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

April 17, 2025 updated by: Yavuz Onur Danacıoğlu, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Investigation of the efficacy of autologous platelet-rich plasma administration on the potency of patients with vasculogenic and/or neurogenic erectile dysfunction

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34147
        • University of Health Sciences, Bakırköy Sadi Konuk Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: intracavernous platelet rich plasma therapy
intracavernous platelet-rich plasma therapy for erectile dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IIEF
Time Frame: 6 months
To observe the increase in the International Index of Erectile Function (IIEF) score after treatment compared to before treatment in patients.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FSFI
Time Frame: 6 months
To observe FSFI score increases in patients' partners before and after treatment using the Female Sexual Function Inventory (FSFI).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2023

Primary Completion (Estimated)

July 29, 2025

Study Completion (Estimated)

July 29, 2025

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICPRPforED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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