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

NCT06942988 | Active Not Recruiting Phase 3

• 1 other identifier: ICPRPforED
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

platelet-rich plasma; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• IIEF

  To observe the increase in the International Index of Erectile Function (IIEF) score after treatment compared to before treatment in patients.

  6 months

Secondary Outcomes (1)

• FSFI

  6 months

Study Arms (1)

ICPRPforED

EXPERIMENTAL

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.

Biological: intracavernous platelet rich plasma therapy

Interventions

intracavernous platelet rich plasma therapy BIOLOGICAL

intracavernous platelet-rich plasma therapy for erectile dysfunction

ICPRPforED

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead
• t-biyoteknoloji labaratuvar estetik medikal kozmetik san. ve tic. ltd. şti.: collaborator

Study Sites (1)

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

Istanbul, Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: December 29, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

TU (1)