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

Erectile Dysfunction With Diabetes Mellitus Clinical Trial

— COCKTAIL-DM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525572
• Other study ID #: 20220540
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 30, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: Thomas A Masterson, MD
• Phone: 305-243-4873
• Email: tmasterson[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction With Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami, School of Medicine - Desai Sethi Urology Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in endothelial function markers	Markers of endothelial function will include Vascular Endothelial Growth Factor (VEGF), Stromal cell-derived factor 1 (SDF-1a), and Stem Cell Factor (SCF). All measured from serum blood samples in units of pg/mL.	Baseline to Month 3, Baseline to Month 6
Primary	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
Primary	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	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
Secondary	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
Secondary	Incidence of Serious Adverse Events (SAEs)	As assessed by treating physician	Up to Month 6