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

NCT07761806 | Completed Phase 2 DMC

• 1 other identifier: PRP in Erectile dysfunction
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Treatment of Erectile Dysfunction

  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

Study Arms (3)

INTRACAVERNOSAL PRP

ACTIVE COMPARATOR

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

5 phosphodiasterase inhibitor

ACTIVE COMPARATOR

About 25 patients suffering from Erectile Function and took a daily dose of oral 5 mg tadalafil tablets

Drug: Tadalafil 5mg

Prp and 5 phosphodiasterase inhibitor combined

ACTIVE COMPARATOR

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

Interventions

Tadalafil 5mg DRUG

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.

Also known as: Platelet Rich Plasma (PRP)

5 phosphodiasterase inhibitor; INTRACAVERNOSAL PRP; Prp and 5 phosphodiasterase inhibitor combined

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Abbasia, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Hisham Mohamed Fathy Salama El Shawaf, Professor

  Professor of Urology, faculty of Medicine, Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Urology Department

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 12, 2026
• Study Start: January 15, 2024
• Primary Completion: August 25, 2024
• Study Completion: October 1, 2024
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

EG (1)