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Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction

16. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in International Index of Erectile Function-5 Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Penile Peak Systolic Velocity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Benha University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. april 2025

Primær færdiggørelse (Faktiske)

15. december 2025

Studieafslutning (Faktiske)

16. december 2025

Datoer for studieregistrering

Først indsendt

16. maj 2026

Først indsendt, der opfyldte QC-kriterier

16. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MD 5-10-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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