A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

Study Overview
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Brief Summary
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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.

Official Title
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A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

Conditions
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Penile Elongation

Intervention / Treatment
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* Combination Product: Platelet-rich plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stretched penile length between 3.5 - 8.0 in Age 20-55 years of age Desire penile length elongation Willing to complete all aspects of combined treatment plan Able to measure erect penile length and mid-shaft girth at 1-month intervals Judged to be in good health based on medical history, physical exam, and laboratory profile Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits) Exclusion Criteria: No prior surgical Peyronie's disease treatment No chordee with or without hypospadias No infiltration by benign or malignant mass No active STD No infiltration by an infectious agent such as lymphogranuloma venereum No uncontrolled psychiatric conditions No uncontrolled neurologic conditions No other uncontrolled medical conditions such as HTN or DM No history of spontaneous priapism Is unable to safely use the study devices as determined by the principal investigator No thrombosis of the dorsal penile artery or vein No known history of coagulation disorder No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study Testosterone level lower than 500

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Group<br>Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation. | Combination Product: Platelet-rich plasma<br>* 12mL of platelet-rich plasma injected into cavernosal bodies bilaterally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stretched penile length | Change in length of stretched, flaccid penile length | baseline to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SHIM Score | Change in erectile function | baseline to six months | 
| BDD-YBOCS | Change in body dysmorphia scale | baseline to six months | 
| Safety Measurement | Incidence of adverse events and serious adverse events | baseline to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet-rich plasma