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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05787769
Other study ID # PRP-ED
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date January 25, 2025

Study information

Verified date March 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 96
Est. completion date January 25, 2025
Est. primary completion date January 25, 2025
Accepts healthy volunteers No
Gender Male
Age group 30 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Erectile Dysfunction
  • Erectile Dysfunction Following Radiation Therapy
  • Phosphodiesterase Inhibitor Adverse Reaction

Intervention

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
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.

Locations

Country Name City State
Egypt Mansoura urology and nephrology center Mansoura Outside U.S./Canada

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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Recruiting NCT05868668 - Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain N/A
Enrolling by invitation NCT03986359 - Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy N/A
Active, not recruiting NCT04434352 - Low Intensity Shockwave Therapy for Erectile Dysfunction N/A
Recruiting NCT04861194 - EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT) N/A
Completed NCT04662398 - Using of Testes' Shocker in Improving Sexual Activity N/A