Overactive Bladder Syndrome: Incobotulinumtoxin Versus Onabotulinumtoxin
Status:
Active, not recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
The aim of the original study was to compare Incobot/A versus Onabot/A in order to evaluate
if the differences in the pharmacologic formulations between the two drugs could affect their
efficacy and safety in the treatment of neurogenic overactive bladder (OAB).
In the original study protocol two different dosages for either Incobot/A and Onabot/A (200 U
and 100 U) were considered, to treat patients with neurogenic detrusor overactivity
incontinence performing intermittent catheterization (IC) with higher dosages and those able
to void spontaneously with lower dosage, with the resulting four treatment groups. For such a
study, a very large sample of participants should have been treated and followed up, to have
adequate power to demonstrate the hypothesis. At the end of last February 2020, we had to
temporarily stop all the clinical activities related to the study and patients' recruitment,
due to the occurrence of Sars-Cov-2 pandemic in our Country. At that point, a non-inferiority
study seemed to be possible and adequate, and we adapted the protocol accordingly. In
addition, on the basis of previously published information, we could hypothesize that the new
drug (Incobot/A) would have had at least a roughly similar effect to the control drug
(Onabot/A). In order to perform a non-inferiority study, the power and sample size analysis
have been re-planned.
Thus, we perform a not planned interim analysis to show the preliminary results of an
ongoing, non-inferiority trial in which patients' recruitment temporarily stopped due to
incontrollable external factors. The present study will be aimed to assess the
non-inferiority of Incobot/A compared to Onabot/A on the efficacy and safety parameters, in
the treatment of patients with refractory NDOI performing IC, who are randomized to receive
200 U of Incobot/A or Onabot/A intradetrusor injections and who are followed up to 12 wks
after treatment
Phase:
Phase 3
Details
Lead Sponsor:
University Of Perugia
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA