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

University of Miami

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Erectile Dysfunction With Diabetes Mellitus

Treatments: Drug: Autologous Platelet-Rich Plasma (PRP); Device: Shockwave Therapy (SWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05525572

20220540

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Male

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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 on International 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 of Hemoglobin 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 at least one month prior to enrollment.
7. Agree to comply with all study related tests/procedures.

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 penile curvature 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 psychiatric disease (such as bipolar disorder or depression).
7. 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.
8. History of consistent treatment failure with Phosphodiesterase 5 (PDE5) inhibitors for therapy of ED.
9. Poorly controlled diabetes as indicated by Hemoglobin a1c > 7.5%.
10. Use of antiplatelet medications

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group

Experimental group

Description:

Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection.

Treatment:

Device: Shockwave Therapy (SWT)

Drug: Autologous Platelet-Rich Plasma (PRP)