OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)
Condition: Urinary Incontinence; Urinary Bladder; Overactive
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: BOTOX®
Intervention description: Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to
      evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to
      overactive bladder (OAB) with inadequate management with anticholinergic therapy.
      Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U
      BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12
      post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until
      they qualified for further retreatment/exited the study. Participants could receive multiple
      treatments dependent upon the number and timing of patient requests/qualification for
      retreatment. At each retreatment the investigator could keep the dose the same or increase it
      one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed
      since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had
      occurred.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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