PRP for the Treatment of Erectile Dysfunction (ED)

Phase 1

Completed

• Conditions: Erectile Dysfunction
• Interventions: Biological: Autologous Platelet Rich Plasma

• Registration Number: NCT04350125
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Start: 2022-03-04
• Status Verified: 2023-10
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

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)
• Biochemical evidence of Hypogonadism (total Testosterone < 300 ng/dL)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma Treatment	Autologous Platelet Rich Plasma	Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections.

Primary Outcome Measures

Name	Time	Method
Treatment-related adverse events	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States