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Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction

NCT04454970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-05-16

No results posted yet for this study

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.

Conditions

  • Transgenderism
  • Catheter Related Complication

Interventions

DEVICE

Urethrotech Urethral catheterisation device (UCD)

Urethral indwelling catheter

DEVICE

Bardia Aquafil long term catheter

Urethral indwelling catheter

Sponsors & Collaborators

  • St Peter's Andrology Centre

    collaborator UNKNOWN

  • University College London Hospitals

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • David J Ralph, MBBS, MS · University College London Hospitals Foundation NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2023-03-04
Completion
2023-03-04

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04454970 on ClinicalTrials.gov