Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT06264635
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.
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:
NCT06264635
Study Brief:
Protocol Section:
NCT06264635