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

Benha University

Status: Not yet enrolling

Conditions: Erectile Dysfunction

Treatments: Device: Low-Intensity Extracorporeal Shock Wave Therapy; Biological: Platelet-Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT07783347

MS.46.4.2026

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Sexually active, with at least one sexual attempt per week.

Exclusion criteria

• 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.
• Uncontrolled diabetes mellitus, defined as HbA1c >9%.
• Uncontrolled hypertension, defined as blood pressure >160/100 mmHg.
• Recent myocardial infarction or stroke within the previous 6 months.
• Unstable angina.
• New York Heart Association class III-IV heart failure.
• Severe hepatic impairment.
• Severe renal impairment.
• Hypogonadism, defined as total testosterone <300 ng/dL.
• Hyperprolactinemia.
• Untreated thyroid disease.
• Current use of nitrates or nitric oxide donors.
• Current use of alpha-blockers, unless the participant is on a stable low dose.
• Current use of other phosphodiesterase type 5 inhibitors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Platelet-Rich Plasma Alone

Active Comparator group

Description:

Participants will receive platelet-rich plasma (PRP) injections alone. PRP will be prepared from approximately 20 mL of autologous blood using a double-spin method, targeting a platelet concentration of 3-5 times baseline. PRP will be administered by intracavernosal injection at two sites. Participants will receive three PRP injections over 6 weeks, with one injection every 2 weeks.

Treatment:

Biological: Platelet-Rich Plasma

Platelet-Rich Plasma Plus Li-ESWT

Experimental group

Description:

Participants will receive the same PRP injection regimen as the PRP-alone group combined with low-intensity extracorporeal shock wave therapy (Li-ESWT). Li-ESWT will be administered at an energy density of 0.15 mJ/mm² with 2,000 shocks per session to the penile shaft with or without the crura. Participants will receive six Li-ESWT sessions over 6 weeks, with one session per week. PRP injections will be administered before Li-ESWT sessions according to the study protocol.

Treatment:

Device: Low-Intensity Extracorporeal Shock Wave Therapy