Intravesical oxybutynin treatment for neurogenic detrusor overactivity : Efficacy and safety data from clinical practice with the first intravesical oxybutynin treatment authorized in Germany

• Published in: Urologie (Heidelberg, Germany) Vol. 63; no. 7; p. 693
• Main Authors: Schindler, O, Ho, H, Leidl, Q, Angermund, A, Elishar, R, Frech-Dörfler, M, Hirsch, A, Kalke, Y-B, Kirschner-Herrmanns, R, Tornic, J, Queissert, F, Rahnama'i, S, Rehme, C, Reitz, A, Schmitz, F, Schultz-Lampel, D, Gedamke, M
• Format: Journal Article
• Language: German
• Published: Germany 01.07.2024
• Subjects: Administration, Intravesical; Germany; Humans; Mandelic Acids - administration & dosage; Mandelic Acids - adverse effects; Mandelic Acids - therapeutic use; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; Muscarinic Antagonists - therapeutic use; Treatment Outcome; Urinary Bladder, Neurogenic - drug therapy; Urinary Bladder, Overactive - drug therapy; Urological Agents - administration & dosage; Urological Agents - adverse effects; Urological Agents - therapeutic use; Germany; Spina bifida; Adult; Multiple sclerosis; Children; Spinal cord injury
• ISSN: 2731-7072; 2731-7072
• DOI: 10.1007/s00120-024-02351-1

Existing therapies for neurogenic detrusor overactivity (NDO), i.e. oral anticholinergics and botulinum toxin injections, can be associated with serious adverse effects or are not always sufficiently effective. Therefore, there is a need for alternative safe and effective treatment options for NDO. Intravesical oxybutynin has been successfully used for several years as a prescription drug in adults and children with spinal cord injury and spina bifida. In 2019, VESOXX® (FARCO-PHARMA, Cologne, Germany) became the first registered intravesical oxybutynin product in Germany, which is indicated for the suppression of neurogenic detrusor overactivity (NDO) in children from 6 years of age and adults, who are managing bladder emptying by clean intermittent catheterisation (CIC), if they cannot be adequately managed by oral anticholinergic treatment due to lack of efficacy and/or intolerable side effects. Overall, there are limited data regarding therapy with intravesical oxybutynin, with the majority of publications being retrospective case series. To date, there are limited data on the efficacy and safety of the newly approved intravesical oxybutynin therapy (VESOXX®) in NDO patients. This noninterventional case series from daily routine treatment which evaluated the physician reports of 38 patients suggests that intravesical oxybutynin effectively improves maximum detrusor pressure (Pdet max) by decreasing it by 59% from 51.94 cm H O ± 26.12 standard deviation (SD) to 21.07 cm H O ± 17.32 SD (P < 0.001, n = 34). Maximum bladder pressure (MBC) increased by 34% from 260.45 ml ± 200.26 SD to 348.45 ml ± 175.90 SD. Positive or similar effects compared to previous therapies were seen in bladder morphology, number of incontinence episodes, urinary tract infections and adverse drug effects. This case series demonstrates that intravesical oxybutynin is an important addition to current therapies for the treatment of NDO and it is also efficacious in the rare setting of other underlying diseases beyond spinal cord injury or spina bifida. The approved intravesical oxybutynin preparation VESOXX® may be a useful alternative for patients who do not respond to other therapies or suffered side effects.