Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction (SAFE)

Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction: a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Catheter Related Complication; Transgenderism
• Intervention / Treatment: Device: Urethrotech Urethral catheterisation device (UCD); Device: Bardia Aquafil long term catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wai Gin Lee, MBChB, PhD; Phone Number: 07577553588; Email: waigin.lee@nhs.net
• Study Contact Backup: Name: David J Ralph, MBBS, MS; Phone Number: 02074863805; Email: david@andrology.co.uk

Study Locations

• United Kingdom
  • London, United Kingdom, KT2 7EG
    • New Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urethral catheterisation device (UCD); First attempt of urethral catheterisation using the Urethrotech(R) Urethral catheterisation device (UCD)	Device: Urethrotech Urethral catheterisation device (UCD); Urethral indwelling catheter; Other Names: UCD-0035-090-0016
Active Comparator: Bardia Aquafil Foley catheter; First attempt of urethral catheterisation using the Bardia Aquafil Foley catheter	Device: Bardia Aquafil long term catheter; Urethral indwelling catheter; Other Names: 165814UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful catheterisation of the bladder	Rate of successful catheterisation is defined by the appearance of urine from the catheter following insertion	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of passes required prior to successfully catheterising the bladder	Number of passes of the integrated guidewire of the urethral catheterisation device or the Bardia Aquafil catheter required in order to catheterise the bladder	15 minutes
Rate of successful catheterisation using flexible cystoscopy into the bladder	Rate of successful catheterisation is defined by the appearance of urine from the catheter following insertion	30 minutes
Complication rate		30 days

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University College London Hospitals; St Peter's Andrology Centre
• Investigators: Principal Investigator: David J Ralph, MBBS, MS, University College London Hospitals Foundation NHS Trust

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Actual): March 4, 2023
• Study Completion (Actual): March 4, 2023

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: transgender; phalloplasty; urethral catheterisation; penile reconstruction
• Other Study ID Numbers: 124568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No