Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT06264635
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The provider and patient are both blinded to which treatment (PRP vs saline) the patient is receiving'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Index of Erectile Function (IIEF)', 'timeFrame': '1, 3, 6 months post-procedure', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1, 3, 6 months post-procedure', 'description': 'Measuring and recording any adverse events post procedure such as hematomas, fibrosis, infections or worsening symptoms of erectile function.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nThe 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.\n\nA1C level ≤ 7% within 1 month prior to enrollment.\n\nExclusion Criteria:\n\n* 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.\n\nHistory 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.\n\nNeurological 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.\n\nAnatomical malformation of the penis, including Peyronie's disease.\n\nA1C level \\> 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.\n\nThe patient is taking blood thinners and has an international normalized ratio (INR) \\>3.\n\nReceived shockwave treatment at least 6 months before enrollment."}, 'identificationModule': {'nctId': 'NCT06264635', 'briefTitle': 'Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Pilot Randomized Controlled Trial Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'HS26227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet-Rich-Plasma (PRP)', 'description': "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.", 'interventionNames': ['Biological: Platelet-Rich-Plasma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Provider will go through the same motions as injecting PRP, but will use saline instead which has no known effect.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Platelet-Rich-Plasma', 'type': 'BIOLOGICAL', 'description': "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.", 'armGroupLabels': ['Platelet-Rich-Plasma (PRP)']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Provider will go through the same motions as injecting PRP, but will use saline instead which has no known effect.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3K 1M3', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Premal Patel, MD', 'role': 'CONTACT', 'email': 'ppatel5@hsc.mb.ca', 'phone': '2042214476'}, {'name': 'Jainik Shah, BFSc', 'role': 'CONTACT', 'email': 'shahj4@myumanitoba.ca', 'phone': '6477721737'}], 'facility': "Men's Health Clinic", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Premal Patel, MD', 'role': 'CONTACT', 'email': 'ppatel5@hsc.mb.ca', 'phone': '204-221-4476'}, {'name': 'Jainik Shah, BFSc', 'role': 'CONTACT', 'email': 'shahj4@myumanitoba.ca', 'phone': '6477721737'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education', 'investigatorFullName': 'Premal Patel, MD', 'investigatorAffiliation': 'University of Manitoba'}}}}