Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.
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|ClinicalTrials.gov Identifier: NCT04396795|
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : September 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Drug: Autologous Platelet Rich Plasma Other: Saline solution||Phase 2|
Platelet-derived therapies are a growing trend across multiple medical and surgical specialties, mainly orthopedics for conditions such as bone and soft tissue trauma, inflammatory conditions, and chronic pain syndromes. One of the most well described platelet-based therapies is autologous platelet-rich plasma (PRP). This concentrate is then administered via injection. When platelets are activated, they release these growth differentiation factors, facilitating even nerve repair and regeneration. Growth factors act locally and are implicated in many aspects of natural wound healing, including chemotaxis, cell proliferation, cell differentiation and angiogenesis.The key role of platelets in these processes makes them an attractive candidate for therapies aimed at accelerating natural healing, as well as tissue regeneration.
Although most of the studies focusing on PRP injections have been relatively small and heterogenous, they largely support the concept of administration in terms of safety, while efficacy remains uncertain.
When platelets are activated, they release many kinds of growth differentiation factors and a few types have been found to facilitate nerve repair and regeneration. Moreover, corporeal dysfunction in ED due to smooth muscle atrophy or other intra-cavernosal pathology can lead to corporo-venous occlusive erectile dysfunction despite a normal arterial inflow. Rejuvenating the Corporeal tissues with PRP, which is well known for its growth and healing factors, is a possible modality as a potential treatment for erectile dysfunction according to Alkhayal et al. In their retrospective study examining the efficacy of one intra-cavernosal PRP injection to 40 ED patients, they reported that mean IIEF-5 score before treatment was 13 (5-20) and post treatment IIEF-5 = 17 (7-24), (p < 0.001).
To date, there are no treatments that address the underlying cause of endothelial dysfunction, although LIST treatment 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Control, Double-Blind, Placebo Controlled, Multicenter Clinical Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma Injection Treatment for Erectile Dysfunction.|
|Actual Study Start Date :||May 21, 2020|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: PRP group
Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days
Drug: Autologous Platelet Rich Plasma
Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.
Other Name: PRP
Placebo Comparator: Placebo group
Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
Other: Saline solution
Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL s each injected to the right and left corpus cavernosum
- Percentage of participants achieving MCID in IIEF-EF [ Time Frame: 9 weeks ]Treatment efficacy of PRP will be assessed via the percentage of participants achieving mild clinically important difference (MCID) in their IIEF-EF scores from baseline to 4 weeks after final treatment. International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.
- Percentage of participants achieving MCID in IIEF-EF [ Time Frame: 24 weeks ]Treatment efficacy of PRP will be assessed via the percentage of participants achieving MCID in their IIEF-EF scores from baseline to 2 and 24 weeks after final treatment. IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.
- Change in IIEF-EF Scores [ Time Frame: Baseline up to Week 9, Baseline up to Week 17, Baseline up to Week 29 ]IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.
- Change in doppler ultrasound parameters [ Time Frame: Baseline, Up to 29 weeks ]Change in Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) assessed in cm/sec via ultrasound.
- Incidence of adverse events [ Time Frame: 24 weeks ]Safety will be evaluated via the incidence of adverse events as assessed by treating physician
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396795
|Contact: Thomas Masterson, MDemail@example.com|
|Contact: Ranjith Ramasamy, MDfirstname.lastname@example.org|
|United States, Florida|
|University of Miami Miller School of Medicine||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Ranjith Ramasamy, MD 305-243-4562 email@example.com|
|Principal Investigator:||Ranjith Ramasamy, MD||University of Miami|