<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/NCT03763097</url>
  </required_header>
  <id_info>
    <org_study_id>Ba2018-4</org_study_id>
    <nct_id>NCT03763097</nct_id>
  </id_info>
  <brief_title>Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success</brief_title>
  <official_title>Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bartin State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bartin State Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transperineal ultrasonography is gaining importance in preoperative and postoperative&#xD;
      evaluation of the patient with urinary incontinence with allowing well detailed information&#xD;
      about the anterior compartment.&#xD;
&#xD;
      There is little evidence that transperineal sonography can aid surgeons to predict the&#xD;
      success or failure after mid-urethral slings.&#xD;
&#xD;
      We aimed to investigate the efficacy of sonography in mini-sling operations to predict the&#xD;
      success or failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women who are scheduled for anti-incontinence operation due to their stress urinary&#xD;
      incontinence will be pre- and postoperatively evaluated by transperineal and introital&#xD;
      ultrasound.&#xD;
&#xD;
      Patients will be followed for at least 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">April 21, 2019</completion_date>
  <primary_completion_date type="Actual">April 21, 2019</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>The correlation of failure with the sonographic features of the mesh</measure>
    <time_frame>Evaluation at postoperative 1st and 4th weeks</time_frame>
    <description>Patients will be accepted as failure if their stress test is positive Sonographic features of the mesh includes the shape of the mesh, the distance to the mid-urethra, the position related to the proximal urethra and the angle between the mesh arms on coronal axis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nocturia</measure>
    <time_frame>Evaluation at postoperative 1st and 4th weeks and preoperatively</time_frame>
    <description>The nocturia episodes will be evaluated by a &quot;non-validated&quot; Likert scale (between 0-3). Minimum and minimum scores are between 0 and 3. &quot;0&quot; will mean no episode of urinating during the sleep. &quot;1&quot; will mean one episode of nocturia. &quot;2&quot; will mean two episodes of nocturia. &quot;3&quot; will mean three or more episodes of nocturia. Higher values represent worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urge symptoms</measure>
    <time_frame>Evaluation at postoperative 1st and 4th weeks and preoperatively</time_frame>
    <description>Michigan Incontinence Severity Index (M-ISI) scale will be used to assess subjective outcome including urge symptoms. This scale has ten items, consisting of a total M-ISI domain (the sum of items 1-8) and a distinct Bother domain (the sum of items 9 and 10). The total M-ISI score consists of three subdomains (items 1-3 for stress urinary incontinence [SUI], items 4-6 for urge urinary incontinence [UUI], and items 7 and 8 for Pad usage [PU]. The responses for each item range from 0 to 4 on a Likert-type scale, with higher values representing greater symptoms and greater bother. Total domain and subdomain scores are obtained by simply adding the respective answers. The minimally important difference has been determined for the following domains/subdomains: total M-ISI (4 points), SUI (2 points), UUI (2 points), and PU (1 point).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective success</measure>
    <time_frame>Evaluation at postoperative 1st and 4th weeks</time_frame>
    <description>Patient Global Improvement of Improvement will be used to assess the subjective success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POP-Q</measure>
    <time_frame>Evaluation at postoperative 1st and 4th weeks and preoperatively</time_frame>
    <description>POP-Q measurements will be assessed to measure the pelvic floor prolapse if exist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior compartment mobility distances</measure>
    <time_frame>Evaluation at postoperative 1st and 4th weeks and preoperatively</time_frame>
    <description>On maximal Valsalva maneuver: Bladder neck descent (mm), pubourethral distance (mm), urethral thickness (mm, measured at proximal, mid and distal portions) and urethral length (mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior compartment mobility angles</measure>
    <time_frame>Evaluation at postoperative 1st and 4th weeks and preoperatively</time_frame>
    <description>On maximal Valsalva maneuver: Proximal urethral rotation (degree), retrovesical angle (degree)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">64</enrollment>
  <condition>Urinary Incontinence,Stress</condition>
  <arm_group>
    <arm_group_label>participants</arm_group_label>
    <description>Patients who are scheduled for single-incision needleless (Contasure-needleless®) mini-sling for their stress urinary incontinence. They will be assessed by Pelvic floor ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pelvic floor ultrasound</intervention_name>
    <description>Pelvic floor ultrasound will include transperineal and introital ultrasound</description>
    <arm_group_label>participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have stress urinary incontinence and who are scheduled for needleless&#xD;
        mini-sling operation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinically stress urinary incontinence&#xD;
&#xD;
          -  Patients who claim that their condition severely impair their quality of life&#xD;
&#xD;
          -  Patients who are failed on conservative management (life style changes and pelvic&#xD;
             floor exercises)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have unregulated diabetes mellitus (they will be included after&#xD;
             appropriate and sustainable blood glucose regulation)&#xD;
&#xD;
          -  Patients who have neurological condition that may affect the incontinence&#xD;
&#xD;
          -  Patients who have psychiatric disease that may affect the subjective evaluation.&#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>Murat Yassa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bartin State Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bartin State Hospital</name>
      <address>
        <city>Bartin</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Dogan O, Kaya AE, Pulatoglu C, Basbug A, Yassa M. A randomized comparison of a single-incision needleless (Contasure-needleless(R)) mini-sling versus an inside-out transobturator (Contasure-KIM(R)) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. Int Urogynecol J. 2018 Sep;29(9):1387-1395. doi: 10.1007/s00192-018-3624-4. Epub 2018 Mar 16.</citation>
    <PMID>29549394</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 21, 2019</last_update_submitted>
  <last_update_submitted_qc>April 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bartin State Hospital</investigator_affiliation>
    <investigator_full_name>Murat Yassa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pelvic floor ultrasonography</keyword>
  <keyword>transperineal ultrasound</keyword>
  <keyword>introital ultrasound</keyword>
  <keyword>mini-sling</keyword>
  <keyword>needleless</keyword>
  <keyword>Urinary Incontinence,Stress</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/NCT03763097
org study id: Ba2018-4
nct id: NCT03763097
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Transperineal ultrasonography is gaining importance in preoperative and postoperative
      evaluation of the patient with urinary incontinence with allowing well detailed information
      about the anterior compartment.

      There is little evidence that transperineal sonography can aid surgeons to predict the
      success or failure after mid-urethral slings.

      We aimed to investigate the efficacy of sonography in mini-sling operations to predict the
      success or failure.
Women who are scheduled for anti-incontinence operation due to their stress urinary
      incontinence will be pre- and postoperatively evaluated by transperineal and introital
      ultrasound.

      Patients will be followed for at least 1 year.
observational model: Cohort
time perspective: Prospective
measure: The correlation of failure with the sonographic features of the mesh
time frame: Evaluation at postoperative 1st and 4th weeks
description: Patients will be accepted as failure if their stress test is positive Sonographic features of the mesh includes the shape of the mesh, the distance to the mid-urethra, the position related to the proximal urethra and the angle between the mesh arms on coronal axis
measure: Nocturia
time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
description: The nocturia episodes will be evaluated by a "non-validated" Likert scale (between 0-3). Minimum and minimum scores are between 0 and 3. "0" will mean no episode of urinating during the sleep. "1" will mean one episode of nocturia. "2" will mean two episodes of nocturia. "3" will mean three or more episodes of nocturia. Higher values represent worse outcome.
measure: Urge symptoms
time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
description: Michigan Incontinence Severity Index (M-ISI) scale will be used to assess subjective outcome including urge symptoms. This scale has ten items, consisting of a total M-ISI domain (the sum of items 1-8) and a distinct Bother domain (the sum of items 9 and 10). The total M-ISI score consists of three subdomains (items 1-3 for stress urinary incontinence [SUI], items 4-6 for urge urinary incontinence [UUI], and items 7 and 8 for Pad usage [PU]. The responses for each item range from 0 to 4 on a Likert-type scale, with higher values representing greater symptoms and greater bother. Total domain and subdomain scores are obtained by simply adding the respective answers. The minimally important difference has been determined for the following domains/subdomains: total M-ISI (4 points), SUI (2 points), UUI (2 points), and PU (1 point).
measure: Subjective success
time frame: Evaluation at postoperative 1st and 4th weeks
description: Patient Global Improvement of Improvement will be used to assess the subjective success
measure: POP-Q
time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
description: POP-Q measurements will be assessed to measure the pelvic floor prolapse if exist
measure: Anterior compartment mobility distances
time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
description: On maximal Valsalva maneuver: Bladder neck descent (mm), pubourethral distance (mm), urethral thickness (mm, measured at proximal, mid and distal portions) and urethral length (mm)
measure: Anterior compartment mobility angles
time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
description: On maximal Valsalva maneuver: Proximal urethral rotation (degree), retrovesical angle (degree)
arm group label: participants
description: Patients who are scheduled for single-incision needleless (Contasure-needleless®) mini-sling for their stress urinary incontinence. They will be assessed by Pelvic floor ultrasound
intervention type: Diagnostic Test
intervention name: Pelvic floor ultrasound
description: Pelvic floor ultrasound will include transperineal and introital ultrasound
arm group label: participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Murat Yassa, MD
role: Principal Investigator
affiliation: Bartin State Hospital
facility: 
country: Turkey
citation: Dogan O, Kaya AE, Pulatoglu C, Basbug A, Yassa M. A randomized comparison of a single-incision needleless (Contasure-needleless(R)) mini-sling versus an inside-out transobturator (Contasure-KIM(R)) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. Int Urogynecol J. 2018 Sep;29(9):1387-1395. doi: 10.1007/s00192-018-3624-4. Epub 2018 Mar 16.
PMID: 29549394
responsible party type: Principal Investigator
investigator affiliation: Bartin State Hospital
investigator full name: Murat Yassa
investigator title: Principal Investigator
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided