Erectile DysfunctionPhase 1COCKTAILNCT05048667
Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction
A Phase 1 study testing Shock Wave therapy (SWT) and Platelet Rich Plasma (PRP) in people with Erectile Dysfunction, run by University of Miami at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Shock Wave therapy (SWT) and Platelet Rich Plasma (PRP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2022to 14 Mar 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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%.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: 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
- Conditions
- Erectile Dysfunction
- Being tested
- Shock Wave therapy (SWT), Platelet Rich Plasma (PRP), Sham SWT, Placebo Saline
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock Wave therapy (SWT)Device
Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
Platelet Rich Plasma (PRP)Drug
5 mL PRP will be administered via intracavernous injection
Sham SWTOther
Sham Shockwave Therapy will be administered in the sham arm.
Placebo SalineOther
5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
| Study group | Role | What they receive |
|---|---|---|
| SWT plus PRP Group | Experimental | 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. Receives: Device: Shock Wave therapy (SWT); Drug: Platelet Rich Plasma (PRP) |
| Sham SWT plus Placebo Saline Group | Placebo comparator | 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. Receives: Other: Sham SWT; Other: Placebo Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period.
A treatment emergent serious adverse event (TE-SAE) is defined as any serious adverse event for which there is a reasonable possibility that the investigational product caused the adverse event. For the purposes of safety reporting, "a reasonable possibility" means there is evidence to suggest a causal relationship between the study product/procedures and the adverse event.
Measured: Baseline, Month 3
Secondary outcomes (3)
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. Score ranges are commonly interpreted as: Severe ED: 0-10, Moderate ED: 11-16, Mild ED: 17-21, No ED / Normal erectile function: 22-25. Change from Baseline at Month 6 reported.
Measured: Baseline, Month 6
Percentage of Participants Achieving MCID in IIEF-EF at Any Post-treatment Timepoint in Each Group.
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. Participants are counted as achieving MCID if they meet the criteria at either the Month 3 or Month 6 assessment (or both).
Measured: Baseline, Month 3, or Month 6
Percentage of Participants Who Either Decrease or Discontinue Use of PDE5i After Three Months Post-therapy Compared to Control Group
The percentage of participants who report either a reduction in frequency of PDE5 inhibitor use or complete discontinuation of PDE5 inhibitors at 3 months following completion of the intervention, compared to the control group. PDE5 inhibitor use will be assessed through participant self-report. A decrease in use is defined as a reduction in dose or frequency. Discontinuation is defined as complete cessation of PDE5 inhibitor use. The percentage will be calculated as the number of participants meeting either criterion divided by the total number of participants in each group.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start27 Jun 2022
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Ibrahim, University of Miami
- Investigators
- Emad Ibrahim, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048667
- Sponsor's protocol ID
- 20210887
- Other IDs
- R01DK130991
- Acronym
- COCKTAIL
- Status last verified
- Apr 2026
- First submitted
- 7 Sep 2021
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24080861Sampson 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.
PubMed 19468902Xie 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.
PubMed 25164150Randelli 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.
PubMed 25184132Vlachopoulos 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.
PubMed 16174548Haupt 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.
PubMed 1615601Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11.
PubMed 10037356Kikuchi 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.
PubMed 20134096Saltzman RG, Molina ML, Ledesma BR, Ibrahim E, Masterson TA, Ramasamy R. Rationale and Design for the COCKTAIL Trial: A Single-center, Randomized, Double-blind, Sham-controlled Study Combining Shockwave Therapy and Platelet-rich Plasma for Erectile Dysfunction. Eur Urol Focus. 2023 Jan;9(1):8-10. doi: 10.1016/j.euf.2022.09.015. Epub 2022 Oct 22.
PubMed 36280578
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT05048667
- Acronym / sponsor ID
- COCKTAIL / 20210887
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWT plus PRP Group | Experimental | Device: Shock Wave therapy (SWT), Drug: Platelet Rich Plasma (PRP)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. |
| Sham SWT plus Placebo Saline Group | Placebo comparator | Other: Sham SWT, Other: Placebo SalineParticipants 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shock Wave therapy (SWT)Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period. | Device | SWT plus PRP Group |
| Platelet Rich Plasma (PRP)5 mL PRP will be administered via intracavernous injection | Drug | SWT plus PRP Group |
| Sham SWTSham Shockwave Therapy will be administered in the sham arm. | Other | Sham SWT plus Placebo Saline Group |
| Placebo Saline5 mL Placebo saline will be administered via intracavernous injection in the sham arm. | Other | Sham SWT plus Placebo Saline Group |
Primary outcome
Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period.
Time frame: Baseline, Month 3
A treatment emergent serious adverse event (TE-SAE) is defined as any serious adverse event for which there is a reasonable possibility that the investigational product caused the adverse event. For the purposes of safety reporting, "a reasonable possibility" means there is evidence to suggest a causal relationship between the study product/procedures and the adverse event.
3 secondary outcomes
Change in IIEF-EF Scores
Time frame: Baseline, Month 6
Percentage of Participants Achieving MCID in IIEF-EF at Any Post-treatment Timepoint in Each Group.
Time frame: Baseline, Month 3, or Month 6
Percentage of Participants Who Either Decrease or Discontinue Use of PDE5i After Three Months Post-therapy Compared to Control Group
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24080861Andia 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.
- Background: PubMed 19468902Sampson 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.
- Background: PubMed 25164150Xie 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.
- Background: PubMed 25184132Randelli 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.
- Background: PubMed 16174548Vlachopoulos 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.
- Background: PubMed 1615601Haupt 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.
- Background: PubMed 10037356Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11.
- Background: PubMed 20134096Kikuchi 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.
- Derived from this study: PubMed 36280578Saltzman RG, Molina ML, Ledesma BR, Ibrahim E, Masterson TA, Ramasamy R. Rationale and Design for the COCKTAIL Trial: A Single-center, Randomized, Double-blind, Sham-controlled Study Combining Shockwave Therapy and Platelet-rich Plasma for Erectile Dysfunction. Eur Urol Focus. 2023 Jan;9(1):8-10. doi: 10.1016/j.euf.2022.09.015. Epub 2022 Oct 22.
- Individual participant dataSharing planned: No
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Ibrahim, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Shock Wave therapy (SWT) and Platelet Rich Plasma (PRP) in people with Erectile Dysfunction, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period. (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05048667, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.