<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04454970</url>
  </required_header>
  <id_info>
    <org_study_id>124568</org_study_id>
    <nct_id>NCT04454970</nct_id>
  </id_info>
  <brief_title>Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction</brief_title>
  <acronym>SAFE</acronym>
  <official_title>Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St Peter's Andrology Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inserting a urinary catheter in transgender men following penile reconstruction is difficult&#xD;
      and usually requires specialist input. Specialist input may not always be readily available&#xD;
      and clinicians may resort to suprapubic catheterisation with the associated risk of injury to&#xD;
      the bowel or blood vessels. There is a need for an evidence-based protocol to guide&#xD;
      clinicians faced with having to catheterise one of these patients. The investigators will&#xD;
      evaluate how successful a specialised catheter (Urethrotech UCD®) is compared with a standard&#xD;
      Foley catheter for catheterisation of these patients. The Urethrotech UCD® is already used&#xD;
      for difficult catheterisation in cisgender men. Transgender men undergoing insertion of an&#xD;
      inflatable penile prosthesis under general anaesthesia will be recruited and randomly&#xD;
      assigned to have either the Urethrotech UCD® or Foley catheter for the first attempt at&#xD;
      urethral catheterisation (required for standard care). If unsuccessful, flexible cystoscopy&#xD;
      will be performed and a Foley catheter will be inserted over a guidewire. The catheter is&#xD;
      generally removed the next day prior to discharge from hospital. Patients will be followed-up&#xD;
      in 30 days by phone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The only patients eligible are transgender men following penile reconstruction undergoing&#xD;
      insertion of an inflatable penile prosthesis under general anaesthesia. Patients will be&#xD;
      identified by the theatre booking lists at St Peter's Andrology and will be contacted by&#xD;
      phone. The trial will be discussed and any concerns addressed. The patient information sheet&#xD;
      will be emailed to them (or posted by mail, if preferred by the patient). Patients will be&#xD;
      given at least 24 hours to consent to participate in the trial. As much time as possible will&#xD;
      be given to consider the information provided.&#xD;
&#xD;
      The study sites (University College London Hospital, The London Clinic and King Edward VII's&#xD;
      Hospital) are where the operations for insertion of inflatable penile prosthesis are&#xD;
      performed. The sites will not play any other role in the study and equipment for the study&#xD;
      will be brought to the hospitals as required.&#xD;
&#xD;
      The consent form will be signed on the morning of the procedure by the patient. Patients who&#xD;
      consent to participate in the study will be randomly assigned to having either a Urethrotech&#xD;
      UCD or a Bardia Aquafil Foley catheter for their first attempt at urethral catheterisation.&#xD;
      If unsuccessful, a flexible cystoscopy (telescopic examination) will be performed and a&#xD;
      guidewire passed directly into the bladder. A Foley catheter will then be passed over the&#xD;
      wire, into the bladder.&#xD;
&#xD;
      Following surgery, patients will be admitted overnight and the catheter removed the next day&#xD;
      followed by discharged. After 30 days, patients will be followed-up by phone.&#xD;
&#xD;
      All data will be kept in a password protected document and no data or intellectual property&#xD;
      will be transferred to other research groups although there may be future need to share&#xD;
      deidentified data with other groups. All study activities will be performed by the research&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2022</start_date>
  <completion_date type="Actual">March 4, 2023</completion_date>
  <primary_completion_date type="Actual">March 4, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomised controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants are blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of successful catheterisation of the bladder</measure>
    <time_frame>15 minutes</time_frame>
    <description>Rate of successful catheterisation is defined by the appearance of urine from the catheter following insertion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of passes required prior to successfully catheterising the bladder</measure>
    <time_frame>15 minutes</time_frame>
    <description>Number of passes of the integrated guidewire of the urethral catheterisation device or the Bardia Aquafil catheter required in order to catheterise the bladder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of successful catheterisation using flexible cystoscopy into the bladder</measure>
    <time_frame>30 minutes</time_frame>
    <description>Rate of successful catheterisation is defined by the appearance of urine from the catheter following insertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Transgenderism</condition>
  <condition>Catheter Related Complication</condition>
  <arm_group>
    <arm_group_label>Urethral catheterisation device (UCD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First attempt of urethral catheterisation using the Urethrotech(R) Urethral catheterisation device (UCD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bardia Aquafil Foley catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>First attempt of urethral catheterisation using the Bardia Aquafil Foley catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Urethrotech Urethral catheterisation device (UCD)</intervention_name>
    <description>Urethral indwelling catheter</description>
    <arm_group_label>Urethral catheterisation device (UCD)</arm_group_label>
    <other_name>UCD-0035-090-0016</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bardia Aquafil long term catheter</intervention_name>
    <description>Urethral indwelling catheter</description>
    <arm_group_label>Bardia Aquafil Foley catheter</arm_group_label>
    <other_name>165814UK</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female to male transgender men following penile reconstruction&#xD;
&#xD;
          -  On waiting list for insertion of inflatable penile prosthesis&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transgender men prior to undergoing penile reconstruction&#xD;
&#xD;
          -  Cisgender men or women&#xD;
&#xD;
          -  Known urethral fistula or stricture that has not been treated&#xD;
&#xD;
          -  Declines to be enrolled in trial&#xD;
&#xD;
          -  Does not require a urethral catheter for clinical reasons&#xD;
&#xD;
          -  Urinary tract infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Transgender</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David J Ralph, MBBS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College London Hospitals Foundation NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New Victoria Hospital</name>
      <address>
        <city>London</city>
        <zip>KT2 7EG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>30251050</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>29971436</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 16, 2019</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urethral catheterisation</keyword>
  <keyword>phalloplasty</keyword>
  <keyword>penile reconstruction</keyword>
  <keyword>transgender</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04454970
org study id: 124568
nct id: NCT04454970
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised controlled trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants are blinded
measure: Rate of successful catheterisation of the bladder
time frame: 15 minutes
description: Rate of successful catheterisation is defined by the appearance of urine from the catheter following insertion
measure: Number of passes required prior to successfully catheterising the bladder
time frame: 15 minutes
description: Number of passes of the integrated guidewire of the urethral catheterisation device or the Bardia Aquafil catheter required in order to catheterise the bladder
measure: Rate of successful catheterisation using flexible cystoscopy into the bladder
time frame: 30 minutes
description: Rate of successful catheterisation is defined by the appearance of urine from the catheter following insertion
measure: Complication rate
time frame: 30 days
arm group label: Urethral catheterisation device (UCD)
arm group type: Experimental
description: First attempt of urethral catheterisation using the Urethrotech(R) Urethral catheterisation device (UCD)
arm group label: Bardia Aquafil Foley catheter
arm group type: Active Comparator
description: First attempt of urethral catheterisation using the Bardia Aquafil Foley catheter
intervention type: Device
intervention name: Urethrotech Urethral catheterisation device (UCD)
description: Urethral indwelling catheter
arm group label: Urethral catheterisation device (UCD)
other name: UCD-0035-090-0016
intervention type: Device
intervention name: Bardia Aquafil long term catheter
description: Urethral indwelling catheter
arm group label: Bardia Aquafil Foley catheter
other name: 165814UK
criteria: 
gender: Female
gender based: Yes
gender description: Transgender
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: David J Ralph, MBBS, MS
role: Principal Investigator
affiliation: University College London Hospitals Foundation NHS Trust
facility: 
country: United Kingdom
citation: 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: 30251050
citation: 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: 29971436
responsible party type: Sponsor
sharing ipd: No