Erectile DysfunctionNCT07783347
Platelet-Rich Plasma Alone Versus PRP Plus Low-Intensity Shock Wave Therapy for Erectile Dysfunction
A study testing Platelet-Rich Plasma and Low-Intensity Extracorporeal Shock Wave Therapy in people with Erectile Dysfunction, run by Benha University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Platelet-Rich Plasma and Low-Intensity Extracorporeal Shock Wave Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha University Hospital
Banhā, Qalyubia Governorate, 13511
Tamer A Diab, MD, 01003583264 ext. +2, Tamer.diab@fmed.bu.edu.com
About this study
Official title: Effect of Platelet-Rich Plasma Injection Alone Versus Combined Platelet-Rich Plasma and Low-Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
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
- Being tested
- Platelet-Rich Plasma, Low-Intensity Extracorporeal Shock Wave Therapy
- Keywords
- Platelet-Rich Plasma, Erectile Function, Low-Intensity Extracorporeal Shock Wave Therapy, Penile Hemodynamics, Regenerative Therapy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich PlasmaBiological
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.
Low-Intensity Extracorporeal Shock Wave TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Low-Intensity Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 4, 12, and 24 weeks after intervention
Secondary outcomes (3)
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.
Measured: Baseline and 4, 12, and 24 weeks after intervention
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.
Measured: Baseline and 4, 12, and 24 weeks after intervention
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.
Measured: 4, 12, and 24 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abd El-Wahab Diab, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783347
- Sponsor's protocol ID
- MS.46.4.2026
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No