A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement

Study Overview
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Brief Summary
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The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.

Official Title
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A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement

Conditions
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Penile Enhancement

Intervention / Treatment
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* Device: Volus/Powerfill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects aged above 20 and below 65. (20≤male≥65) be rating himself, when screening, as Small or Very Small on Self-Questioned Questionnaire ( SQQ) including the question:  How do you rate your penile size? // Very small, Small, Normal, Big, Very Big? During the study period, subjects will not received any treatments associated with penile enhancement. Subjects will sign an informed consent form Exclusion Criteria: Prior treatment for penile enhancement (e.g. fat, dermal graft). Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention Allergic to hyalluronic acid. Inflammatory or/and infectious disease on penis that can affect on this study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volus<br>Maxium: 22ml | Device: Volus/Powerfill<br>* Maximum: 22ml<br>|
| Active Comparator: Powerfill<br>Maxium: 22ml | Device: Volus/Powerfill<br>* Maximum: 22ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control. | Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement. Baseline value: Measured baseline length before the intervention. | baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Penile Circumference (each to be measured) at 4, 12 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control. |  | baseline, 4 weeks, 12 weeks, 24 weeks | 
| The Difference in 5-point scale of penile appearance (each to be measured) at 4, 12, 24 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control. |  | baseline, 4 weeks, 12 weeks, 24 weeks | 
| The Difference in 5-point scale of sexual satisfaction (each to be measured) at 12, 24 weeks (post last treatment)from Baseline value after using Volus application, compared to the Control. |  | baseline, 12 weeks, 24 weeks | 
| The Difference in penile length† (each to be measured) at 4, 12, 24 weeks (post last treatment) from ‡B after using Volus application, compared to the Control. | † penile length: A length of penile distribution measured from the ventral side of pubo-penile skin junction to the apex of prepuce when relaxed using a tape( or stick)- measure. | baseline, 4 weeks, 12 weeks, 24 weeks |