PS-05-007 Safety and efficacy of intra-cavernosal Botulinum toxin injection in the treatment of patients with severe erectile dysfunction

To evaluate the safety and efficacy of Botulinum toxin in the treatment of severe erectile dysfunction (ED). A prospective, double-blind, randomised study of 70 patients with ED, not responding to PDE5i and ICI. Patients were randomized into treatment and control with 35 patients in each group. The treatment group received a single intra-cavernosal injection of 100 units of Botulinum toxin (BTX) A. The control group received an intra-cavernosal injection of 1 ml of saline (0.9% NaCl). Assessment for both groups was done by penile duplex and erection hardness score (EHS) at baseline and 2 weeks after treatment. The SHIM questionnaire, the Sexual Encounter Profile (SEP Questions 2 and 3) and the Global Assessment Question (GAQ1&2)) were completed at baseline, 6 and 12 weeks after treatment respectively. In the treatment but not in the control group, there was a statistically-significant (p <0.001) improvement in each of: the mean peak systolic velocity from 35(12) cm/sec to 46 (13) cm/sec; the end diastolic velocity from 2 (3.5) cm/sec to 1.7 (3.4) cm/sec; and the mean EHS from 2.34 (0.59) to 2.89 (0.76). There was a statistically-significant improvement in the mean SHIM score (from 5.4 (1.67) to 9.97 (5.52), p<0.001)) in the treatment group but not in the control group; 18 patients answered “yes” to SEP1 and 3 patients answered “yes” to SEP2 in the treatment group versus 1 patient answering “yes” to SEP1 in the control group; and 22 and 14 patients answered “yes” to GAQ1 and GAQ2 respectively versus none in the control group. There were no local or systemic adverse events. The improvement was maintained up to the 12-week follow up in the majority of patients.