Efficacy of Intracavernous Platelet-rich Plasma Injection in the Treatment of Erectile Dysfunction

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status and phase: Active, not recruiting; Phase 3

Conditions: Erectile Dysfunction

Treatments: Biological: intracavernous platelet rich plasma therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06942988

ICPRPforED

Details and patient eligibility

About

Investigation of the efficacy of autologous platelet-rich plasma administration on the potency of patients with vasculogenic and/or neurogenic erectile dysfunction

Enrollment: 34 patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1)40-70 years old male, sexually active heterosexual, 2) Patients with a diagnosis of mild to moderate erectile dysfunction (IIEF score between 8-21) according to the International Index of Erectile Function (IIEF) for at least 3 months, 3) Patients who cannot achieve an erection despite peroral PDE5 inhibitor and intracavernous alprostadil injection therapy

Exclusion criteria

1. Patients with psychogenic erectile dysfunction, 2) Patients with a history of priapism, penile fracture, peyronie, penile curvature 3) Patients with a history of radical prostatectomy, 4) Patients with a history of major pelvic trauma, surgery, radiotherapy, 5) Patients with a history of malignancy affecting survival, 6) Patients with severe psychiatric illness that impairs adherence to treatment, 7) Patients with any bleeding disorder or on anti-aggregants/coagulants.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

ICPRPforED

Experimental group

Description:

Patients were planned to receive 3 sessions of intracavernous PRP injection once a month. Patients will be evaluated with IIEF scores and their partners with FSFI scores before treatment, during each procedure and 3 months after treatment. Two tubes of venous blood (8 ml each) will be collected from the patient by phlebotomy into MEDEX PRP tube. PRP will be prepared with 2000rpm-2min protocol and all plasma will be collected. PRP (approximately 5cc) will be applied proximally and distally to the bilateral cavernous body of the penis. In order to decrease venous return and increase the effectiveness of platelets in the cavernous body, a tourniquet will be applied to the penis with a ring from the proximal side, wait 20 minutes and remove the tourniquet.

Treatment:

Biological: intracavernous platelet rich plasma therapy