Platelet-rich Plasma (PRP) Injection for Treatment of Erectile Function

Institute for the Study of Urological Diseases, Greece60 enrolled

Overview

The primary objective of the present study is to investigate and compare the treatment efficacy of PRP injection vs placebo treatment in men with mild-moderate vasculogenic ED, as measured by IIEF.The secondary objective of the present clinical trial is to study the adverse events and safety of the PRP injection treatment in vasculogenic ED patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Erectile Dysfunction Due to Arterial Insufficiency

Interventions

Platelet-Rich Plasma (PRP)BIOLOGICAL

All subjects of this group will receive 2 sessions of PRP penile injection with 30 +/- 3 day treatment interval, 10 ml of PRP will be injected at each session.

Normal saline injectionBIOLOGICAL

All subjects of this group will receive 2 sessions of normal saline penile injection with 30 +/- 3 day treatment interval for all subjects, 10 ml of normal saline will be injected at each session.

Eligibility

Sex: MALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Consent to participate. 2. Age 40-70 years. 3. Sexually active in a stable, heterosexual relationship of more than three months duration. 4. Presence of Erectile Dysfunction for at least 6 months. 5. IIEF-ED: 11-25 at visit 1 6. PDE5i users and report some/good response to PDE5i at the last month before screening. 7. Agree to suspend all ED therapy for the duration of the study. 8. Agree to attempt sexual intercourse at least 4 times every 4 weeks, for the duration of the study without being under the influence of alcohol or recreational drugs. Agree to document the outcome using the Sexual Encounter Profile (SEP) diary, as needed. Exclusion Criteria: 1. Previous major pelvic surgery or pelvic trauma that could impact erectile function, such as radical prostatectomy, radical cystectomy, rectal surgery. Patients with previous TURP surgery without sequelae of iatrogenic ED, may be included. 2. Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting. 3. Previous history of priapism or penile fracture 4. Previous radiation therapy to pelvis. 5. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL +/- 5 %(indicative of untreated hypogonadism), or greater than 1197 ng/dL +/- 5%. 6. Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded. 7. Psychogenic ED. 8. Peyronie's Disease or penile curvature that negatively influences sexual activity. 9. Anatomical or neurological abnormalities in the treatment area. 10. Any untreated medical condition (medical history) 11. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease. 12. Refusal to suspend ED therapy for duration of study. Subjects who are using Tadalafil as a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded. 13. Men deemed not healthy enough to participate in sexual activity. 14. Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits. 15. Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study. 16. History of consistent treatment failure with PDE5 inhibitors for therapy of ED. 17. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using SSRI or psychotropic medications. 18. Partners who are \< 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit participation in sexual intercourse. 19. Patients with any hematological disorder.

Locations (1)

G.Gennimatas Hospital

Thessaloniki, Greece

Outcomes

Primary Outcomes

The % of patients in each group who attain Minimal Clinically Important Difference (MCID) in International Index of Erectile Function -Erectile Function (IIEF-EF) domain from baseline to 24 weeks after final treatment.

MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED at baseline and by 2 or more in the EF domain score of the IIEF for patients with moderate ED at baseline

Time frame: at 24 weeks follow up visit

Secondary Outcomes

The % of patients in each group who attain MCID in IIEF-EF domain from baseline to 12 weeks after final treatment.

Time frame: at 12 weeks follow up visit

The % of patients in each group who attain MCID in IIEF-EF domain from baseline to 4 weeks after final treatment.

Time frame: at 4 weeks follow up visit

The difference between the PRP group (2 sessions of PRP) and the placebo group in the change of the IIEF-ED score from baseline to 4 weeks after final treatment.

EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction).

Time frame: baseline and 4 weeks follow up visit

Data from ClinicalTrials.gov

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