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OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due

BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age

  • Clinical Trial Information

    Trial Contact: Beltran, Yajira; Parrimon, Yazandra

    Trial Phone: 321.841.7619 ; 321.841.1361

  • IRB No: 17.155.11

    Protocol Abbrev: Botox for OAB

    Principal Investigator: Hubert S. Swana, MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: 191622-137

    Treatment: BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin

    Therapies Involved: Medication ID: NCT02097121

  • Objective

    To evaluate the safety and efficacy of BOTOX for the treatment of urinary incontinence due to overactive bladder (OAB) in patients 12 to 17 years of age who have not been adequately managed with anticholinergic therapy.

  • Key Eligibility

    Inclusion Criteria: •   12 to 17 years of age•   symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months•  OAB symptoms not adequately managed by 1 or more anticholinergic agents Exclusion Criteria:•  OAB caused by a neurological condition
    •  Use of anticholinergics or other medications to treat OAB symptoms within 7 days•  Current use of indwelling catheter or clean intermittent catheterization to empty the bladder •  Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use•  Myasthenia gravis,Eaton-Lambert syndrome, or amyotrophic lateral sclerosis