- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06264635
Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction
Pilot Randomized Controlled Trial Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Premal Patel, MD
- Phone Number: 204-221-4476
- Email: ppatel5@hsc.mb.ca
Study Contact Backup
- Name: Jainik Shah, BFSc
- Phone Number: 6477721737
- Email: shahj4@myumanitoba.ca
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3K 1M3
- Men's Health Clinic
-
Contact:
- Jainik Shah, BFSc
- Phone Number: 6477721737
- Email: shahj4@myumanitoba.ca
-
Contact:
- Premal Patel, MD
- Phone Number: 2042214476
- Email: ppatel5@hsc.mb.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Provider will go through the same motions as injecting PRP, but will use saline instead which has no known effect.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, 3, 6 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 1, 3, 6 months post-procedure
|
Measuring and recording any adverse events post procedure such as hematomas, fibrosis, infections or worsening symptoms of erectile function.
|
1, 3, 6 months post-procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS26227
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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