{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T06:25:21Z","timestamp":1791440721998,"version":"4.3.3"},"reference-count":24,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2023,6,5]],"date-time":"2023-06-05T00:00:00Z","timestamp":1685923200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Toxins"],"abstract":"<jats:p>Intracavernosal injections of botulinum toxin A (BTX\/A ic) may be effective for difficult-to-treat erectile dysfunction (ED). This is a retrospective case series study of the effectiveness of repeated off-label BTX\/A ic (onabotulinumtoxinA 100U, incobotulinumtoxinA 100U or abobotulinumtoxinA 500U) in men with ED and insufficient response to phosphodiesterase type 5 inhibitors (PDE5-Is) or prostaglandinE1 intracavernosal injections (PGE1 ICIs), defined as an International Index of Erectile Function-Erectile Function domain score (IIEF-EF) &lt; 26 on treatment. Further injections were performed on patients\u2019 requests, and the files of men who underwent at least two injections were reviewed. The response to BTX\/A ic was defined as the achievement of the minimally clinically important difference in IIEF-EF adjusted to the severity of ED on treatment at baseline. Out of 216 men treated with BTX\/A ic and PDE5-Is or PGE1-ICIs, 92 (42.6%) requested at least a second injection. The median time since the preceding injection was 8.7 months. In total, 85, 44 and 23 men received, respectively, two, three and four BTX\/A ic. The overall response rate was 77.5%: 85.7% in men with mild ED, 79% for moderate ED and 64.3% for severe ED on treatment. The response increased with repeated injections: 67.5%, 87.5% and 94.7%, respectively, after the second, third and fourth injections. Post-injection changes in IIEF-EF were similar across injections. The time from injection to request for a further injection varied little. Four men reported penile pain at the time of injection (1.5% of all injections), and one experienced a burn at the penile crus. Repeated BTX\/A injections combined with PDE5-Is or PGE1-ICIs produced an effective and durable response, with acceptable safety.<\/jats:p>","DOI":"10.3390\/toxins15060382","type":"journal-article","created":{"date-parts":[[2023,6,5]],"date-time":"2023-06-05T02:57:47Z","timestamp":1685933867000},"page":"382","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Safety and Effectiveness of Repeated Botulinum Toxin A Intracavernosal Injections in Men with Erectile Dysfunction Unresponsive to Approved Pharmacological Treatments: Real-World Observational Data"],"prefix":"10.3390","volume":"15","author":[{"given":"Fran\u00e7ois","family":"Giuliano","sequence":"first","affiliation":[{"name":"Neuro-Uro-Andrology R. Poincare University Hospital, AP-HP, 104 Bvd R. Poincare, 92380 Garches, France"},{"name":"UMR 1179, Inserm Faculty of Medicine, Versailles Saint Quentin University, Paris Saclay, 78180 Montigny le Bretonneux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4831-6499","authenticated-orcid":false,"given":"Pierre","family":"Denys","sequence":"additional","affiliation":[{"name":"Neuro-Uro-Andrology R. Poincare University Hospital, AP-HP, 104 Bvd R. Poincare, 92380 Garches, France"},{"name":"UMR 1179, Inserm Faculty of Medicine, Versailles Saint Quentin University, Paris Saclay, 78180 Montigny le Bretonneux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Joussain","sequence":"additional","affiliation":[{"name":"Neuro-Uro-Andrology R. Poincare University Hospital, AP-HP, 104 Bvd R. Poincare, 92380 Garches, France"},{"name":"UMR 1179, Inserm Faculty of Medicine, Versailles Saint Quentin University, Paris Saclay, 78180 Montigny le Bretonneux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,6,5]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"333","DOI":"10.1016\/j.eururo.2021.06.007","article-title":"European Association of Urology Guidelines on Sexual and Reproductive Health-2021 Update: Male Sexual Dysfunction","volume":"80","author":"Salonia","year":"2021","journal-title":"Eur. Urol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"902","DOI":"10.1016\/j.eururo.2013.01.012","article-title":"Comparative Effectiveness and Safety of Oral Phosphodiesterase Type 5 Inhibitors for Erectile Dysfunction: A Systematic Review and Network Meta-Analysis","volume":"63","author":"Yuan","year":"2013","journal-title":"Eur. 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Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport\u00ae) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies. Toxins, 11.","DOI":"10.3390\/toxins11050283"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1016\/j.jsxm.2021.10.011","article-title":"Long Term Effectiveness and Safety of Intracavernosal Botulinum Toxin A as an Add-on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 Injections for Erectile Dysfunction","volume":"19","author":"Giuliano","year":"2022","journal-title":"J. Sex. Med."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Giuliano, F., Denys, P., and Joussain, C. (2022). Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin\u00ae) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series. 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Urol."}],"container-title":["Toxins"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6651\/15\/6\/382\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T19:48:20Z","timestamp":1760125700000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6651\/15\/6\/382"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,5]]},"references-count":24,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2023,6]]}},"alternative-id":["toxins15060382"],"URL":"https:\/\/doi.org\/10.3390\/toxins15060382","relation":{},"ISSN":["2072-6651"],"issn-type":[{"value":"2072-6651","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,5]]}}}