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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami

Criteria

Inclusion Criteria:

• Male

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

• Have a diagnosis of Mild to Moderate ED based on International Index of Erectile Dysfunction - Erectile Function (IIEF-EF) questionnaire.

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

• In a stable heterosexual relationship and have a minimum of 2 sexual attempts per month for at least one month prior to enrollment.

• 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, penile fracture, Peyronie's Disease, or penile curvature that negatively influences sexual activity.

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

• Psychogenic ED as determined by study investigator.

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

• Patients with generalized polyneuropathy, neurological conditions, or psychiatric disease (such as bipolar disorder or depression).

• Have a serious comorbid illness or condition 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 5 (PDE5) inhibitors for therapy of ED.

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

• Use of antiplatelet medications