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

NCT ID: NCT06942988

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-29
• Study Completion Date: 2025-07-29

Brief Summary

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

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICPRPforED

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.

Group Type: EXPERIMENTAL

intracavernous platelet rich plasma therapy

Intervention Type: BIOLOGICAL

intracavernous platelet-rich plasma therapy for erectile dysfunction

Interventions

intracavernous platelet rich plasma therapy

intracavernous platelet-rich plasma therapy for erectile dysfunction

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

t-biyoteknoloji labaratuvar estetik medikal kozmetik san. ve tic. ltd. şti.

UNKNOWN

Sponsor Role: collaborator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yavuz Onur Danacıoğlu

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Health Sciences, Bakırköy Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ICPRPforED

Identifier Type: -

Identifier Source: org_study_id