Table 4. Summary of emerging therapy for ED: therapies using physical energies.
| Treatment | Type of study | Protocol | Population studied | Main findings | Date (year) | Author |
|---|---|---|---|---|---|---|
| LI-SWT | Prospective, randomized, double-blind, sham controlled study | Duration of session: 20 min Energy intensity: 0.09 mJ/mm2 Frequency: 120 shock waves per min Total of 12 sessions Total of 1,500 pulses per session Schedule: 9 wk protocol (2 sessions per wk for 3 wk-3 wk break-2 sessions per wk for 3 wk) Assessment: 1 mo after last treatment |
Vasculogenic ED (37=LI-SWT, 18=sham probe) | 54% of treatment group achieved erection hard to penetration (EHS of 3). Meaningful improvement of IIEF score was shown in 40.5% of treatment group according to the MCID criteria. There was no adverse effect reported. |
2016 | Kitrey et al [88] |
| LI-SWT | Double-blinded, randomized, sham-controlled trial | Duration of session: 20 min Energy intensity: 0.09 mJ/mm2 Frequency: 160 shock waves per min Total of 12 sessions Total of 1,500 shocks per session Schedule: 9 wk protocol (2 sessions per wk for 3 wk-3wk break-2 sessions per wk for 3 wk) Assessment: 1, 3, 6, 9, and 12 mo after last treatment |
Vasculogenic ED (30=LI-SWT, 16=sham probe) | For the IIEF-EF score, the MCID criteria for the treatment group were met in 56.7% of treatment group at 1 mo, and 75% at 12 mo. Mean peak systolic velocity increased by 4.5 and 0.6 cm/s in the LI-SWT and sham groups (p<0.001). |
2017 | Kalyvianakis et al [89] |
| LI-SWT | Prospective, randomized, double blinded, sham-controlled study | Duration of session: 10 min Energy intensity: 0.09 mJ/mm2 Frequency: 160 shock waves per min Total of 6 sessions Total of 2,000 shocks per session Assessment: 1, 4, and 12 mo after last treatment Schedule: 3 wk protocol (2 sessions per wk for 3 wk) |
ED patients (10=LI-SWT, 10=sham probe) | For the IIEF-EF score, the MCID criteria for the treatment group were met in 56.7% of treatment group at 1 mo, and 75% at 12 mo. | 2019 | Yamaçake et al [90] |
| LI-SWT | Retrospective study | Duration of session: 10 min Energy intensity: 0.09 mJ/mm2 Frequency: 120 shock waves per min Total of 12 sessions Total of 1,500 shocks per session Schedule: 9 wk protocol (2 sessions per wk for 3 wk-3wk break-2 sessions per wk for 3 wk) Assessment: 6, 12, 18, and 24 mo after last treatment |
ED patients (156 LI-SWT) | Clinical beneficial decreased from 64% at 1 mo to 34% at 2 y. The efficacy lasted longer in mild form of ED without comorbidity such as diabetes. |
2018 | Kitrey et al [91] |
| LI-SWT | Prospective, randomized, double-blinded, placebo controlled study | Duration of each session: 20 min Energy density: 0.09 mJ/mm2 Frequency: 120 shock waves per min Total of 12 sessions Total of 1,500 shocks per session Schedule: 9 wk protocol (2 sessions per wk for 3 wk-3wk break-2 sessions per wk for 3 wk) Assessment: 1 mo after last treatment |
ED patients (30=LI-SWT 28=sham probe) | No differences of clinical outcomes (EHS and IIEF score) were shown between LI-SWT group and control group. | 2014 | Yee et al [95] |
| Linear LISWT | Double-blinded, shamcontrolled, randomized clinical trial | Energy density: 0.09 mJ/mm2 Frequency: 300 shock waves per min Total of 10 sessions Total of 600 shocks per session Schedule: 18 wk protocol (once a wk for 5 wk-4-wk break-once a wk for 5 wk-4 wk break) Assessment: 9, 18 wk after first treatment |
ED patients (58=LI-SWT 60=sham probe) | No clinically relevant effect (IIEF and EHS score) of linear LI-SWT on ED was found. | 2017 | Fojecki et al [96] |
| LIPUS | Multicenter, randomized, double-blind, sham-controlled clinical study | Energy intensity: 300 mW/cm2 Pulse duration time-to-pulse rest time ratio of 1:4 (200 µs:800 µs) at 1,000 Hz and frequency at 1.7 MHz Twice a wk for 4 wk Assessment: 4, 8, and 12 wk after last treatment |
Mild to moderate ED (80=LIPUS, 40=sham treated control) | The rate of patients with increased IIEF score ≥3 was 68% which was significantly higher than 20% in control group at 12 wk. The percentage of patients with positive answers to SEP-3 (successful vaginal intercourse) were 73% at 12 wk after treatment which were significantly higher than 29% in control group. |
2019 | Cui et al [100] |
ED: erectile dysfunction, LI-SWT: low-intensity shock wave therapy, EHS: erection hardness score, IIEF: international index of erectile function, MCID: minimum clinically important differences, IIEF-EF: international index of erectile function-erectile function, LIPUS: low intensity pulsed ultrasound, SEP-3: sexual encounter profile questionnaires 3.