Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction

Summary

Erectile dysfunction (ED) affects approximately 30 million men in the United States and is associated with factors such as aging, smoking, diabetes, hypertension, obesity, and sedentary lifestyle. ED can also negatively impact the quality of life of patients and their partners. Treatment decisions are typically made jointly between patients and their urologists, often starting with less invasive options. Oral phosphodiesterase-5 inhibitors (PDE5 inhibitors), including sildenafil, tadalafil, and vardenafil, are commonly used as first-line therapy. While these medications improve erectile function in many patients, approximately 30-40% do not respond adequately to PDE5 inhibitor therapy alone. Patients who do not achieve sufficient benefit may require additional or more invasive treatment options.

Timeline

Start

2026-06

Primary completion

2028-06

Completion

2028-06

Publications

• Background Abou Zahr R, Bou Kheir G, Mjaess G, Jabbour T, Chalhoub K, Diamand R, Roumeguere T. Intra-Cavernosal Injection of Botulinum Toxin in the Treatment of Erectile Dysfunction: a Systematic Review and Meta-Analysis. Urology. 2022 Dec;170:5-13. doi: 10.1016/j.urology.2022.08.039. Epub 2022 Sep 15.
• Background Giuliano F, Joussain C, Denys P, Laurin M, Behr-Roussel D, Assaly R. Intracavernosal OnabotulinumtoxinA Exerts a Synergistic Pro-Erectile Effect When Combined With Sildenafil in Spontaneously Hypertensive Rats. J Sex Med. 2022 Jun;19(6):899-906. doi: 10.1016/j.jsxm.2022.03.213. Epub 2022 Mar 29.
• Background Giuliano F, Joussain C, Denys P. Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport(R)) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies. Toxins (Basel). 2019 May 21;11(5):283. doi: 10.3390/toxins11050283.
• Background Giuliano F, Joussain C, Denys P. 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. J Sex Med. 2022 Jan;19(1):83-89. doi: 10.1016/j.jsxm.2021.10.011. Epub 2021 Dec 20.
• Background Giuliano F, Denys P, Joussain C. Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin(R)) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series. Toxins (Basel). 2022 Apr 16;14(4):286. doi: 10.3390/toxins14040286.
• Background Giuliano F, Denys P, Joussain C. Safety and Effectiveness of Repeated Botulinum Toxin A Intracavernosal Injections in Men with Erectile Dysfunction Unresponsive to Approved Pharmacological Treatments: Real-World Observational Data. Toxins (Basel). 2023 Jun 5;15(6):382. doi: 10.3390/toxins15060382.
• Background Lowe G, Bahnson R. Non-invasive management of primary phosphodiesterase type 5 inhibitor failure in patients with erectile dysfunction. Ther Adv Urol. 2009 Dec;1(5):235-42. doi: 10.1177/1756287210362069.
• Background Burnett AL, Nehra A, Breau RH, Culkin DJ, Faraday MM, Hakim LS, Heidelbaugh J, Khera M, McVary KT, Miner MM, Nelson CJ, Sadeghi-Nejad H, Seftel AD, Shindel AW. Erectile Dysfunction: AUA Guideline. J Urol. 2018 Sep;200(3):633-641. doi: 10.1016/j.juro.2018.05.004. Epub 2018 May 7.

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