Erectile dysfunction is a common condition that may result from vascular, neurological, hormonal, psychological, or medication-related factors. Platelet-rich plasma (PRP) and low-intensity extracorporeal shock wave therapy (Li-ESWT) are regenerative treatment approaches that may improve erectile function through mechanisms involving angiogenesis, tissue repair, and improvement of penile vascular function.
This randomized prospective study will compare the efficacy and safety of PRP injection alone with combined PRP injection and Li-ESWT in men with erectile dysfunction. A total of 80 participants will be randomly assigned to two groups. One group will receive PRP injections alone, while the other group will receive PRP injections combined with Li-ESWT. Participants will be followed after treatment to assess changes in erectile function, erection hardness, penile blood flow, patient satisfaction, and treatment-related adverse events.
The study hypothesis is that adding Li-ESWT to PRP therapy will result in greater improvement in erectile function than PRP therapy alone.
Male participants aged 30-65 years.
Diagnosis of erectile dysfunction for at least 3 months.
Mild to moderate erectile dysfunction, defined by an International Index of Erectile Function-5 (IIEF-5) score of 8-21.
In a stable heterosexual relationship for at least 6 months.
Severe erectile dysfunction, defined as IIEF-5 score <8.
Primary psychogenic erectile dysfunction based on clinical history with or without psychosexual assessment.
Anatomical penile abnormalities, including Peyronie's disease.
History of radical pelvic surgery or pelvic radiotherapy.
Parallel
Platelet-Rich Plasma
Biological/VaccineAutologous platelet-rich plasma will be prepared from approximately 20 mL of the participant's blood using a double-spin centrifugation method, targeting a platelet concentration of 3-5 times baseline. PRP will be administered by intracavernosal injection at two sites, with three injections given over 6 weeks at 2-week intervals.
Low-Intensity Extracorporeal Shock Wave Therapy
DeviceLow-intensity extracorporeal shock wave therapy will be delivered to the penile shaft with or without treatment of the crura using an energy density of 0.15 mJ/mm² and 2,000 shocks per session. Participants will receive six sessions over 6 weeks, at a frequency of one session per week.
Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5), a 5-item self-administered questionnaire assessing erectile function and intercourse-related sexual performance. Each item is scored from 1 to 5, giving a total score ranging from 5 to 25, with higher scores indicating better erectile function. Scores are interpreted as: 22-25, no erectile dysfunction; 17-21, mild erectile dysfunction; 12-16, mild-to-moderate erectile dysfunction; 8-11, moderate erectile dysfunction; and 5-7, severe erectile dysfunction. Change from baseline in the total IIEF-5 score will be compared between the treatment groups.
Change From Baseline in Erection Hardness Score (EHS)
Erection hardness will be assessed using the Erection Hardness Score (EHS), a single-item scale ranging from 0 to 4, with higher scores indicating greater erection rigidity. Scores are defined as follows: 0, penis does not enlarge; 1, penis is larger but not hard; 2, penis is hard but not hard enough for penetration; 3, penis is hard enough for penetration but not completely rigid; and 4, penis is completely hard and fully rigid. Change from baseline in the EHS will be compared between the treatment groups.
Change From Baseline in Penile Peak Systolic Velocity
Peak systolic velocity (PSV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile arterial blood flow following treatment.
Change From Baseline in Penile End-Diastolic Velocity
End-diastolic velocity (EDV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile hemodynamics following treatment.
Patient Satisfaction With Treatment
Patient satisfaction with treatment will be assessed using a 5-point Likert scale. Participants will rate their overall satisfaction as: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater treatment satisfaction. Satisfaction scores will be compared between the two treatment groups.
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