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

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