<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/NCT03831217</url>
  </required_header>
  <id_info>
    <org_study_id>29081991</org_study_id>
    <nct_id>NCT03831217</nct_id>
  </id_info>
  <brief_title>Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery</brief_title>
  <official_title>Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery Using Urogynecologic Ultrasonographic and Urodynamic Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara University</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 patients who underwent mid-urethral sling surgery for stress urinary incontinence will&#xD;
      evaluate. The aim of our study is to assess long term surgical outcomes and post operative&#xD;
      clinical findings include physical examinations, quality of life questionnaires,&#xD;
      ultrasonographic measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and&#xD;
      Gynecology Department since 2007 will be included.&#xD;
&#xD;
      Primary outcome measure is to describe factors effecting long term success in mid-urethral&#xD;
      sling surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2019</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>Objective cure rates</measure>
    <time_frame>1-11 years</time_frame>
    <description>Objective cure is negative cough stress test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective cure rates</measure>
    <time_frame>1-11 years</time_frame>
    <description>Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tape localization</measure>
    <time_frame>1-11 years</time_frame>
    <description>Length of urethra, length of mesh, distance between urethra and mesh, distance between mesh and bladder neck will be measured. The correlation between these parameters and surgical success will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life(QoL) after surgery</measure>
    <time_frame>1-11 years</time_frame>
    <description>Impact of surgery on quality of life will be evaluated by QoL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>1-11 years</time_frame>
    <description>Patient satisfaction will be assessed using a 10-points Visual Analogue Scale (VAS) that ranged from ''complete achievement of my goal'' (10 points) to ''no achievement of my goal'' (0 points). Patient Global Impression of Improvement (PGI-I) and VAS scale correlation will be evaluated.</description>
  </secondary_outcome>
  <enrollment type="Actual">58</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mid urethral sling surgery</intervention_name>
    <description>patients with clinically and/or urodynamically proven stress urinary incontinence underwent mid urethral sling surgery under general anesthesia.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with underwent mid-urethral surgery in Ankara University Obstetrics and Gynecology&#xD;
        Department since 2007 at any age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing surgery in Ankara University Obstetrics and Gynecology Department since&#xD;
             2007&#xD;
&#xD;
          -  Patients come to follow up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability in verbal and written communication&#xD;
&#xD;
          -  impairment in cognitive functions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Kaan Baydemir</name>
      <address>
        <city>Ankara</city>
        <state>Çankaya</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara University</investigator_affiliation>
    <investigator_full_name>kaan baydemir</investigator_full_name>
    <investigator_title>kaan baydemir md</investigator_title>
  </responsible_party>
  <keyword>Trans-Obturator Tape</keyword>
  <keyword>Tension-Free Vaginal Tape</keyword>
  <keyword>Mid-Urethral Sling surgeries</keyword>
  <keyword>Stress Urinary Incontinence</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/NCT03831217
org study id: 29081991
nct id: NCT03831217
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The patients who underwent mid-urethral sling surgery for stress urinary incontinence will
      evaluate. The aim of our study is to assess long term surgical outcomes and post operative
      clinical findings include physical examinations, quality of life questionnaires,
      ultrasonographic measurements.
Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and
      Gynecology Department since 2007 will be included.

      Primary outcome measure is to describe factors effecting long term success in mid-urethral
      sling surgery.
observational model: Cohort
time perspective: Prospective
measure: Objective cure rates
time frame: 1-11 years
description: Objective cure is negative cough stress test.
measure: Subjective cure rates
time frame: 1-11 years
description: Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured.
measure: Tape localization
time frame: 1-11 years
description: Length of urethra, length of mesh, distance between urethra and mesh, distance between mesh and bladder neck will be measured. The correlation between these parameters and surgical success will be evaluated
measure: Quality of life(QoL) after surgery
time frame: 1-11 years
description: Impact of surgery on quality of life will be evaluated by QoL questionnaire
measure: Patient satisfaction
time frame: 1-11 years
description: Patient satisfaction will be assessed using a 10-points Visual Analogue Scale (VAS) that ranged from ''complete achievement of my goal'' (10 points) to ''no achievement of my goal'' (0 points). Patient Global Impression of Improvement (PGI-I) and VAS scale correlation will be evaluated.
intervention type: Procedure
intervention name: mid urethral sling surgery
description: patients with clinically and/or urodynamically proven stress urinary incontinence underwent mid urethral sling surgery under general anesthesia.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara University
investigator full name: kaan baydemir
investigator title: kaan baydemir md
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided