BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
NCT ID: NCT03320850
Last Updated: 2021-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
383 participants
INTERVENTIONAL
2017-10-04
2020-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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100U cohort - BOTOX® plus Hydrogel admixture
100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
100U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation
300U cohort - BOTOX® plus Hydrogel admixture
300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
300U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation
400U cohort - BOTOX® plus Hydrogel admixture
400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
400U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation
500U cohort - BOTOX® plus Hydrogel admixture
500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
500U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation
Interventions
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OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB
Exclusion Criteria
* Patient has predominance of stress incontinence
* History or evidence of pelvic or urological abnormality
* Prior use of BOTOX for any urological condition
18 Years
75 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Till Geib
Role: STUDY_DIRECTOR
Allergan
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Coastal Clinical Research, Inc., an AMR company
Mobile, Alabama, United States
Urological Assoc. of South AZ
Tucson, Arizona, United States
Hope Clinical Research
Canoga Park, California, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States
Wr-McCr, Llc
San Diego, California, United States
San Diego Clinical Trials
San Diego, California, United States
Sutter Institute for Medical Health
Vacaville, California, United States
West Coast Urology
Whittier, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Urology Associates, P.C
Englewood, Colorado, United States
Adult and Pediatric Urology
Bridgeport, Connecticut, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
CT Clinical Research Center/Urologist Specialist
Middlebury, Connecticut, United States
Innovative Medical Research of South FL, Inc.
Aventura, Florida, United States
South Florida Medical Research
Aventura, Florida, United States
Manatee Medical Research Institute
Bradenton, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
Urological Research Network
Miramar, Florida, United States
Florida Urology Partners
North Redington Beach, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, United States
North Idaho Urology
Coeur d'Alene, Idaho, United States
Idaho Urologic Institute
Meridian, Idaho, United States
Comprehensive Urological Care
Lake Barrington, Illinois, United States
Urogynecology Associates, PC
Carmel, Indiana, United States
First Urology,PSC
Jeffersonville, Indiana, United States
The Iowa Clinic
West Des Moines, Iowa, United States
DelRicht Research, LLC
New Orleans, Louisiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Chesapeake Urology Associates
Hanover, Maryland, United States
Chesapeake Urology
Owings Mills, Maryland, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Women's Health Care Specialists
Kalamazoo, Michigan, United States
Michigan Institute of Urology
Troy, Michigan, United States
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Premier Urology Group
Edison, New Jersey, United States
Delaware Valley Urology
Mount Laurel, New Jersey, United States
Western New York Urology Associates
Cheektowaga, New York, United States
AccuMed Research Associates
Garden City, New York, United States
Urological Surgeons of Long Island
Garden City, New York, United States
Manhattan Medical Research Practice PLLC
New York, New York, United States
Urology Institute of Long Island
Plainview, New York, United States
Associated Medical Professionals- Urology
Syracuse, New York, United States
American Health Research
Charlotte, North Carolina, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Clinical Research Solutions, LLC
Middleburg Heights, Ohio, United States
The Center for Men's & Women's Urology
Gresham, Oregon, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Virginia Urology
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Washington Urology and Urogynecology Associates
Kirkland, Washington, United States
Multicare Allenmore Hospital
Tacoma, Washington, United States
Aurora Research Institute
West Allis, Wisconsin, United States
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com.
Other Identifiers
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1839-201-021
Identifier Type: -
Identifier Source: org_study_id
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