Platelet-Rich Plasma Alone Versus PRP Plus Low-Intensity Shock Wave Therapy for Erectile Dysfunction
20 augustus 2026 bijgewerkt door: Tamer Abd El-Wahab Diab, Benha University
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Tamer A Diab, MD
- Telefoonnummer: +2 01003583264
- E-mail: Tamer.diab@fmed.bu.edu.com
Studie Locaties
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egypte, 13511
- Benha University Hospital
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Contact:
- Tamer A Diab, MD
- Telefoonnummer: +2 01003583264
- E-mail: Tamer.diab@fmed.bu.edu.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Platelet-Rich Plasma Alone
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.
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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.
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Experimenteel: Platelet-Rich Plasma Plus Li-ESWT
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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
Tijdsspanne: Baseline and 4, 12, and 24 weeks after intervention
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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.
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Baseline and 4, 12, and 24 weeks after intervention
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Change From Baseline in Erection Hardness Score (EHS)
Tijdsspanne: Baseline and 4, 12, and 24 weeks after intervention
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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.
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Baseline and 4, 12, and 24 weeks after intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Baseline in Penile Peak Systolic Velocity
Tijdsspanne: Baseline and 4, 12, and 24 weeks after intervention
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Peak systolic velocity (PSV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile arterial blood flow following treatment.
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Baseline and 4, 12, and 24 weeks after intervention
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Change From Baseline in Penile End-Diastolic Velocity
Tijdsspanne: Baseline and 4, 12, and 24 weeks after intervention
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End-diastolic velocity (EDV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile hemodynamics following treatment.
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Baseline and 4, 12, and 24 weeks after intervention
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Patient Satisfaction With Treatment
Tijdsspanne: 4, 12, and 24 weeks after intervention
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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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4, 12, and 24 weeks after intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 maart 2027
Studie voltooiing (Geschat)
1 maart 2027
Studieregistratiedata
Eerst ingediend
20 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
20 augustus 2026
Eerst geplaatst (Werkelijk)
24 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
20 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MS.46.4.2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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