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

Urinary Incontinence Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320850
• Other study ID #: 1839-201-021
• Status: Completed
• Phase: Phase 2
• Start date: October 4, 2017
• Est. completion date: July 21, 2020

Study information

• Verified date: July 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: July 21, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder With Urinary Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
United States	Innovative Medical Research of South FL, Inc.	Aventura	Florida
United States	South Florida Medical Research	Aventura	Florida
United States	Urologic Consultants of SE PA	Bala-Cynwyd	Pennsylvania
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Manatee Medical Research Institute	Bradenton	Florida
United States	Adult and Pediatric Urology	Bridgeport	Connecticut
United States	Hope Clinical Research	Canoga Park	California
United States	Urogynecology Associates, PC	Carmel	Indiana
United States	American Health Research	Charlotte	North Carolina
United States	Western New York Urology Associates	Cheektowaga	New York
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	Urology Clinics of North Texas	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Premier Urology Group	Edison	New Jersey
United States	Urology Associates, P.C	Englewood	Colorado
United States	Women's Health Specialty Care	Farmington	Connecticut
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	AccuMed Research Associates	Garden City	New York
United States	Urological Surgeons of Long Island	Garden City	New York
United States	The Center for Men's & Women's Urology	Gresham	Oregon
United States	Chesapeake Urology Associates	Hanover	Maryland
United States	Houston Metro Urology	Houston	Texas
United States	First Urology,PSC	Jeffersonville	Indiana
United States	Women's Health Care Specialists	Kalamazoo	Michigan
United States	Washington Urology and Urogynecology Associates	Kirkland	Washington
United States	Comprehensive Urological Care	Lake Barrington	Illinois
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Sunrise Medical Research	Lauderdale Lakes	Florida
United States	Idaho Urologic Institute	Meridian	Idaho
United States	Clinical Research Solutions, LLC	Middleburg Heights	Ohio
United States	CT Clinical Research Center/Urologist Specialist	Middlebury	Connecticut
United States	Urological Research Network	Miramar	Florida
United States	Coastal Clinical Research, Inc., an AMR company	Mobile	Alabama
United States	Delaware Valley Urology	Mount Laurel	New Jersey
United States	Florida Urology Partners	N. Redington Beach	Florida
United States	DelRicht Research, LLC	New Orleans	Louisiana
United States	Manhattan Medical Research Practice PLLC	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	Adult Pediatric Urology & Urogynecology	Omaha	Nebraska
United States	Chesapeake Urology	Owings Mills	Maryland
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Urology Institute of Long Island	Plainview	New York
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Virginia Urology	Richmond	Virginia
United States	Pinellas Urology, Inc.	Saint Petersburg	Florida
United States	San Bernardino Urological Associates Medical Group	San Bernardino	California
United States	San Diego Clinical Trials	San Diego	California
United States	Wr-McCr, Llc	San Diego	California
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Associated Medical Professionals- Urology	Syracuse	New York
United States	Multicare Allenmore Hospital	Tacoma	Washington
United States	Michigan Institute of Urology	Troy	Michigan
United States	Urological Assoc. of South AZ	Tucson	Arizona
United States	Sutter Institute for Medical Health	Vacaville	California
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Aurora Research Institute	West Allis	Wisconsin
United States	The Iowa Clinic	West Des Moines	Iowa
United States	West Coast Urology	Whittier	California
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Primary	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.	Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)
Secondary	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.	Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Secondary	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.	Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com.