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#Grand Rounds

What AbobotulinumtoxinA Dosage Is Best for Treating Overactive Bladder?

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BACKGROUND AND PURPOSE:

  • Overactive bladder is a common condition with significant impact on quality of life
  • 1st and 2nd line therapies
    • anti‐muscarinics or oral ß3 adrenoceptor agonists
  • 3rd line for refractory cases
    • OnabotulinumtoxinA (ONA), a specific formulation of Botulinum toxin type A (licensed in the US and Europe for neurogenic detrusor overactivity and idiopathic detrusor overactivity
  • Another formulation, abobotulinumtoxinA (ABO), has also been shown to be of benefit in smaller, uncontrolled studies
  • De Sá Dantas Bezerra et al. (Neurology and Urodynamics, 2018) sought to determine dosing for abobotulinumtoxinA (ABO) intravesical injections for the treatment of idiopathic overactive bladder (OAB)

METHODS:

  • Randomized controlled trial
    • Women who failed conservative treatment
  • Patients were randomized to 2 groups
    • 300 U of ABO
    • 500 U of ABO
  • Drug injected using cystoscope
    • 30 injections, 1 ml per site, into detrusor muscle (not trigone)
    • Spinal or IV anesthesia in OR with antibiotic prophylaxis
  • Patients assessed at baseline, 4, 12, and at 24 weeks post injection
  • All treatments were evaluated by
    • Voiding diary
    • International Consultation on Incontinence Questionnaire OAB (ICIQ‐OAB)
    • Patient Global Impression of Improvement (PGI‐I)
    • Urodynamic testing as per ICS recommendations
    • Visual analogue scale (VAS) for treatment satisfaction
  • Primary outcome: Change in maximum cistometric capacity (MCC)
  • Secondary outcomes
    • Changes in urgency | Complete continence | Subjective success (VAS and PGI‐I) | Adverse events (urinary retention, UTI, and catheterization)
  • Statistical analysis
    • 90% power to detect 30% difference in delta of MCC
    • Delta measured as the difference in MCC from baseline to post-treatment

RESULTS:

  • 21 patients were included
  • From baseline to 12 weeks, change in MCC was not significantly different between groups
    • 185.0 to 270.9 mL in the 300 U group
    • 240.8 to 311.7 mL in the 500 U group
  • At 12 weeks, 91% of patients were dry in both groups
  • At 24 weeks, episodes of incontinence had returned in
    • 50% (300 U)
    • 0% (500 U) (P = 0.013)
  • Patients were better or much better (PGI‐I) in 12 weeks
    • 70% (300 U)
    • 88.9% (500 U)
  • Better in 24 weeks
    • 50% (300 U)
    • 100% (500 U) (P = 0.027)
  • Peak of post-void residual urine volume at 4 weeks:
  • 300 U: 71.7 mL
  • 400 U: 96.5 mL
  • General UTI incidence was 35.7% with no difference between groups
    • Successfully treated with antibiotics
  • One patient (500 U) required intermittent catheterization for 2 weeks
    • Spontaneous improvement

CONCLUSION:

  • The long term efficacy/quality of life benefits of ABO was much higher when given in the 500 U dose, although there was no difference in the primary outcome (based on power of this current study)
  • Limitations of study include lack of blinded independent interviewer
  • Larger studies required to assess secondary outcomes, particularly safety

Learn More – Primary Sources:

A prospective randomized clinical trial comparing two doses of AbobotulinumtoxinA for idiopathic overactive bladder

Now You Can Get ObG Clinical Research Summaries Direct to Your Phone

Learn More »

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