Clinical trial NCT02833532: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Penile Enhancement
Lead sponsor: Hugel
Sponsor class: INDUSTRY
Collaborators: name: Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
First posted: 2016-07-14
Enrollment: 68
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control.
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: baseline, 4 weeks, 12 weeks, 24 weeks
measure: 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.
timeFrame: baseline, 4 weeks, 12 weeks, 24 weeks
measure: 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.
timeFrame: baseline, 12 weeks, 24 weeks
measure: 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.
timeFrame: baseline, 4 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: HUGEL
Study officials:
References:
citation: Yang DY, Ko K, Lee SH, Lee WK. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med. 2019 Apr;16(4):577-585. doi: 10.1016/j.jsxm.2019.01.310. Epub 2019 Mar 2.