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

Primary Purpose

Erectile Dysfunction With Diabetes Mellitus

Status

Not yet recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Shockwave Therapy (SWT)

Autologous Platelet-Rich Plasma (PRP)

About this trial

This is an interventional treatment trial for Erectile Dysfunction With Diabetes Mellitus

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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.

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.

Incidence of Serious Adverse Events (SAEs)

As assessed by treating physician

Full Information

NCT ID

NCT05525572

First Posted

April 13, 2022

Last Updated

October 2, 2023

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT05525572

Brief Title

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

Acronym

COCKTAIL-DM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 30, 2023 (Anticipated)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

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.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction With Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Shockwave Therapy (SWT)

Intervention Description

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

Drug

Intervention Name(s)

Autologous Platelet-Rich Plasma (PRP)

Intervention Description

Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.

Primary Outcome Measure Information:

Title

Changes in markers of vasodilation

Description

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.

Time Frame

Baseline to Month 3, Baseline to Month 6

Title

Changes in endothelial function markers

Description

Time Frame

Baseline to Month 3, Baseline to Month 6

Title

Changes in markers of neo-angiogenesis

Description

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.

Time Frame

Baseline to Month 3, Baseline to Month 6

Title

Changes in Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)

Description

Endothelial Progenitor Cell - Colony Forming Units (EPCs-CFUs) as measured from peripheral blood samples in units of average cells per well.

Time Frame

Baseline to Month 3, Baseline to Month 6

Secondary Outcome Measure Information:

Title

Change in Penile Blood Flow

Description

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.

Time Frame

Baseline to Month 6

Title

EDITS questionnaire scores

Description

Time Frame

At Month 3 and At Month 6

Title

Incidence of Serious Adverse Events (SAEs)

Description

As assessed by treating physician

Time Frame

Up to Month 6

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male Between 30 to 80 years of age (inclusive). Be able to provide written informed consent. 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. Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C > 7% OR on medical therapy for Diabetes. Be in a stable 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas A Masterson, MD

Phone

305-243-4873

tmasterson@med.miami.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Manuel Molina, MD

Phone

305-243-4873

m.molina.leyba@miami.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas A Masterson, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manuel Molina, MD

Phone

305-243-4873

m.molina.leyba@miami.edu

First Name & Middle Initial & Last Name & Degree

Thomas A Masterson, MD

First Name & Middle Initial & Last Name & Degree

Ranjith Ramasamy, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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