Safety and Effectiveness of Repeated Botulinum Toxin A Intracavernosal Injections in Men with Erectile Dysfunction Unresponsive to Approved Pharmacological Treatments: Real-World Observational Data

• Published in: Toxins 2023-06, Vol.15 (6), p.382
• Main Authors: Giuliano, François, Denys, Pierre, Joussain, Charles
• Format: Article
• Language: English
• Subjects: abobotulinumtoxinA; Alprostadil - adverse effects; Botulinum toxin; Botulinum toxin type A; Botulinum Toxins, Type A - adverse effects; Care and treatment; Clinical trials; Communication; Dosage and administration; Drug therapy; Effectiveness; Erectile dysfunction; Erectile Dysfunction - drug therapy; Evaluation; Health aspects; Humans; Impotence; incobotulinumtoxinA phosphodiesterase type 5 inhibitors; Injection; Life Sciences; Male; Men; onabotulinumtoxinA; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors - adverse effects; Placebo effect; prostaglandinE1; Response rates; Retrospective Studies; Safety; Smooth muscle; Toxins; Treatment Outcome
• ISSN: 2072-6651; 2072-6651
• DOI: 10.3390/toxins15060382

Intracavernosal injections of botulinum toxin A (BTX/A ) 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 (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) < 26 on treatment. Further injections were performed on patients' requests, and the files of men who underwent at least two injections were reviewed. The response to BTX/A 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 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 . 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.