Intra‐cavernous injection of BOTOX ® (50 and 100 Units) for treatment of vasculogenic erectile dysfunction: Randomized controlled trial

Autor: Hussein Ghanem, Waleed El-Shaer, Ahmed Abo-Taleb, Tamer O. Diab, Wael Kandeel
Rok vydání: 2021
Předmět:
Zdroj: Andrology. 9:1166-1175
ISSN: 2047-2927
2047-2919
DOI: 10.1111/andr.13010
Popis: Background Erectile dysfunction (ED) is a socioeconomic problem.There are several options for its management including intra-cavernosal injection (ICI). Objective To compare the safety, efficacy, and durability of ICI of onabotulinum toxin-A (BTX) in different doses (50 and 100 U) against placebo (saline) in the management of vasculogenic ED non-responding to pharmacological therapy (phosphodiesterase type 5 inhibitors or/and ICI of trimix). Materials and methods A prospective randomized double-blind placebo-controlled trial was conducted between July 2016 and February 2019. A total of 176 patients were randomly assigned (1:1:1) to one of the treatment sequences: Botox 100 U group (BTX-100; 62 patients), Botox 50 U group (BTX-50; 59 patients), or placebo group (55 patients). All patients were followed up for 6 months. Results Significant improvement in all parameters, that is, SHIM score & Erection Hardness Score (EHS), Sexual Encounter Profile (SEP), Global Assessment Score (GAS), and Doppler parameters (p 0.05). In the 6th month, there was a statistically significant difference between the aforementioned groups in favor of BTX-100 (p Conclusions Only one-time ICI of BTX (50 U and 100 U) is effective and safe for the treatment of refractory ED. This agent has a considerable long duration of action, particularly BTX-100U seems to be more durable.
Databáze: OpenAIRE