research Network
Miramar, Florida, 33029
Coastal Clinical Research, Inc., an AMR company
Mobile, Alabama, 36608
Delaware Valley Urology
Mount Laurel, New Jersey, 08043
DelRicht Research, LLC
New Orleans, Louisiana, 70115
Manhattan Medical Research Practice PLLC
New York, New York, 10016
Florida Urology Partners
North Redington Beach, Florida, 33708
Renstar Medical Research
Ocala, Florida, 34471
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, 68114
Chesapeake Urology
Owings Mills, Maryland, 21117
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Urology Institute of Long Island
Plainview, New York, 11803
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Virginia Urology
Richmond, Virginia, 23235
San Bernardino Urological Associates Medical Group
San Bernardino, California, 92404
Wr-McCr, Llc
San Diego, California, 92108
San Diego Clinical Trials
San Diego, California, 92120
Regional Urology, LLC
Shreveport, Louisiana, 71106
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710
Associated Medical Professionals- Urology
Syracuse, New York, 13210
Multicare Allenmore Hospital
Tacoma, Washington, 98405
Michigan Institute of Urology
Troy, Michigan, 48084
Urological Assoc. of South AZ
Tucson, Arizona, 85715
Sutter Institute for Medical Health
Vacaville, California, 95688
Urology of Virginia
Virginia Beach, Virginia, 23462
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
Aurora Research Institute
West Allis, Wisconsin, 53227
The Iowa Clinic
West Des Moines, Iowa, 50266
West Coast Urology
Whittier, California, 90603
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: 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.
- Being tested
- OnabotulinumtoxinA and Hydrogel admixture, Placebo and Hydrogel admixture
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA and Hydrogel admixtureDrug
Also called BOTOX®, Botulinum Toxin Type A
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Placebo and Hydrogel admixtureDrug
Placebo and Hydrogel admixture administered as a single intravesical instillation
| Study group | Role | What they receive |
|---|---|---|
| 100U cohort - BOTOX® plus Hydrogel admixture | Experimental | 100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 Receives: Drug: OnabotulinumtoxinA and Hydrogel admixture |
| 100U cohort - Placebo plus Hydrogel admixture | Placebo comparator | Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 Receives: Drug: Placebo and Hydrogel admixture |
| 300U cohort - BOTOX® plus Hydrogel admixture | Experimental | 300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 Receives: Drug: OnabotulinumtoxinA and Hydrogel admixture |
| 300U cohort - Placebo plus Hydrogel admixture | Placebo comparator | Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 Receives: Drug: Placebo and Hydrogel admixture |
| 400U cohort - BOTOX® plus Hydrogel admixture | Experimental | 400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 Receives: Drug: OnabotulinumtoxinA and Hydrogel admixture |
| 400U cohort - Placebo plus Hydrogel admixture | Placebo comparator | Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 Receives: Drug: Placebo and Hydrogel admixture |
| 500U cohort - BOTOX® plus Hydrogel admixture | Experimental | 500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 Receives: Drug: OnabotulinumtoxinA and Hydrogel admixture |
| 500U cohort - Placebo plus Hydrogel admixture | Placebo comparator | Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 Receives: Drug: Placebo and Hydrogel admixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start4 Oct 2017
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Till Geib, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320850
- Sponsor's protocol ID
- 1839-201-021
- Acronym
- APOLLO
- Status last verified
- Jul 2021
- First submitted
- 23 Oct 2017
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: * 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03320850
- Acronym / sponsor ID
- APOLLO / 1839-201-021
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 13 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 100U cohort - BOTOX® plus Hydrogel admixture | Experimental | Drug: OnabotulinumtoxinA and Hydrogel admixture100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 100U cohort - Placebo plus Hydrogel admixture | Placebo comparator | Drug: Placebo and Hydrogel admixturePlacebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 300U cohort - BOTOX® plus Hydrogel admixture | Experimental | Drug: OnabotulinumtoxinA and Hydrogel admixture300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 300U cohort - Placebo plus Hydrogel admixture | Placebo comparator | Drug: Placebo and Hydrogel admixturePlacebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 400U cohort - BOTOX® plus Hydrogel admixture | Experimental | Drug: OnabotulinumtoxinA and Hydrogel admixture400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 400U cohort - Placebo plus Hydrogel admixture | Placebo comparator | Drug: Placebo and Hydrogel admixturePlacebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 500U cohort - BOTOX® plus Hydrogel admixture | Experimental | Drug: OnabotulinumtoxinA and Hydrogel admixture500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 500U cohort - Placebo plus Hydrogel admixture | Placebo comparator | Drug: Placebo and Hydrogel admixturePlacebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinA and Hydrogel admixtureAlso: BOTOX®, Botulinum Toxin Type ABOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation | Drug | 100U cohort - BOTOX® plus Hydrogel admixture, 300U cohort - BOTOX® plus Hydrogel admixture, 400U cohort - BOTOX® plus Hydrogel admixture, 500U cohort - BOTOX® plus Hydrogel admixture |
| Placebo and Hydrogel admixturePlacebo and Hydrogel admixture administered as a single intravesical instillation | Drug | 100U cohort - Placebo plus Hydrogel admixture, 300U cohort - Placebo plus Hydrogel admixture, 400U cohort - Placebo plus Hydrogel admixture, 500U cohort - Placebo plus Hydrogel admixture |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. * 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Till Geib study director
Allergan
63 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OnabotulinumtoxinA and Hydrogel admixture in people with Urinary Incontinence and Overactive Bladder With Urinary Incontinence, run by Allergan at 63 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.