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The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP group | Experimental | Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days |
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| Placebo group | Placebo Comparator | Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet Rich Plasma | Drug | Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving MCID in IIEF-EF. | Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. 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. This outcome is reported as the number of participants who achieve MCID in each treatment group. | 1 month, 3 month, 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IIEF-EF Scores | IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function. | Baseline up to Month 1, Month 3, and Month 6 |
| Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ranjith Ramasamy, 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 | PRP Group | Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days Autologous Platelet Rich Plasma: Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum. |
| FG001 | Placebo Group | Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days. Saline solution: Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Month 1 |
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| Month 3 |
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| Month 6 |
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| ID | Title | Description |
|---|---|---|
| BG000 | PRP Group | Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days Autologous Platelet Rich Plasma: Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Achieving MCID in IIEF-EF. | Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. 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. This outcome is reported as the number of participants who achieve MCID in each treatment group. | Not all subjects completed all visits due to lost to follow up or did not complete the IIEF questionnaire. | Posted | Count of Participants | Participants | 1 month, 3 month, 6 month |
|
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 | PRP Group | Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days Autologous Platelet Rich Plasma: Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ranjith Ramasamy | University of Miami, Miller School of Medicine - Desai Sethi Urology Institute | 305-243-4562 | ramasamy@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 | Jan 23, 2023 | Aug 31, 2023 | Prot_SAP_000.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 |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Saline solution | Other | Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum |
|
Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound. |
| Baseline to Month 6 |
| Number of Adverse Events | Incidence of adverse events were reported as all urological and/or reproductive system AEs and all AEs with severity grade 3 or higher. Adverse Events severity was determined using CTCAE v5 criteria. | 24 weeks |
| Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6. | Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound. | Baseline and Month 6 |
| 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. |
| 23648197 | Background | Galliera E, Corsi MM, Banfi G. Platelet rich plasma therapy: inflammatory molecules involved in tissue healing. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2 Suppl 1):35S-42S. |
| 18508453 | Background | Nurden AT, Nurden P, Sanchez M, Andia I, Anitua E. Platelets and wound healing. Front Biosci. 2008 May 1;13:3532-48. doi: 10.2741/2947. |
| 19493269 | Background | Lin G, Shindel AW, Fandel TM, Bella AJ, Lin CS, Lue TF. Neurotrophic effects of brain-derived neurotrophic factor and vascular endothelial growth factor in major pelvic ganglia of young and aged rats. BJU Int. 2010 Jan;105(1):114-20. doi: 10.1111/j.1464-410X.2009.08647.x. Epub 2009 Jun 2. |
| 19802878 | Background | Apel PJ, Ma J, Callahan M, Northam CN, Alton TB, Sonntag WE, Li Z. Effect of locally delivered IGF-1 on nerve regeneration during aging: an experimental study in rats. Muscle Nerve. 2010 Mar;41(3):335-41. doi: 10.1002/mus.21485. |
| 12843410 | Background | Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835. |
| 24748436 | Background | Kushida S, Kakudo N, Morimoto N, Hara T, Ogawa T, Mitsui T, Kusumoto K. Platelet and growth factor concentrations in activated platelet-rich plasma: a comparison of seven commercial separation systems. J Artif Organs. 2014 Jun;17(2):186-92. doi: 10.1007/s10047-014-0761-5. Epub 2014 Apr 20. |
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| Placebo Group |
Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days. Saline solution: Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| PRP Group |
Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days Autologous Platelet Rich Plasma: Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum. |
| OG001 | Placebo Group | Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days. Saline solution: Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum |
|
|
| Secondary | Change in IIEF-EF Scores | IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function. | Not all subjects completed all visits due to lost to follow up or did not complete the IIEF questionnaire. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline up to Month 1, Month 3, and Month 6 |
|
|
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| Secondary | Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV) | Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound. | Not all subjects completed all visits due to lost to follow up. | Posted | Median | Inter-Quartile Range | cm/sec | Baseline to Month 6 |
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|
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| Secondary | Number of Adverse Events | Incidence of adverse events were reported as all urological and/or reproductive system AEs and all AEs with severity grade 3 or higher. Adverse Events severity was determined using CTCAE v5 criteria. | Posted | Number | events | 24 weeks |
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| Secondary | Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6. | Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound. | The number of participants analyzed are different in certain rows due to attrition and lost to follow up. | Posted | Count of Participants | Participants | Baseline and Month 6 |
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| 0 |
| 28 |
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | Placebo Group | Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days. Saline solution: Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum | 0 | 33 | 0 | 33 | 1 | 33 |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment | New Penile Plaque |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Baseline to Month 3 |
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| Baseline to Month 6 |
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| Month 6 |
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