Comparsion of Effect of PRP,PDE5 Inhibitor in Treatment of Erectile Dysfunction

August 8, 2026 updated by: Amr AbdelFattah, Ain Shams University

Comparison Between The Effect of Intracavernosal Injection of Platelet-Rich Plasma as a Single Agent vs Daily Oral 5 Phosphodiesterase Inhibitor Intake as a Single Agent Vs Combination In Improving of Erectile Dysfunction

Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.Erectile dysfunction (ED) is one of the commonest disorders in adult males and affects 12-19% of men of reproductive age.Erectile dysfunction can be due to vasculogenic, neurogenic, hormonal, veno-occlusive, psychogenic and/or pharmacogenic factors.

PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation. PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) leading to dilatation of the penile arteries leads to a more prolonged erection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.The prevalence of erectile dysfunction (ED) increases with age, from 5% in men aged 20-39 years to 70% in men aged >70 years.

PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) present in the smooth muscle cells of the vessels. By inhibiting this enzyme, these drugs prevent the degradation of cGMP by PDE-5. GMP can cause activation of protein kinase G, leading to relaxation of the vascular smooth muscle. Prevention of degradation of cGMP by PDE-5 leads to the accumulation of cGMP in the vascular smooth muscle, thereby leading to dilatation of the blood vessels through phosphorylation of different downstream effector molecules. Dilatation of the penile arteries leads to a more prolonged erection. In addition, PDE5Is improve endothelial function and reduce apoptosis of vascular smooth muscle cells in the corpus cavernosum.

PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation.PRP has 7 fundamental proteins: platelet derived growth factors (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and adhesive proteins - fibrin, fibronectin and vitronectin.

PDGF is a glycoprotein, which emerges from degranulation of platelets at the site of injection. It activates cell membrane receptors on target cell which in turn develop high energy phosphate bonds, which activates the signal proteins to initiate specific activity of target cells. These specific activities include mitogenesis, angiogenesis.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • 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

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt
        • Ain Shams University 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:

  • Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
  • Sexually active in a stable, heterosexual relationship of more than three months duration.
  • Agree to attempt sexual intercourse at least 3 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
  • Agree to comply with all study related tests/procedures.
  • provide written informed consent.

Exclusion Criteria:

  • Previous penile surgery of any kind (except circumcision ).
  • Previous history of penile fracture or priapism.
  • Psychogenic ED as determined by study investigator.
  • Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity).
  • Patients using Intracavernosal Injection (ICI) for management of ED.
  • Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
  • Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
  • Any history of significant psychiatric disease.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: INTRACAVERNOSAL PRP
About 25 patients suffering from Erectile Function and underwent Intracaveronsal injection of 7-9 ml of PRP for 3 times 4weeks apart
Drug: Tadalafil 5mg
To compare between Intra Cavernous Injection of Platelet Rich Plasma (PRP) as a single agent , 5 PDE inhibitor as a single agent vs combined effect of two agent to achieve an efficient therapy with less cost for the treatment of Erectile Dysfunction.
Other Names:
  • Platelet Rich Plasma (PRP)
Active Comparator: 5 phosphodiasterase inhibitor
About 25 patients suffering from Erectile Function and took a daily dose of oral 5 mg tadalafil tablets
Drug: Tadalafil 5mg
To compare between Intra Cavernous Injection of Platelet Rich Plasma (PRP) as a single agent , 5 PDE inhibitor as a single agent vs combined effect of two agent to achieve an efficient therapy with less cost for the treatment of Erectile Dysfunction.
Other Names:
  • Platelet Rich Plasma (PRP)
Active Comparator: Prp and 5 phosphodiasterase inhibitor combined
About 25 patients suffering from Erectile Function and underwent combined of both agents which includes daily dose of oral 5mg tadalafil tablets and Intracaveronsal injection of 7-9 ml of PRP for 3 injections 4 weeks apart
Drug: Tadalafil 5mg
To compare between Intra Cavernous Injection of Platelet Rich Plasma (PRP) as a single agent , 5 PDE inhibitor as a single agent vs combined effect of two agent to achieve an efficient therapy with less cost for the treatment of Erectile Dysfunction.
Other Names:
  • Platelet Rich Plasma (PRP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment of Erectile Dysfunction
Time Frame: 6 Months
Treatment of the patients whom suffering from Erectile Dysfunction by using Intracavernosal Injection of Platelet-Rich Plasma as a single agent and daily oral 5 Phosphodiesterase Inhibitor intake as a single agent and combination of both agents evaluated by International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF).
6 Months

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Chair: Hisham Mohamed Fathy Salama El Shawaf, Professor, Professor of Urology, faculty of Medicine, Ain Shams University

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)

January 15, 2024

Primary Completion (Actual)

August 25, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

August 8, 2026

First Submitted That Met QC Criteria

August 8, 2026

First Posted (Actual)

August 12, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 8, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP in Erectile dysfunction

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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