Clinical trial NCT03052764: Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Urinary Incontinence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 120
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 study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with an anticholinergic.


Eligibility criteria: Inclusion Criteria:

* Participant weighs ≥ 40 kg (88 lb)
* Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening.

Exclusion Criteria:

* Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
* Participant has received pharmacologic therapy to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures
* Participant uses clean intermittent catheterization (CIC) or indwelling catheter to manage urinary incontinence
* Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within 12 months of Day 1
* Participant has had previous or current botulinum toxin therapy of any serotype for any urological condition
* Participant has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of Day 1
* Participant has been immunized for any botulinum toxin serotype
* Participant has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
* Participant has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening
* Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy
* Participant is male with previous or current diagnosis of prostate cancer
* Participant has a history of 2 or more urinary tract infections (UTIs) within 6 months of Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs
* Participant has current or previous uninvestigated hematuria
* Participant has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis
* Participant cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to Day 1
* Participant has a known allergy or sensitivity to any botulinum toxin preparation
* Participant has any medical condition that may put him/her at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Participant has current swallowing or breathing difficulties.

Primary outcomes:
measure: Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
timeFrame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved Complete Continence
timeFrame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12]
measure: Change From Baseline in Daily Average Number of Micturition Episodes
timeFrame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
measure: Change From Baseline in Daily Average Number of Urgency Episodes
timeFrame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
measure: Change From Baseline in Daily Average Number of Nocturia Episodes
timeFrame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12
measure: Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)
timeFrame: Week 12
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Orange County Urology Associates
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Champaign
country: United States
facility: PMG Research of Christie Clinic
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Indianapolis
country: United States
facility: Urogynecology Associates
state: Indiana
city: Noblesville
country: United States
facility: Urology of Indiana
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Clinic
state: Iowa
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Owings Mills
country: United States
facility: Chesapeake Urology
state: Maryland
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology, P.C.
state: Michigan
city: Omaha
country: United States
facility: Adult and Pediatric Urology
state: Nebraska
city: Edison
country: United States
facility: Premier Urology LLC
state: New Jersey
city: Cheektowaga
country: United States
facility: Western New York Urology Associates
state: New York
city: New York
country: United States
facility: Manhattan Medical Research
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: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Hamlet
country: United States
facility: Sandhills Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania
state: Pennsylvania
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Richmond
country: United States
facility: Virginia Urology Center
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
Study officials:
affiliation: Allergan
name: Dana Fetterolf
role: STUDY_DIRECTOR
affiliation: Allergan
name: Amin Boroujerdi
role: STUDY_DIRECTOR
References:
citation: Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.