Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction
16 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
160
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egypte, 13511
- Benha University Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in International Index of Erectile Function-5 Score
Délai: Baseline, 1 month, 3 months, and 6 months after treatment initiation
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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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Penile Peak Systolic Velocity
Délai: 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.
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Baseline and 6 months after treatment initiation
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Change in Penile End-Diastolic Velocity
Délai: Baseline and 6 months after treatment initiation
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End-diastolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation.
It was used to assess venous outflow status during erection.
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Baseline and 6 months after treatment initiation
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Change in Penile Resistive Index
Délai: Baseline and 6 months after treatment initiation
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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.
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Baseline and 6 months after treatment initiation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 avril 2025
Achèvement primaire (Réel)
15 décembre 2025
Achèvement de l'étude (Réel)
16 décembre 2025
Dates d'inscription aux études
Première soumission
16 mai 2026
Première soumission répondant aux critères de contrôle qualité
16 mai 2026
Première publication (Réel)
22 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Les troubles mentaux
- Maladies génitales, sexe masculin
- Maladies urogénitales masculines
- Dysfonction sexuelle, physiologique
- Dysfonctions sexuelles, psychologiques
- Dysérection
- Pyridines
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Indoles
- Alcaloïdes indole
- Composés hétérocycliques, 3 ring
- Carbolines
- Tadalafil
Autres numéros d'identification d'étude
- MD 5-10-2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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