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

Hugel68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Penile Enhancement

Interventions

Volus/PowerfillDEVICE

Maximum: 22ml

Eligibility

Sex: MALEMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male subjects aged above 20 and below 65. (20≤male≥65) 2. 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?" 3. During the study period, subjects will not received any treatments associated with penile enhancement. 4. Subjects will sign an informed consent form Exclusion Criteria: 1. Prior treatment for penile enhancement (e.g. fat, dermal graft). 2. Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention 3. Allergic to hyalluronic acid. 4. Inflammatory or/and infectious disease on penis that can affect on this study

Locations (1)

HUGEL

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: baseline, 24 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline, 4 weeks, 12 weeks, 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.