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.

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

Official Title
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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.

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

Intervention / Treatment
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* Drug: P shot arm ( Autologous Platelet Rich Plasma)
* Drug: PDE5i arm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: P shot arm<br>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)<br>* 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<br>* Other names: Autologous Platelet Rich Plasma;|
| Active Comparator: PDE5i arm<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction , Phosphodiesterase Inhibitor Adverse Reaction, platelet- rich plasma