<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/NCT03037008</url>
  </required_header>
  <id_info>
    <org_study_id>2016-00054</org_study_id>
    <nct_id>NCT03037008</nct_id>
  </id_info>
  <brief_title>Perineal Ultrasound in Men Before and After Radical Prostatectomy</brief_title>
  <official_title>Comparison of Perineal Ultrasound in Men Before and After Radical Prostatectomy and in Incontinent Men After Radical Prostatectomy Before and After Operative Treatment With Male Sling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Winterthur KSW</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Winterthur KSW</source>
  <oversight_info>
    <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>
      Prospective study to evaluate a new technique. Comparison of perineal sonography in men&#xD;
      before and after radical prostatectomy and in incontinent men after radical prostatectomy&#xD;
      before and after operative treatment with male sling and comparison with pre- and&#xD;
      postoperative functional MRI&#xD;
&#xD;
      Inclusion / Exclusion criteria: Inclusion: male, elder than 18years, planned RALP or history&#xD;
      of RALP and PPSUI (Post Prostatectomy Stress Urinary Incontinence).&#xD;
&#xD;
      Exclusion: Patients with history of urinary incontinence before radical prostatectomy.&#xD;
      Patients with history of radiotherapy in the pelvis. Other diseases involving pelvic floor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After radical prostatectomy, a part of all patients suffer from urinary incontinence. Until&#xD;
      now, only few information exists about the functional anatomy of the male pelvic floor,&#xD;
      especially in incontinent men. Transperineal ultrasound is non-hazardous, cheap and easy&#xD;
      available method to visualize the pelvic floor and is well established in gynecological&#xD;
      examination. literature described the technique of transperineal ultrasound but there are no&#xD;
      well established reference lines measured and the number of examined men in the series are&#xD;
      small. The investigators want to confirm the published data and probably find new reference&#xD;
      lines/parameters, e.g. the distance between the posterior wall of the symphysis to the&#xD;
      posterior wall of the urethra in a direct, horizontal line. At the moment, the authors&#xD;
      published data about urethral mobility, bladder neck opening and urethral angle. The&#xD;
      investigators estimate that there is also a possible significant difference in the distance&#xD;
      from the urethra to the symphysis in incontinent men compare to continent men after radical&#xD;
      prostatectomy.&#xD;
&#xD;
      Incontinent men can be treated by pelvic floor exercises or, in case of persisting&#xD;
      incontinence, with operative treatment. There exists several techniques of implanted slings&#xD;
      and meshes, similar to the better known TVT (tension free vaginal tape) in female urinary&#xD;
      incontinence, besides the gold standard - the implantation of an artificial sphincter&#xD;
      prosthesis. The sling-operations are less invasive, cheaper and preferred by patients du to&#xD;
      the fact, that normal micturition is still possible. Nevertheless, around 20% of patients&#xD;
      stay incontinent after sling operation. At the moment, it is unknown why they do not profit&#xD;
      from the sling. In a previous study functional pelvic cine-MRI in patients with&#xD;
      post-prostatectomy incontinence before and after implantation of a bulbourethral composite&#xD;
      Suspension were compared. The investigators could find significant differences in the&#xD;
      membranous urethral length and could show an elevation oft he bladder neck postoperatively&#xD;
      but no significant MRI differences were found between patients showing clinical success or&#xD;
      failure. With perineal sonography, the investigators want to establish a prediction tool for&#xD;
      sling-operations in patients with urinary stress incontinence after radical prostatectomy.&#xD;
&#xD;
      The purpose of this study is to evaluate whether perineal ultrasound in men is an adequate&#xD;
      possibility to evaluate the pelvic floor and its function in the regard of urinary&#xD;
      incontinence. The study is trying to find a prediction tool for bulbourethral composite&#xD;
      suspension (sling-operation) using transperineal sonography. The investigators further want&#xD;
      to establish and confirm parameters/standards to measure the male pelvic floor with the new&#xD;
      technique of perineal sonography in men. Further the investigators want to to compare&#xD;
      findings from perineal sonography with data from functional MRI in men with urinary&#xD;
      incontinence following radical prostatectomy before and after bulbourethral composite&#xD;
      suspension. Findings from perineal sonography with results from questionnaires concerning&#xD;
      quality of life will be compared.&#xD;
&#xD;
      There is a comparison study with two arms to compare the anatomy and function of the pelvic&#xD;
      floor with perineal ultrasound from men prior to RALP due to prostate cancer, without prior&#xD;
      history of diseases involving the pelvic floor.&#xD;
&#xD;
      Participants will be asked to participate the study during routine consultations in the&#xD;
      department of Kantonsspital Winterthur or selected in our database of the clinical&#xD;
      information system searching for radical prostatectomies in the past and recruit these&#xD;
      participants by telephone.&#xD;
&#xD;
      In a modified lithotomy position (supine position with elevated legs), probands will get an&#xD;
      examination of their pelvic floor by using a common ultrasound probe head on the perineum.&#xD;
      During the examination, the bladder should be filled with around 300ml. If patient appear&#xD;
      with empty bladder, the examination can be repeated on an other date. During the examination,&#xD;
      the pelvic floor is observed during rest, coughing and valsalva-maneuver. One examination&#xD;
      takes around 30minutes. During ultrasound, the investigators want to illustrate the urethral&#xD;
      mobility, the bladder neck opening and the urethral angle as well as the distance from the&#xD;
      urethra to the symphysis.&#xD;
&#xD;
      Urinary incontinence is measured by 24h pad test: Probands have to collect their pads, and&#xD;
      scale them before and after using it during 24 hours, to measure the difference. The&#xD;
      difference (after-before) shows the amount of lost urine. The results don't have to be exact&#xD;
      and a result with a precision of approximately 50ml (= 50g) is acceptable.&#xD;
&#xD;
      Results from urinary analysis (culture) are taken out of medical history from the hospitals&#xD;
      database during the period of incontinence to exclude urinary tract infection. If no data is&#xD;
      available, urinary analysis will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">February 5, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>perineal sonography</measure>
    <time_frame>1 - 4 weeks before RALP</time_frame>
    <description>In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IPSS (International Prostate Symptom Score)</measure>
    <time_frame>1 - 4 weeks before RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24h pad test</measure>
    <time_frame>1 - 4 weeks before RALP</time_frame>
    <description>incontinence is measured by 24 pad test. pads are measured through scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>perineal sonography</measure>
    <time_frame>6 weeks after RALP</time_frame>
    <description>In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IPSS (International Prostate Symptom Score)</measure>
    <time_frame>6 weeks after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24h pad test</measure>
    <time_frame>6 weeks after RALP</time_frame>
    <description>incontinence is measured by 24 pad test. pads are measured through scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>perineal sonography</measure>
    <time_frame>6 months after RALP</time_frame>
    <description>In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IPSS (International Prostate Symptom Score)</measure>
    <time_frame>6 months after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24h pad test</measure>
    <time_frame>6 months after RALP</time_frame>
    <description>incontinence is measured by 24 pad test. pads are measured through scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)</measure>
    <time_frame>1 - 4 weeks before RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)</measure>
    <time_frame>6 weeks after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)</measure>
    <time_frame>6 months after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IIEF 5 (International Index of Erectile Function)</measure>
    <time_frame>1 - 4 weeks before RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IIEF 5 (International Index of Erectile Function)</measure>
    <time_frame>6 weeks after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IIEF 5 (International Index of Erectile Function)</measure>
    <time_frame>6 months after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS QoL (Visual Analogue Scale - Quality of Life)</measure>
    <time_frame>1 - 4 weeks before RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS QoL (Visual Analogue Scale - Quality of Life)</measure>
    <time_frame>6 weeks after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS QoL (Visual Analogue Scale - Quality of Life)</measure>
    <time_frame>6 months after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PGI (Patient Generated Index)</measure>
    <time_frame>1 - 4 weeks before RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PGI (Patient Generated Index)</measure>
    <time_frame>6 weeks after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PGI (Patient Generated Index)</measure>
    <time_frame>6 months after RALP</time_frame>
    <description>score Points (numeric)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Urinary Incontinence, Stress</condition>
  <arm_group>
    <arm_group_label>continent men after RALP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>perineal sonography, questionnaires, 24h pad tests</description>
  </arm_group>
  <arm_group>
    <arm_group_label>incontinent men after RALP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>perineal sonography, questionnaires, 24h pad tests</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Perineal Sonography</intervention_name>
    <description>In a modified lithotomy position (supine position with elevated legs), probands will get an examination of their pelvic floor by using a common ultrasound probe head on the perineum. During the examination, the bladder should be filled with around 300ml. If patient appear with empty bladder, the examination can be repeated on an other date. During the examination, the pelvic floor will be observed during rest, coughing and valsalva-maneuver. One examination takes around 30minutes. During ultrasound, we want to illustrate the urethral mobility, the bladder neck opening and the urethral angle as well as the distance from the urethra to the symphysis.</description>
    <arm_group_label>continent men after RALP</arm_group_label>
    <arm_group_label>incontinent men after RALP</arm_group_label>
    <other_name>Perineal Ultrasound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male,&#xD;
&#xD;
          -  Elder than 18years&#xD;
&#xD;
          -  Planned RALP or history of RALP and PPSUI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of urinary incontinence before radical prostatectomy.&#xD;
&#xD;
          -  Patients with history of radiotherapy in the pelvis.&#xD;
&#xD;
          -  Other diseases involving pelvic floor.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hubert John, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Head of Kantonsspital Winterthur Urology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonsspital Winterthur</name>
      <address>
        <city>Winterthur</city>
        <zip>8401</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 2, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>perineal sonography</keyword>
  <keyword>male sling</keyword>
  <keyword>post prostatectomy incontinence</keyword>
  <keyword>ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <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/NCT03037008
org study id: 2016-00054
nct id: NCT03037008
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Prospective study to evaluate a new technique. Comparison of perineal sonography in men
      before and after radical prostatectomy and in incontinent men after radical prostatectomy
      before and after operative treatment with male sling and comparison with pre- and
      postoperative functional MRI

      Inclusion / Exclusion criteria: Inclusion: male, elder than 18years, planned RALP or history
      of RALP and PPSUI (Post Prostatectomy Stress Urinary Incontinence).

      Exclusion: Patients with history of urinary incontinence before radical prostatectomy.
      Patients with history of radiotherapy in the pelvis. Other diseases involving pelvic floor.
After radical prostatectomy, a part of all patients suffer from urinary incontinence. Until
      now, only few information exists about the functional anatomy of the male pelvic floor,
      especially in incontinent men. Transperineal ultrasound is non-hazardous, cheap and easy
      available method to visualize the pelvic floor and is well established in gynecological
      examination. literature described the technique of transperineal ultrasound but there are no
      well established reference lines measured and the number of examined men in the series are
      small. The investigators want to confirm the published data and probably find new reference
      lines/parameters, e.g. the distance between the posterior wall of the symphysis to the
      posterior wall of the urethra in a direct, horizontal line. At the moment, the authors
      published data about urethral mobility, bladder neck opening and urethral angle. The
      investigators estimate that there is also a possible significant difference in the distance
      from the urethra to the symphysis in incontinent men compare to continent men after radical
      prostatectomy.

      Incontinent men can be treated by pelvic floor exercises or, in case of persisting
      incontinence, with operative treatment. There exists several techniques of implanted slings
      and meshes, similar to the better known TVT (tension free vaginal tape) in female urinary
      incontinence, besides the gold standard - the implantation of an artificial sphincter
      prosthesis. The sling-operations are less invasive, cheaper and preferred by patients du to
      the fact, that normal micturition is still possible. Nevertheless, around 20% of patients
      stay incontinent after sling operation. At the moment, it is unknown why they do not profit
      from the sling. In a previous study functional pelvic cine-MRI in patients with
      post-prostatectomy incontinence before and after implantation of a bulbourethral composite
      Suspension were compared. The investigators could find significant differences in the
      membranous urethral length and could show an elevation oft he bladder neck postoperatively
      but no significant MRI differences were found between patients showing clinical success or
      failure. With perineal sonography, the investigators want to establish a prediction tool for
      sling-operations in patients with urinary stress incontinence after radical prostatectomy.

      The purpose of this study is to evaluate whether perineal ultrasound in men is an adequate
      possibility to evaluate the pelvic floor and its function in the regard of urinary
      incontinence. The study is trying to find a prediction tool for bulbourethral composite
      suspension (sling-operation) using transperineal sonography. The investigators further want
      to establish and confirm parameters/standards to measure the male pelvic floor with the new
      technique of perineal sonography in men. Further the investigators want to to compare
      findings from perineal sonography with data from functional MRI in men with urinary
      incontinence following radical prostatectomy before and after bulbourethral composite
      suspension. Findings from perineal sonography with results from questionnaires concerning
      quality of life will be compared.

      There is a comparison study with two arms to compare the anatomy and function of the pelvic
      floor with perineal ultrasound from men prior to RALP due to prostate cancer, without prior
      history of diseases involving the pelvic floor.

      Participants will be asked to participate the study during routine consultations in the
      department of Kantonsspital Winterthur or selected in our database of the clinical
      information system searching for radical prostatectomies in the past and recruit these
      participants by telephone.

      In a modified lithotomy position (supine position with elevated legs), probands will get an
      examination of their pelvic floor by using a common ultrasound probe head on the perineum.
      During the examination, the bladder should be filled with around 300ml. If patient appear
      with empty bladder, the examination can be repeated on an other date. During the examination,
      the pelvic floor is observed during rest, coughing and valsalva-maneuver. One examination
      takes around 30minutes. During ultrasound, the investigators want to illustrate the urethral
      mobility, the bladder neck opening and the urethral angle as well as the distance from the
      urethra to the symphysis.

      Urinary incontinence is measured by 24h pad test: Probands have to collect their pads, and
      scale them before and after using it during 24 hours, to measure the difference. The
      difference (after-before) shows the amount of lost urine. The results don't have to be exact
      and a result with a precision of approximately 50ml (= 50g) is acceptable.

      Results from urinary analysis (culture) are taken out of medical history from the hospitals
      database during the period of incontinence to exclude urinary tract infection. If no data is
      available, urinary analysis will be collected.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: perineal sonography
time frame: 1 - 4 weeks before RALP
description: In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
measure: IPSS (International Prostate Symptom Score)
time frame: 1 - 4 weeks before RALP
description: score Points (numeric)
measure: 24h pad test
time frame: 1 - 4 weeks before RALP
description: incontinence is measured by 24 pad test. pads are measured through scales.
measure: perineal sonography
time frame: 6 weeks after RALP
description: In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
measure: IPSS (International Prostate Symptom Score)
time frame: 6 weeks after RALP
description: score Points (numeric)
measure: 24h pad test
time frame: 6 weeks after RALP
description: incontinence is measured by 24 pad test. pads are measured through scales.
measure: perineal sonography
time frame: 6 months after RALP
description: In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
measure: IPSS (International Prostate Symptom Score)
time frame: 6 months after RALP
description: score Points (numeric)
measure: 24h pad test
time frame: 6 months after RALP
description: incontinence is measured by 24 pad test. pads are measured through scales.
measure: ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
time frame: 1 - 4 weeks before RALP
description: score Points (numeric)
measure: ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
time frame: 6 weeks after RALP
description: score Points (numeric)
measure: ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
time frame: 6 months after RALP
description: score Points (numeric)
measure: IIEF 5 (International Index of Erectile Function)
time frame: 1 - 4 weeks before RALP
description: score Points (numeric)
measure: IIEF 5 (International Index of Erectile Function)
time frame: 6 weeks after RALP
description: score Points (numeric)
measure: IIEF 5 (International Index of Erectile Function)
time frame: 6 months after RALP
description: score Points (numeric)
measure: VAS QoL (Visual Analogue Scale - Quality of Life)
time frame: 1 - 4 weeks before RALP
description: score Points (numeric)
measure: VAS QoL (Visual Analogue Scale - Quality of Life)
time frame: 6 weeks after RALP
description: score Points (numeric)
measure: VAS QoL (Visual Analogue Scale - Quality of Life)
time frame: 6 months after RALP
description: score Points (numeric)
measure: PGI (Patient Generated Index)
time frame: 1 - 4 weeks before RALP
description: score Points (numeric)
measure: PGI (Patient Generated Index)
time frame: 6 weeks after RALP
description: score Points (numeric)
measure: PGI (Patient Generated Index)
time frame: 6 months after RALP
description: score Points (numeric)
arm group label: continent men after RALP
arm group type: Active Comparator
description: perineal sonography, questionnaires, 24h pad tests
arm group label: incontinent men after RALP
arm group type: Active Comparator
description: perineal sonography, questionnaires, 24h pad tests
intervention type: Device
intervention name: Perineal Sonography
description: In a modified lithotomy position (supine position with elevated legs), probands will get an examination of their pelvic floor by using a common ultrasound probe head on the perineum. During the examination, the bladder should be filled with around 300ml. If patient appear with empty bladder, the examination can be repeated on an other date. During the examination, the pelvic floor will be observed during rest, coughing and valsalva-maneuver. One examination takes around 30minutes. During ultrasound, we want to illustrate the urethral mobility, the bladder neck opening and the urethral angle as well as the distance from the urethra to the symphysis.
arm group label: continent men after RALP
arm group label: incontinent men after RALP
other name: Perineal Ultrasound
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hubert John, Prof.
role: Study Chair
affiliation: Head of Kantonsspital Winterthur Urology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Urinary Incontinence, Stress
sharing ipd: No