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The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Autologous PRP followed by Placebo Group | Experimental | Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later. |
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| Experimental: Placebo followed by Autologous PRP Group | Experimental | Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet Rich Plasma | Drug | 2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects in each group who attain degree change in penile curvature. | Treatment efficacy of PRP will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis. | 7 months |
| Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother). | Treatment efficacy will be assessed via the percentage of participants achieving any decrease in Peyronie's disease Questionnaire (PDQ) sub-domain scoring from baseline. The sub-domains that will be assessed in primary outcome is Psychological and Physical Symptoms and Symptom Bother. PDQ is a validated 15-item questionnaire that assess Psychological and Physical Symptoms, Symptom Bother, and Penile Pain subdomains. The Psychological and Physical Symptoms subdomain is measured from 0 to 24 (most severe symptoms). Symptom Bother subdomain is measured from 0 to 30 (most severe pain). | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events in all patients | Safety will be evaluated via the incidence of adverse events as assessed by treating physician | Baseline, 6 months (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Molina, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36100520 | Derived | Chu KY, Molina ML, Ledesma B, Zucker I, Saltzman RG, Masterson TA, Ramasamy R. A Phase 2 Randomized, Placebo-controlled Crossover Trial to Evaluate Safety and Efficacy of Platelet-rich Plasma Injections for Peyronie's Disease: Clinical Trial Update. Eur Urol Focus. 2023 Jan;9(1):11-13. doi: 10.1016/j.euf.2022.08.017. Epub 2022 Sep 10. |
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| ID | Term |
|---|---|
| D010411 | Penile Induration |
| D012735 | Sexual Dysfunction, Physiological |
| D005832 | Genital Diseases, Male |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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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 | 2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque. |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |