Back to resultsBOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence (APOLLO)
Primary Purpose
Urinary Incontinence, Overactive Bladder With Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OnabotulinumtoxinA and Hydrogel admixture
Placebo and Hydrogel admixture
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
- Coastal Clinical Research, Inc., an AMR company
- Urological Assoc. of South AZ
- Hope Clinical Research
- San Bernardino Urological Associates Medical Group
- Wr-McCr, Llc
- San Diego Clinical Trials
- Sutter Institute for Medical Health
- West Coast Urology
- The Urology Center of Colorado
- Urology Associates, P.C
- Adult and Pediatric Urology
- Women's Health Specialty Care
- CT Clinical Research Center/Urologist Specialist
- Innovative Medical Research of South FL, Inc.
- South Florida Medical Research
- Manatee Medical Research Institute
- Sunrise Medical Research
- Urological Research Network
- Florida Urology Partners
- Renstar Medical Research
- Clinical Research Center of Florida
- Pinellas Urology, Inc.
- North Idaho Urology
- Idaho Urologic Institute
- Comprehensive Urological Care
- Urogynecology Associates, PC
- First Urology,PSC
- The Iowa Clinic
- DelRicht Research, LLC
- Regional Urology, LLC
- Chesapeake Urology Associates
- Chesapeake Urology
- Bay State Clinical Trials, Inc.
- Women's Health Care Specialists
- Michigan Institute of Urology
- Adult Pediatric Urology & Urogynecology
- Excel Clinical Research
- Premier Urology Group
- Delaware Valley Urology
- Western New York Urology Associates
- AccuMed Research Associates
- Urological Surgeons of Long Island
- Manhattan Medical Research Practice PLLC
- Urology Institute of Long Island
- Associated Medical Professionals- Urology
- American Health Research
- Carolina Institute for Clinical Research
- Associated Urologists of North Carolina
- Lyndhurst Clinical Research
- Clinical Research Solutions, LLC
- The Center for Men's & Women's Urology
- Urologic Consultants of SE PA
- University of Pittsburgh
- Urology Clinics of North Texas
- Houston Metro Urology
- Virginia Urology
- Urology of Virginia
- Washington Urology and Urogynecology Associates
- Multicare Allenmore Hospital
- Aurora Research Institute
- Sunnybrook Health Sciences Centre
- Toronto Western Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
100U cohort - BOTOX® plus Hydrogel admixture
100U cohort - Placebo plus Hydrogel admixture
300U cohort - BOTOX® plus Hydrogel admixture
300U cohort - Placebo plus Hydrogel admixture
400U cohort - BOTOX® plus Hydrogel admixture
400U cohort - Placebo plus Hydrogel admixture
500U cohort - BOTOX® plus Hydrogel admixture
500U cohort - Placebo plus Hydrogel admixture
Arm Description
100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03320850
Brief Title
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
Acronym
APOLLO
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
July 21, 2020 (Actual)
Study Completion Date
July 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Overactive Bladder With Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
383 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100U cohort - BOTOX® plus Hydrogel admixture
Arm Type
Experimental
Arm Description
100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Arm Title
100U cohort - Placebo plus Hydrogel admixture
Arm Type
Placebo Comparator
Arm Description
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Arm Title
300U cohort - BOTOX® plus Hydrogel admixture
Arm Type
Experimental
Arm Description
300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Arm Title
300U cohort - Placebo plus Hydrogel admixture
Arm Type
Placebo Comparator
Arm Description
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Arm Title
400U cohort - BOTOX® plus Hydrogel admixture
Arm Type
Experimental
Arm Description
400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Arm Title
400U cohort - Placebo plus Hydrogel admixture
Arm Type
Placebo Comparator
Arm Description
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Arm Title
500U cohort - BOTOX® plus Hydrogel admixture
Arm Type
Experimental
Arm Description
500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Arm Title
500U cohort - Placebo plus Hydrogel admixture
Arm Type
Placebo Comparator
Arm Description
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Intervention Type
Drug
Intervention Name(s)
OnabotulinumtoxinA and Hydrogel admixture
Other Intervention Name(s)
BOTOX®, Botulinum Toxin Type A
Intervention Description
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Intervention Type
Drug
Intervention Name(s)
Placebo and Hydrogel admixture
Intervention Description
Placebo and Hydrogel admixture administered as a single intravesical instillation
Primary Outcome Measure Information:
Title
Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day
Description
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.
Time Frame
Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Title
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period
Description
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.
Time Frame
Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)
Secondary Outcome Measure Information:
Title
Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day
Description
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.
Time Frame
Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Title
Stage 2: Change From Baseline in the Average Volume Voided Per Micturition
Description
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.
Time Frame
Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Till Geib
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Coastal Clinical Research, Inc., an AMR company
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Urological Assoc. of South AZ
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
San Bernardino Urological Associates Medical Group
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
Wr-McCr, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sutter Institute for Medical Health
City
Vacaville
State/Province
California
ZIP/Postal Code
95688
Country
United States
Facility Name
West Coast Urology
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Urology Associates, P.C
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Adult and Pediatric Urology
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Women's Health Specialty Care
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
CT Clinical Research Center/Urologist Specialist
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Innovative Medical Research of South FL, Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Manatee Medical Research Institute
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Sunrise Medical Research
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Urological Research Network
City
Miramar
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Florida Urology Partners
City
N. Redington Beach
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Pinellas Urology, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
North Idaho Urology
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Idaho Urologic Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Comprehensive Urological Care
City
Lake Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
Urogynecology Associates, PC
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
First Urology,PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
The Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
DelRicht Research, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Chesapeake Urology
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Women's Health Care Specialists
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Adult Pediatric Urology & Urogynecology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Premier Urology Group
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Delaware Valley Urology
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Western New York Urology Associates
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Urological Surgeons of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Manhattan Medical Research Practice PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Urology Institute of Long Island
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Associated Medical Professionals- Urology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Associated Urologists of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Research Solutions, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
The Center for Men's & Women's Urology
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Urologic Consultants of SE PA
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Washington Urology and Urogynecology Associates
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Multicare Allenmore Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Aurora Research Institute
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
http://AllerganClinicalTrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com.
Learn more about this trial
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
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