Back to resultsEvaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)
Primary Purpose
Urinary Bladder, Overactive, Urinary Incontinence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
onabotulinumtoxinA
Placebo (saline)
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive
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.
Sites / Locations
- Orange County Urology Associates
- Tower Urology
- University of California, Irvine Medical Center
- Genitourinary Surgical Consultants
- East Coast Institute for Research, LLC
- PMG Research of Christie Clinic
- Deaconess Clinic, Inc.
- Women's Health Advantage
- Urogynecology Associates
- Urology of Indiana
- Iowa Clinic
- Regional Urology
- Chesapeake Urology
- Beyer Research
- Michigan Institute of Urology, P.C.
- Adult and Pediatric Urology
- Premier Urology LLC
- Western New York Urology Associates
- Manhattan Medical Research
- Advanced Urology Centers of NY A division of IMP
- Premier Medical Group of the Hudson Valley
- Alliance Urology Specialists
- Sandhills Medical Center
- PMG Research of Wilmington
- Urologic Consultants of Southeastern Pennsylvania
- Center for Pelvic Health
- Urology Clinics of North Texas
- Virginia Urology
- Virginia Urology Center
- Urology of Virginia
- Integrity Medical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
BOTOX® 100 U/BOTOX® 100 U
Placebo/BOTOX® 100 U
Arm Description
BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants Who Achieved Complete Continence
Complete continence is defined as 100% reduction in urinary incontinence from Baseline.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03052764
Brief Title
Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive, Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX® 100 U/BOTOX® 100 U
Arm Type
Active Comparator
Arm Description
BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
Arm Title
Placebo/BOTOX® 100 U
Arm Type
Placebo Comparator
Arm Description
Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
Intervention Type
Biological
Intervention Name(s)
onabotulinumtoxinA
Other Intervention Name(s)
BOTOX®, botulinum toxin Type A
Intervention Description
OnabotulinumtoxinA (BOTOX®) injection into the bladder.
Intervention Type
Drug
Intervention Name(s)
Placebo (saline)
Intervention Description
Placebo (saline) injection into the bladder.
Primary Outcome Measure Information:
Title
Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
Description
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.
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Complete Continence
Description
Complete continence is defined as 100% reduction in urinary incontinence from Baseline.
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]
Title
Change From Baseline in Daily Average Number of Micturition Episodes
Description
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.
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
Title
Change From Baseline in Daily Average Number of Urgency Episodes
Description
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.
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
Title
Change From Baseline in Daily Average Number of Nocturia Episodes
Description
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.
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
Title
Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)
Description
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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Fetterolf
Organizational Affiliation
Allergan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amin Boroujerdi
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Orange County Urology Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Tower Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
PMG Research of Christie Clinic
City
Champaign
State/Province
Illinois
ZIP/Postal Code
81820
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47113
Country
United States
Facility Name
Women's Health Advantage
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Urogynecology Associates
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Facility Name
Urology of Indiana
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Facility Name
Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Michigan Institute of Urology, P.C.
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Adult and Pediatric Urology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Premier Urology LLC
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Western New York Urology Associates
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Advanced Urology Centers of NY A division of IMP
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Sandhills Medical Center
City
Hamlet
State/Province
North Carolina
ZIP/Postal Code
28345
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Urologic Consultants of Southeastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Center for Pelvic Health
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Virginia Urology Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Integrity Medical Research, LLC
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33955921
Citation
Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information
Learn more about this trial
Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence
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