Erectile DysfunctionPhase 1NCT06264635
Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction
A Phase 1 study testing Platelet-Rich-Plasma and Saline in people with Erectile Dysfunction, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Platelet-Rich-Plasma and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2025to Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Men's Health Clinic
Winnipeg, Manitoba, R3K 1M3
Premal Patel, MD, 2042214476, ppatel5@hsc.mb.ca
Jainik Shah, BFSc, 6477721737, shahj4@myumanitoba.ca
About this study
Official title: Pilot Randomized Controlled Trial Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction
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.
Read the detailed description
The proposed study is a prospective, double-blinded, randomized placebo-controlled trial. This study will take place at the Manitoba Men's Health Clinic (Winnipeg, MB, Canada). All patients will undergo blood sampling in a 60 ml syringe containing 8 mL of anticoagulant. Patients will receive 2 treatments 1 month apart. Preparation of PRP and placebo injections will occur in a separate room. Samples of patients in the placebo arm will be discarded and sample of those randomized to the PRP group will be processed via an FDA-approved platelet separator (Magellan Autologous Platelet Separator; Arteriocyte Medical Systems, Hopkinton, MA) to yield approximately 10 mL of PRP. Once prepared, the patient will be placed in the supine position with a tourniquet placed around the base of the penis. A total of 5 mL will be infused in each corpus cavernosum - slowly retracting the needle for better distribution of PRP into the erectile tissue - over a 2-minute period. The whole procedure will be performed under sterile conditions. Following administration, additional compression of the penis will be performed with a dressing placed around the penile shaft. The penile tourniquet will be removed 20 minutes after the injections and patients are released. The placebo group will include a sterile saline injection. Follow-Up Procedures and Evaluations: Follow-up visits will be conducted at months: 1, 3, 6, after the last treatment session and shall include: Measuring IIEF-EF of patients at the clinic at every follow-up visit, as well as reporting and recording adverse events.
- Conditions
- Erectile Dysfunction
- Being tested
- Platelet-Rich-Plasma, Saline
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich-PlasmaBiological
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.
SalineOther
Provider will go through the same motions as injecting PRP, but will use saline instead which has no known effect.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich-Plasma (PRP) | Experimental | 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. Receives: Biological: Platelet-Rich-Plasma |
| Saline | Placebo comparator | Provider will go through the same motions as injecting PRP, but will use saline instead which has no known effect. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF)
Follow-up visits will be conducted at months: 1, 3, 6, after the last treatment session and shall include: Measuring IIEF-EF of patients at the clinic at every follow-up visit. This is a validated form of assessing erectile function.
Measured: 1, 3, 6 months post-procedure
Secondary outcomes (1)
Adverse Events
Measuring and recording any adverse events post procedure such as hematomas, fibrosis, infections or worsening symptoms of erectile function.
Measured: 1, 3, 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start24 Jan 2025
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premal Patel, MD, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264635
- Sponsor's protocol ID
- HS26227
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06264635
- Acronym / sponsor ID
- HS26227
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study is a prospective, double-blinded, randomized placebo-controlled trial. This study will take place at the Manitoba Men's Health Clinic (Winnipeg, MB, Canada). All patients will undergo blood sampling in a 60 ml syringe containing 8 mL of anticoagulant. Patients will receive 2 treatments 1 month apart. Preparation of PRP and placebo injections will occur in a separate room. Samples of patients in the placebo arm will be discarded and sample of those randomized to the PRP group will be processed via an FDA-approved platelet separator (Magellan Autologous Platelet Separator; Arteriocyte Medical Systems, Hopkinton, MA) to yield approximately 10 mL of PRP. Once prepared, the patient will be placed in the supine position with a tourniquet placed around the base of the penis. A total of 5 mL will be infused in each corpus cavernosum - slowly retracting the needle for better distribution of PRP into the erectile tissue - over a 2-minute period. The whole procedure will be performed under sterile conditions. Following administration, additional compression of the penis will be performed with a dressing placed around the penile shaft. The penile tourniquet will be removed 20 minutes after the injections and patients are released. The placebo group will include a sterile saline injection. Follow-Up Procedures and Evaluations: Follow-up visits will be conducted at months: 1, 3, 6, after the last treatment session and shall include: Measuring IIEF-EF of patients at the clinic at every follow-up visit, as well as reporting and recording adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich-Plasma (PRP) | Experimental | Biological: Platelet-Rich-PlasmaPRP 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 | Placebo comparator | Other: SalineProvider will go through the same motions as injecting PRP, but will use saline instead which has no known effect. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich-PlasmaPRP 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. | Biological | Platelet-Rich-Plasma (PRP) |
| SalineProvider will go through the same motions as injecting PRP, but will use saline instead which has no known effect. | Other | Saline |
Primary outcome
International Index of Erectile Function (IIEF)
Time frame: 1, 3, 6 months post-procedure
Follow-up visits will be conducted at months: 1, 3, 6, after the last treatment session and shall include: Measuring IIEF-EF of patients at the clinic at every follow-up visit. This is a validated form of assessing erectile function.
1 secondary outcome
Adverse Events
Time frame: 1, 3, 6 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Platelet-Rich-Plasma and Saline in people with Erectile Dysfunction, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Premal Patel, MD (204-221-4476, ppatel5@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (IIEF) (time frame: 1, 3, 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.