Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction (COCKTAIL)

July 19, 2023 updated by: Ranjith Ramasamy, MD, University of Miami

Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma

The purpose of this research study is to evaluate whether the combination of Shock Wave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function by improving vasodilation, and endothelial function

Study Overview

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine
        • Contact:
        • Principal Investigator:
          • Ranjith Ramasamy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be Male
  2. Be 30 to 80 years of age (inclusive).
  3. Be able to provide written informed consent.
  4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
  5. Sexually active in a stable, heterosexual relationship of more than three months duration.
  6. IIEF-EF score 12-25 at screening
  7. Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
  8. 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 or penile fracture
  3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
  4. Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
  5. Psychogenic ED as determined by study investigator.
  6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
  7. Patients using Intracavernosal Injection (ICI) for management of ED
  8. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
  9. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
  10. History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED.
  11. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitors (SSRI) or psychotropic medications.
  12. Hemoglobin a1c >9%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SWT plus PRP Group
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
5 mL PRP will be administered via intracavernous injection
Placebo Comparator: Sham SWT plus Placebo Saline Group
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Sham Shockwave Therapy will be administered in the sham arm.
5 mL Placebo saline will be administered via intracavernous injection in the sham arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IIEF-EF Scores
Time Frame: Baseline, Month 3, Month 6
International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function.
Baseline, Month 3, Month 6
Percentage of participants achieving MCID in IIEF-EF
Time Frame: Baseline, Month 3, Month 6
IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. Mild Clinically Important Difference (MCID) is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.
Baseline, Month 3, Month 6
Penile Blood Flow
Time Frame: Baseline, Month 6
Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography
Baseline, Month 6
Circulating Angiogenic Factor levels
Time Frame: Baseline, Month 3, Month 6
Circulating angiogenic factor levels including Vascular Endothelial Growth Factor (VEGF), Stromal Cell Derived Factor-1 (SDF-1 alpha) and Stem cell Factor (SCF), all reported in pg/mL, will be assessed via blood samples
Baseline, Month 3, Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors
Time Frame: Baseline, Month 3
The number of participants reporting a decrease or discontinue in use of PDE5 inhibitors will be reported
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ranjith Ramasamy, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2022

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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