Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence

Phase 4

Completed

Conditions: Urinary Incontinence
Urinary Bladder, Overactive

Interventions: Biological: onabotulinumtoxinA
Drug: Placebo (saline)

Registration Number: NCT03052764

Lead Sponsor: Allergan

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/BOTOX® 100 U	onabotulinumtoxinA	Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
BOTOX® 100 U/BOTOX® 100 U	onabotulinumtoxinA	BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
Placebo/BOTOX® 100 U	Placebo (saline)	Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12	The participant recorded urinary incontinence in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with treatment as a factor at 2 levels, and the number of Urgency Urinary Incontinence (UUI) episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) and Baseline daily average number of episodes of incontinence as covariates was used for analyses.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Complete Continence	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12]	Complete continence is defined as 100% reduction in urinary incontinence from Baseline.
Change From Baseline in Daily Average Number of Micturition Episodes	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12	The participant recorded the number of micturition episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) and Baseline daily average number of micturition as covariates was used for analyses.
Change From Baseline in Daily Average Number of Urgency Episodes	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12	The participant recorded the number of urgency episode in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) and Baseline daily average number of urgency episodes as covariates was used for analyses.
Change From Baseline in Daily Average Number of Nocturia Episodes	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12	The participants recorded the number of nocturia episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) and Baseline daily average number of nocturia episodes as covariates was used for analyses.
Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)	Week 12	The participant rated their condition during treatment using the TBS 4-point scale where: 1=greatly improved, 2=improved, 3=not changed or 4=worsened. A positive treatment response is either as score of 1=greatly improved or 2=improved.

Trial Locations

Locations (31): Urology Clinics of North Texas
🇺🇸
Dallas, Texas, United States
Adult and Pediatric Urology
🇺🇸
Omaha, Nebraska, United States
Regional Urology
🇺🇸
Shreveport, Louisiana, United States
University of California, Irvine Medical Center
🇺🇸
Orange, California, United States
Orange County Urology Associates
🇺🇸
Laguna Hills, California, United States
Tower Urology
🇺🇸
Los Angeles, California, United States
PMG Research of Christie Clinic
🇺🇸
Champaign, Illinois, United States
Deaconess Clinic, Inc.
🇺🇸
Evansville, Indiana, United States
Urology of Indiana
🇺🇸
Noblesville, Indiana, United States
Women's Health Advantage
🇺🇸
Fort Wayne, Indiana, United States
Iowa Clinic
🇺🇸
West Des Moines, Iowa, United States
Beyer Research
🇺🇸
Kalamazoo, Michigan, United States
Chesapeake Urology
🇺🇸
Owings Mills, Maryland, United States
Michigan Institute of Urology, P.C.
🇺🇸
Troy, Michigan, United States
Premier Urology LLC
🇺🇸
Edison, New Jersey, United States
Genitourinary Surgical Consultants
🇺🇸
Denver, Colorado, United States
Urogynecology Associates
🇺🇸
Indianapolis, Indiana, United States
Western New York Urology Associates
🇺🇸
Cheektowaga, New York, United States
Sandhills Medical Center
🇺🇸
Hamlet, North Carolina, United States
Virginia Urology
🇺🇸
Richmond, Virginia, United States
Premier Medical Group of the Hudson Valley
🇺🇸
Poughkeepsie, New York, United States
Urologic Consultants of Southeastern Pennsylvania
🇺🇸
Bala-Cynwyd, Pennsylvania, United States
Advanced Urology Centers of NY A division of IMP
🇺🇸
Plainview, New York, United States
Alliance Urology Specialists
🇺🇸
Greensboro, North Carolina, United States
Center for Pelvic Health
🇺🇸
Franklin, Tennessee, United States
Manhattan Medical Research
🇺🇸
New York, New York, United States
Virginia Urology Center
🇺🇸
Richmond, Virginia, United States
Integrity Medical Research, LLC
🇺🇸
Mountlake Terrace, Washington, United States
East Coast Institute for Research, LLC
🇺🇸
Jacksonville, Florida, United States
Urology of Virginia
🇺🇸
Virginia Beach, Virginia, United States
PMG Research of Wilmington
🇺🇸
Wilmington, North Carolina, United States