SAFE trial version 1.0
Research type
Research Study
Full title
Safe access for bladder entry (SAFE) in transgender men following penile reconstruction: a randomised controlled trial
IRAS ID
268621
Contact name
David Ralph
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
19/LO/1422, REC reference no
Duration of Study in the UK
0 years, 3 months, 26 days
Research summary
Inserting a urinary catheter in transgender men following penile reconstruction is difficult and usually requires specialist input. Specialist input may not always be readily available and clinicians may resort to suprapubic catheterisation with the associated risk of injury to the bowel or blood vessels. There is a need for an evidence-based protocol to guide clinicians faced with having to catheterise one of these patients. We will evaluate how successful a specialised catheter (Urethrotech UCD®) is compared with a standard Foley catheter for catheterisation of these patients. The Urethrotech UCD® is already used for difficult catheterisation in cisgender men. Transgender men undergoing insertion of an inflatable penile prosthesis under general anaesthesia will be recruited and randomly assigned to have either the Urethrotech UCD® or Foley catheter for their first attempt at urethral catheterisation (required for standard care). If unsuccessful, flexible cystoscopy will be performed and a Foley catheter will be inserted over a guidewire. The catheter is generally removed the next day prior to discharge from hospital. Patients will be followed-up in 30 days by phone.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1422
Date of REC Opinion
29 Jul 2020
REC opinion
Further Information Favourable Opinion