Clinical outcomes, novel surgical techniques, and proposed standards for clinical outcomes reporting domains to support the use of the two-piece inflatable penile prosthesis after gender-affirming phalloplasty
Authors: Sandhu Sandhu S. , Mallavarapu Samhita , Garcia Maurice M. 
Published: October 2024

ABSTRACT

Background:
Many transgender men (TM) who undergo phalloplasty seek the ability to achieve an erection for insertive intercourse with a partner. Given that all currently available penile prostheses in the US are designed for cisgender anatomy and are used off-label for transgender patients, there is no current consensus regarding surgical approach or specific prosthesis to use. In addition, published articles evaluating penile prosthesis use have significant heterogeneity regarding outcome reporting. Given our institution utilizes 2-piece inflatable penile prostheses (IPP) in our TM, we sought to evaluate the current published evidence available for these devices.

Objectives:
We sought to: (1) perform the first Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guidelines-based meta-analysis of all publications that include two-piece IPP devices; (2) review our institution’s 7-year experience using two-piece IPP’s for TM following phalloplasty; (3) propose a list of key outcome domains that we feel should be included in any critical review of post-phalloplasty penile prosthesis outcomes; 4) present a critical assessment of our technique and outcomes; and (5) include a live surgical video of our technique for insertion of a 2-piece IPP.

Materials and Methods:
We conducted a literature review and a meta-analysis to evaluate the current literature which incorporates the 2-piece Ambicor penile prosthesis and determine the most important measures to create a standardized system of evaluating the outcome. We then undertook a chart review to critically review the outcomes in accordance with the standardized system. Finally, we created and linked a surgical video of our technique for insertion of a 2-piece IPP.

Results:
A total of eight published studies were included in our review following a PRISMA guideline search for articles reviewing outcomes for 2-piece IPPs in TM. We identified a total of eight outcome domains of importance across all published studies and found significant heterogeneity in reporting.
Our sample included 35 IPP insertions, of which, 34/35 (97%) were AMS Ambicor. We had 28/35 (80%) primary insertions and 7/35 (20%) revision insertions. For Ambicor devices, we had an infection rate of 1/34 (3%), erosion rate of 1/34 (3%) and malfunction rate of 2/34 (6%) requiring removal and eventual replacement. We describe our outcomes based on the eight outcome domains identified across all other studies.
Surgical Technique Video: https://youtu.be/9u7MMP0li4g

Conclusions:
Our study is the first to summarize all current published studies utilizing 2-piece IPPs in TM. We noted a high level of heterogeneity in reporting outcomes between published studies and propose a standardized set of criteria that we feel should be included in future studies incorporating the use of penile prostheses in TM. Finally, we describe our surgical technique for TM who undergo phalloplasty without urethral lengthening using a fused double-cylinder technique