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

NCT04050020 | Completed Phase 2

• 1 other identifier: 65-08/10/18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Erectile Dysfunction Due to Arterial Insufficiency

Keywords

PRP; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (1)

• 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

  at 24 weeks follow up visit

Secondary Outcomes (11)

• 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 % 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 of the IIEF-ED 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 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

Biological: Platelet-Rich Plasma (PRP)

Group B

PLACEBO COMPARATOR

Biological: Normal saline injection

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.

Group A

Normal saline injection BIOLOGICAL

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.

Group B

Eligibility Criteria

• Age: 40 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease.
• 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.
• Men deemed not healthy enough to participate in sexual activity.
• Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
• 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.

Sponsors & Collaborators

• Institute for the Study of Urological Diseases, Greece: lead
• European Society for Sexual Medicine: collaborator

Study Sites (1)

G.Gennimatas Hospital

Thessaloniki, 54621, Greece

Location

Related Publications (3)

• 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.

  PMID: 30898594 BACKGROUND

• 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.

  PMID: 30833169 BACKGROUND

• 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.

  PMID: 23950105 BACKGROUND

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dimitrios Hatzichristou, Prof.

  G.Gennimatas General Hospital, Thessaloniki,Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: September 2, 2019
• Primary Completion: March 26, 2020
• Study Completion: September 24, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

GR (1)