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OpenTrials
Completed

NCT Number: NCT04350125

PRP for the Treatment of Erectile Dysfunction (ED)

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

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Autologous Platelet Rich Plasma

Biological

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2020
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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