Platelet-Rich Plasma for Erectile Dysfunction

Overseen By Premal Patel, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Manitoba

Must not be taking: Antidepressants, Anxiolytics, Antipsychotics, others

Disqualifiers: Cancer, Neurological disease, Diabetes, others

Compensation: Varies

Number of Visits: 5

Duration: 2 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for men experiencing erectile dysfunction. Participants should be seeking a non-invasive treatment option and have not found success with other therapies. Specific eligibility criteria are not provided, but typically include age range, health status, and the severity of ED.

Inclusion Criteria

I am willing and able to give my consent for treatment.

I am a man aged 31-69 with mild to moderate erectile dysfunction.

I have had erectile dysfunction for more than 6 months but less than 5 years.

Exclusion Criteria

I have a neurological or psychiatric condition or take medication that affects my sexual function.

I have not been in another study in the last 3 months, am not under judicial protection, and am willing to sign consent.

I had shockwave treatment over 6 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 PRP or placebo treatments 1 month apart

2 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measuring IIEF-EF and recording adverse events

6 months

3 visits (in-person) at months 1, 3, and 6

Treatment Details

Interventions

• Platelet-Rich-Plasma

Trial Overview The study is testing the effectiveness of Platelet-Rich-Plasma (PRP) injections compared to saline (a placebo) in treating erectile dysfunction. It's Canada's first pilot randomized controlled trial on PRP for ED, aiming to see if it can improve underlying tissue and nerve function.

Participant Groups

Group I: Platelet-Rich-Plasma (PRP) Experimental Treatment 1 Intervention

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.

Group II: Saline Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+