Clinical trial NCT01945489: OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
Official title: OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-09-18
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.


Eligibility criteria: Inclusion Criteria:

-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.

Exclusion Criteria:

* Symptoms of OAB due to a neurological reason
* Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
* Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
* Use of botulinum toxin therapy of any serotype for any urological condition
* Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
* History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
* Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.

Primary outcomes:
measure: Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Daily Average Number of Micturition Episodes
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Daily Average Number of Urgency Episodes
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Daily Average Number of Nocturia Episodes
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Urologic Clinics of North Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Urological Institute dba Alaska Clinical Research Center
state: Alaska
city: Laguna Hills
country: United States
facility: South Orange County Medical Research Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Diego
country: United States
facility: Genesis Research LLC
state: California
city: Aurora
country: United States
facility: U. Colorado, School of Med.
state: Colorado
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Norwalk
country: United States
facility: Urology Associates of Norwalk
state: Connecticut
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Miramar
country: United States
facility: Bladder and Prostate Health Investigations, LLC
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: Urology Health Team, PLLC
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Research Group, Inc.
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute
state: Georgia
city: Fort Wayne
country: United States
facility: Northeast Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Urogynecology Associates
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Noblesville
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Owings Mills
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
city: Garden City
country: United States
facility: Accumed Research
state: New York
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Newburgh
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Plainview
country: United States
facility: Advanced Urology Centers of NY A division of IMP
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of New York, PLLC
state: New York
city: Gastonia
country: United States
facility: Carolina Urology Partners, PLLC
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: TriState Urologic Services PSC Inc., dba The Urology Group
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
city: Allentown
country: United States
facility: Institute of Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southern Pennsylvania
state: Pennsylvania
city: State College
country: United States
facility: Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Richmond
country: United States
facility: Virginia Women's Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
city: Seattle
country: United States
facility: The Polyclinic
state: Washington
Study officials:
affiliation: Allergan
name: Tamer Aboushwareb
role: STUDY_DIRECTOR
References:
citation: McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914.