Introduction: Evidence has been arising suggesting that Botulinum toxin type A (BTX-A) injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar effect on cavernosal smooth muscles would help in the treatment of erectile dysfunction (ED) resistant to oral and intracavernous injection (ICI) therapy, thus it could be an alternative option for failed medical and other injectable therapy.
Aim: to compare safety, efficacy and durability of different doses of BTX-A (50 and 100 Unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy.
Method: Forty-five patients with Vasculogenic erectile dysfunction who are failed treatment with non-surgical options were included at this study after elimination of all patients who are not matching eligible criteria or not complete the follow up program. Were simply randomized into 3equal groups A, B and C group, control, 50 unit, and 100 unit BTX-A respectively. all groups underwent to follow up at 2 weeks, 3 months and 6 months intervals after injection, for assessment of all subjective data as, IIEF-5 Questionnaire (SHIM score), Erection hardness score (EHS), Sexual encounter profile (SEP 2 and 3), Global assessment score( GAS 2 and 3). Also assessment of objective data by penile Doppler details.
Results: Although 28 patients (62.2%) respond to BTX-A injection subjectively and objectively { 14 patients (31.1% ) treated with BTX-A 50 Unite and 14 patients (31.1%) treated with BTX-A 100 Unite }, but not all efficacy are durable as, 17 patients (37.8%) had a drop effect with complete follow up { 11 patients (24.4%) treated with BTX-A 50 Unite and 6 patients (13.4%) treated with BTX-A 100 Unite }. Also 17 patients (37.8 %) not responding to treatment {0ne patient (2.2%) for each group A and B beside, 15 patients (33.4 %) of control group who are injected with saline}.
Conclusion: BTX-A could be a potential but not durable therapy for erectile dysfunction, BTX-A (50 and 100 Unite) show almost same efficacy but, BTX-A 100 Unite is more durable especially in treatment of patient with arterial insufficiency (AI) not responding to medical and other types of injectable therapy.
Key words: Intracavernosal injection, Botulinum Toxin type A (50 and 100 Unit), Erectile dysfunction, Efficacy and Durability, Arterial insufficiency.
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