Recruiting
Phase 1

PRP

Sponsor:

University of Manitoba

Code:

NCT06264635

Conditions

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 30 - 70

Healthy Volunteers: Accepted

Interventions

Platelet-Rich-Plasma

Saline

Study Details

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

Study ID

NCT06264635

Start date

Jan 24, 2025

Status verified date

Mar, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Platelet-Rich-Plasma

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.

Saline

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

Primary outcome measure

  • International Index of Erectile Function (IIEF) [ Time Frame: 1, 3, 6 months post-procedure ]

Central Contacts and Locations

Central contacts

Locations

Men's Health Clinic

Recruiting

Winnipeg, Manitoba, Canada, R3K 1M3

Contacts

More Information

Sponsor

University of Manitoba

Last update posted

Jan 28, 2025

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-01-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.