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.