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

Primary Purpose

Erectile Dysfunction

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Shock Wave therapy (SWT)

Platelet Rich Plasma (PRP)

Sham SWT

Placebo Saline

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

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

Inclusion Criteria:

Be Male
Be 30 to 80 years of age (inclusive).
Be able to provide written informed consent.
Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
Sexually active in a stable, heterosexual relationship of more than three months duration.
IIEF-EF score 12-25 at screening
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.
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 or penile fracture
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%).
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.
Psychogenic ED as determined by study investigator.
Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
Patients using Intracavernosal Injection (ICI) for management of ED
Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
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.
History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED.
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.
Hemoglobin a1c >9%.

Sites / Locations

University of Miami Miller School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SWT plus PRP Group

Sham SWT plus Placebo Saline Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in IIEF-EF Scores

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.

Percentage of participants achieving MCID in IIEF-EF

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.

Penile Blood Flow

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

Circulating Angiogenic Factor levels

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

Secondary Outcome Measures

Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors

The number of participants reporting a decrease or discontinue in use of PDE5 inhibitors will be reported

Full Information

NCT ID

NCT05048667

First Posted

September 7, 2021

Last Updated

July 19, 2023

Sponsor

University of Miami

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT05048667

Brief Title

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

Acronym

COCKTAIL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 27, 2022 (Actual)

Primary Completion Date

December 10, 2024 (Anticipated)

Study Completion Date

December 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 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

6. Conditions and Keywords

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

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SWT plus PRP Group

Arm Type

Experimental

Arm Description

Arm Title

Sham SWT plus Placebo Saline Group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Shock Wave therapy (SWT)

Intervention Description

Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.

Intervention Type

Drug

Intervention Name(s)

Platelet Rich Plasma (PRP)

Intervention Description

5 mL PRP will be administered via intracavernous injection

Intervention Type

Other

Intervention Name(s)

Sham SWT

Intervention Description

Sham Shockwave Therapy will be administered in the sham arm.

Intervention Type

Other

Intervention Name(s)

Placebo Saline

Intervention Description

5 mL Placebo saline will be administered via intracavernous injection in the sham arm.

Primary Outcome Measure Information:

Title

Change in IIEF-EF Scores

Description

Time Frame

Baseline, Month 3, Month 6

Title

Percentage of participants achieving MCID in IIEF-EF

Description

Time Frame

Baseline, Month 3, Month 6

Title

Penile Blood Flow

Description

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

Time Frame

Baseline, Month 6

Title

Circulating Angiogenic Factor levels

Description

Time Frame

Baseline, Month 3, Month 6

Secondary Outcome Measure Information:

Title

Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors

Description

The number of participants reporting a decrease or discontinue in use of PDE5 inhibitors will be reported

Time Frame

Baseline, Month 3

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: Be Male Be 30 to 80 years of age (inclusive). Be able to provide written informed consent. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent. Sexually active in a stable, heterosexual relationship of more than three months duration. IIEF-EF score 12-25 at screening 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. 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 or penile fracture 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%). 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. Psychogenic ED as determined by study investigator. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area. Patients using Intracavernosal Injection (ICI) for management of ED Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease. 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. History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED. 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. Hemoglobin a1c >9%.

Central Contact Person:

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

Ranjith Ramasamy, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami Miller School of Medicine

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ranjith Ramasamy, MD

Phone

305-243-4562

ramasamy@miami.edu

First Name & Middle Initial & Last Name & Degree

Ranjith Ramasamy, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24080861

Citation

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Results Reference

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PubMed Identifier

19468902

Citation

Sampson S, Gerhardt M, Mandelbaum B. Platelet rich plasma injection grafts for musculoskeletal injuries: a review. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):165-74. doi: 10.1007/s12178-008-9032-5.

Results Reference

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PubMed Identifier

25164150

Citation

Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. doi: 10.1186/ar4493.

Results Reference

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PubMed Identifier

25184132

Citation

Randelli P, Randelli F, Ragone V, Menon A, D'Ambrosi R, Cucchi D, Cabitza P, Banfi G. Regenerative medicine in rotator cuff injuries. Biomed Res Int. 2014;2014:129515. doi: 10.1155/2014/129515. Epub 2014 Aug 13.

Results Reference

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PubMed Identifier

16174548

Citation

Vlachopoulos C, Rokkas K, Ioakeimidis N, Aggeli C, Michaelides A, Roussakis G, Fassoulakis C, Askitis A, Stefanadis C. Prevalence of asymptomatic coronary artery disease in men with vasculogenic erectile dysfunction: a prospective angiographic study. Eur Urol. 2005 Dec;48(6):996-1002; discussion 1002-3. doi: 10.1016/j.eururo.2005.08.002. Epub 2005 Aug 24.

Results Reference

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PubMed Identifier

1615601

Citation

Haupt G, Haupt A, Ekkernkamp A, Gerety B, Chvapil M. Influence of shock waves on fracture healing. Urology. 1992 Jun;39(6):529-32. doi: 10.1016/0090-4295(92)90009-l.

Results Reference

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PubMed Identifier

10037356

Citation

Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11.

Results Reference

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PubMed Identifier

20134096

Citation

Kikuchi Y, Ito K, Ito Y, Shiroto T, Tsuburaya R, Aizawa K, Hao K, Fukumoto Y, Takahashi J, Takeda M, Nakayama M, Yasuda S, Kuriyama S, Tsuji I, Shimokawa H. Double-blind and placebo-controlled study of the effectiveness and safety of extracorporeal cardiac shock wave therapy for severe angina pectoris. Circ J. 2010 Mar;74(3):589-91. doi: 10.1253/circj.cj-09-1028. Epub 2010 Feb 4.

Results Reference

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

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