Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Platelet-Rich Plasma Alone Versus PRP Plus Low-Intensity Shock Wave Therapy for Erectile Dysfunction

20 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Egipto
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egipto, 13511
        • Benha University Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Comparador activo: 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.
Biológico: Platelet-Rich Plasma
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.
Experimental: 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.
Dispositivo: Low-Intensity Extracorporeal Shock Wave Therapy
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
Periodo de tiempo: Baseline and 4, 12, and 24 weeks after intervention
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.
Baseline and 4, 12, and 24 weeks after intervention
Change From Baseline in Erection Hardness Score (EHS)
Periodo de tiempo: Baseline and 4, 12, and 24 weeks after intervention
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.
Baseline and 4, 12, and 24 weeks after intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Penile Peak Systolic Velocity
Periodo de tiempo: Baseline and 4, 12, and 24 weeks after intervention
Peak systolic velocity (PSV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile arterial blood flow following treatment.
Baseline and 4, 12, and 24 weeks after intervention
Change From Baseline in Penile End-Diastolic Velocity
Periodo de tiempo: Baseline and 4, 12, and 24 weeks after intervention
End-diastolic velocity (EDV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile hemodynamics following treatment.
Baseline and 4, 12, and 24 weeks after intervention
Patient Satisfaction With Treatment
Periodo de tiempo: 4, 12, and 24 weeks after intervention
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.
4, 12, and 24 weeks after intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Benha University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

20 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de agosto de 2026

Publicado por primera vez (Actual)

24 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MS.46.4.2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir