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

Urinary Incontinence Clinical Trial

— LO-BOT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052764
• Other study ID #: CMO-US-URO-0470
• Status: Completed
• Phase: Phase 4
• Start date: December 12, 2016
• Est. completion date: December 10, 2018

Study information

• Verified date: December 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Biological:
• onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injection into the bladder.

Drug:
• Placebo (saline)
Placebo (saline) injection into the bladder.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	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.	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Secondary	Percentage of Participants Who Achieved Complete Continence	Complete continence is defined as 100% reduction in urinary incontinence from Baseline.	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12]
Secondary	Change From Baseline in Daily Average Number of Micturition Episodes	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.	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Secondary	Change From Baseline in Daily Average Number of Urgency Episodes	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.	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Secondary	Change From Baseline in Daily Average Number of Nocturia Episodes	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.	Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12
Secondary	Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)	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.	Week 12

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