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

NCT ID: NCT05525572

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2024-08-02

Brief 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.

Conditions

Erectile Dysfunction With Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Shockwave Therapy (SWT)

Intervention Type: DEVICE

Shockwave Therapy (SWT):

720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions.

Autologous Platelet-Rich Plasma (PRP)

Intervention Type: DRUG

Autologous Platelet Rich Plasma (PRP):

5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.

Interventions

Shockwave Therapy (SWT)

Shockwave Therapy (SWT):

720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions.

Intervention Type: DEVICE

Autologous Platelet-Rich Plasma (PRP)

Autologous Platelet Rich Plasma (PRP):

5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Thomas Masterson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas A Masterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20220540

Identifier Type: -

Identifier Source: org_study_id