Comparison of Clinical Outcomes between Hyaluronic and Polylactic Acid Filler Injections for Penile Augmentation in Men Reporting a Small Penis: A Multicenter, Patient-Blinded/Evaluator-Blinded, Non-Inferiority, Randomized Comparative Trial with 18 Months of Follow-up.

Dae Yul Yang,Kyungtae Ko,Won Ki Lee,Young Goo Lee,Seong Ho Lee,Hyun Cheol Jeong

doi:10.3390/jcm9041024

Abstract

Although several types of penile augmentation (PA) fillers have been recently introduced, no long-term follow-up studies have compared them. This study aimed to compare the long-term clinical outcomes of hyaluronic acid (HA) and polylactic acid (PLA) filler injections for PA. Our multicenter, patient-blinded/evaluator-blinded, randomized comparative trial was performed for 18 months after the single injection of fillers. Sixty-seven healthy men reporting a small penis were administered an injection between November 2016 and May 2017. Subjects were divided into the HA group (n = 33) and PLA group (n = 34). At 18 months, the mean penile girths had significantly increased in both groups (each p < 0.001). Changes in the mean penile girth of both groups were not significantly different during the study period. Satisfaction levels at 18 months were significantly higher than those at baseline in both groups (each p < 0.01). Changes in satisfaction levels did not differ significantly during the study period. Injection-associated adverse events (AEs) occurred in three (9.1%) patients in the HA group and in two (5.9%) patients in the PLA group; no serious AEs occurred. In conclusion, HA and PLA filler injections for PA led to significant augmentation and increased satisfaction. Clinical efficacy and safety were comparable between groups.

Highlights

The need for safer, more effective, and less invasive treatments has increased in all areas of modern medicine
Men suspected of having a micropenis, which is a normally formed penis that is at least 2.5 standard deviations (SD) below the mean size in stretched length for age, were excluded because an etiologic evaluation is required for these cases [16]
Our study showed that hyaluronic acid (HA) and polylactic acid (PLA) fillers injected in the penis led to significant augmentation of the penile girth and to increased injection-associated satisfaction

Summary

Introduction

The need for safer, more effective, and less invasive treatments has increased in all areas of modern medicine. This is especially true for aesthetic medicine [1]. Soft tissue filler injections have become the main treatment for soft tissue augmentation because they are relatively safe, effective, less invasive, and less expensive than most surgical procedures [2]. Many men are dissatisfied with their penile size and desire a larger penis [5]. The amount of fillers injected in the penis is much larger than that injected in the face [8,9]. The proven clinical utility in the face does not indicate clinical utility in the penis

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