TransgenderismSAFENCT04454970
Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction
A study testing Urethrotech Urethral catheterisation device (UCD) and Bardia Aquafil long term catheter in people with Transgenderism and Catheter Related Complication, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Transgenderism, Catheter Related Complication
- What is being tested?
- Urethrotech Urethral catheterisation device (UCD) and Bardia Aquafil long term catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Sep 2022to 4 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Urethrotech Urethral catheterisation device (UCD), Bardia Aquafil long term catheter
- Keywords
- urethral catheterisation, phalloplasty, penile reconstruction, transgender
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urethrotech Urethral catheterisation device (UCD)Device
Also called UCD-0035-090-0016
Urethral indwelling catheter
Bardia Aquafil long term catheterDevice
Also called 165814UK
Urethral indwelling catheter
| Study group | Role | What they receive |
|---|---|---|
| Urethral catheterisation device (UCD) | Experimental | First attempt of urethral catheterisation using the Urethrotech(R) Urethral catheterisation device (UCD) Receives: Device: Urethrotech Urethral catheterisation device (UCD) |
| Bardia Aquafil Foley catheter | Active comparator | First attempt of urethral catheterisation using the Bardia Aquafil Foley catheter Receives: Device: Bardia Aquafil long term catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful catheterisation of the bladder
Rate of successful catheterisation is defined by the appearance of urine from the catheter following insertion
Measured: 15 minutes
Secondary outcomes (3)
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
Measured: 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
Measured: 30 minutes
Complication rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start16 Sep 2022
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- St Peter's Andrology Centre, University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- David J Ralph, MBBS, MS, Principal investigator, University College London Hospitals Foundation NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454970
- Sponsor's protocol ID
- 124568
- Acronym
- SAFE
- Status last verified
- May 2023
- First submitted
- 16 Jul 2019
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30251050Saint 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.
PubMed 29971436Frost A, Gobbo A, Christopher N, Ralph D, Lee WG. Catheterisation after urethral lengthening in transgender/gender-diverse individuals: a randomised controlled trial (Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction [SAFE]). BJU Int. 2026 Apr 1. doi: 10.1111/bju.70260. Online ahead of print.
PubMed 41919660
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04454970
- Acronym / sponsor ID
- SAFE / 124568
- Conditions
- Transgenderism, Catheter Related Complication
- Keywords
- urethral catheterisation, phalloplasty, penile reconstruction, transgender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- St Peter's Andrology Centre, University College London Hospitals
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Urethral catheterisation device (UCD) | Experimental | Device: Urethrotech Urethral catheterisation device (UCD)First attempt of urethral catheterisation using the Urethrotech(R) Urethral catheterisation device (UCD) |
| Bardia Aquafil Foley catheter | Active comparator | Device: Bardia Aquafil long term catheterFirst attempt of urethral catheterisation using the Bardia Aquafil Foley catheter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urethrotech Urethral catheterisation device (UCD)Also: UCD-0035-090-0016Urethral indwelling catheter | Device | Urethral catheterisation device (UCD) |
| Bardia Aquafil long term catheterAlso: 165814UKUrethral indwelling catheter | Device | Bardia Aquafil Foley catheter |
Primary outcome
Rate of successful catheterisation of the bladder
Time frame: 15 minutes
Rate of successful catheterisation is defined by the appearance of urine from the catheter following insertion
3 secondary outcomes
Number of passes required prior to successfully catheterising the bladder
Time frame: 15 minutes
Rate of successful catheterisation using flexible cystoscopy into the bladder
Time frame: 30 minutes
Complication rate
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Results publication: PubMed 30251050Bugeja 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.
- Results publication: PubMed 29971436Saint 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.
- Derived from this study: PubMed 41919660Frost A, Gobbo A, Christopher N, Ralph D, Lee WG. Catheterisation after urethral lengthening in transgender/gender-diverse individuals: a randomised controlled trial (Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction [SAFE]). BJU Int. 2026 Apr 1. doi: 10.1111/bju.70260. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Ralph, MBBS, MS principal investigator
University College London Hospitals Foundation NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urethrotech Urethral catheterisation device (UCD) and Bardia Aquafil long term catheter in people with Transgenderism and Catheter Related Complication, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful catheterisation of the bladder (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454970, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.