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

NCT07783347 | Not Yet Recruiting

• 1 other identifier: MS.46.4.2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Erectile Dysfunction

Keywords

Platelet-Rich Plasma; Erectile Function; Low-Intensity Extracorporeal Shock Wave Therapy; Penile Hemodynamics; Regenerative Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 4, 12, and 24 weeks after intervention

• 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.

  Baseline and 4, 12, and 24 weeks after intervention

Secondary Outcomes (3)

• Change From Baseline in Penile Peak Systolic Velocity

  Baseline and 4, 12, and 24 weeks after intervention

• Change From Baseline in Penile End-Diastolic Velocity

  Baseline and 4, 12, and 24 weeks after intervention

• Patient Satisfaction With Treatment

  4, 12, and 24 weeks after intervention

Study Arms (2)

Platelet-Rich Plasma Alone

ACTIVE COMPARATOR

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.

Biological: Platelet-Rich Plasma

Platelet-Rich Plasma Plus Li-ESWT

EXPERIMENTAL

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.

Device: Low-Intensity Extracorporeal Shock Wave Therapy

Interventions

Platelet-Rich Plasma BIOLOGICAL

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.

Platelet-Rich Plasma Alone

Low-Intensity Extracorporeal Shock Wave Therapy DEVICE

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.

Platelet-Rich Plasma Plus Li-ESWT

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Tamer A Diab, MD

CONTACT

01003583264; Tamer.diab@fmed.bu.edu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Model Details: Participants will be randomized in parallel to receive either platelet-rich plasma injections alone or platelet-rich plasma injections combined with low-intensity extracorporeal shock wave therapy.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)