A Pilot Study Evaluating the Use of Autologous Platelet-rich Plasma (PRP) for the Treatment of Erectile Dysfunction

Mayo Clinic1 site in 1 country4 target enrollmentMarch 4, 2022

ConditionsErectile Dysfunction

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: Mayo Clinic
Enrollment: 4
Locations: 1
Primary Endpoint: Treatment-related adverse events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).

Registry

clinicaltrials.gov

Start Date

March 4, 2022

End Date

October 23, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Gregory A. Broderick

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•The patient must have given his informed and signed written consent
•The patient has ED for longer than 1 year but less than 5 years.
•The subject has a stable partner for at least 3 months.
•The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
•IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV \> 25 cm/sec

Exclusion Criteria

•The patient is participating in another study that may interfere with the results or conclusions of this study
•History of radical prostatectomy or pelvic cancer surgery
•Prior history of pelvic malignancies
•Prior pelvic radiation therapy
•Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
•Psychiatric disease which effects erectile function
•The patient is taking blood thinners
•History of Diabetes Mellitus
•History of Coronary Artery Disease
•Evidence Based Criteria: Doppler Clinical Exam ( PSV \< 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies)

Outcomes

Primary Outcomes

Treatment-related adverse events

Time Frame: 35 weeks

Number of participants to experience treatment-related adverse events defined as reaction in the skin (e.g., swelling, erythema, and warmth), injection site discomfort, penile pain, change in penile appearance, novel sexual concerns and any systemic reactions seen by the investigators, or concerns expressed by patients.