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Completed

NCT Number: NCT04396795

Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.

The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with 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

30 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be Male
  • Be 30 to 75 years of age (inclusive).
  • Be able to provide written informed consent.
  • Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
  • Sexually active in a stable, heterosexual relationship of more than three months duration.
  • IIEF-EF score 11-25 at screening (even if taking a single PDE5).
  • Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
  • Agree to comply with all study related tests/procedures.

Exclusion criteria

  • Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
  • Previous history of priapism or penile fracture
  • Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
  • Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
  • Psychogenic ED as determined by study investigator.
  • Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
  • Patients using Intra Cavernous Injection (ICI)for management of ED
  • Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
  • Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
  • History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
  • Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitor or psychotropic medications.
  • Hemoglobin a1c >9%.

Treatment and study plan

Autologous Platelet Rich Plasma

Drug

Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum.

Other names: PRP

Saline solution

Other

Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum

Primary outcomes

  1. Number of Participants Achieving MCID in IIEF-EF.

    Time frame: 1 month, 3 month, 6 month

    Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. 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. This outcome is reported as the number of participants who achieve MCID in each treatment group.

Secondary outcomes

  1. Change in IIEF-EF Scores

    Time frame: Baseline up to Month 1, Month 3, and Month 6

    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.

  2. Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)

    Time frame: Baseline to Month 6

    Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound.

  3. Number of Adverse Events

    Time frame: 24 weeks

    Incidence of adverse events were reported as all urological and/or reproductive system AEs and all AEs with severity grade 3 or higher. Adverse Events severity was determined using CTCAE v5 criteria.

  4. Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6.

    Time frame: Baseline and Month 6

    Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 21, 2020
Registry last updated
Jan 9, 2024

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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