The Effect of Platelet-rich Plasma(PRP) Injection Treatment on Erectile Function: a Double-blind, Placebo Controlled Randomized Clinical Trial

Institute for the Study of Urological Diseases, Greece1 site in 1 country60 target enrollmentSeptember 2, 2019

ConditionsErectile Dysfunction Due to Arterial Insufficiency

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Erectile Dysfunction Due to Arterial Insufficiency
Sponsor: Institute for the Study of Urological Diseases, Greece
Enrollment: 60
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2, 2019

End Date

September 24, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Institute for the Study of Urological Diseases, Greece

Responsible Party

Principal Investigator

Dimitrios Hatzichristou

Professor

Institute for the Study of Urological Diseases, Greece

Eligibility Criteria

Inclusion Criteria

•Consent to participate.
•Age 40-70 years.
•Sexually active in a stable, heterosexual relationship of more than three months duration.
•Presence of Erectile Dysfunction for at least 6 months.
•IIEF-ED: 11-25 at visit 1
•PDE5i users and report some/good response to PDE5i at the last month before screening.
•Agree to suspend all ED therapy for the duration of the study.
•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

•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.
•Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
•Previous history of priapism or penile fracture
•Previous radiation therapy to pelvis.
•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%.
•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.
•Psychogenic ED.
•Peyronie's Disease or penile curvature that negatively influences sexual activity.
•Anatomical or neurological abnormalities in the treatment area.
•Any untreated medical condition (medical history)

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.

Time Frame: at 24 weeks follow up visit

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

Secondary Outcomes

The % of patients in each group who attain MCID in IIEF-EF domain from baseline to 12 weeks after final treatment.(at 12 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.(baseline and 4 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.(at 4 weeks follow up visit)
The difference between the PRP group (2 sessions of PRP) and the placebo group in the change in Sexual Encounter Profile Question 3 (SEP3) score from baseline to 4 weeks after final treatment.(baseline and 4 weeks follow up visit)
The difference between the PRP group (2 sessions of PRP) and the placebo group in the change in Sexual Encounter Profile Question 3 (SEP3) score from baseline to 12 weeks after final treatment.(baseline and 12 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 12 weeks after final treatment.(baseline and 12 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 24 weeks after final treatment.(baseline and 24 weeks follow up visit)
The difference between the PRP group (2 sessions of PRP) and the placebo group in the change in Sexual Encounter Profile Question 3 (SEP3) score from baseline to 24 weeks after final treatment.(baseline and 24 weeks follow up visit)
The difference between the PRP group (2 sessions of PRP) and the placebo group in Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire score(4,12, 24 weeks follow up visit)
The difference between the PRP group (2 sessions of PRP) and the placebo group in the the Pain Visual Analogue Scale (VAS) after each injection treatment session(at week 0 and 4)
Number of patients with treatment related adverse events(28 weeks)