Penile Enhancement
Conditions
Brief summary
The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.
Interventions
DEVICEVolus/Powerfill
Maximum: 22ml
Sponsors
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control. | baseline, 24 weeks | Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement. Baseline value: Measured baseline length before the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | baseline, 4 weeks, 12 weeks, 24 weeks | † 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. |
Countries
South Korea
Outcome results
None listed