Intra-Cavernous Injection of BOTOX® (50 and 100 Units) For Treatment of Vasculogenic Erectile Dysfunction: Randomized Controlled Trial.

El-Shaer, Waleed; Ghanem, Hussein; Diab, Tamer; Abo-Taleb, Ahmed; Kandeel, Wael

BACKGROUND Erectile dysfunction (ED) is a socio-economic 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 & 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 conducted between July 2016 to 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 i.e.; SHIM score & Erection Hardness Score (EHS), Sexual Encounter Profile (SEP), Global Assessment Score (GAS) and Doppler parameters (P < 0.001) was observed in patients of BTX-100 and BTX-50 groups with maximum improvement at 3rd month of treatment. Around 40% of patients were responders and abled to engage in sexual intercourse. Patients in placebo group didn't experience significant improvement (P = 0.264). It was noted that; at the 2nd week and 3rd months after treatment, there was no statistically significant difference in the improvement of these parameters in BTX-100 & BTX-50 groups (P >0.05). In the 6th month, there was a statistically significant difference between the aforementioned groups in favor of BTX-100 (P< 0.01). 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.