Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence
NCT ID: NCT03052764
Last Updated: 2019-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2016-12-12
2018-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injection into the bladder.
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.
onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injection into the bladder.
Placebo (saline)
Placebo (saline) injection into the bladder.
Interventions
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onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injection into the bladder.
Placebo (saline)
Placebo (saline) injection into the bladder.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Dana Fetterolf
Role: STUDY_DIRECTOR
Allergan
Amin Boroujerdi
Role: STUDY_DIRECTOR
Allergan
Locations
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Orange County Urology Associates
Laguna Hills, California, United States
Tower Urology
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
PMG Research of Christie Clinic
Champaign, Illinois, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Urogynecology Associates
Indianapolis, Indiana, United States
Urology of Indiana
Noblesville, Indiana, United States
Iowa Clinic
West Des Moines, Iowa, United States
Regional Urology
Shreveport, Louisiana, United States
Chesapeake Urology
Owings Mills, Maryland, United States
Beyer Research
Kalamazoo, Michigan, United States
Michigan Institute of Urology, P.C.
Troy, Michigan, United States
Adult and Pediatric Urology
Omaha, Nebraska, United States
Premier Urology LLC
Edison, New Jersey, United States
Western New York Urology Associates
Cheektowaga, New York, United States
Manhattan Medical Research
New York, New York, 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
Alliance Urology Specialists
Greensboro, North Carolina, United States
Sandhills Medical Center
Hamlet, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, United States
Center for Pelvic Health
Franklin, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Virginia Urology
Richmond, Virginia, United States
Virginia Urology Center
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, United States
Countries
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References
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Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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More Information
Other Identifiers
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CMO-US-URO-0470
Identifier Type: -
Identifier Source: org_study_id