Penile Elongation
Conditions
Keywords
platelet-rich plasma
Brief summary
The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.
Interventions
12mL of platelet-rich plasma injected into cavernosal bodies bilaterally
Sponsors
Study design
Eligibility
Inclusion criteria
1. Stretched penile length between 3.5 - 8.0 in 2. Age 20-55 years of age 3. Desire penile length elongation 4. Willing to complete all aspects of combined treatment plan 5. Able to measure erect penile length and mid-shaft girth at 1-month intervals 6. Judged to be in good health based on medical history, physical exam, and laboratory profile 7. Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)
Exclusion criteria
1. No prior surgical Peyronie's disease treatment 2. No chordee with or without hypospadias 3. No infiltration by benign or malignant mass 4. No active STD 5. No infiltration by an infectious agent such as lymphogranuloma venereum 6. No uncontrolled psychiatric conditions 7. No uncontrolled neurologic conditions 8. No other uncontrolled medical conditions such as HTN or DM 9. No history of spontaneous priapism 10. Is unable to safely use the study devices as determined by the principal investigator 11. No thrombosis of the dorsal penile artery or vein 12. No known history of coagulation disorder 13. No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study 14. Testosterone level lower than 500
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stretched penile length | baseline to six months | Change in length of stretched, flaccid penile length |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SHIM Score | baseline to six months | Change in erectile function |
| BDD-YBOCS | baseline to six months | Change in body dysmorphia scale |
| Safety Measurement | baseline to six months | Incidence of adverse events and serious adverse events |
Countries
United States