NCT04454970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 16, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

July 16, 2019

Last Update Submit

May 12, 2023

Conditions

TransgenderismCatheter Related Complication

Keywords

urethral catheterisationphalloplastypenile reconstructiontransgender

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of passes required prior to successfully catheterising the bladder

    15 minutes

  • Rate of successful catheterisation using flexible cystoscopy into the bladder

    30 minutes

  • Complication rate

    30 days

Study Arms (2)

Urethral catheterisation device (UCD)

EXPERIMENTAL

First attempt of urethral catheterisation using the Urethrotech(R) Urethral catheterisation device (UCD)

Device: Urethrotech Urethral catheterisation device (UCD)

Bardia Aquafil Foley catheter

ACTIVE COMPARATOR

First attempt of urethral catheterisation using the Bardia Aquafil Foley catheter

Device: Bardia Aquafil long term catheter

Interventions

Urethrotech Urethral catheterisation device (UCD)DEVICE

Urethral indwelling catheter

Also known as: UCD-0035-090-0016
Urethral catheterisation device (UCD)
Bardia Aquafil long term catheterDEVICE

Urethral indwelling catheter

Also known as: 165814UK
Bardia Aquafil Foley catheter

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTransgender
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Victoria Hospital

London, KT2 7EG, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 30251050RESULT

  • 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.

    PMID: 29971436RESULT

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Officials

  • David J Ralph, MBBS, MS

    University College London Hospitals Foundation NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 2, 2020

Study Start

September 16, 2022

Primary Completion

March 4, 2023

Study Completion

March 4, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)