- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05048667
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Manuel Molina, MD
- Phone Number: 305-243-4873
- Email: m.molina.leyba@miami.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami Miller School of Medicine
-
Contact:
- Ranjith Ramasamy, MD
- Phone Number: 305-243-4562
- Email: ramasamy@miami.edu
-
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:
- 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%.
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.
Sponsor
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
- 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.
- 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.
- Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. 2013 Dec;9(12):721-30. doi: 10.1038/nrrheum.2013.141. Epub 2013 Oct 1.
- 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.
- 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.
- 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.
- Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210887
- R01DK130991 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Erectile Dysfunction
-
University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
-
Cairo UniversityRecruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple Prostatectomy | Erectile Dysfunction With Diabetes Mellitus | Erectile Dysfunction Due to Arterial Disease | Erectile Dysfunction Due to Injury | Erectile Dysfunction Due to Neuropathy and other conditionsEgypt
-
University of BaghdadCompletedSexual Dysfunction | Erectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Sexual Abstinence | Erectile Dysfunction With Diabetes Mellitus | Sexual Desire Disorder | Erectile Dysfunction Following Cryotherapy | Erectile Dysfunction... and other conditionsIraq
-
BayerCompletedSexual Dysfunction | Male Erectile DysfunctionBelgium, Italy, France, Germany, Spain, Netherlands, South Africa
-
Vancouver Coastal HealthRecruitingSituational Erectile DysfunctionCanada
-
University of VirginiaDIREX SYSTEMS CORPORATIONWithdrawnVasculogenic Erectile Dysfunction
-
Johns Hopkins UniversityTerminatedOrganic Erectile DysfunctionUnited States
-
University of MiamiDIREX SYSTEMS CORPORATIONCompletedVasculogenic Erectile DysfunctionUnited States
-
Cairo UniversityCompletedVasculogenic Erectile DysfunctionEgypt
-
InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
Clinical Trials on Shock Wave therapy (SWT)
-
Tri-Service General HospitalCompleted
-
Tri-Service General HospitalCompletedCarpal Tunnel SyndromeTaiwan
-
Rodrigo Marcel Valentim da SilvaUniversidade Federal do Rio Grande do NorteCompletedPain | Muscle Tonus
-
Northern Orthopaedic Division, DenmarkCompletedChronic Inflammatory Disorder
-
Yuzuncu Yıl UniversityCompleted
-
Isfahan University of Medical SciencesUnknownPlantar FasciitisIran, Islamic Republic of
-
Yonsei UniversityUnknownPost-Stroke Elbow SpasticityKorea, Republic of
-
Carol Davila University of Medicine and PharmacyActive, not recruitingStroke, Ischemic | Stroke Hemorrhagic | Balance; Distorted | Spasticity as Sequela of Stroke | Spastic GaitRomania
-
Oslo University HospitalUnknownShoulder Impingement Syndrome | Subacromial Shoulder PainNorway
-
Saglik Bilimleri UniversitesiEnrolling by invitationStroke | Spasticity as Sequela of StrokeTurkey