gms | German Medical Science

Introduction: Therapeutic option for the treatment of NDO according to guidelines are in the order of recommendation, orale anticholinergics, intravesical oxybutynin (e.g. VESOXX) and botulinumtoxin A as medical treatments. AEs of therapies often result in treatment cessations. Here we compare AEs of the above-mentioned treatments using the EUDRA vigilance data base.

Methods: AE listings for orale anticholinergics, intravesical oxybutynin and botulinumtoxin A were retrieved from the EUDRA vigilance data base from 2018 to 29.03.2023. Data from the line listings were filtered by year, seriousness and indication.

Results: Total number of reported AE in the indication “hypertonic bladder” were 225, 17 and 666 for oral oxybutynin, intravesical oxybutynin and botulinumtoxin A respectively. In the indication of “neurogenic bladder” AE were reported in 17, 17, 160. Major reported AEs in “hypertonic bladder” were anxiety, dry mouth, ineffectiveness, constipation, depressed mood, hallucination and panic disorder (3.6%, 2.7%, 2.2%, 1.8%, 1.8%, 1.8%, 1.8% respectively) for oral oxybutynin. For intravesical oxybutynin there were two AEs reported twice (urinary infection and nausea) all other 13 events were single reports.

For botulinumtoxin A the most frequent AEs were urinary retention 15.6%, urinary tract infection 5.9%, off-label use 5.7%, residual urine volume increased 3.6%, dysuria 2.1%. Serious AE were reported in 52%, 12% and 47% for oral oxybutynin, intravesical oxybutynin and botulinum toxin A respectively.

Conclusion: This analysis from EUDRA vigilance database clearly shows the least number and the least serious AEs are related to intravesical oxybutynin, when compared to oral oxybutynin and botulinumtoxin A.

Conflicts of interest:

• Michael Gedamke is active as a consultant for FARCO Pharma GmbH since 2021.
• Dr. Yvonne Steffen is an employee of FARCO Pharma GmbH.
• Quentin Leidl is an employee of FARCO Pharma GmbH.