Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction

16 mei 2026 bijgewerkt door: Mahmoud Mahmoud Ahmed M. Ghanim, Benha University

Efficacy of Intracavernosal Injection of Platelet-Rich Plasma Alone Versus Combined With Oral Tadalafil in The Management of Erectile Dysfunction; A Prospective Randomized Study

Platelet-rich plasma is being studied as a regenerative treatment option for erectile dysfunction, but it is unclear whether adding daily tadalafil gives additional benefit over platelet-rich plasma alone. This study evaluates adult men with mild to mild-moderate erectile dysfunction who had an inadequate response to previous phosphodiesterase type 5 inhibitor treatment.

Participants were randomly assigned to receive either intracavernosal platelet-rich plasma injections combined with oral tadalafil 5 milligrams once daily, or intracavernosal platelet-rich plasma injections alone. The platelet-rich plasma injection protocol consisted of three intracavernosal treatment sessions spaced two weeks apart. Erectile function was assessed using the International Index of Erectile Function-5 questionnaire at baseline and during follow-up at 1, 3, and 6 months. Penile duplex Doppler ultrasound was performed at baseline and after 6 months to assess erectile blood-flow parameters.

The study hypothesis is that adding daily tadalafil to intracavernosal platelet-rich plasma may produce greater improvement in patient-reported erectile function compared with platelet-rich plasma alone, while also allowing assessment of whether this improvement is accompanied by measurable changes in penile Doppler parameters. The study included 156 participants in the final analysis, with 78 participants in each treatment group.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

160

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Egypte
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypte, 13511
        • Benha University Hospital

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:

  • Adult men aged 18 years or older.
  • Diagnosis of mild to mild-moderate erectile dysfunction according to the International Index of Erectile Function-5.
  • Inadequate response to previous phosphodiesterase type 5 inhibitor treatment.
  • Eligible for intracavernosal platelet-rich plasma injection.
  • Eligible for oral tadalafil treatment.
  • Baseline penile duplex Doppler ultrasound assessment available.

Exclusion Criteria:

  • Severe erectile dysfunction.
  • Peyronie's disease.
  • Previous major pelvic surgery.
  • Previous pelvic trauma.
  • Known bleeding or coagulation disorder.
  • Contraindication to phosphodiesterase type 5 inhibitors, including nitrate therapy.
  • Significant cardiac disease contraindicating tadalafil use.
  • Total testosterone less than 300 nanograms per deciliter.
  • Refusal or inability to provide written informed consent.

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
Experimenteel: Platelet-Rich Plasma Plus Tadalafil
Participants received intracavernosal platelet-rich plasma injections combined with oral tadalafil. Tadalafil was given as 5 milligrams tablet by mouth once daily. Platelet-rich plasma was prepared from autologous whole blood using a two-step centrifugation method, activated with calcium chloride, and injected intracavernosally using a fine-gauge needle after topical local anesthesia. The injection protocol consisted of three treatment sessions spaced two weeks apart.
Geneesmiddel: Tadalafil
Tadalafil was administered orally as a 5 milligram tablet once daily in combination with intracavernosal platelet-rich plasma injections. It was used as adjunct pharmacologic therapy to support erectile function during the study follow-up period.
Procedure: Intracavernosal Platelet-Rich Plasma Injection
Autologous platelet-rich plasma was prepared from whole blood using a two-step centrifugation technique and activated with calcium chloride before administration. It was injected intracavernosally using a fine-gauge needle after topical local anesthesia. The treatment protocol included three intracavernosal injection sessions spaced two weeks apart.
Actieve vergelijker: Platelet-Rich Plasma Alone
Participants received intracavernosal platelet-rich plasma injections alone without adjunct oral tadalafil. Platelet-rich plasma was prepared from autologous whole blood using a two-step centrifugation method, activated with calcium chloride, and injected intracavernosally using a fine-gauge needle after topical local anesthesia. The injection protocol consisted of three treatment sessions spaced two weeks apart.
Procedure: Intracavernosal Platelet-Rich Plasma Injection
Autologous platelet-rich plasma was prepared from whole blood using a two-step centrifugation technique and activated with calcium chloride before administration. It was injected intracavernosally using a fine-gauge needle after topical local anesthesia. The treatment protocol included three intracavernosal injection sessions spaced two weeks apart.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in International Index of Erectile Function-5 Score
Tijdsspanne: Baseline, 1 month, 3 months, and 6 months after treatment initiation
Erectile function was assessed using the International Index of Erectile Function-5 questionnaire. The total score ranges from 5 to 25, with higher scores indicating better erectile function. Scores were compared over time between the platelet-rich plasma plus tadalafil group and the platelet-rich plasma alone group.
Baseline, 1 month, 3 months, and 6 months after treatment initiation

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Penile Peak Systolic Velocity
Tijdsspanne: Baseline and 6 months after treatment initiation
Peak systolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation. It was used to assess arterial penile blood flow. Higher values indicate better arterial inflow.
Baseline and 6 months after treatment initiation
Change in Penile End-Diastolic Velocity
Tijdsspanne: Baseline and 6 months after treatment initiation
End-diastolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation. It was used to assess venous outflow status during erection.
Baseline and 6 months after treatment initiation
Change in Penile Resistive Index
Tijdsspanne: Baseline and 6 months after treatment initiation
Resistive index was calculated from penile duplex Doppler ultrasound parameters after pharmacologic stimulation. It was used as an additional measure of penile vascular resistance and erectile hemodynamics.
Baseline and 6 months after treatment initiation

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Benha University

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 (Werkelijk)

15 april 2025

Primaire voltooiing (Werkelijk)

15 december 2025

Studie voltooiing (Werkelijk)

16 december 2025

Studieregistratiedata

Eerst ingediend

16 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

16 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MD 5-10-2025

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Deidentified individual participant data supporting the main study results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, treatment allocation, International Index of Erectile Function-5 scores, and penile duplex Doppler ultrasound parameters. No directly identifying participant information will be shared.

IPD-tijdsbestek voor delen

Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.

IPD-toegangscriteria voor delen

Data will be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the study investigators. Data will be provided only after approval of the request and, when required, completion of a data sharing agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren