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Completed

NCT Number: NCT05048667

Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction

The purpose of this research study is to evaluate whether the combination of Shock Wave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function by improving vasodilation, and endothelial function

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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–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

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 80 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 12-25 at screening
  • 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 Intracavernosal 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 Phosphodiesterase Type 5 (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 Inhibitors (SSRI) or psychotropic medications.
  • Hemoglobin a1c >9%.

Treatment and study plan

Shock Wave therapy (SWT)

Device

Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.

Platelet Rich Plasma (PRP)

Drug

5 mL PRP will be administered via intracavernous injection

Sham SWT

Other

Sham Shockwave Therapy will be administered in the sham arm.

Placebo saline

Other

5 mL Placebo saline will be administered via intracavernous injection in the sham arm.

Primary outcomes

  1. Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period.

    Time frame: Baseline, Month 3

    A treatment emergent serious adverse event (TE-SAE) is defined as any serious adverse event for which there is a reasonable possibility that the investigational product caused the adverse event. For the purposes of safety reporting, "a reasonable possibility" means there is evidence to suggest a causal relationship between the study product/procedures and the adverse event.

Secondary outcomes

  1. Change in IIEF-EF Scores

    Time frame: Baseline, Month 6

    International Index of Erectile Function - Erectile Function Subdomain Score (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. Score ranges are commonly interpreted as: Severe ED: 0-10, Moderate ED: 11-16, Mild ED: 17-21, No ED / Normal erectile function: 22-25. Change from Baseline at Month 6 reported.

  2. Percentage of Participants Achieving MCID in IIEF-EF at Any Post-treatment Timepoint in Each Group.

    Time frame: Baseline, Month 3, or Month 6

    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. Mild Clinically Important Difference (MCID) is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED. Participants are counted as achieving MCID if they meet the criteria at either the Month 3 or Month 6 assessment (or both).

  3. Percentage of Participants Who Either Decrease or Discontinue Use of PDE5i After Three Months Post-therapy Compared to Control Group

    Time frame: Baseline, Month 3

    The percentage of participants who report either a reduction in frequency of PDE5 inhibitor use or complete discontinuation of PDE5 inhibitors at 3 months following completion of the intervention, compared to the control group. PDE5 inhibitor use will be assessed through participant self-report. A decrease in use is defined as a reduction in dose or frequency. Discontinuation is defined as complete cessation of PDE5 inhibitor use. The percentage will be calculated as the number of participants meeting either criterion divided by the total number of participants in each group.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma

Acronym: COCKTAIL

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2021
Registry last updated
May 22, 2026

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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