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.

NCT ID: NCT05787769

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-01-25

Brief 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.

Conditions

Erectile Dysfunction Following Radiation Therapy; Phosphodiesterase Inhibitor Adverse Reaction; Platelet- Rich Plasma (PRP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

P shot arm ( Autologous Platelet Rich Plasma)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

PDE5i arm

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Autologous Platelet Rich Plasma

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed El-assmy

Role: STUDY_DIRECTOR

Mansoura University

Locations

Mansoura urology and nephrology center

Al Mansurah, Outside U.S./Canada, Egypt

Countries

Egypt

Other Identifiers

PRP-ED

Identifier Type: -

Identifier Source: org_study_id