Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)

Last updated: February 24, 2025
Sponsor: University of Miami
Overall Status: Terminated

Phase

1/2

Condition

Erectile Dysfunction

Impotence

Infertility

Treatment

Shockwave Therapy (SWT)

Autologous Platelet-Rich Plasma (PRP)

Clinical Study ID

NCT05525572
20220540
  • Ages 30-80
  • Male

Study Summary

The purpose of this research study is to evaluate whether the combination of Shockwave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function in diabetics patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male

  2. Between 30 to 80 years of age (inclusive).

  3. Be able to provide written informed consent.

  4. Have a diagnosis of Mild to Moderate ED (12-21) or Mild ED (22-25) based onInternational Index of Erectile Dysfunction - Erectile Function (IIEF-EF)questionnaire score.

  5. Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history ofHemoglobin A1C > 7% OR on medical therapy for Diabetes.

  6. Be in a stable relationship and have a minimum of 2 sexual attempts per month for atleast one month prior to enrollment.

  7. Agree to comply with all study related tests/procedures.

Exclusion

Exclusion Criteria:

  1. Previous penile surgery of any kind (except circumcision and condyloma removal),such as penile lengthening, penile cancer surgery, penile plication, grafting.

  2. Previous history of priapism, penile fracture, Peyronie's Disease, or penilecurvature that negatively influences sexual activity.

  3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%).

  4. Psychogenic ED as determined by study investigator.

  5. Patients using Intracavernous Injections (ICI) for management of ED.

  6. Patients with generalized polyneuropathy, neurological conditions, or psychiatricdisease (such as bipolar disorder or depression).

  7. Have a serious comorbid illness or condition that, in the opinion of theinvestigator, may compromise the safety or compliance of the subject or precludesuccessful completion of the study.

  8. History of consistent treatment failure with Phosphodiesterase 5 (PDE5) inhibitorsfor therapy of ED.

  9. Poorly controlled diabetes as indicated by Hemoglobin a1c > 7.5%.

  10. Use of antiplatelet medications

Study Design

Total Participants: 2
Treatment Group(s): 2
Primary Treatment: Shockwave Therapy (SWT)
Phase: 1/2
Study Start date:
February 12, 2024
Estimated Completion Date:
August 02, 2024

Connect with a study center

  • University of Miami, School of Medicine - Desai Sethi Urology Institute

    Miami, Florida 33136
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.