Implantation of the ZSI 475 FTM Erectile Device After Phalloplasty: A Prospective Analysis of Surgical Outcomes. Issue 3 (18th December 2020)

• Record Type: Journal Article
• Authors: Verla, Wesley; Goedertier, Wouter; Lumen, Nicolaas; Spinoit, Anne-Françoise; Waterloos, Marjan; Waterschoot, Mieke; Buncamper, Marlon; Monstrey, Stan; Hoebeke, Piet
• Is Part Of: Journal of sexual medicine. Volume 18:Issue 3(2021)
• Page Start: 615
• Page End: 622
• Publication Date: 2020-12-18
• Subjects: Zephyr -- erectile device -- penile prosthesis -- phalloplasty -- trans men; Sexual disorders -- Periodicals; Sex -- Periodicals; Sexual health -- Periodicals; 616.69005
• DOI: 10.1016/j.jsxm.2020.11.008
• Languages: English
• ISSNs: 1743-6095

Abstract

ABSTRACT: Background: Until recently, all available erectile devices were manufactured in accordance with the anatomy of a native penis and led to high explantation rates when implanted in the neophallus. Aim: The aim of this study was to investigate surgical outcomes after implantation of the ZSI 475 FTM in the neophallus; this is the first erectile device specifically manufactured for implantation after phalloplasty. Methods: This is a prospective observational study of patients undergoing implantation of the ZSI 475 FTM in the neophallus at a tertiary referral center since September 2017. Patients with a follow-up < 3 months were excluded from this analysis. Outcomes: Intraoperative and postoperative complications were analyzed with descriptive statistics and explantation-free survival was assessed using a Kaplan-Meier survival analysis. RESULTS: In total, 57 patients were included with a median (IQR) follow-up of 16 (10-21) months. No intraoperative complications occurred. Postoperative complications were seen in 18 of 57 (32%) patients and included cylinder protrusion (1/57, 1.8%), infection (8/57, 14%), malpositioning (4/57, 7.0%), mechanical failure (4/57, 7.0%), and urinary retention (1/57, 1.8%). A total of 13 of 57 (23%) devices were explanted which corresponds with an estimated explantation-free survival rate (SD) of 84% (4.9), 80% (5.6), and 80% (5.6) after, respectively, 6, 12, and 18 months of follow-up. Clinical implications: By better addressing the specific needs after phalloplasty, this innovative erectile device might lead to improved cylinder protrusion, malpositioning, and mechanical failure rates, but device infection remains common. Strengths & limitations: This is the largest study on this topic to date and the first to report prospective data. Main limitations involve the relatively small sample size and the limited follow-up. CONCLUSION: Short-term cylinder protrusion, malpositioning, and mechanical failure rates are encouraging, although device infection remains a common problem. These complications resulted in a device explantation rate of 23%.