Extracorporeal shock-wave therapy (ESWT) in treatment of ED: results of sham-controlled study
Spivak, L1; Vinarov, A1; Platonova, D1; Demidko, Y1
1: Sechenov University, Russia
Objectives: extracorporeal shock-wave therapy can stimulate angiogenesis, improving blood flow and endothelial function, and thus improve erectile function. There are not enough randomised sham-controlled studies. The aim of the study was to determine the efficacy and safety of ESWT in men with ED by performing a prospective randomised double-blind sham-controlled study.
Material and Methods: ESWT was performed on patients above 18 yo diagnosed with vascular ED with SHIM<20. No other treatment of ED was allowed. Six sessions were applied twice a week in three consecutive weeks and repeated again after 3 weeks using Medispec Model ED1000 - in total 12 sessions. The intensity of shockwaves was predefined by the manufacturer. Patients received 300 shocks to each of the 5 locations: 3 spots along the penile shaft and 2 spots on the penile crura. Follow-up (FU) visits were performed in 1 and 3 months after treatment. After the end of the FU patients randomised in sham-control group were invited for open treatment. Unblinded team was responsible for changing treatment and sham applicators according to patients' randomisation numbers, whereas the blind team performed the procedure and collected all data from patients.
Results: in total, 51 men with ED were included and 50 patients completed the study: 14 in control and 36 in treatment group. Mean age was 44 (25-67) years. SHIM score before treatment was 16 (12-20); 17 (12-20) in treatment group and 16 (14-20) in control group. The efficacy was assessed by comparing SHIM score before, immediately after, 1 month and 3 months after the treatment (control group had additional evaluation after the open treatment). In total, 50 men completed the SHIM score questionaries according to study design.The result in treatment group was 23 (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, where it remained at 17 (12-20). During the treatment and FU there were no adverse events in both groups. One patient from control group performed early termination from the study and was lost to FU. After the open treatment period 14 patients from control group had the SHIM score 22 (19-24).
Conclusion: results of the study demonstrate good efficacy and excellent tolerability of ESWT in treatment of erectile dysfunction.
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