Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction
Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction
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. The investigators 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 the 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.
The only patients eligible are transgender men following penile reconstruction undergoing
 insertion of an inflatable penile prosthesis under general anaesthesia. Patients will be
 identified by the theatre booking lists at St Peter's Andrology and will be contacted by
 phone. The trial will be discussed and any concerns addressed. The patient information sheet
 will be emailed to them (or posted by mail, if preferred by the patient). Patients will be
 given at least 24 hours to consent to participate in the trial. As much time as possible will
 be given to consider the information provided.

 The study sites (University College London Hospital, The London Clinic and King Edward VII's
 Hospital) are where the operations for insertion of inflatable penile prosthesis are
 performed. The sites will not play any other role in the study and equipment for the study
 will be brought to the hospitals as required.

 The consent form will be signed on the morning of the procedure by the patient. Patients who
 consent to participate in the study will be randomly assigned to having either a Urethrotech
 UCD or a Bardia Aquafil Foley catheter for their first attempt at urethral catheterisation.
 If unsuccessful, a flexible cystoscopy (telescopic examination) will be performed and a
 guidewire passed directly into the bladder. A Foley catheter will then be passed over the
 wire, into the bladder.

 Following surgery, patients will be admitted overnight and the catheter removed the next day
 followed by discharged. After 30 days, patients will be followed-up by phone.

 All data will be kept in a password protected document and no data or intellectual property
 will be transferred to other research groups although there may be future need to share
 deidentified data with other groups. All study activities will be performed by the research
 group.
Inclusion Criteria:

 -  Female to male transgender men following penile reconstruction

 -  On waiting list for insertion of inflatable penile prosthesis

 -  Willing and able to provide written informed consent

 Exclusion Criteria:

 -  Transgender men prior to undergoing penile reconstruction

 -  Cisgender men or women

 -  Known urethral fistula or stricture that has not been treated

 -  Declines to be enrolled in trial

 -  Does not require a urethral catheter for clinical reasons

 -  Urinary tract infection