Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction
Condition: Transgenderism; Catheter Related Complication
Study type: Interventional

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. 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.
    

Detailed description: 
      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.
    

Intervention name(s): Urethrotech Urethral catheterisation device (UCD); Bardia Aquafil long term catheter
Intervention type(s): Device; Device
Intervention description(s): Urethral indwelling catheter; Urethral indwelling catheter
Other intervention name(s): UCD-0035-090-0016; 165814UK
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: urethral catheterisation; phalloplasty; penile reconstruction; transgender