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

December 9, 2019 updated by: Allergan

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Orange County Urology Associates
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Genitourinary Surgical Consultants
    • Florida
      • Jacksonville, Florida, United States, 32204
        • East Coast Institute for Research, LLC
    • Illinois
      • Champaign, Illinois, United States, 81820
        • PMG Research of Christie Clinic
    • Indiana
      • Evansville, Indiana, United States, 47113
        • Deaconess Clinic, Inc.
      • Fort Wayne, Indiana, United States, 46825
        • Women's Health Advantage
      • Indianapolis, Indiana, United States, 46062
        • Urogynecology Associates
      • Noblesville, Indiana, United States, 46062
        • Urology of Indiana
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Clinic
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Chesapeake Urology
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology, P.C.
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Adult and Pediatric Urology
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Premier Urology LLC
    • New York
      • Cheektowaga, New York, United States, 14225
        • Western New York Urology Associates
      • New York, New York, United States, 10016
        • Manhattan Medical Research
      • Plainview, New York, United States, 11803
        • Advanced Urology Centers of NY A division of IMP
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Alliance Urology Specialists
      • Hamlet, North Carolina, United States, 28345
        • Sandhills Medical Center
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Urologic Consultants of Southeastern Pennsylvania
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Center for Pelvic Health
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Urology Center
      • Richmond, Virginia, United States, 23230
        • Virginia Urology
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Integrity Medical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BOTOX® 100 U/BOTOX® 100 U
BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
Biological: onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injection into the bladder.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Placebo Comparator: Placebo/BOTOX® 100 U
Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
Biological: onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injection into the bladder.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Drug: Placebo (saline)
Placebo (saline) injection into the bladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
Time Frame: 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.
Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Complete Continence
Time Frame: 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.
Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12]
Change From Baseline in Daily Average Number of Micturition Episodes
Time Frame: 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.
Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Change From Baseline in Daily Average Number of Urgency Episodes
Time Frame: 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.
Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Change From Baseline in Daily Average Number of Nocturia Episodes
Time Frame: 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.
Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12
Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)
Time Frame: 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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Dana Fetterolf, Allergan
  • Study Director: Amin Boroujerdi, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2016

Primary Completion (Actual)

December 10, 2018

Study Completion (Actual)

December 10, 2018

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 10, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMO-US-URO-0470

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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