PMID- 33988002 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220414 IS - 2287-4208 (Print) IS - 2287-4690 (Electronic) IS - 2287-4208 (Linking) VI - 40 IP - 2 DP - 2022 Apr TI - Efficacy and Safety of Penile Girth Enhancement Using Hyaluronic Acid Filler and the Clinical Impact on Ejaculation: A Multi-Center, Patient/Evaluator-Blinded, Randomized Active-Controlled Trial. PG - 299-307 LID - 10.5534/wjmh.210007 [doi] AB - PURPOSE: We aimed to evaluate the efficacy and safety of penile girth enhancement (PGE) using hyaluronic acid (HA) filler with different physical properties from previous studies. Additionally, we evaluated the clinical impact on ejaculation after PGE. MATERIALS AND METHODS: This was a prospective, patient/evaluator-blinded, randomized, active-controlled, multicenter trial. Patients recruited between December 2017 and March 2018 were randomly assigned to the HA filler or control group (polylactic acid [PLA] filler). Penile girth, satisfaction level, Premature Ejaculation Profile (PEP), and self-estimated intravaginal ejaculation latency time (IELT) were assessed at baseline and at 24 weeks post-injection. RESULTS: Sixty-four subjects (32 in each group) completed the trial. The mean increase in girth was 22.74+/-12.60 mm and 20.23+/-8.73 mm in the HA and control groups, respectively. Satisfaction level regarding penile appearance and sexual life significantly increased in both groups. There was no statistically significant difference between the groups in terms of increase in penile girth or change in satisfaction level. Both groups showed significant improvements in PEP index scores. Self-estimated IELT also significantly increased in the HA group (from 5.36+/-3.51 to 7.86+/-4.73 minutes, p=0.0001) and control group (from 5.23+/-3.55 to 6.43+/-4.22 minutes, p=0.021). No serious adverse events (AEs) were reported. CONCLUSIONS: PGE with HA and PLA fillers resulted in significant enhancement of girth without serious AEs with no significant differences. Furthermore, PGE using filler improved clinical symptoms related to ejaculation. CI - Copyright (c) 2022 Korean Society for Sexual Medicine and Andrology. FAU - Ahn, Sun Tae AU - Ahn ST AUID- ORCID: 0000-0003-1233-5951 AD - Department of Urology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea. FAU - Shim, Ji Sung AU - Shim JS AUID- ORCID: 0000-0002-6745-1776 AD - Department of Urology, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea. FAU - Bae, Woong Jin AU - Bae WJ AUID- ORCID: 0000-0001-7703-1161 AD - Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. FAU - Kim, Sae Woong AU - Kim SW AUID- ORCID: 0000-0002-9127-9400 AD - Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. FAU - Kim, Je Jong AU - Kim JJ AUID- ORCID: 0000-0002-1195-9845 AD - Department of Urology, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea. FAU - Moon, Du Geon AU - Moon DG AUID- ORCID: 0000-0002-9031-9845 AD - Department of Urology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea. dgmoon@korea.ac.kr. LA - eng GR - Humedix, Co., Ltd./Korea PT - Journal Article DEP - 20210507 PL - Korea (South) TA - World J Mens Health JT - The world journal of men's health JID - 101596899 PMC - PMC8987147 OTO - NOTNLM OT - Ejaculation OT - Filler OT - Girth enhancement OT - Hyaluronic acid OT - Penis COIS- The authors have nothing to disclose. EDAT- 2021/05/15 06:00 MHDA- 2021/05/15 06:01 PMCR- 2022/04/01 CRDT- 2021/05/14 07:24 PHST- 2021/01/25 00:00 [received] PHST- 2021/03/31 00:00 [revised] PHST- 2021/03/31 00:00 [accepted] PHST- 2021/05/15 06:00 [pubmed] PHST- 2021/05/15 06:01 [medline] PHST- 2021/05/14 07:24 [entrez] PHST- 2022/04/01 00:00 [pmc-release] AID - 39.e23 [pii] AID - 10.5534/wjmh.210007 [doi] PST - ppublish SO - World J Mens Health. 2022 Apr;40(2):299-307. doi: 10.5534/wjmh.210007. Epub 2021 May 7.