Clinical trial NCT04454970: Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction
Official title: Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transgenderism
Catheter Related Complication
Keywords: urethral catheterisation
phalloplasty
penile reconstruction
transgender
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: St Peter's Andrology Centre
name: University College London Hospitals
First posted: 2020-07-02
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of successful catheterisation of the bladder
timeFrame: 15 minutes
Secondary outcomes:
measure: Number of passes required prior to successfully catheterising the bladder
timeFrame: 15 minutes
measure: Rate of successful catheterisation using flexible cystoscopy into the bladder
timeFrame: 30 minutes
measure: Complication rate
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: New Victoria Hospital
Study officials:
affiliation: University College London Hospitals Foundation NHS Trust
name: David J Ralph, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bugeja S, Mistry K, Yim IHW, Tamimi A, Roberts N, Mundy AR. A new urethral catheterisation device (UCD) to manage difficult urethral catheterisation. World J Urol. 2019 Apr;37(4):595-600. doi: 10.1007/s00345-018-2499-9. Epub 2018 Sep 24.
citation: Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018 Aug 1;178(8):1078-1085. doi: 10.1001/jamainternmed.2018.2417.