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

NCT02833532 | Completed Phase 3 DMC

• 1 other identifier: AC-Volus-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Penile Enhancement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Volus

EXPERIMENTAL

Maxium: 22ml

Device: Volus/Powerfill

Powerfill

ACTIVE COMPARATOR

Maxium: 22ml

Device: Volus/Powerfill

Interventions

Volus/Powerfill DEVICE

Maximum: 22ml

Powerfill; Volus

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugel: lead
• Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials: collaborator

Study Sites (1)

HUGEL

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30833149 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: June 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 8, 2017

Record last verified: 2016-07

Locations

KR (1)