Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin®) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series

Giuliano, François; Denys, Pierre; Joussain, Charles

doi:10.3390/toxins14040286

Cited by 4 publications

(8 citation statements)

References 31 publications

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“…The results relating to safety are consistent with those of previous studies [ 11 , 12 , 13 , 14 , 15 , 16 ] and confirm that BTX/A ic is well tolerated and has a consistent safety profile over long-term, repeated treatment with no new safety signal. The only adverse effects were related to the intracavernosal injection procedure itself.…”

Section: Discussionsupporting

confidence: 89%

“…Interestingly, and conversely to previous findings regarding the effectiveness of the first BTX/A ic in men with ED and insufficient response to standard pharmacological treatment [ 16 ], ED severity on treatment prior to BTX/A ic did not seem to influence the response to repeated treatment after the first injection, as shown in Figure 2 . This might be explained by the fact that only the best responders requested further treatment among those with severe ED, whereas those with smaller responses did not request further injections.…”

Section: Discussionsupporting

confidence: 60%

“…Intracavernosal botulinum toxin A (BTX/A ic ) is another alternative pharmacological option that is currently emerging [ 10 ]. The results of randomized controlled clinical trials [ 11 , 12 , 13 ] and uncontrolled [ 14 , 15 , 16 ] studies of single BTX/A ic injections suggest the treatment is effective and has a good safety profile in men with difficult-to-treat ED. In those studies, 50 then 100U of onabotulinumtoxinA, 250 then 500 Speywood U of abobotulinumtoxinA and 100U of incoabotulinumtoxinA were found to be effective and to have acceptable tolerability.…”

Section: Introductionmentioning

confidence: 99%

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

Giuliano

Denys

Joussain

2023

Toxins

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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) < 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 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.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 60%

Section: Introductionmentioning

confidence: 99%

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

Giuliano

Denys

Joussain

2023

Toxins

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“…According to this study, the treatment effect lasted for more than three months with no reported collateral effects. The findings of this Phase I trial, have been confirmed and extended by other studies in patients with different botulinum neurotoxin A formulations and doses [41,[231][232][233] and are corroborated by animal studies [40,234], which support the promising role of intracavernous botulinum neurotoxin A in ED treatment. The mechanism by which botulinum neurotoxin A facilitates the relaxation of cavernous smooth muscles has not been clarified by the above studies.…”

Section: Botulinum Neurotoxin Asupporting

confidence: 79%

“…Starting just five years ago, a few studies have shown that botulinum neurotoxin A injected intracavernously was able to induce penile erection in patients with intractable ED and made them able to engage in sexual intercourse, and even to complete it, with the help of a PDe5 inhibitor. The effect was long-lasting (three-six months) with no collateral effect [40,41,[231][232][233][234]. These studies suggest that cavernous smooth muscles may be the target for this effect of botulinum neurotoxin A.…”

Section: Final Remarksmentioning

confidence: 73%

Erectile Dysfunction: Treatments, Advances and New Therapeutic Strategies

Argiolas

et al. 2023

Brain Sciences

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Erectile dysfunction (ED) is the inability to get and maintain an adequate penile erection for satisfactory sexual intercourse. Due to its negative impacts on men’s life quality and increase during aging (40% of men between 40 and 70 years), ED has always attracted researchers of different disciplines, from urology, andrology and neuropharmacology to regenerative medicine, and vascular and prosthesis implant surgery. Locally and/or centrally acting drugs are used to treat ED, e.g., phosphodiesterase 5 inhibitors (first in the list) given orally, and phentolamine, prostaglandin E1 and papaverine injected intracavernously. Preclinical data also show that dopamine D4 receptor agonists, oxytocin and α-MSH analogues may have a role in ED treatment. However, since pro-erectile drugs are given on demand and are not always efficacious, new strategies are being tested for long lasting cures of ED. These include regenerative therapies, e.g., stem cells, plasma-enriched platelets and extracorporeal shock wave treatments to cure damaged erectile tissues. Although fascinating, these therapies are laborious, expensive and not easily reproducible. This leaves old vacuum erection devices and penile prostheses as the only way to get an artificial erection and sexual intercourse with intractable ED, with penile prosthesis used only by accurately selected patients.

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