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PURPOSE: 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.
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Objective@#To evaluate the clinical efficacy and safety of low-intensity extracorporeal shock wave therapy (LI-ESWT) in the treatment of ED based on the available clinical evidence.@*METHODS@#We searched PubMed, MEDLINE, EMBASE, Cochrane Library, CNKI, VIP, CBM and Wanfang Database up to June 2018 for published randomized controlled trials on the treatment of ED by LI-ESWT. We performed literature screening, data extraction and quality evaluation according to inclusion and exclusion criteria, and conducted a meta-analysis of the data obtained using the RevMan 5.3 software.@*RESULTS@#A total of 595 ED cases in 8 double-blind randomized controlled trials (RCT) were included in this study, 362 in the LI-ESWT and 233 in the control group. Compared with the controls, the patients treated by LI-ESWT showed significantly improved IIEF (WMD = 1.70, 95% CI: 0.44－2.96, P = 0.008) and erection hardness score (EHS) (RR = 11.72, 95% CI: 5.13－26.80, P < 0.01). The IIEF scores of the patients were markedly increased at 4 and 24 weeks after LI-ESWT (WMD = 1.43, 95% CI: 0.10－2.75, P = 0.03; WMD = 3.09, 95% CI: 1.49－4.68, P = 0.0002), as well as after the 10th to 12th treatment (WMD = 1.81, 95% CI: 0.31－3.31, P = 0.02) though not after the 5th to 6th (WMD = 1.88, 95% CI: －2.10 to 5.86, P = 0.35). LI-ESWT also significantly increased the IIEF scores in the patients with the baseline IIEF ≥12 (WMD = 2.13, 95% CI: 0.51－3.75, P = 0.01) but not in those with the baseline IIEF ≤11 (WMD = 1.04, 95% CI: －0.96 to 3.03, P = 0.31). No significant adverse events were reported in the 8 RCTs.@*CONCLUSIONS@#As a non-invasive treatment, LI-ESWT is safe and effective and can significantly improve IIEF and EHS in ED patients.
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<p><b>Objective</b>To make a preliminary investigation on the safety and efficacy of focused low-intensity extracorporeal shock wave therapy (LI-ESWT) in the treatment of erectile dysfunction (ED).</p><p><b>METHODS</b>We treated 32 ED patients by focused LI-ESWT with the device of Medispec's ED1000. Before and at 4 and 12 weeks after treatment, we evaluated the erectile function of the patients using the International Index of Erectile Function-erectile function domain (IIEF-EF), Erection Hardness Score (EHS), Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), and Global Assessment Questionnaire questions 1 and 2 (GAQ1 and GAQ2), and recorded the incidence rate of adverse events.</p><p><b>RESULTS</b>The patients averaged 30.69 years of age. Compared with the baseline, the mean IIEF-EF score of the patients was significantly increased at 4 and 12 weeks after LI-ESWT (14.94 vs 20.97 and 21.47, P <0.01), and so were the EHS (1.75 vs 2.66 and 2.56, P <0.01) and the "Yes" answers to SEP2 (21.88% vs 68.75% and 71.88%), SEP3 (0 vs 43.75% and 56.25%), GAQ1 (NA vs 81.25% and 71.88%) and GAQ2 (NA vs 65.63% and 68.75%). The total effectiveness rates at 4 weeks and 12 weeks were 75% and 71.88% respectively. One of the patients felt penile shaft pain with mild ecchymosis after LI-ESWT but was recovered without special treatment a week later.</p><p><b>CONCLUSIONS</b>LI-ESWT can significantly improve the erectile function of ED patients with no obvious adverse effects within 12 weeks after treatment.</p>