Clinical trial NCT03320850: BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Overactive Bladder With Urinary Incontinence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and 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

Primary outcomes:
measure: Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day
timeFrame: Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
measure: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period
timeFrame: Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)
Secondary outcomes:
measure: Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day
timeFrame: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
measure: Stage 2: Change From Baseline in the Average Volume Voided Per Micturition
timeFrame: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc., an AMR company
state: Alabama
city: Tucson
country: United States
facility: Urological Assoc. of South AZ
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates Medical Group
state: California
city: San Diego
country: United States
facility: Wr-McCr, Llc
state: California
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Vacaville
country: United States
facility: Sutter Institute for Medical Health
state: California
city: Whittier
country: United States
facility: West Coast Urology
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Englewood
country: United States
facility: Urology Associates, P.C
state: Colorado
city: Bridgeport
country: United States
facility: Adult and Pediatric Urology
state: Connecticut
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: Middlebury
country: United States
facility: CT Clinical Research Center/Urologist Specialist
state: Connecticut
city: Aventura
country: United States
facility: Innovative Medical Research of South FL, Inc.
state: Florida
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Bradenton
country: United States
facility: Manatee Medical Research Institute
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Miramar
country: United States
facility: Urological Research Network
state: Florida
city: N. Redington Beach
country: United States
facility: Florida Urology Partners
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Lake Barrington
country: United States
facility: Comprehensive Urological Care
state: Illinois
city: Carmel
country: United States
facility: Urogynecology Associates, PC
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology,PSC
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: New Orleans
country: United States
facility: DelRicht Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Owings Mills
country: United States
facility: Chesapeake Urology
state: Maryland
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Kalamazoo
country: United States
facility: Women's Health Care Specialists
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Omaha
country: United States
facility: Adult Pediatric Urology & Urogynecology
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group
state: New Jersey
city: Mount Laurel
country: United States
facility: Delaware Valley Urology
state: New Jersey
city: Cheektowaga
country: United States
facility: Western New York Urology Associates
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Garden City
country: United States
facility: Urological Surgeons of Long Island
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: Plainview
country: United States
facility: Urology Institute of Long Island
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals- Urology
state: New York
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions, LLC
state: Ohio
city: Gresham
country: United States
facility: The Center for Men's & Women's Urology
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Kirkland
country: United States
facility: Washington Urology and Urogynecology Associates
state: Washington
city: Tacoma
country: United States
facility: Multicare Allenmore Hospital
state: Washington
city: West Allis
country: United States
facility: Aurora Research Institute
state: Wisconsin
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Allergan
name: Till Geib
role: STUDY_DIRECTOR
References: