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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07602608
Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egipto, 13511
- Benha University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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Comparador activo: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in International Index of Erectile Function-5 Score
Periodo de tiempo: 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.
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Baseline, 1 month, 3 months, and 6 months after treatment initiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Penile Peak Systolic Velocity
Periodo de tiempo: Baseline and 6 months after treatment initiation
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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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Desordenes mentales
- Enfermedades Genitales Masculinas
- Enfermedades urogenitales masculinas
- Disfunción Sexual Fisiológica
- Disfunciones Sexuales Psicológicas
- Disfuncion erectil
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Indoles
- Alcaloides de indol
- Compuestos heterocíclicos, 3 anillos
- Carbolines
- Tadalafilo
Otros números de identificación del estudio
- MD 5-10-2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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