Abobotulinum toxin F (Dysport®) for the treatment of neurogenic detrusor overactivity


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Increasing of treatment efficiency in patients with neurogenic detrusor overactivity is an important medical and social problem. Its significance is determined not only by the high prevalence of neurogenic lower urinary tract dysfunctions, but also by the high risk of complications, among which an impaired renal function takes the leading place. Botulinum toxin therapy is considered as a second-line treatment and is carried out in case of insufficient efficacy, unsatisfactory tolerability or the presence of contraindications to anticholinergic therapy. Botulinum toxin therapy has been actively used in our country for more than 12 years. In 2022, abobotulinum toxin A (Dysport®) was registered in the Russian Federation for the treatment of neurogenic detrusor overactivity. An overview of the results of clinical trials of Dysport®, indicating its high efficacy and favorable safety profile, is presented in the article. The availability of botulinum toxin in the arsenal of a urologist, which has a high efficiency, opens up additional prospects for the treatment of patients with a neurourological profile.

Full Text

Restricted Access

About the authors

G. G. Krivoborodov

FGBOU VO Pirogov Russian National Research Medical University of the Russian Ministry of Healthcare of Russian Federation

Email: dr.krivoborodov@yandex.ru
ORCID iD: 0000-0001-6433-4219
SPIN-code: 8431-1205
Scopus Author ID: 6602856939

Ph.D., MD, professor at the Department of Urology and Andrology

Russian Federation, Moscow

I. V. Kuzmin

Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia

Author for correspondence.
Email: kuzminigor@mail.ru
ORCID iD: 0000-0002-7724-7832
SPIN-code: 2684-4070
Scopus Author ID: 56878681300

Ph.D., MD, professor of the Department of Urology

Russian Federation, Saint Petersburg

V. V. Romikh

N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology – Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation

Email: vromikh@yandex.ru
ORCID iD: 0000-0003-3342-7281
SPIN-code: 7761-0372

Head of the Department of Urodynamics and Neurourology

Russian Federation, Moscow

References

  1. Neurogenic dysfunction of the lower urinary tract. Clinical recommendations of the Ministry of Health of the Russian Federation. 2020. https://cr.minzdrav.gov.ru/schema/588_2.
  2. Panicker J.N., Fowler C.J., Kessler T.M. Lower urinary tract dysfunction in the neurological patient: clinical assessment and management. Lancet Neurol. 2015;14(7):720–732. doi: 10.1016/S1474-4422(15)00070-8.
  3. Kasyan G.R., Dreval R.O., Krivoborodov G.G., Gadzhieva Z.K., Salyukov R.V., Stroganov R.V., Shipitsyn V.V. Socio-economic aspects of neurogenic dysfunctions in urology. Urologiia. 2020;(5):127–132. Doi: https: //dx.doi.org/10.18565/urology.2020.5.127-132.
  4. Gajewski J.B., Schurch B., Hamid R., Averbeck M., Sakakibara R., Agrò E.F., Dickinson T., Payne C.K., Drake M.J., Haylen B.T. An International Continence Society (ICS) report on the terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD). Neurourol Urodyn. 2018;37(3):1152–1161. doi: 10.1002/nau.23397.
  5. Ruffion A., Castro-Diaz D., Patel H., Khalaf K., Onyenwenyi A., Globe D., Lereun C., Teneishvili M., Edwards M. Systematic review of the epidemiology of urinary incontinence and detrusor overactivity among patients with neurogenic overactive bladder. Neuroepidemiology. 2013;41(3–4):146–155. doi: 10.1159/000353274
  6. Lee B.B., Cripps R.A., Fitzharris M., Wing P.C. The global map for traumatic spinal cord injury epidemiology: update 2011, global incidence rate. Spinal Cord. 2014;52(2):110–116. doi: 10.1038/sc.2012.158.
  7. Filippova E.S., Bazhenov I.V., Zyryanov A.V., Zhuravlev V.N. The epidemiology of neurogenic urination disorders. Experimental and Clinical Urology 2020;(3):25–33. doi: 10.29188/2222-8543-2020-12-3-25-33.
  8. Al-Shukri SH, Kuzmin IV. Quality of life in patients with overactive bladder. Urologicheskie vedomosti. 2011;1(1):21–26.
  9. Quarto G., Autorino R., Gallo A., De Sio M., D’Armiento M., Perdonà S., Damiano R. Quality of life in women with multiple sclerosis and overactive bladder syndrome. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(2):189–194. doi: 10.1007/s00192-006-0131-9.
  10. Baron M., Grise P., Cornu J.N. How botulinum toxin in neurogenic detrusor overactivity can reduce upper urinary tract damage? World J Nephrol 2016; 5(2):195–203. doi: 10.5527/wjn.v5.i2.195.
  11. Haab F. Chapter 1. The conditions of neurogenic detrusor overactivity and overactive bladder. Neurourol Urodyn. 2014;33 Suppl 3:S2–5. doi: 10.1002/nau.22636.
  12. Mehnert U., Chartier-Kastler E., de Wachter S., van Kerrebroek P., van Koeveringe G. The Management of Urine Storage Dysfunction in the Neurological Patient. SN Compr. Clin. Med. 2019;(1): 160–182 (2019). doi: 10.1007/s42399-018-0005-8.
  13. de Sèze M., Ruffion A., Denys P., Joseph P.A., Perrouin-Verbe B. GENULF. The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines. Mult Scler. 2007;13(7):915–928. doi: 10.1177/1352458506075651.
  14. Neuro-Urology/Blok B., Castro-Diaz D., Del Popolo G. et al. Guideline of European Urological Association. 2022. https://uroweb.org/guideline/neuro-urology. Дата доступа 01.02.2023.
  15. Averbeck M.A., Madersbacher H. Follow-up of the neuro-urological patient: a systematic review. BJU Int. 2015;115 Suppl 6:39–46. doi: 10.1111/bju.13084.
  16. Kavanagh A., Baverstock R., Campeau L., Carlson K., Cox A., Hickling D., Nadeau G., Stothers L., Welk B. Canadian Urological Association guideline: Diagnosis, management, and surveillance of neurogenic lower urinary tract dysfunction - Full text. Can Urol Assoc J. 2019;13(6):E157–E176. doi: 10.5489/cuaj.5912.
  17. Krivoborodov G.G., Tur E.I., Shirin D.A. Hyperactive bladder the concept of disease and paradigms in the treatment. Meditsinskiy sovet = Medical Council. 2021;(4):121–126. doi: 10.21518/2079-701X-2021-4-121-126.
  18. Romikh V.V., Zakharchenko A.V., Kukushkina L.Yu., et al. Current concepts of the overactive bladder in women. Strategy for choosing drug therapy. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2021;(8):183–191. doi: 10.18565/aig.2021.8.183-191.
  19. Kulchavenya E.V., Kholtobin D.P. Overactive bladder in a complicated patient: which drug to choose? Urologiia. 2021;(1):120–125. doi: 10.18565/urology.2021.1.120-125.
  20. Madersbacher H., Mürtz G., Stöhrer M. Neurogenic detrusor overactivity in adults: a review on efficacy, tolerability and safety of oral antimuscarinics. Spinal Cord. 2013;51(6):432–441. doi: 10.1038/sc.2013.19.
  21. Kuzmin I.V., Kuzmina S.V. Anticholinergic therapy of an overactive bladder: clinical practice aspects. Russian Medical Inquiry. 2021;5(5):273–279. doi: 10.32364/2587-6821-2021-5-5-273-279
  22. Hegde S.S. Muscarinic receptors in the bladder: from basic research to therapeutics. Br J Pharmacol. 2006;147(Suppl 2):S80-87. doi: 10.1038/sj.bjp.0706560
  23. Pontari M.A., Braverman A.S., Ruggieri M.R. Sr. The M2 muscarinic receptor mediates in vitro bladder contractions from patients with neurogenic bladder dysfunction. Am J Physiol Regul Integr Comp Physiol. 2004;286(5):R874–880. doi: 10.1152/ajpregu.00391.2003.
  24. Nardulli R., Losavio E., Ranieri M., Fiore P., Megna G., Bellomo R.G., Cristella G., Megna M. Combined antimuscarinics for treatment of neurogenic overactive bladder. Int J Immunopathol Pharmacol. 2012;25(1 Suppl):35S–41S. doi: 10.1177/03946320120250s106.
  25. Chancellor M., Boone T. Anticholinergics for overactive bladder therapy: central nervous system effects. CNS Neurosci Ther. 2012;18(2):167–174. doi: 10.1111/j.1755-5949.2011.00248.x.
  26. Kuzmin IV, Slesarevskaya MN. Anticholinergic bladder therapy: geriatric aspects. Clin Gerontol. 2021; 27(11–12):21–34. doi: 10.26347/1607-2499202111-12021-034.
  27. Manack A., Motsko S.P., Haag-Molkenteller C., Dmochowski R.R,. Goeh-ring E.L. Jr, Nguyen-Khoa B.A., Jones J.K. Epidemiology and healthcare utilization of neurogenic bladder patients in a US claims database. Neurourol Urodyn. 2011;30(3):395–401. doi: 10.1002/nau.21003.
  28. Biardeau X., Corcos J. Intermittent catheterization in neurologic patients: Update on genitourinary tract infection and urethral trauma. Ann Phys Rehabil Med. 2016;59(2):125–129. doi: 10.1016/j.rehab.2016.02.006.
  29. Zhang D., Sun F., Yao H., Bao X., Wang D., Cui Y., Wu J. The Efficacy and Safety of Mirabegron for the Treatment of Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review and Meta-analysis. Front Pharmacol. 2021;12:756582. doi: 10.3389/fphar.2021.756582.
  30. Whitcup S.M. The History of Botulinum Toxins in Medicine: A Thousand Year Journey. Handb Exp Pharmacol. 2021;263:3–10. doi: 10.1007/164_2019_271.
  31. Choudhury S., Baker M.R, Chatterjee S., Kumar H. Botulinum Toxin: An Update on Pharmacology and Newer Products in Development. Toxins (Basel). 2021;13(1):58. doi: 10.3390/toxins13010058.
  32. Dan Spinu A., Gabriel Bratu O., Cristina Diaconu C., Maria Alexandra Stanescu A., Bungau S., Fratila O., Bohiltea R., Liviu Dorel Mischianu D. Botulinum toxin in low urinary tract disorders – over 30 years of practice (Review). Exp Ther Med. 2020;20(1):117–120. doi: 10.3892/etm.2020.8664.
  33. Dykstra D.D., Sidi A.A., Scott A.B., Pagel J.M., Goldish G.D. Effects of botulinum A toxin on detrusor-sphincter dyssynergia in spinal cord injury patients. J Urol. 1988;139(5):919-922. doi: 10.1016/s0022-5347(17)42717-0
  34. Schurch B., Stöhrer M., Kramer G., Schmid D.M., Gaul G., Hauri D. Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs? Preliminary results. J Urol. 2000;164(3 Pt 1):692–697. doi: 10.1097/00005392-200009010-00018.
  35. Nitti V.W., Dmochowski R., Herschorn S., Sand P., Thompson C., Nardo C., Yan X., Haag-Molkenteller C. EMBARK Study Group. Onabotulinumtoxin A for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013;189(6):2186–2193. doi: 10.1016/j.juro.2012.12.022.
  36. Cruz F., Herschorn S., Aliotta P., Brin M., Thompson C., Lam W., Daniell G. Heesakkers J., Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxin A in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011;60(4):742–750. doi: 10.1016/j.eururo.2011.07.002.
  37. Krivoborodov GG, Vasiliev AV, Shumilo DV, et al. Botulinum toxin type A in patients with overactive bladder. Urologiia. 2010;(3):36–40.
  38. Arkhireev AS, Romikh VV, Panteleyev VV, et al. The efficacy of therapy in patients with neurogenic and idiopathic detrusor hyperactivity depending on the dose of botulinum toxin type A. Experimental and Clinical Urology. 2017;(3);98–103.
  39. Filippova ЕS, Bazhenov I.V., Zyrjanov A.V., et al. Clinical effectiveness of intradetrusor injections of botulinum toxin type a in dose 100 units in multiple sclerosis patients with neurogenic detrusor overactivity. Urology reports (St.-Petersburg). 2020;10(1):25–32. doi: 10.17816/uroved10125-32.
  40. Kuzmin I.V., Slesarevskaya M.N., Amdiy R.E., Ulitko T.V., Al-Shukri S.K. Long-term botulinum therapy for overactive bladder: myths and reality // Urology reports (St.-Petersburg). 2022;12(1):71–84. doi: 10.17816/uroved104335.
  41. Goel S., Pierce H., Pain K., Christos P., Dmochowski R., Chughtai B. Use of Botulinum Toxin A (BoNT-A) in Detrusor External Sphincter Dyssynergia (DESD): A Systematic Review and Meta-analysis. Urology. 2020;140:7–13. doi: 10.1016/j.urology.2020.03.007.
  42. Lee C.L., Kuo H.C. Long-Term Efficacy and Safety of Repeated Intravescial Onabotulinumtoxin A Injections Plus Hydrodistention in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome. Toxins (Basel). 2015;7(10):4283–4293. doi: 10.3390/toxins7104283.
  43. Al-Shukri S.H., Kuzmin I.V., Slesarevskaya M.N., Ignashov Yu.A. Botulinum toxin type A in the treatment of bladder pain syndrome in women: initial results. Urologicheskie vedomosti. 2018;8(2):5–10. doi: 10.17816/uroved825-10.
  44. Arnouk R., Suzuki Bellucci C.H., Benatuil Stull R., de Bessa J .Jr, Malave C.A., Mendes Gomes C. Botulinum neurotoxin type A for the treatment of benign prostatic hyperplasia: randomized study comparing two doses. Scientific World Journal. 2012;2012:463574. doi: 10.1100/2012/463574.
  45. Abou Zahr R., Bou Kheir G., Mjaess G., Jabbour T., Chalhoub K., Diamand R., Roumeguère T. Intra-Cavernosal Injection of Botulinum Toxin in the Treatment of Erectile Dysfunction: a Systematic Review and Meta-Analysis. Urology. 2022;170:5–13. doi: 10.1016/j.urology.2022.08.039.
  46. Orlova O.R., Timerbaeva S.L., Khat’kova S.E., Kostenko E.V., Krasavina D.A., Zakharov D.V. Conversion ratio between different botulinum neuroprotein product in neurological practice. Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova. 2017;117(9):132–141. doi: 10.17116/jnevro201711791132-141.
  47. Ruffion A, Capelle O, Paparel P, Leriche B, Leriche A, Grise P. What is the optimum dose of type A botulinum toxin for treating neurogenic bladder overactivity? BJU Int. 2006;97(5):1030-1034. doi: 10.1111/j.1464-410X.2006.06091.x
  48. Ehren I., Volz D., Farrelly E., Berglund L., Brundin L., Hultling C., Lafolie P. Efficacy and impact of botulinum toxin A on quality of life in patients with neurogenic detrusor overactivity: a randomised, placebo-controlled, double-blind study. Scand J Urol Nephrol. 2007;41(4):335–340. doi: 10.1080/00365590601068835.
  49. Grise P., Ruffion A., Denys P., Egon G., Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010;58(5):759–766. doi: 10.1016/j.eururo.2010.06.035.
  50. Denys P., Del Popolo G., Amarenco G., Karsenty G., Le Berre P., Padrazzi B., Picaut P. Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport® (abobotulinumtoxin A) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017;36(2):457–462. doi: 10.1002/nau.22954.
  51. Del Popolo G., Filocamo M.T., Li Marzi V., Macchiarella A., Cecconi F., Lombardi G., Nicita G. Neurogenic detrusor overactivity treated with english botulinum toxin a: 8-year experience of one single centre. Eur Urol. 2008;53(5):1013–1019. doi: 10.1016/j.eururo.2007.09.034.
  52. Kennelly M., Cruz F., Herschorn S., Abrams P., Onem K., Solomonov V.K. Del Rosario Figueroa Coz E, Manu-Marin A, Giannantoni A, Thompson C., Vilain C., Volteau M., Denys P. Dysport CONTENT Program Group. Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2). Eur Urol. 2022;82(2):223–232. doi: 10.1016/j.eururo.2022.03.010.
  53. Bottet F., Peyronnet B., Boissier R., Reiss B., Previnaire J.G., Manunta A., Kerdraon J., Ruffion A., Lenormand L., Perrouin Verbe B., Gaillet S., Gamé X., Karsenty G. Groupe d’Etude de Neuro-Urologie de Langue Française (GENULF) and the committee of NeuroUrology of the French Association of Urology (AFU). Switch to Abobotulinum toxin A may be useful in the treatment of neurogenic detrusor overactivity when intradetrusor injections of Onabotulinum toxin A failed. Neurourol Urodyn. 2018;37(1):291–297. doi: 10.1002/nau.23291.
  54. Denys P., Castaño Botero J.C., Vita Nunes R.L., Wachs B., Mendes Gomes C., Krivoborodov G., Tu L.M., Del-Popolo G., Thompson C., Vilain C., Volteau M., Kennelly M. Dysport CONTENT program group. AbobotulinumtoxinA is effective in patients with urinary incontinence due to neurogenic detrusor overactivity regardless of spinal cord injury or multiple sclerosis etiology: Pooled analysis of two phase III randomized studies (CONTENT1 and CONTENT2). Neurourol Urodyn. 2023;42(1):153–167. doi: 10.1002/nau.25062.
  55. Cruz F., Danchenko N., Fahrbach K., Freitag A., Tarpey J., Whalen J. Efficacy of abobotulinumtoxinA versus onabotulinumtoxinA for the treatment of refractory neurogenic detrusor overactivity: a systematic review and indirect treatment comparison. J Med Econ. 2023:1–12. doi: 10.1080/13696998.2023.2165366.
  56. Baron M., Aublé A., Paret F., Pfister C., Cornu J.N. Long-term follow-up reveals a low persistence rate of abobotulinumtoxinA injections for idiopathic overactive bladder. Prog Urol. 2020;30(12):684–691. doi: 10.1016/j.purol.2020.07.242.
  57. Sharifiaghdas F., Taheri M., Borumandnia N, Sheikhi Z. Evaluation of the Clinical Effects of Abobotolinum Toxin A (Dysport) Injection in the Treatment of Neurogenic Lower Urinary Tract Dysfunction. Urol J. 2021;19(1):63–68. doi: 10.22037/uj.v18i.6720.
  58. Field M., Splevins A., Picaut P., van der Schans M., Langenberg J., Noort D., Snyder D., Foster K. Abobotulinumtoxin A (Dysport®), Onabotulinumtoxin A (Botox® ), and Incobotulinumtoxin A (Xeomin®) Neurotoxin Content and Potential Implications for Duration of Response in Patients. Toxins (Basel). 2018;10(12):535. doi: 10.3390/toxins10120535.
  59. Instructions for use Dysport 500 units, RU No. PN011520/01.
  60. Instructions for use of Botox 200 units, RU No. LP-002949.

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies