Abstract: PD45-10
Sources of Funding: none

Introduction

Clinical and experimental data shows that shock-wave therapy can stimulate angiogenesis, improving blood flow and endothelial function, and thus improve erectile function. There is not enough clinical data showing the improvement of erectile function following ESWT in randomized sham-controlled studies. The aim of the study is to determine the efficacy and safety of ESWT in men with ED by performing a prospective randomized double-blind sham-controlled study. Primary endpoint: increase in Sexual Health Inventory for Men (SHIM or IIEF-5) score.

Methods

ESWT was performed on patients above 18 years old diagnosed with vascular ED all in stable relationships, with SHIM<20. No PDE-5 inhibitors or any other treatment of ED was allowed. Six treatment sessions were applied twice a week in three consecutive weeks using Omnispec Model ED1000. The intensity of shockwaves was predefined by the manufacturer. Patient received 300 shocks to each of the 5 locations: 3 spots along the penile shaft and 2 spots on the penile crus. Follow-up visits were performed in 1 and 3 months after the end of treatment. After the end of the follow-up period patients randomized in sham-control group were invited for open treatment. Urologist from the unblinded team was responsible for changing treatment applicator and sham applicator according to patients' randomization numbers, whereas the blind team performed the procedure and collected all data from patients.

Results

In total, 51 men with ED were included in the study at the moment of publication. 34 patients completed the study: 11 in control and 23 in treatment group. Mean age was 44 (25-67) years. Average time of ED was 13 (6-27) months. SHIM score total in both groups before treatment was 16 (12-20); 17 (12-20) in treatment group and 16 (14-20) in control group. The efficacy of treatment was assessed by comparing SHIM score results before and immediately after treatment, 1 month and 3 months after the treatment. During the treatment period there were no adverse events in both groups. All patients received 6 procedures. In total, 34 men completed the SHIM score questionnaire after the end of treatment period. The result in treatment group was 22 (18-25). Pairwise comparison demonstrated significant increase of the score (p=0.001). Control group did not show any significant increase of the SHIM score, neither in total comparison, where it remained at 17 (12-20), nor in pairwise comparison (p=0.001).

Conclusions

First results of the study demonstrate good efficacy and excellent tolerability of ESWT in treatment of erectile dysfunction.

Funding

none