Efficacy and safety of Volus (hyaluronic acid) for penile girth enhancement: multi-center, randomized, subject blind, active controlled study
Ko, K1; Lee, WK1; Lee, SH1; Yang, DY1
1: Hallym University, college of medicine, Korea, South
Purpose: To evaluate the efficacy and safety of Volus on penile girth enhancement in patient with small penis syndrome.
Material and Methods: From 4 March 2016 to 5 August 2016, 72 patients who have a small penis syndrome were enrolled in this study. Subjects were randomized for injections with Volus or PLA (Poly-D,L-lactide) into penile body. After lidocaine was injected at penile base, Volus Injection using with 19 gauze needle was applied from penile base to coronal sulcus up to 22ml. The efficacy was determined by calculating the change in penile circumference, penile length and patient’s satisfaction at 4, 12 and 24 weeks. Penile circumference was measured from three parts of penis - distal, mid, proximal. Penile length was defined from pubo-penile junction to apex of glans. Patient’s satisfaction was evaluated by 5-point scale. Safety evaluation was assessed by reported adverse events.
Results: At 24 weeks follow up. Changes of penile circumference were 20.63 ± 10.97 mm in Volus and 14.65 ± 10.41 mm in PLA (p < 0.026). This difference of penile circumference remained at 4 and 12 weeks follow up (p < 0.001, p = 0.003). Changes of penile length were not significant between two groups at 4 and 12 weeks. At 24 weeks follow up, Changes of penile length in Volus (23.68 ± 3.43 mm) were significantly prominent than in PLA (10.04 ± 3.43 mm, p = 0.011). Changes in patient’s satisfaction were not different between two groups at 4 and 12 weeks. At 24 weeks, Changes in satisfaction were 1.71 ± 0.24 in Volus while changes were 1.00 ± 0.24 in PLA. This difference was nearly siginificant (p=0.06).
Conclusion: Volus, a newly developed Hyaluronic acid filler, is effective and safe material for the penile girth enhancement with good durability
Work supported by industry: yes, by Across Corporation (industry funding only - investigator initiated and executed study).Go Back