Table 1.
Clinical trials of LiSWT
| Intervention | Authors | Year | Patients | Study design | Device | Treatment | Findings |
|---|---|---|---|---|---|---|---|
| LiSWT | Vardi et al | 2012 | n = 60 (40 LiSWT, 20 sham) | randomized, double-blind, sham control | Electrohydraulic, Omnispec ED1000, Medispec Ltd., Yehud, Israel | energy density of 0.09 mJ/mm2 and a frequency of 120 shocks/min; 12 week period (2 treatments/wk) | PDE5i responding patients treated with 12 sessions of 300 shocks. LiSWT had 6.7 point vs 3 point improvement in sham for IIEF-EF scores. 19/28 improved to an EHS > 3 in Li-SWT compared to sham. |
| Yee et al | 2014 | n = 58 (30 LiSWT, 20 sham) | randomized, double-blind, placebo control | Electrohydraulic, Omnispec ED1000, Medispec Ltd., Yehud, Israel | energy density of 0.09 mJ/mm2 and a frequency of 120 shocks/min; 300 shocks each at distal, mid, proximal penile shaft, left and right crura; 12 week period (2 treatments/wk) | Subgroup analyses revealed IIEF-EF improvement in LiSWT patients with baseline severe ED compared to sham. No differences in overall comparison. | |
| Srini et al | 2015 | n = 77 (60 LiSWT, 17 sham) | randomized, sham group | Electrohydraulic, Omnispec ED1000, Medispec Ltd., Yehud, Israel | energy density of 0.09 mJ/mm2 and a frequency of 120 shocks/min; 300 shocks each at distal, mid, proximal penile shaft, left and right crura; 12-week period (2 treatments/wk) | Subgroup analyses revealed IIEF-EF improvement in LiSWT patients of at least 7 points in moderate and severe ED patients compared to sham. 83% LiSWT had EHS ≥ 3 compared to regressed EHS in sham. | |
| Olsen et al | 2015 | n = 105 (51 LiSWT, 51 sham) | randomized, sham group | Electromagnetic, Duolith SD1, Storz, Tagerwilen, Switzerland | energy density of 0.15 mJ/mm2; 500 impulses at distal, centre, proximal part of corpora cavernosum (bilaterally); 5 week period (1 treatment/wk) | 29/51 Li-SWT improved to EHS ≥ 3 compared to 5/51 sham. No observable differences in IIEF-EF score improvements between the 2 groups. | |
| Kitrey et al | 2016 | n = 55 (37 LiSWT, 18 sham) | randomized, sham group | Electrohydraulic, Omnispec ED1000, Medispec Ltd., Yehud, Israel | energy density of 0.09 mj/mm2 at a frequency of 120 shocks/min; 3 week period (2 treatments/wk) | Patients treated with 12 sessions of 1,500 shocks. LiSWT, 40.5% achieved MCID in IIEF-EF improvement vs none in sham. 54.1% of Li-SWT had EHS ≥ 3 vs none in sham. | |
| Fojecki et al | 2017 | n = 118 (58 LiSWT, 60 sham) | randomized, sham group | Piezoelectric, FBL10, Richard-Wolf GmbH, Knitlingen, Germany | energy density of 0.09 mJ/mm2, 5Hz; 600 shocks to corpora cavernosa; 10-week period | No observed difference between IIEF-EF and EHS scores between LiSWT and sham groups. | |
| Fojecki et al | 2018 | n = 126 (43 Linear LiSWT 5 weekly sessions, 52 10 weekly sessions) | randomized | Piezoelectric, FBL10, Richard-Wolf GmbH, Knitlingen, Germany | energy density of 0.09 mJ/mm2, 5Hz; 600 shocks to corpora cavernosa; 10 week period | No noted differences between 2 cycles of linear LiSWT vs one cycle in ED outcomes. | |
| Kalvianakis et al | 2018 | n = 46 (30 LiSWT, 16 sham) | randomized, sham group | Electrohydraulic, Omnispec ED1000, Medispec Ltd., Yehud, Israel | energy density of 0.05 mJ/mm2 and frequency of 8Hz; 12 week period (2 treatments/wk) | PDE5i responding patients treated with either protocol (1 or 2 sessions for 6 weeks with 5000 shocks). LiSWT had 75% achieved MCID in IIEF-EF compared to only 25% in sham. | |
| Kalvianakis et al | 2018 | n = 42 (21 LiSWT 1 theapy/week, 21 LiSWT 2 therapies/week | randomized | Electromagnetic, Aries 2, Dornier MedTech GmbH, Wessling, Germany | energy density of 0.05 mJ/mm2, 8Hz; 1,000 shockwaves each to the left and right shaft, 1,000 shockwaves each to the 2 crura, and 500 shockwaves each to the left and right penile hilum; 6 week period | Two shockwave therapies per week resulted in better IIEF-EF outcomes. | |
| Yamaacake et al | 2019 | n = 20 (10 LiSWT, 10 sham) | randomized, sham group | Electropneumatic, Swiss Dolorclast Smart, Electro Medical Systems, Swizerland | energy density of 0.09 mJ/mm2 and a total of 2,000 shocks per session (throughout penile shaft); 3 weeks (2 treatments/wk) | Study population was kidney transplant recipients. Li-SWT, 70% had IIEF-EF score improvements of at least 5 compared to only 10% having that same interval improvement in sham. | |
| Kalvianakis et al | 2020 | n = 97 (4 LiSWT groups of various sessions/week and energy flux density (EFD)) | randomized | Electromagnetic, Aries 2, Dornier MedTech GmbH, Wessling, Germany | Group A: energy density of 0.05 mJ/mm2, 8 Hz, 2 sessions/wk, 12 sessions; Group B: energy density of 0.05 mJ/mm2, 8 Hz, 3 sessions/wk, 12 sessions; Group C: energy density of 0.096 mJ/mm2, 5 Hz, 2 sessions/wk, 12 sessions; Group D: energy density of 0.096 mJ/mm2, 5 Hz, 3 sessions/wk, 12 sessions | No noted differences between study groups of sessions/week and EFD in achieveing MCID in IIEF-EF scores. | |
| Ramasamy et al | 2020 | n = 80 (40 LiSWT 3600 shocks/week, 40 LiSWT 3600 shocks/2 weeks | randomized | Electromagnetic, MoreNova, DirexGroup, Israel | energy density of 0.09 mJ/mm2, 1Hz; Group A: 720 shocks on M,T,W,Th, F; Group B: 600 shocks on M, W, F (2 weeks) | Overall improvement of IIEF-EF and EHS scores between the 2 groups. Frequency of shockwave sessions did not affect outcomes. | |
| Adeldaeim et al | 2020 | n = 425 (all received 6 sessions over 6 weeks) | Non-randomized | PiezoWave2, Richard-Wolf GmbH, Knitlingen, Germany | first 500 shocks at energy density of 0.16 mJ/mm2 elevated to 0.20 mJ/mm for the rest of 6000 total shocks. Shocks distributed to 5 separate site with 1200 shocks each. | Largest study with signficant follow up (30 months) found age, DM, hypertension, smoking, obesity, hyperlipidemia all affected success of LiSWT and of those who had success from treatment, a majority (76.3%) had durability of resutls at follow up without need for PDE5i |