Low-intensity pulsed ultrasound for severe erectile dysfunction: A prospective study with 3-year follow-up

Background: Evidence on low-intensity pulsed ultrasound (LIPUS) for severe erectile dysfunction, particularly regarding long-term outcomes, remains limited. We assessed short-term within-group changes after LIPUS and respondent-reported outcomes at 3 years. Materials and methods: In this single-arm prospective observational study, 52 men commenced an 8-session LIPUS course; 43 completed treatment and had paired baseline and 8-week data. The primary endpoint was change in International Index of Erectile Function–Erectile Function. Erection Hardness Score and other exploratory secondary outcomes were analyzed with false discovery rate control. Three-year outcomes were summarized for 20 telephone respondents, with extreme-case analyses for 23 nonrespondents. Results: Mean International Index of Erectile Function–Erectile Function increased from 6.98 to 14.53 (mean change, 7.56; 95% confidence interval, 5.38–9.73; p < 0.001); 22/43 participants met the ≥7-point minimum clinically important difference (51.2%; 95% confidence interval, 36.8%–65.4%), or 22/52 (42.3%) when 9 discontinuers were classified as nonresponders. Erection Hardness Score improved in 31/43 participants ( p < 0.001). No adverse events were recorded among 43 participants with available safety data. Among 20 three-year respondents, positive responses were 80.0% for Sexual Encounter Profile question 2, 65.0% for Sexual Encounter Profile question 3, 70.0% for perceived erectile function improvement, and 55.0% for sexual satisfaction; corresponding worst-case proportions among all 43 participants were 37.2%, 30.2%, 32.6%, and 25.6%. Conclusions: Low-intensity pulsed ultrasound was associated with short-term within-group improvement in erectile function; however, the uncontrolled design, incomplete safety ascertainment, and substantial long-term nonresponse preclude causal inference or conclusions about durable benefit. Randomized, sham-controlled trials using consistent objective endpoints are warranted.