BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
- Conditions
- Urinary IncontinenceOveractive Bladder With Urinary Incontinence
- Interventions
- Drug: Placebo and Hydrogel admixture
- Registration Number
- NCT03320850
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 383
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 300U cohort - BOTOX® plus Hydrogel admixture OnabotulinumtoxinA and Hydrogel admixture 300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 400U cohort - BOTOX® plus Hydrogel admixture OnabotulinumtoxinA and Hydrogel admixture 400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 500U cohort - BOTOX® plus Hydrogel admixture OnabotulinumtoxinA and Hydrogel admixture 500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 100U cohort - BOTOX® plus Hydrogel admixture OnabotulinumtoxinA and Hydrogel admixture 100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 500U cohort - Placebo plus Hydrogel admixture Placebo and Hydrogel admixture Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 100U cohort - Placebo plus Hydrogel admixture Placebo and Hydrogel admixture Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 400U cohort - Placebo plus Hydrogel admixture Placebo and Hydrogel admixture Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 300U cohort - Placebo plus Hydrogel admixture Placebo and Hydrogel admixture Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
- Primary Outcome Measures
Name Time Method Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day 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 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.
- Secondary Outcome Measures
Name Time Method Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day 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.
Stage 2: Change From Baseline in the Average Volume Voided Per Micturition 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.
Trial Locations
- Locations (63)
Urological Assoc. of South AZ
🇺🇸Tucson, Arizona, United States
Adult and Pediatric Urology
🇺🇸Bridgeport, Connecticut, United States
CT Clinical Research Center/Urologist Specialist
🇺🇸Middlebury, Connecticut, United States
DelRicht Research, LLC
🇺🇸New Orleans, Louisiana, United States
Chesapeake Urology Associates
🇺🇸Hanover, Maryland, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
San Bernardino Urological Associates Medical Group
🇺🇸San Bernardino, California, United States
Sunrise Medical Research
🇺🇸Lauderdale Lakes, Florida, United States
Sutter Institute for Medical Health
🇺🇸Vacaville, California, United States
Innovative Medical Research of South FL, Inc.
🇺🇸Aventura, Florida, United States
Urogynecology Associates, PC
🇺🇸Carmel, Indiana, United States
Urological Research Network
🇺🇸Miramar, Florida, United States
Comprehensive Urological Care
🇺🇸Lake Barrington, Illinois, United States
Pinellas Urology, Inc.
🇺🇸Saint Petersburg, Florida, United States
Urological Surgeons of Long Island
🇺🇸Garden City, New York, United States
West Coast Urology
🇺🇸Whittier, California, United States
Western New York Urology Associates
🇺🇸Cheektowaga, New York, United States
Carolina Institute for Clinical Research
🇺🇸Fayetteville, North Carolina, United States
Florida Urology Partners
🇺🇸N. Redington Beach, Florida, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
The Iowa Clinic
🇺🇸West Des Moines, Iowa, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Women's Health Care Specialists
🇺🇸Kalamazoo, Michigan, United States
Aurora Research Institute
🇺🇸West Allis, Wisconsin, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Virginia Urology
🇺🇸Richmond, Virginia, United States
Chesapeake Urology
🇺🇸Owings Mills, Maryland, United States
Urology Institute of Long Island
🇺🇸Plainview, New York, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
The Center for Men's & Women's Urology
🇺🇸Gresham, Oregon, United States
Washington Urology and Urogynecology Associates
🇺🇸Kirkland, Washington, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Clinical Research Solutions, LLC
🇺🇸Middleburg Heights, Ohio, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Wr-McCr, Llc
🇺🇸San Diego, California, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
San Diego Clinical Trials
🇺🇸San Diego, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Urology Associates, P.C
🇺🇸Englewood, Colorado, United States
Women's Health Specialty Care
🇺🇸Farmington, Connecticut, United States
Manatee Medical Research Institute
🇺🇸Bradenton, Florida, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
First Urology,PSC
🇺🇸Jeffersonville, Indiana, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Bay State Clinical Trials, Inc.
🇺🇸Watertown, Massachusetts, United States
Premier Urology Group
🇺🇸Edison, New Jersey, United States
Delaware Valley Urology
🇺🇸Mount Laurel, New Jersey, United States
Associated Medical Professionals- Urology
🇺🇸Syracuse, New York, United States
Manhattan Medical Research Practice PLLC
🇺🇸New York, New York, United States
American Health Research
🇺🇸Charlotte, North Carolina, United States
Urologic Consultants of SE PA
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Multicare Allenmore Hospital
🇺🇸Tacoma, Washington, United States
Coastal Clinical Research, Inc., an AMR company
🇺🇸Mobile, Alabama, United States
Adult Pediatric Urology & Urogynecology
🇺🇸Omaha, Nebraska, United States