Minerva Urology and Nephrology 2021 Mar 26

DOI: 10.23736/S2724-6051.21.04227-2

Copyright © 2021 EDIZIONI MINERVA MEDICA

lingua: Inglese

IncobotulinumtoxinA versus OnabotulinumtoxinA intradetrusor injections in patients with neurogenic detrusor overactivity incontinence: a double-blind, randomized, non-inferiority trial

Antonella GIANNANTONI ¹, Marilena GUBBIOTTI ² ✉, Emanuele RUBILOTTA ³, Matteo BALZARRO ³, Alessandro ANTONELLI ³, Vittorio BINI ⁴

¹ Functional and Surgical Urology Unit, Department of Medical and Surgical Sciences and Neurosciences, University of Siena, Siena, Italy; ² Urology Clinic, San Donato Hospital, Arezzo, Italy; ³ Department of Urology, University Hospital of Verona, Verona, Italy; ⁴ Department of Medicine, University of Perugia, Perugia, Italy

BACKGROUND: A randomized, double-blind, non-inferiority clinical study was performed on the efficacy and tolerability of IncobotulinumtoxinA vs OnabotulinumtoxinA intradetrusor injections in patients with refractory neurogenic detrusor overactivity incontinence performing intermittent catheterization.
METHODS: Sixty-four patients with Spinal Cord Injury or Multiple Sclerosis were randomized to receive 30 intradetrusor injections of IncobotulinumtoxinA or OnabotulinumtoxinA 200 U; 28 patients in IncobotulinumtoxinA group and 29 in OnabotulinumtoxinA group completed the study. Primary outcome measure was the noninferior variation from baseline in daily urinary incontinence episodes (week 12), with a non-inferiority margin of one episode/day. Secondary outcomes measures were changes in Incontinence- Quality of Life questionnaire, Visual Analog Scale score (bother of symptoms on Quality of Life), urodynamic parameters, occurrence of adverse effects and related costs (week 12).
RESULTS: At week 12, mean value of difference in urinary incontinence episodes/day between the two groups was -0.2 (95% two-sided CI: -1; 0.7); the difference in incontinence episodes/day between the two groups was −0.4 with a higher limit of one-sided 95% CI of 0.2 episodes/day which was much lower than the non-inferiority margin of one episode/day. Total score and subscores of Incontinence- Quality of Life questionnaire, Visual Analog Scale Scores and urodynamics did not show differences between the two groups. Adverse effects were similar for both treatments, with urinary tract infection being the most frequent, localised effect. Minor costs were observed following IncobotulinumtoxinA.
CONCLUSIONS: In patients with refractory neurogenic incontinence due to Spinal Cord Injury or Multiple Sclerosis, IncobotulinumtoxinA was not inferior to OnabotulinumtoxinA in improving clinical and urodynamic findings in the short-term follow-up, with comparable adverse effects but minor costs.

KEY WORDS: IncobotulinumtoxinA; OnabotulinumtoxinA; Neurogenic detrusor overactivity incontinence; Spinal cord injury; Multiple sclerosis