Evaluating Platelet-Rich Plasma for Erectile Dysfunction
Pilot Randomized Controlled Trial Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction
This study is testing if platelet-rich plasma injections can help men with erectile dysfunction feel better compared to a placebo treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | Male |
| Sponsor | University of Manitoba Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT06264635 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of platelet-rich plasma (PRP) injections for treating erectile dysfunction (ED). It is a prospective, double-blinded, randomized placebo-controlled trial conducted at the Manitoba Men's Health Clinic in Winnipeg, Canada. Participants will receive either PRP or saline injections, with follow-up evaluations to measure treatment outcomes. The study seeks to provide clinical evidence for a therapy that is currently being used without sufficient data on its effectiveness.
Who should consider this trial
Good fit: Ideal candidates are men aged 30 to 70 with erectile dysfunction lasting over 6 months and not more than 5 years.
Not a fit: Patients with a history of radical prostatectomy, extensive pelvic surgery, or those participating in other conflicting studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could offer a new, non-invasive option for men suffering from erectile dysfunction.
How similar studies have performed: While there is limited data on PRP for ED, other studies on similar restorative therapies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Winnipeg, Manitoba
- Men's Health Clinic — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Study coordinator: Premal Patel, MD
- Email: ppatel5@hsc.mb.ca
- Phone: 204-221-4476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.