Clinical trial NCT04050020: Platelet-rich Plasma (PRP) Injection for Treatment of Erectile Function
Official title: The Effect of Platelet-rich Plasma(PRP) Injection Treatment on Erectile Function: a Double-blind, Placebo Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Erectile Dysfunction Due to Arterial Insufficiency
Keywords: PRP
Platelet-Rich Plasma
Lead sponsor: Institute for the Study of Urological Diseases, Greece
Sponsor class: OTHER
Collaborators: name: European Society for Sexual Medicine
First posted: 2019-08-08
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: at 24 weeks follow up visit
Secondary outcomes:
measure: The % of patients in each group who attain MCID in IIEF-EF domain from baseline to 12 weeks after final treatment.
timeFrame: at 12 weeks follow up visit
measure: The % of patients in each group who attain MCID in IIEF-EF domain from baseline to 4 weeks after final treatment.
timeFrame: at 4 weeks follow up visit
measure: 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.
timeFrame: baseline and 4 weeks follow up visit
measure: 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.
timeFrame: baseline and 12 weeks follow up visit
measure: 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.
timeFrame: baseline and 24 weeks follow up visit
measure: 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.
timeFrame: baseline and 4 weeks follow up visit
measure: 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.
timeFrame: baseline and 12 weeks follow up visit
measure: 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.
timeFrame: baseline and 24 weeks follow up visit
measure: The difference between the PRP group (2 sessions of PRP) and the placebo group in Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire score
timeFrame: 4,12, 24 weeks follow up visit
measure: 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
timeFrame: at week 0 and 4
measure: Number of patients with treatment related adverse events
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: G.Gennimatas Hospital
Study officials:
affiliation: G.Gennimatas General Hospital, Thessaloniki,Greece
name: Dimitrios Hatzichristou, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epifanova MV, Gvasalia BR, Durashov MA, Artemenko SA. Platelet-Rich Plasma Therapy for Male Sexual Dysfunction: Myth or Reality? Sex Med Rev. 2020 Jan;8(1):106-113. doi: 10.1016/j.sxmr.2019.02.002. Epub 2019 Mar 19.
citation: Scott S, Roberts M, Chung E. Platelet-Rich Plasma and Treatment of Erectile Dysfunction: Critical Review of Literature and Global Trends in Platelet-Rich Plasma Clinics. Sex Med Rev. 2019 Apr;7(2):306-312. doi: 10.1016/j.sxmr.2018.12.006. Epub 2019 Mar 2.
citation: Wu YN, Wu CC, Sheu MT, Chen KC, Ho HO, Chiang HS. Optimization of platelet-rich plasma and its effects on the recovery of erectile function after bilateral cavernous nerve injury in a rat model. J Tissue Eng Regen Med. 2016 Oct;10(10):E294-E304. doi: 10.1002/term.1806. Epub 2013 Aug 16.