<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/NCT04452890</url>
  </required_header>
  <id_info>
    <org_study_id>BC-06980-ADP</org_study_id>
    <nct_id>NCT04452890</nct_id>
  </id_info>
  <brief_title>Pre-operative Assessment by Sonourethrography Only in Anterior Urethral Strictures.</brief_title>
  <acronym>PASTIS</acronym>
  <official_title>PASTIS-Trial: Pre-operative Assessment by Sonourethrography Only in Anterior Urethral Strictures: A Prospective Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The choice of the best surgical technique for urethral stricture repair depends on the&#xD;
      stricture length. Estimating the length of urethral strictures is therefore of utmost&#xD;
      importance.&#xD;
&#xD;
      Different clinical studies have proven that SUG has a higher sensitivity to evaluate the&#xD;
      length of urethral strictures compared to RUG or VCUG.&#xD;
&#xD;
      The goal of this study is to assess the feasibility of using SUG as single pre-operative&#xD;
      assessment tool in patients with suspicion of anterior urethral strictures. In this way, use&#xD;
      of RUG and/or VCUG could be omitted in the pre-operative work-up of patients with anterior&#xD;
      urethral strictures, thereby avoiding significant radiation load of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urethral stricture disease (USD) is a medical condition in which a narrowing of the urethral&#xD;
      lumen occurs due to pathological fibrosis and cicatrix formation of the urethral mucosa and&#xD;
      surrounding spongious tissue (spongiofibrosis). Urethral strictures may occur at any location&#xD;
      from the bladder neck to the external urethral meatus and are categorized based on their&#xD;
      localisation in anterior strictures (including the urethral meatus, penile urethra and bulbar&#xD;
      urethra) and posterior strictures (including the prostatic urethra and membranous urethra).&#xD;
      USD is a disease of all ages but the prevalence increases with increasing age since the&#xD;
      cumulative risk of having had urethral instrumentation equally increases. All processes that&#xD;
      cause urethral trauma may provoke USD. The majority of strictures nowadays is idiopathic or&#xD;
      caused by iatrogenic trauma of the urethra.&#xD;
&#xD;
      The pathological narrowing of the urethral lumen can lead to a wide variety of symptoms which&#xD;
      ask for specific diagnostic investigations, in which imaging of the urethra plays a central&#xD;
      role. Retrograde urethrography (RUG) and voiding cystourethrography (VCUG) are considered to&#xD;
      be the gold standard diagnostic investigation techniques for diagnosis of USD.&#xD;
&#xD;
      In both techniques, contrast is instilled in the urethra through the urethral meatus and&#xD;
      radiographic imaging is used to visualize the urethra. RUG and VCUG offer the possibility to&#xD;
      visualize the urethra completely and to evaluate the number, length and location of urethral&#xD;
      strictures. On the other hand, these techniques have some crucial disadvantages. First and&#xD;
      foremost, the radiation load of the genitopelvic region in often young patients is inevitable&#xD;
      in RUG and VCUG. Secondly, it is impossible to evaluate the degree of spongiofibrosis with&#xD;
      radiographic imaging.&#xD;
&#xD;
      In 1988, McAnnich, et al. were the first to describe sonourethrography (SUG) for the&#xD;
      diagnosis of anterior urethral strictures in males. In this technique, a Foley catheter is&#xD;
      inserted in the urethral meatus and a physiological solution is instilled in the urethra&#xD;
      while a linear 7,5 MHz ultrasound probe is placed sagitally over the course of the urethra.&#xD;
      SUG is not only able to evaluate the length and localization of a US, but it also enables the&#xD;
      investigator to evaluate the grade of spongiofibrosis.&#xD;
&#xD;
      Different strudies have shown that SUG has a higher sensitivity for the measurement of&#xD;
      urethral stricture length compared to classical radiographic imaging such as RUG or VCUG.&#xD;
      Since the choice of the most adequate surgical technique depends on the length of the&#xD;
      urethral stricture, correct estimation of the urethral stricture length is of the utmost&#xD;
      importance.&#xD;
&#xD;
      The goal of this study is to evaluate the feasibility of the use of sonourethrography as&#xD;
      single diagnostic tool in the pre-operative diagnostic work-up of males with suspicion of&#xD;
      anterior urethral strictures. In this way, classic radiographic imaging such as RUG and VCUG&#xD;
      could be omitted in these patients, saving them from a significant radiation load.&#xD;
&#xD;
      Fifty patients with penile strictures and fifty patients with bulbar strictures will be&#xD;
      included in this study. When 50% of patients (25 penile and 25 bulbar strictures) have&#xD;
      completed the study, an interim analysis will be conducted. If this analysis shows that RUG&#xD;
      or VCUG can be omitted in 80% or more of patients, the study will be stopped.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single center, prospective feasibility trial</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sonourethrography feasibility: proportion of patients in whom the pre-operative surgical treatment planning was accurate</measure>
    <time_frame>2 years</time_frame>
    <description>To evaluate the proportion of patients in whom the pre-operative surgical treatment planning was accurate based on sonourethrography only.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of predictors for failure of treatment planning by sonourethrography by regression analysis.</measure>
    <time_frame>2 years</time_frame>
    <description>To evaluate which factors are predictive for failure of treatment planning by sonourethrography only.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Anterior Urethral Stricture, Male</condition>
  <arm_group>
    <arm_group_label>Sonourethrography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound of the urethra (Sonourethrography - SUG): In this procedure, a Foley catheter is inserted into the top of the urethra and physiological serum is instilled into the urethra while a linear 7.5 MHz ultrasound probe is placed sagitally on the course of the urethra to detect a narrowing of the urethra.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sonourethrography</intervention_name>
    <description>Ultrasound of the urethra.</description>
    <arm_group_label>Sonourethrography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years or older&#xD;
&#xD;
          -  Anterior urethral strictures (except for meatal strictures)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Posterior urethral strictures&#xD;
&#xD;
          -  Meatal strictures&#xD;
&#xD;
          -  History of hypospadias repair&#xD;
&#xD;
          -  History of phalloplasty&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only biological males with anterior urethral stricture disease will be included in the study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dept. of Urology, Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urethral Stricture</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <!-- 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/NCT04452890
org study id: BC-06980-ADP
nct id: NCT04452890
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The choice of the best surgical technique for urethral stricture repair depends on the
      stricture length. Estimating the length of urethral strictures is therefore of utmost
      importance.

      Different clinical studies have proven that SUG has a higher sensitivity to evaluate the
      length of urethral strictures compared to RUG or VCUG.

      The goal of this study is to assess the feasibility of using SUG as single pre-operative
      assessment tool in patients with suspicion of anterior urethral strictures. In this way, use
      of RUG and/or VCUG could be omitted in the pre-operative work-up of patients with anterior
      urethral strictures, thereby avoiding significant radiation load of patients.
Urethral stricture disease (USD) is a medical condition in which a narrowing of the urethral
      lumen occurs due to pathological fibrosis and cicatrix formation of the urethral mucosa and
      surrounding spongious tissue (spongiofibrosis). Urethral strictures may occur at any location
      from the bladder neck to the external urethral meatus and are categorized based on their
      localisation in anterior strictures (including the urethral meatus, penile urethra and bulbar
      urethra) and posterior strictures (including the prostatic urethra and membranous urethra).
      USD is a disease of all ages but the prevalence increases with increasing age since the
      cumulative risk of having had urethral instrumentation equally increases. All processes that
      cause urethral trauma may provoke USD. The majority of strictures nowadays is idiopathic or
      caused by iatrogenic trauma of the urethra.

      The pathological narrowing of the urethral lumen can lead to a wide variety of symptoms which
      ask for specific diagnostic investigations, in which imaging of the urethra plays a central
      role. Retrograde urethrography (RUG) and voiding cystourethrography (VCUG) are considered to
      be the gold standard diagnostic investigation techniques for diagnosis of USD.

      In both techniques, contrast is instilled in the urethra through the urethral meatus and
      radiographic imaging is used to visualize the urethra. RUG and VCUG offer the possibility to
      visualize the urethra completely and to evaluate the number, length and location of urethral
      strictures. On the other hand, these techniques have some crucial disadvantages. First and
      foremost, the radiation load of the genitopelvic region in often young patients is inevitable
      in RUG and VCUG. Secondly, it is impossible to evaluate the degree of spongiofibrosis with
      radiographic imaging.

      In 1988, McAnnich, et al. were the first to describe sonourethrography (SUG) for the
      diagnosis of anterior urethral strictures in males. In this technique, a Foley catheter is
      inserted in the urethral meatus and a physiological solution is instilled in the urethra
      while a linear 7,5 MHz ultrasound probe is placed sagitally over the course of the urethra.
      SUG is not only able to evaluate the length and localization of a US, but it also enables the
      investigator to evaluate the grade of spongiofibrosis.

      Different strudies have shown that SUG has a higher sensitivity for the measurement of
      urethral stricture length compared to classical radiographic imaging such as RUG or VCUG.
      Since the choice of the most adequate surgical technique depends on the length of the
      urethral stricture, correct estimation of the urethral stricture length is of the utmost
      importance.

      The goal of this study is to evaluate the feasibility of the use of sonourethrography as
      single diagnostic tool in the pre-operative diagnostic work-up of males with suspicion of
      anterior urethral strictures. In this way, classic radiographic imaging such as RUG and VCUG
      could be omitted in these patients, saving them from a significant radiation load.

      Fifty patients with penile strictures and fifty patients with bulbar strictures will be
      included in this study. When 50% of patients (25 penile and 25 bulbar strictures) have
      completed the study, an interim analysis will be conducted. If this analysis shows that RUG
      or VCUG can be omitted in 80% or more of patients, the study will be stopped.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single center, prospective feasibility trial
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sonourethrography feasibility: proportion of patients in whom the pre-operative surgical treatment planning was accurate
time frame: 2 years
description: To evaluate the proportion of patients in whom the pre-operative surgical treatment planning was accurate based on sonourethrography only.
measure: Identification of predictors for failure of treatment planning by sonourethrography by regression analysis.
time frame: 2 years
description: To evaluate which factors are predictive for failure of treatment planning by sonourethrography only.
arm group label: Sonourethrography
arm group type: Experimental
description: Ultrasound of the urethra (Sonourethrography - SUG): In this procedure, a Foley catheter is inserted into the top of the urethra and physiological serum is instilled into the urethra while a linear 7.5 MHz ultrasound probe is placed sagitally on the course of the urethra to detect a narrowing of the urethra.
intervention type: Diagnostic Test
intervention name: Sonourethrography
description: Ultrasound of the urethra.
arm group label: Sonourethrography
criteria: 
gender: Male
gender based: Yes
gender description: Only biological males with anterior urethral stricture disease will be included in the study.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Urethral Stricture
mesh term: Constriction, Pathologic