<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/NCT01660438</url>
  </required_header>
  <id_info>
    <org_study_id>TVT 112010</org_study_id>
    <nct_id>NCT01660438</nct_id>
  </id_info>
  <brief_title>Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure</brief_title>
  <official_title>Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cantonal Hospital, Frauenfeld</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hospital, Frauenfeld</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, non-randomized, observational, multicenter study in which urethral&#xD;
      length is measured in women with surgically-correctable stress urinary incontinence who&#xD;
      undergo a suburethral sling operative procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, observational, multicenter study in which urethral&#xD;
      length is measured in women with surgically-correctable stress urinary incontinence who&#xD;
      undergo a suburethral sling operative procedure. Data will be collected from preoperative&#xD;
      urogynecological testing and medical histories. The urethral length will be measured&#xD;
      intraoperatively using scaled catheters. Outcome data, including the development of&#xD;
      postoperative complications, will be collected at several time intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cure rate</measure>
    <time_frame>3 months</time_frame>
    <description>Patients are classified as 'cured' if the postoperative cough test is negative, the 1-hour pad test is negative (less than 2 g) and the degree of subjective suffering improves to over 90% (VAS score of 0 or 1). All other patients are classified as therapeutic 'failures', even though they may experience marked improvement in one of the parameters compared with their preoperative status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pelvic floor sonography</measure>
    <time_frame>Pre-operation, day 1 and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual urine</measure>
    <time_frame>Pre-operation, day 1 and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pad test</measure>
    <time_frame>Pre-operation and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urethral length measurement</measure>
    <time_frame>Intra-operation</time_frame>
    <description>Urethral length will be measured using scaled catheters.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">188</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Stress urinary incontinence</arm_group_label>
    <description>Stress urinary incontinence</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women who have surgically-correctable stress urinary incontinence and undergo a suburethral&#xD;
        sling operative procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has objective, demonstrable signs of stress urinary incontinence (SUI),&#xD;
             including patients with intrinsic sphincter deficiency (ISD). Objective testing&#xD;
             includes: standing stress test, urodynamics evaluation or pad test.&#xD;
&#xD;
          2. Patient is age 18 or older.&#xD;
&#xD;
          3. Patient agrees to participate in the study, including completion of all study-related&#xD;
             procedures and evaluations, and documents this agreement by signing the Institutional&#xD;
             Review Board/Ethics Committee-approved informed consent form.&#xD;
&#xD;
          4. Patient is able to fill in all questionnaires (based on judgment of investigator)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has an associated or suspected neurological disease.&#xD;
&#xD;
          2. Patient has an active lesion or present injury to perineum or urethra.&#xD;
&#xD;
          3. Patient has a urethral obstruction.&#xD;
&#xD;
          4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical&#xD;
             treatment.&#xD;
&#xD;
          5. Patient has current urinary tract infection.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Volker Viereck, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cantonal Hospital, Frauenfeld</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe</name>
      <address>
        <city>Hagen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital im M. Madurowicza</name>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blasenzentrum, Cantonal Hospital</name>
      <address>
        <city>Frauenfeld</city>
        <state>Thurgau</state>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Poland</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>May 19, 2016</last_update_submitted>
  <last_update_submitted_qc>May 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hospital, Frauenfeld</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Volker Viereck</investigator_full_name>
    <investigator_title>Prof. Dr. Volker Viereck</investigator_title>
  </responsible_party>
  <keyword>Stress urinary incontinence</keyword>
  <keyword>Suburethral sling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01660438
org study id: TVT 112010
nct id: NCT01660438
lead sponsor: 
has dmc: Yes
This is a prospective, non-randomized, observational, multicenter study in which urethral
      length is measured in women with surgically-correctable stress urinary incontinence who
      undergo a suburethral sling operative procedure.
This is a prospective, non-randomized, observational, multicenter study in which urethral
      length is measured in women with surgically-correctable stress urinary incontinence who
      undergo a suburethral sling operative procedure. Data will be collected from preoperative
      urogynecological testing and medical histories. The urethral length will be measured
      intraoperatively using scaled catheters. Outcome data, including the development of
      postoperative complications, will be collected at several time intervals.
observational model: Cohort
time perspective: Prospective
measure: Cure rate
time frame: 3 months
description: Patients are classified as 'cured' if the postoperative cough test is negative, the 1-hour pad test is negative (less than 2 g) and the degree of subjective suffering improves to over 90% (VAS score of 0 or 1). All other patients are classified as therapeutic 'failures', even though they may experience marked improvement in one of the parameters compared with their preoperative status.
measure: Pelvic floor sonography
time frame: Pre-operation, day 1 and 3 months
measure: Residual urine
time frame: Pre-operation, day 1 and 3 months
measure: Pad test
time frame: Pre-operation and 3 months
measure: Urethral length measurement
time frame: Intra-operation
description: Urethral length will be measured using scaled catheters.
arm group label: Stress urinary incontinence
description: Stress urinary incontinence
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Volker Viereck, Prof. Dr.
role: Principal Investigator
affiliation: Cantonal Hospital, Frauenfeld
facility: 
facility: 
facility: 
country: Germany
country: Poland
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Cantonal Hospital, Frauenfeld
investigator full name: Prof. Dr. Volker Viereck
investigator title: Prof. Dr. Volker Viereck
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided