Early outcomes of short‐course low intensity shockwave therapy ( LiSWT ) for erectile dysfunction: A prospective, randomized, double‐blinded, sham‐controlled study in Malaysia

Low-intensity shockwave therapy (LiSWT) has emerged as a promising non-invasive treatment modality for erectile dysfunction (ED) yet the well-designed randomized clinical trials are still lacking to prove its claimed benefits. A randomized, prospective, double-blinded sham-controlled study was conducted to evaluate the effectiveness and safety profile of short course LiSWT on vasculogenic ED patients. The International Index of Erectile Function-5 (IIEF-5) and Erection Hardness Score (EHS) questionnaires were used for evaluation. Patients underwent weekly sessions for 4 weeks and were re-assessed at 1, 3 and 6 months post therapy. Fifty one patients were recruited and randomized into sham and treatment arms. The mean IIEF-5 scores were significantly improved in the treatment arm compared to worsening of scores in the sham arm after 1 month (14.1 vs. 9.3 p < 0.001), 3 months (14.9 vs. 8.6, p < 0.001) and 6 months (14.2 vs. 7.9, p < 0.001) post treatment. A significant improvement of EHS was demonstrated at 1 month (2.4 vs. 1.8, p = 0.001, 3 months 2.7 vs. 1.7, p < 0.001) and 6 months (2.7 vs. 1.6, p < 0.001) in the treatment arm compared to sham arm. The success rate based on IIEF score increment more than five points was 26% in treatment arm and 0% in sham arm. Improvement in EHS score ≥3 in the treatment versus sham arm was 63% and 4%, respectively. There was no adverse effect reported. This 4-week LiSWT protocol reflects better treatment compliance, and it prevents further deterioration of erectile function among this cohort of patients. This study proves that LiSWT is a well-tolerated treatment with modest improvements in erectile function and hardness, among patients with vasculogenic ED.