<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/NCT03772015</url>
  </required_header>
  <id_info>
    <org_study_id>240918</org_study_id>
    <nct_id>NCT03772015</nct_id>
  </id_info>
  <brief_title>The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension</brief_title>
  <official_title>The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bartin State Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sisli Hamidiye Etfal 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>
      Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative&#xD;
      to sacropexy to treat female genital apical prolapse. Investigators hypothesized that&#xD;
      uterus-preserving lateral suspension provides a better anatomical positioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may&#xD;
      properly mimic cardinal ligament and restore the normal vaginal axis. To prove the null&#xD;
      hypothesis, it is planned to compare the vaginal axis on Magnetic Resonans Imaging taken&#xD;
      preoperatively and postoperatively in patients who are scheduled for lateral mesh suspension&#xD;
      for apical prolapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 9, 2018</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal axis</measure>
    <time_frame>at 6th months after the operation</time_frame>
    <description>From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.&#xD;
The angles between the pubococcygeal line and lower vaginal segment (angle A), between the levator plate and the pubococcygeal (angle B) and between lower and upper vaginal segments (angle C) will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaginal distances</measure>
    <time_frame>at 6th months after the operation</time_frame>
    <description>The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urge Symptoms</measure>
    <time_frame>Evaluation at postoperative 6th month</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>Prolapse symptoms</measure>
    <time_frame>Evaluation at postoperative 6th month</time_frame>
    <description>The POP-SS consists of seven items, each with a 5-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). A total score (range 0-28) is calculated by summing the seven individual symptom responses to derive the POP-SS score. In addition, women indicate which one of the seven symptoms causes them most bother.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual functions</measure>
    <time_frame>Evaluation at postoperative 6th month</time_frame>
    <description>The FSFI evaluates sexual functioning in women and comprises of 19 questions with different answer choice scales referring the sexual life in the previous 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter, there is a threshold at 26.55 which means tFhat all values below are classed as indicating female sexual dysfunction (FSD). The domain scores are obtained as the sum of points attributed to questions in that domain multiplied by the domain factor.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Prolapse Genital</condition>
  <condition>Anatomical Pathological Condition</condition>
  <arm_group>
    <arm_group_label>Study</arm_group_label>
    <description>Patients who had the operation of &quot;laparoscopic lateral mesh suspension&quot; for apical prolapse will have magnetic resonance imaging preoperatively and at postoperative 6th month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Multiparous, sexually active participants who have grade 0 or 1 (asymptomatic if exists) prolapse will have magnetic resonance imaging as a control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Magnetic resonance imaging</intervention_name>
    <description>MRI will be performed using a standard body spiral in the supine position with 5 mm section thickness, on the axial, coronal and sagittal planes and the diffusion weighted images acquired will be evaluated by a specialised radiologist who will be blind to the participants.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are scheduled for lateral mesh suspension operation to treat apical prolapse.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female genital prolapse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had pouch of Douglas obliteration&#xD;
&#xD;
          -  Patients with enterocele&#xD;
&#xD;
          -  Patients who have any congenital or acquired anatomic and reproductive anomaly&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ozan Dogan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamidiye Sisli Etfal Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Murat Yassa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bartin State Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamidiye Sisli Etfal Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.</citation>
    <PMID>28816554</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>OZAN DOGAN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>laparoscopic lateral mesh suspension</keyword>
  <keyword>lateral abdominocervicopexy</keyword>
  <keyword>apical prolapse</keyword>
  <keyword>anterior prolapse</keyword>
  <keyword>vaginal axis</keyword>
  <keyword>magnetic resonance imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pathological Conditions, Anatomical</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/NCT03772015
org study id: 240918
nct id: NCT03772015
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative
      to sacropexy to treat female genital apical prolapse. Investigators hypothesized that
      uterus-preserving lateral suspension provides a better anatomical positioning.
Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may
      properly mimic cardinal ligament and restore the normal vaginal axis. To prove the null
      hypothesis, it is planned to compare the vaginal axis on Magnetic Resonans Imaging taken
      preoperatively and postoperatively in patients who are scheduled for lateral mesh suspension
      for apical prolapse.
observational model: Case-Control
time perspective: Prospective
measure: Vaginal axis
time frame: at 6th months after the operation
description: From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.
The angles between the pubococcygeal line and lower vaginal segment (angle A), between the levator plate and the pubococcygeal (angle B) and between lower and upper vaginal segments (angle C) will be measured.
measure: Vaginal distances
time frame: at 6th months after the operation
description: The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.
measure: Urge Symptoms
time frame: Evaluation at postoperative 6th month
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: Prolapse symptoms
time frame: Evaluation at postoperative 6th month
description: The POP-SS consists of seven items, each with a 5-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). A total score (range 0-28) is calculated by summing the seven individual symptom responses to derive the POP-SS score. In addition, women indicate which one of the seven symptoms causes them most bother.
measure: Sexual functions
time frame: Evaluation at postoperative 6th month
description: The FSFI evaluates sexual functioning in women and comprises of 19 questions with different answer choice scales referring the sexual life in the previous 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter, there is a threshold at 26.55 which means tFhat all values below are classed as indicating female sexual dysfunction (FSD). The domain scores are obtained as the sum of points attributed to questions in that domain multiplied by the domain factor.
arm group label: Study
description: Patients who had the operation of "laparoscopic lateral mesh suspension" for apical prolapse will have magnetic resonance imaging preoperatively and at postoperative 6th month
arm group label: Control
description: Multiparous, sexually active participants who have grade 0 or 1 (asymptomatic if exists) prolapse will have magnetic resonance imaging as a control group
intervention type: Diagnostic Test
intervention name: Magnetic resonance imaging
description: MRI will be performed using a standard body spiral in the supine position with 5 mm section thickness, on the axial, coronal and sagittal planes and the diffusion weighted images acquired will be evaluated by a specialised radiologist who will be blind to the participants.
arm group label: Control
arm group label: Study
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ozan Dogan, MD
role: Principal Investigator
affiliation: Hamidiye Sisli Etfal Training and Research Hospital
last name: Murat Yassa, MD
role: Principal Investigator
affiliation: Bartin State Hospital
facility: 
country: Turkey
citation: Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.
PMID: 28816554
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: OZAN DOGAN
investigator title: Principal Investigator
mesh term: Prolapse
mesh term: Pathological Conditions, Anatomical
sharing ipd: No