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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK130991 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emad Ibrahim, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24080861 | Background | 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. | |
| 19468902 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SWT + 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. 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. Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection |
| FG001 | Sham SWT + 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 SWT: Sham Shockwave Therapy will be administered in the sham arm. Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | SWT + 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. 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. Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline, Month 3 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SWT + 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. 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. Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emad Ibrahim | University of Miami, Miller School of Medicine - Desai Sethi Urology Institute (DSUI) | 305-243-6090 | eibrahim@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2024 | Jan 5, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2024 | Feb 18, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| Platelet Rich Plasma (PRP) | Drug | 5 mL PRP will be administered via intracavernous injection |
|
| Sham SWT | Other | Sham Shockwave Therapy will be administered in the sham arm. |
|
| Placebo Saline | Other | 5 mL Placebo saline will be administered via intracavernous injection in the sham arm. |
|
| 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). | 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. | Baseline, Month 3 |
| 25164150 | Background | 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. |
| 25184132 | Background | 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. |
| 16174548 | Background | 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. |
| 1615601 | Background | 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. |
| 10037356 | Background | Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11. |
| 20134096 | Background | 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. |
| 36280578 | Derived | Saltzman 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. |
| BG001 | Sham SWT + 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 SWT: Sham Shockwave Therapy will be administered in the sham arm. Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sham SWT + 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 SWT: Sham Shockwave Therapy will be administered in the sham arm. Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm. |
|
|
| Secondary | 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. | Number of participants analyzed is less than the total number of subjects enrolled due to attrition, lost to follow up, and missing data. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Month 6 |
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|
|
| Secondary | 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). | Number of participants analyzed is less than the total number of subjects enrolled due to attrition, lost to follow up, and missing data. | Posted | Count of Participants | Participants | Baseline, Month 3, or Month 6 |
|
|
|
| Secondary | 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. | This outcome measure only applies to subjects who were taking PDE5i at baseline. those who were not taking medicaitons in theis class were excluded from the analysis. In addition, participants who withdrew consent or were lost to follow up before the month 3 visit were also excluded from the analysis due to missing data. | Posted | Count of Participants | Participants | Baseline, Month 3 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Sham SWT + 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 SWT: Sham Shockwave Therapy will be administered in the sham arm. Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |