60 Participants Needed

Platelet-Rich Plasma for Erectile Dysfunction

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PP
Overseen ByPremal Patel, MD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of platelet-rich plasma (PRP) injections for treating erectile dysfunction (ED). PRP uses a person's own blood, processed to concentrate platelets, and re-injected to aid tissue repair. The trial compares PRP to a placebo (a harmless treatment with no effect) to determine its efficacy for ED. Men who have experienced ED for more than six months but less than five years and are in a stable relationship might be suitable candidates.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial does not clearly specify if you need to stop your current medications. However, if you are taking psychiatric medications or blood thinners with an INR greater than 3, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that platelet-rich plasma (PRP) treatments for erectile dysfunction (ED) are usually well-tolerated. Studies indicate that PRP injections can improve ED symptoms with few side effects. For example, a review of several studies found that PRP has a low rate of negative effects. Another study found that PRP injections are generally safe for most people. These findings suggest that PRP could be a promising option for those exploring new treatments for ED.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Platelet-Rich Plasma (PRP) for treating erectile dysfunction because it uses the body's own healing processes to potentially repair tissue and improve function. Unlike standard treatments such as oral medications like Viagra or Cialis, which enhance blood flow temporarily, PRP involves injecting concentrated platelets from the patient's own blood directly into the affected area, aiming to stimulate natural tissue repair and regeneration. This novel approach could offer a more sustainable and natural solution for erectile dysfunction, addressing underlying issues rather than just providing short-term relief.

What evidence suggests that platelet-rich plasma might be an effective treatment for erectile dysfunction?

Research suggests that platelet-rich plasma (PRP) might help treat erectile dysfunction (ED). In this trial, participants will receive either PRP or a saline placebo. Studies have shown that PRP can improve ED symptoms, especially in men with mild to moderate cases. A review of several studies found PRP somewhat effective with few side effects. PRP uses a patient's own blood to heal and repair tissues, potentially addressing the underlying causes of ED. However, more research is needed to confirm these findings and understand the long-term effects.16789

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet-Rich-Plasma (PRP)Experimental Treatment1 Intervention
Group II: SalinePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Citations

Efficacy and safety of platelet-rich plasma (PRP) in erectile ...The results of meta-analysis showed that the use of PRP had some clinical effectiveness and a low incidence of side effects. What is the ...
Is platelet rich plasma a promising treatment for erectile ...Platelet-Rich Plasma appears to be a safe and promising long-term therapeutic option for men with mild to moderate erectile dysfunction. In this ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38983474/
Efficacy and safety of platelet-rich plasma (PRP) in erectile ...Conclusions: Our study results demonstrated significant efficacy and safety of PRP in treating ED. Due to the fact that most of the ...
Full article: The efficacy of platelet-rich plasma (PRP) alone ...PRP demonstrated a better efficacy in treating ED, especially during a follow-up period of 6 months. Compared with using Li-SWT alone, the addition of PRP can ...
A meta-analysis of controlled and single-arm trials | PLOS OnePRP appears effective in treating erectile dysfunction, but further high-quality, large-sample trials with longer follow-up are needed to fully understand its ...
Clinical Effects and Safety Outcomes of Platelet-Rich ...Studies have shown notable improvements in ED symptoms following PRP treatment, highlighting its effectiveness as a complementary or alternative ...
Efficacy and safety of platelet-rich plasma intracavernous ...Conclusion. PRP intracavernous injection may offer benefits in improving erectile function in patients with ED with a relatively good safety profile.
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40263961/
Clinical Effects and Safety Outcomes of Platelet-Rich ...This systematic review and meta-analysis (SRMA) evaluates the effectiveness of penile PRP injections for vasculogenic ED and updates clinical guidelines based ...
Safety and efficacy of platelet-rich plasma injection for ...This study aimed to assess the safety and effectiveness of platelet-rich plasma (PRP) injections in treating patients with erectile dysfunction (ED).
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