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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction With Diabetes Mellitus
• Intervention / Treatment: Device: Shockwave Therapy (SWT); Drug: Autologous Platelet-Rich Plasma (PRP)

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Thomas A Masterson, MD; Phone Number: 305-243-4873; Email: tmasterson@med.miami.edu
• Study Contact Backup: Name: Manuel Molina, MD; Phone Number: 305-243-4873; Email: m.molina.leyba@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami, School of Medicine - Desai Sethi Urology Institute
      • Principal Investigator: Thomas A Masterson, MD
      • Sub-Investigator: Ranjith Ramasamy, MD
      • Contact: Manuel Molina, MD; Phone Number: 305-243-4873; Email: m.molina.leyba@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in markers of vasodilation	Markers of vasodilation including Endothelial Nitric Oxide Synthase (eNOS) and Neuronal Nitric Oxide Synthase (nNOS) will be measured from serum blood samples in units of ug/mL.	Baseline to Month 3, Baseline to Month 6
Changes in endothelial function markers	Markers of endothelial function will include Vascular Endothelial Growth Factor (VEGF), Stromal cell-derived factor 1 (SDF-1α), and Stem Cell Factor (SCF). All measured from serum blood samples in units of pg/mL.	Baseline to Month 3, Baseline to Month 6
Changes in markers of neo-angiogenesis	Markers of neo-angiogenesis reported as the percentage of Cluster of Differentiation 31 positive cells (CD31+), as measured from serum blood samples and expressed as a percentage.	Baseline to Month 3, Baseline to Month 6
Changes in Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)	Endothelial Progenitor Cell - Colony Forming Units (EPCs-CFUs) as measured from peripheral blood samples in units of average cells per well.	Baseline to Month 3, Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Penile Blood Flow	Penile Blood Flow will be reported as change in Peak Systolic Velocity (PSV) and change in End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography.	Baseline to Month 6
EDITS questionnaire scores	Treatment satisfaction is assessed by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. EDITS questionnaire is an 11-item tool addressing participant satisfaction with ED therapy. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.	At Month 3 and At Month 6
Incidence of Serious Adverse Events (SAEs)	As assessed by treating physician	Up to Month 6

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Thomas A Masterson, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: 20220540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No