O 04. Tolerability and efficacy of newly developed penile injection of cross - linked dextran and polymethylmethacrylate mixture on penile enhancement: 1-year follow - up

Introduction: Cross-linked dextran and polymethylmethacrylate (PMMA) mixture (Lipen-10^®) is a newly developed tissue filler for soft tissue augmentation. The purpose of this study was to evaluate efficacy and tolerability of cross-linked dextran and PMMA mixture on penile enhancement.

Materials and Methods: A total 20 adult males who wanted penile enhancement were enrolled at 2 centers. Mean patients age were 44.4 years (20-70). Lipen-10^® was injected into the subcutaneous tissue of the penile shaft, between Dartos fascia and Buck's fascia, using the fanning technique. The penile girth and length were measured with a caliper in the flaccid state, before and 3, 6 and 12 months after the injection. Any adverse events were also recorded during the trial.

Results: Mean injected volume of Lipen-10^® was 23.73 mL(range 17 to 30 mL). The circumference increased by 3.7 cm (50.5 %, P<0.0001) at penile base, 4.2 cm (59.2 %, P<0.001) at mid-shaft, and 3.8±1.0 cm (53.8 %, P<0.0001) at distal shaft, and the length by 3.0 cm (83.3 %, P<0.001). There was no significant difference in 3 circumferences between 6 and 12 months post-treatment (P-values of 0.796, 0.498, and 0.6 for penile base, mid-shaft and distal shaft, respectively). A 5 mmsized palpable nodule on penile shaft and a mild asymmetry of penile shape were observed as complication. There were no clinically significant adverse events in all subjects.

Conclusions: Penile injection of cross-linked dextran and PMMA mixture led to a significant increase in penile size, showed a good durability, and was well tolerated, without serious adverse events. These results suggest that penile injection of cross-linked dextran and PMMA mixture may be a new effective method for penile enhancement.