Real Practice Confirmatory Study of Adjustable Initial Injection Volume and Necessity of Retouch and Reinjection in Penile Girth Enhancement with Hyaluronic Acid Gel, a Filler

초록

Introduction: Despite the proven efficacy and safety in approval studies of PGE (Penile Girth Enhancement) with HA gel, PGE with injectable HA is not popular for both patients and physicians. In contrast to the importance of theoretical study designs for the approval study, key topics to emphasize clinical experience are quite different. In real practice, the most important drawbacks of PGE with HA are irregular unnatural shape of penis due to distal ventral migration of initial large volume of implants, relatively soft texture compared to conventional method, and lack of maintenance method and study which replace the longevity. Objective: This study was performed to determine the feasibility of adjustable initial injection volume and importance of retouch for making good penile appearance and reinjection of HA filler to maintain penile appearance for longer time and factors that influence patient decisionmaking to choose PGE with hyaluronic acid (HA) in real clinical practice at a single center of one highly experienced operator, prospective, open-label, exploratory study for 1 year. Methods: Patients were recruited between November 2023 and February 2024. Penile girth, length, satisfaction level of penile shape, and self-estimated satisfaction sexual satisfaction level of penile shape, were assessed at baseline and at 48 weeks post-injection with hyaluronic acid (HA). Results: A total of 20 patients were enrolled and 60% (12 of 20) of the patients had previous PGE with HA. The mean girth measured at proximal, mid, and distal body significantly increased at 4wks after injection and maintained at 12, 24 and 48 weeks, respectively. Penile length increased at 4 weeks and significantly increased from 12 weeks and maintained by 48 weeks. Means satisfaction score of penile appearance significantly increased from 2.15±0.72 to 3.95±1.12 in 80%(16/20) of patients at 48 weeks. Satisfaction level in sexual life significantly increased from 2.5±0.92 to 3.95±0.67 and changed 85%(17/20) of unsatisfaction to 85%(17/20) of satisfaction at 48 weeks, respectively. In all patients, no serious adverse events (AEs) were reported. Conclusions: PGE with HA fillers resulted in significant enhancement of girth, penile length, satisfaction of penile appearance, and sexual satisfaction without serious AEs for 1 year. Rather than the longevity of filler, the necessity of retouch to reduce uneven distribution of filler and reinjection to maintain enhanced girth should be considered in real practice of PGE with fillers.