<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/NCT04426682</url>
  </required_header>
  <id_info>
    <org_study_id>ATADEK / 2020.06</org_study_id>
    <nct_id>NCT04426682</nct_id>
  </id_info>
  <brief_title>Incontinence Surgery and Urodynamics Parameters</brief_title>
  <official_title>In Patients Who Underwent Incontinence Surgery and Who Had Postoperative Recurrence Comparison of Urodynamics Parameters Performed in Preoperative and Postoperative Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research 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>
      In patients who have previously had incontinence surgery due to stress incontinence&#xD;
      (Midurethral slings (tvt, tot, etc.)), the symptoms may return in the following years and the&#xD;
      patient can reapply with urinary incontinence. Urodynamic evaluation is important before&#xD;
      stress incontinence surgery to confirm clinical diagnosis based on symptoms and findings and&#xD;
      to determine the factors that may affect the effectiveness of surgery and the possibility of&#xD;
      complications. Urodynamics evaluation is performed in the preoperative period in patients&#xD;
      scheduled for incontinence. Urodynamics evaluation is performed again in patients who applied&#xD;
      with post-operative recurrence due to surgery failure or different reasons.&#xD;
&#xD;
      It is aimed to show whether there is a difference between the urodynamics parameters of these&#xD;
      patients who were examined preoperatively and the urodynamics parameters examined in case of&#xD;
      postoperative failure. Thus, the primary goal; to show which of these parameters has&#xD;
      deterioration or if the surgical method is insufficient if it is within certain limits or&#xD;
      urinary incontinence may recur.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>urodynamics parameters V max</measure>
    <time_frame>5 YEARS</time_frame>
    <description>urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urodynamics parameters bladder complians</measure>
    <time_frame>5 YEARS</time_frame>
    <description>urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urodynamics parameters valsalva leak point pressure</measure>
    <time_frame>5 YEARS</time_frame>
    <description>urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urodynamics parameters abdominal leak point pressure</measure>
    <time_frame>5 YEARS</time_frame>
    <description>urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urodynamics parameters P det</measure>
    <time_frame>5 YEARS</time_frame>
    <description>urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urodynamics parameters P abd</measure>
    <time_frame>5 YEARS</time_frame>
    <description>urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urodynamics parameters P urethral</measure>
    <time_frame>5 YEARS</time_frame>
    <description>urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urodynamics parameters UPP</measure>
    <time_frame>5 YEARS</time_frame>
    <description>urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">210</enrollment>
  <condition>Incontinence</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>post-operative urinary incontinents</arm_group_label>
    <description>In patients who have previously had incontinence surgery due to stress incontinence, symptoms may return in the following years, and the patient may reapply with urinary incontinence. The first group will consist of postoperative urinary incontinence recurrent patients. Patients whose urodynamics are reperformed due to recurrence are the study group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without postoperative urinary incontinence</arm_group_label>
    <description>Patients who previously had incontinence surgery due to stress incontinence and who did not have postopertive urinary incontinence but whose urodynamics were repeated during the routine controls will constitute the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>urodynamics parameters</intervention_name>
    <description>Urodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence.&#xD;
Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons.&#xD;
It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure.</description>
    <arm_group_label>post-operative urinary incontinents</arm_group_label>
    <arm_group_label>without postoperative urinary incontinence</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The files of the patients will be accessed through the system, and patients who have had&#xD;
        incontinence surgery and applied again due to recurrence will be selected. The data of&#xD;
        these patients will be scanned and recorded. The control group will also be created in the&#xD;
        same way, and data of patients who have undergone surgery and have no urinary incontinence&#xD;
        and who have postoperative urodynamics will be recorded. .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have previously undergone surgery for stress incontinence&#xD;
&#xD;
          -  Those who are symptomatic again in their post-operative follow-up (urinary&#xD;
             incontinence),&#xD;
&#xD;
          -  Patients who underwent preoperative and postoperative urodynamics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with chronic diseases or medications that may cause urinary incontinence&#xD;
&#xD;
          -  Patients with mixed or urge incontinence&#xD;
&#xD;
          -  Patients who are not symptomatic postoperatively&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Kanuni Sultan Süleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>33404</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Pınar Kadirogulları</investigator_full_name>
    <investigator_title>Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT04426682
org study id: ATADEK / 2020.06
nct id: NCT04426682
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In patients who have previously had incontinence surgery due to stress incontinence
      (Midurethral slings (tvt, tot, etc.)), the symptoms may return in the following years and the
      patient can reapply with urinary incontinence. Urodynamic evaluation is important before
      stress incontinence surgery to confirm clinical diagnosis based on symptoms and findings and
      to determine the factors that may affect the effectiveness of surgery and the possibility of
      complications. Urodynamics evaluation is performed in the preoperative period in patients
      scheduled for incontinence. Urodynamics evaluation is performed again in patients who applied
      with post-operative recurrence due to surgery failure or different reasons.

      It is aimed to show whether there is a difference between the urodynamics parameters of these
      patients who were examined preoperatively and the urodynamics parameters examined in case of
      postoperative failure. Thus, the primary goal; to show which of these parameters has
      deterioration or if the surgical method is insufficient if it is within certain limits or
      urinary incontinence may recur.
observational model: Case-Control
time perspective: Retrospective
measure: urodynamics parameters V max
time frame: 5 YEARS
description: urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3
measure: urodynamics parameters bladder complians
time frame: 5 YEARS
description: urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians
measure: urodynamics parameters valsalva leak point pressure
time frame: 5 YEARS
description: urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)
measure: urodynamics parameters abdominal leak point pressure
time frame: 5 YEARS
description: urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)
measure: urodynamics parameters P det
time frame: 5 YEARS
description: urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)
measure: urodynamics parameters P abd
time frame: 5 YEARS
description: urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)
measure: urodynamics parameters P urethral
time frame: 5 YEARS
description: urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)
measure: urodynamics parameters UPP
time frame: 5 YEARS
description: urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)
arm group label: post-operative urinary incontinents
description: In patients who have previously had incontinence surgery due to stress incontinence, symptoms may return in the following years, and the patient may reapply with urinary incontinence. The first group will consist of postoperative urinary incontinence recurrent patients. Patients whose urodynamics are reperformed due to recurrence are the study group.
arm group label: without postoperative urinary incontinence
description: Patients who previously had incontinence surgery due to stress incontinence and who did not have postopertive urinary incontinence but whose urodynamics were repeated during the routine controls will constitute the control group.
intervention type: Diagnostic Test
intervention name: urodynamics parameters
description: Urodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence.
Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons.
It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure.
arm group label: post-operative urinary incontinents
arm group label: without postoperative urinary incontinence
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Pınar Kadirogulları
investigator title: Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator