Study design, materials and methods
A total of 164 men with ED were enrolled and randomly assigned into two equal groups. Group 1 (n = 82) received penile ESWT (Dornier Aries) twice weekly for 6 weeks (mean age 40.1 years [20–69]; mean ED duration 4.1 years [0.5–19]). Group 2 (n = 82) received two sessions per week for 6 weeks: Session 1 included ESWT followed by intrapenile PRP injections, with PRP subsequently activated by ESWT; Session 2 consisted of ESWT alone (mean age 45.6 years [19–71]; mean ED duration 3.7 years [0.5–16]). Comparative assessments were performed at baseline, day 60, and 6 months after therapy using IIEF-5, EHS, SEP, GAQ, and penile duplex Doppler ultrasound (PDDU; median [IQR]). The study was approved by the Ethics Committee of the RUDN University Medical Institute.
Results
At day 60, both groups showed significant improvement in erectile function according to IIEF-5, EHS, SEP, GAQ, PSV, and RI (p < 0.05). The combined PRP + ESWT therapy demonstrated superior outcomes compared to ESWT monotherapy (p < 0.05). By 180 days, Group 1 (ESWT alone) demonstrated a decline in all parameters compared to the 60-day results: IIEF-5 decreased from 20.2 (15.9–22.6) to 19.6 (13.8–22) (p > 0.05); SEP remained unchanged at 3 (2–4) (p > 0.05); EHS declined from 3 (2.4–3) to 2.1 (2–3) (p > 0.05). PDDU revealed a significant reduction in PSV from 25.8 cm/s (20.2–28.9) to 21.4 (19–27.5) (p < 0.05), while RI changed from 0.91 (0.81–1) to 0.9 (0.8–0.97) (p > 0.05). At day 60, 55 patients (67%) reported improvement per GAQ, decreasing to 40 (48.8%) at 6 months. In Group 2 (PRP + ESWT), IIEF-5 slightly decreased from 19.6 (17–23) at 60 days to 19.0 (16–22) at 180 days (p > 0.05). SEP changed from 3.8 (3–4) to 3.5 (2.7–4) (p > 0.05); EHS from 3 (3–4) to 2.7 (2.5–3.5) (p > 0.05). PDDU showed minor changes in PSV from 28 cm/s (23.3–34.9) to 25.8 (23–31.8) (p > 0.05) and RI from 1 (0.88–1) to 0.9 (0.86–1) (p > 0.05). Positive GAQ responses were reported by 68 men (82.9%) at 60 days and 59 (71.9%) at 180 days. Overall, both groups demonstrated a slight decline in outcomes at 6 months, but a significant reduction in PSV was observed only in Group 1. Intergroup comparison confirmed that combination therapy (Group 2) provided higher erectile function scores according to SEP, EHS, and PDDU, with the effect persisting even after 6 months (p < 0.05).
Interpretation of results
Both ESWT and combined PRP + ESWT therapy were well tolerated and effective in improving erectile function. The combination of PRP with ESWT demonstrated greater efficacy and sustained benefits at long-term follow-up, making it a more promising therapeutic option for ED management.