Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction

NCT06264635 | Recruiting Phase 1

• 1 other identifier: HS26227
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is great interest in restorative therapies (platelet-rich plasma (PRP) injections, shockwave therapy and stem cell therapy) for ED given their non-invasive nature. However, data is still limited and requires further research prior to widespread adoption. Unfortunately, therapies such as PRP injections are being widely used without clinical evidence demonstrating its safety or effectiveness for the treatment of erectile dysfunction. 2-7 To date, there are no treatments that address the underlying cause of endothelial dysfunction, although low-intensity shockwave therapy for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction. The investigators propose to perform Canada's first pilot RCT to evaluate and safety and efficacy of PRP for the treatment of ED.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function (IIEF)

  Follow-up visits will be conducted at months: 1, 3, 6, after the last treatment session and shall include: Measuring IIEF-EF of patients at the clinic at every follow-up visit. This is a validated form of assessing erectile function.

  1, 3, 6 months post-procedure

Secondary Outcomes (1)

• Adverse Events

  1, 3, 6 months post-procedure

Study Arms (2)

Platelet-Rich-Plasma (PRP)

EXPERIMENTAL

PRP refers to a treatment where a patient's own blood is used to promote healing. Blood is drawn, processed to concentrate the platelets, and then re-injected into the injured area to stimulate tissue repair.

Biological: Platelet-Rich-Plasma

Saline

PLACEBO COMPARATOR

Provider will go through the same motions as injecting PRP, but will use saline instead which has no known effect.

Other: Saline

Interventions

Platelet-Rich-Plasma BIOLOGICAL

PRP refers to a treatment where a patient's own blood is used to promote healing. Blood is drawn, processed to concentrate the platelets, and then re-injected into the injured area to stimulate tissue repair.

Platelet-Rich-Plasma (PRP)

Saline OTHER

Provider will go through the same motions as injecting PRP, but will use saline instead which has no known effect.

Saline

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be able willing and able to provide informed consent. The investigators wil enroll males between \>30 and \<70 years of age who have ED based on IIEF scores (score between 16 and 25.) with patients suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
• The patient has been in a stable relationship for over 3 months prior to enrollment with a minimum of 2 sexual attempts per month for at least one month prior to enrollment.
• A1C level ≤ 7% within 1 month prior to enrollment.

You may not qualify if:

• Participating in another study within the past three months that may interfere with the results or conclusions of this study, under judicial protection (prison or custody), adult under guardianship, or patient refuses to sign the consent.
• History of radical prostatectomy or extensive pelvic surgery, past radiation therapy of the pelvic region within 12 months prior to enrolment, recovering from any cancer within 12 months prior to enrollment.
• Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function at the discretion of the investigator, psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.
• Anatomical malformation of the penis, including Peyronie's disease.
• A1C level \> 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
• The patient is taking blood thinners and has an international normalized ratio (INR) \>3.
• Received shockwave treatment at least 6 months before enrollment.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Men's Health Clinic

Winnipeg, Manitoba, R3K 1M3, Canada

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Premal Patel, MD

CONTACT

204-221-4476; ppatel5@hsc.mb.ca

Jainik Shah, BFSc

CONTACT

6477721737; shahj4@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The provider and patient are both blinded to which treatment (PRP vs saline) the patient is receiving
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: January 24, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)