Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction

NCT ID: NCT04454970

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-16
• Study Completion Date: 2023-03-04

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.

Conditions

Transgenderism; Catheter Related Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Urethral catheterisation device (UCD)

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

Group Type: EXPERIMENTAL

Urethrotech Urethral catheterisation device (UCD)

Intervention Type: DEVICE

Urethral indwelling catheter

Bardia Aquafil Foley catheter

First attempt of urethral catheterisation using the Bardia Aquafil Foley catheter

Group Type: ACTIVE_COMPARATOR

Bardia Aquafil long term catheter

Intervention Type: DEVICE

Urethral indwelling catheter

Interventions

Urethrotech Urethral catheterisation device (UCD)

Urethral indwelling catheter

Intervention Type: DEVICE

Bardia Aquafil long term catheter

Urethral indwelling catheter

Intervention Type: DEVICE

Other Intervention Names

UCD-0035-090-0016; 165814UK

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St Peter's Andrology Centre

UNKNOWN

Sponsor Role: collaborator

University College London Hospitals

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Ralph, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals Foundation NHS Trust

Locations

New Victoria Hospital

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 30251050 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29971436 (View on PubMed)

Other Identifiers

124568

Identifier Type: -

Identifier Source: org_study_id