PRP for the Treatment of Erectile Dysfunction (ED)

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350125
• Other study ID #: 18-010364
• Status: Completed
• Phase: Phase 1
• Start date: March 4, 2022
• Est. completion date: October 23, 2023

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Biological:
• Autologous Platelet Rich Plasma
One 4-5mL platelet rich plasma injection administered to each side of the intracavernosal space on the right and left side of the corpus cavernosum at the base of the penis, every two weeks for 6 weeks.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related adverse events	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.	35 weeks

External Links

•   Mayo Clinic Clinical Trials