Pilot Randomized Controlled Trial Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Canada
Men's Health Clinic
RECRUITING
Winnipeg
Contact Information
Primary
Premal Patel, MD
ppatel5@hsc.mb.ca
204-221-4476
Backup
Jainik Shah, BFSc
shahj4@myumanitoba.ca
6477721737
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2025-03
Participants
Target number of participants: 60
Treatments
Experimental: Platelet-Rich-Plasma (PRP)
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.
Placebo_comparator: Saline
Provider will go through the same motions as injecting PRP, but will use saline instead which has no known effect.
Related Therapeutic Areas
Sponsors
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov