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Platelet-Rich Plasma Alone Versus PRP Plus Low-Intensity Shock Wave Therapy for Erectile Dysfunction

NCT07783347 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Platelet-Rich Plasma

Autologous 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.

DEVICE

Low-Intensity Extracorporeal Shock Wave Therapy

Low-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.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-03-01
Completion
2027-03-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783347 on ClinicalTrials.gov