Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-Controlled, Double-Blind, Randomized Prospective Study

Abstract

The aim of the present study was to evaluate the efficacy and safety of the electromagnetic-type low-intensity extracorporeal shock wave therapy (Li-ESWT) in patients with erectile dysfunction (ED). Materials and Methods: The randomized, sham-controlled, double-blind prospective study was performed at two referral hospitals. Participants were randomized in a 1:1 ratio to receive sham or Li-ESWT for 6 weeks. ED was evaluated at screening and at 4 and 7 weeks after treatment. Participants were asked to complete the international index of erectile function-erectile function (IIEF-EF) domain questionnaire, erection hardness scale (EHS), and sexual encounter profile questionnaire (SEPQ 2 and 3). The development of complications was investigated. Results: Eighty-one of 96 patients completed the study. The median change in the IIEF-EF score in the Li-ESWT and sham groups was 5.1 and-2.2 (p<0.001), respectively, at the 7-week follow-up; 47.4% (18/38) patients had EHS <3, of which 77.8% (14/18) showed significant improvement in virtue of Li-ESWT treatment (p=0.001). A significant improvement was observed in the percentage of 'Yes" responses to SEPQ 2 and 3 in the Li-ESWT group vs. sham group from baseline to 7-week follow-up (91.3% vs. 69.4%; p=0.008 and 50.0% vs. 14.3%; p=0.002, respectively). No patients reported pain or other adverse events during treatment or follow-up. Conclusions: Thus, Li-ESWT could have a role in improving erectile function. Furthermore, it is safe. We believe that Li-ESWT is an attractive new treatment modality for patients with ED.

Erectile Dysfunction A Prospective Randomized Placebo-Controlled Study Evaluating the Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) in Men With Erectile Dysfunction Following Radical Prostatectomy

“…The most recent study of LI-ESWT was published by Kim et al who measured outcome by IIEF-ef and EHS in a heterogeneous group of 81 participants with ED. 26 A significant increase in IIEF-ef score of 5.1 (medians) was seen in the active group at 7 weeks of follow-up. In addition, the proportion of participant in the active group with EHS >3 improved from 52.6% at baseline to 89.5% at 7 weeks of follow-up.…”

Effect of low‐intensity extracorporeal shock wave therapy on diabetic erectile dysfunction: Randomised control trial

“…However, it is still a controversial methodology in this respect. Multiple randomised clinical trials (Kalyvianakis & Hatzichristou, 2017; Kim et al., 2020; Srini et al., 2015; Vardi et al., 2012) and meta‐analyses (Clavijo et al., 2017; Dong et al., 2019; Rizk et al., 2018) have demonstrated a significant benefit of Li‐ESWT in the treatment of ED.…”

Low-intensity shock wave therapy for the treatment of vasculogenic erectile dysfunction: a narrative review of technical considerations and treatment outcomes

“…I n t o t a l , 7 / 1 1 ( 6 4 % ) s h a m -c o n t r o l l e d t r i a l s showed a statistically significant increase in IIEF scores in the treatment arm when compared with the control arm. IIEF scores (either IIEF-EF or IIEF-5) in the treatment arm ranged from +1-12.5 points, depending on the specific study (32,35,36,(38)(39)(40)(41)(42). 3/11 trials (27%) did not show a benefit favoring LiSWT over sham (33,34,37).…”

“…Since that time, multiple retrospective, single-arm prospective, and randomized-controlled trials have been published. This includes 11 randomized, sham-controlled trials evaluating the impact of LiSWT on men with vasculogenic ED (Table 2) (32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42). Results are somewhat mixed owing in part to differences in patient populations, study design, outcomes assessed, follow-up duration, and the type of shockwave technology utilized.…”