Catheterisation after urethral lengthening in transgender/gender-diverse individuals: a randomised controlled trial (Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction [SAFE]).

Abstract

To conduct a randomised controlled trial (RCT) to assess the efficacy of the Urethrotech urethral catheterisation device (UCD®; Urethrotech Ltd., Kingston Upon Thames, Surrey, UK) catheter compared to a standard Foley catheter for catheterisation in post-phalloplasty transgender and gender diverse (TGD) individuals following urethral lengthening. In a prospective, single-blind RCT (Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction [SAFE]; ClinicalTrials.gov identifier NCT04454970), patients were allocated to catheterisation using either the UCD or a standard Foley catheter. Participants underwent insertion or revision of an inflatable penile prosthesis, with catheterisation as part of the planned surgery. The primary endpoint was successful catheterisation with the allocated catheter. If catheterisation failed, flexible cystoscopy with guidewire-assisted insertion of a standard Foley catheter was performed. Secondary endpoints included time to successful catheterisation, requirement for flexible cystoscopy or suprapubic catheter insertion, and 30-day complications. A total of 20 patients were randomised into two groups. The UCD was successfully inserted six of 10 patients, compared to three of 10 patients for the Foley catheter. The UCD is a promising device for catheterising tortuous urethras and addressing the unique challenges faced by clinicians managing patients after phalloplasty.