A Randomized Trial to Evaluate Efficacy and Safety of Intracavernosal Injection of Platelet-Rich Plasma Versus Phosphodiesterase Type-5 Inhibitors for Treatment of Erectile Dysfunction.

The aim of this study is to evaluate the efficacy and safety of intracavernosal injection of PRP in patients with moderate to severe ED.

Study Overview

• Status: Active, not recruiting
• Conditions: Erectile Dysfunction Following Radiation Therapy; Phosphodiesterase Inhibitor Adverse Reaction; Platelet- Rich Plasma (PRP)
• Intervention / Treatment: Drug: P shot arm ( Autologous Platelet Rich Plasma); Drug: PDE5i arm

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Outside U.S./Canada
    • Mansoura, Outside U.S./Canada, Egypt, 35516
      • Mansoura Urology and Nephrology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 1) Signed an ethics committee-reviewed and approved informed consent form. 2) Subjects must meet all inclusion criteria to be eligible for study enrollment.

  3) Men between 30 and 75 years old, 4) Sexually active in a stable, heterosexual relationship of at least six months duration.

  5) ED for at least 6 months with an IIEF-EF between 5 and 16 points, inclusive. 6) ED of vascular origin. 7) Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS).

  8) Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc.).

  9) Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions.

Exclusion Criteria:

• 1) Refuse to complete study requirements. 2) Psychogenic ED as determined by study investigator. 3) ED of neurogenic origin (radical cystectomy, radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, DM is not included unless documented diabetic neuropathy).

  4) Previous penile surgery of any kind (except circumcision, frenuloplasty and condyloma removal), such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication, grafting.

  5) Previous history of penile fracture, Peyronie's disease or priapism. 6) Previous radiation to pelvis. 7) History of symptomatic hypogonadism (testosterone level <346ng/dl) not treated.

  8) Major hematologic, renal, or hepatic abnormalities. 9) Severe decompensated cardiac, CNS or vascular insufficiency. 10) Poorly controlled hypertension or DM (HbA1c >12%). 11) Neoplasm of any origin in active treatment or active progression or recovering from cancer within 12 months prior to enrollment.

  12) History of alcohol abuse or drug. 13) Treatment with oral anticoagulants, antiandrogens or nitrates. 14) Thrombopenia less than 100 x 103 / L. 15) Hemoglobin <10g/dl. 16) Poor venous access or any other circumstance that preclude an apheresis procedure.

  17) Sexually inactive in recent months. 18) participation in another study that may interfere with the results or conclusions of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: P shot arm; Drug: Autologous Platelet Rich Plasma + placebo tab Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.	Drug: P shot arm ( Autologous Platelet Rich Plasma); Autologous Platelet Rich Plasma + placebo tab Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum; Other Names: Autologous Platelet Rich Plasma
Active Comparator: PDE5i arm; Drug: Tadalafil + placebo injection Patients will be treated by tadalafil 5 mg tablet daily in addition to four Tadalafil 5 mg tablet 3 hours before intercourse on demand in addition to placebo injection. Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.	Drug: PDE5i arm; Patients will be treated by tadalafil 5 mg tablet daily in addition to four Tadalafil 5 mg tablet 3 hours before intercourse on demand in addition to placebo injection. Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of intracavernosal injections of platelet-rich plasma (PRP) in patients Erectile Dysfunction.	assessed by the proportion of patients attaining minimal clinically important difference in the international index of erectile function - erection dpmain.	6 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Ahmed El-assmy, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): January 25, 2025
• Study Completion (Anticipated): January 25, 2025

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Erectile Dysfunction , Phosphodiesterase Inhibitor Adverse Reaction, platelet- rich plasma
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: PRP-ED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No