<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/NCT03280654</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03280654</nct_id>
  </id_info>
  <brief_title>Visceral Adiposity Index and Overactive Bladder</brief_title>
  <official_title>Visceral Adiposity Index and Overactive Bladder: A Novel Predictive Risk Factor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Recep Tayyip Erdogan University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Recep Tayyip Erdogan University 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 present study, we aimed to investigate the association between visceral adiposity index&#xD;
      and overactive bladder symptoms in female patients aged over 18 years.Between January-2015&#xD;
      and July-2017, 151 female patient with overactive bladder symptoms were evaluated in Recep&#xD;
      Tayyip Erdogan University Training and Research Hospital Urology Department. Antropometric&#xD;
      and laboratory features including serum lipid levels, AST, ALT, fasting glucose levels, and&#xD;
      also urodynamic findings were recorded. Visceral adiposity index was calculated according to&#xD;
      gender-specific formula. Participants were divided into two groups according to 7,55 cut-off&#xD;
      level for visceral adiposity index levels. Statistical significance were discussed between&#xD;
      two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Antropometric and laboratory features including serum lipid levels, AST, ALT, fasting glucose&#xD;
      levels were recorded. Urodynamic study was performed all of patients to evaluate bladder&#xD;
      functions. Over active bladder questionnaire-8 Turkish validated short form was filled out&#xD;
      and recorded for each patients. Detailed medical histories of all patients were obtained&#xD;
      before the study. Height, weight, and waist circumference (WC) were measured with the&#xD;
      subjects in their underwear. Body mass ındex (BMI) was computed by the formula as the ratio&#xD;
      of weight to the square of height (kg/m2). WC was measured on the line between the iliac&#xD;
      crest and the lower costal margin parallel to the ground after subjects exhaled. Inclusion&#xD;
      criteria of study was female patients who have over active bladder symptomes with or without&#xD;
      urinary incontinence. Exclusion criterias of study were male gender, pregnancy, alcohol&#xD;
      intake, bladder cancer history, previous incontinence surgery history, presence of&#xD;
      neurological disease, urinary infection or bladder stone and pelvic radiotherapy history.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>30 Months</target_duration>
  <primary_outcome>
    <measure>Visceral adiposity index</measure>
    <time_frame>1 day</time_frame>
    <description>Group 1(lower visceral adiposity index score) has lower over active bladder questionnaire scores than group 2(higher visceral adiposity index score)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Visceral Adiposity Index</condition>
  <arm_group>
    <arm_group_label>Group 1:VAI levels &lt;7,55</arm_group_label>
    <description>7,55 value was calculated as cut-off level for VAI by ROC analyse and area under curve was calculated as 0,487 Group 1 was defined as VAI levels &lt;7,55</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2:VAI levels &gt;=7,55</arm_group_label>
    <description>7,55 value was calculated as cut-off level for VAI by ROC analyse and area under curve was calculated as 0,487 group 2 was defined as VAI levels &gt;=7,55</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>overactive bladder</intervention_name>
    <description>Association between groups and over active bladder symptoms</description>
    <arm_group_label>Group 1:VAI levels &lt;7,55</arm_group_label>
    <arm_group_label>group 2:VAI levels &gt;=7,55</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        female patients over 18 years aged with overactive bladder symptoms&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients over 18 years aged with overactive bladder symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male gender, pregnancy, alcohol intake, bladder cancer history, previous incontinence&#xD;
             surgery history, presence of neurological disease, urinary infection or bladder stone&#xD;
             and pelvic radiotherapy history&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients with overactive bladder symptoms</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 9, 2017</last_update_submitted>
  <last_update_submitted_qc>September 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Recep Tayyip Erdogan University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Mustafa Ozan HORSANALI</investigator_full_name>
    <investigator_title>Recepteutrh</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Overactive Bladder</keyword>
  <keyword>Urinary incontinence</keyword>
  <keyword>Visceral Adiposity Index</keyword>
  <keyword>Waist Circumference</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Obesity</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/NCT03280654
org study id: 1
nct id: NCT03280654
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In present study, we aimed to investigate the association between visceral adiposity index
      and overactive bladder symptoms in female patients aged over 18 years.Between January-2015
      and July-2017, 151 female patient with overactive bladder symptoms were evaluated in Recep
      Tayyip Erdogan University Training and Research Hospital Urology Department. Antropometric
      and laboratory features including serum lipid levels, AST, ALT, fasting glucose levels, and
      also urodynamic findings were recorded. Visceral adiposity index was calculated according to
      gender-specific formula. Participants were divided into two groups according to 7,55 cut-off
      level for visceral adiposity index levels. Statistical significance were discussed between
      two groups.
Antropometric and laboratory features including serum lipid levels, AST, ALT, fasting glucose
      levels were recorded. Urodynamic study was performed all of patients to evaluate bladder
      functions. Over active bladder questionnaire-8 Turkish validated short form was filled out
      and recorded for each patients. Detailed medical histories of all patients were obtained
      before the study. Height, weight, and waist circumference (WC) were measured with the
      subjects in their underwear. Body mass ındex (BMI) was computed by the formula as the ratio
      of weight to the square of height (kg/m2). WC was measured on the line between the iliac
      crest and the lower costal margin parallel to the ground after subjects exhaled. Inclusion
      criteria of study was female patients who have over active bladder symptomes with or without
      urinary incontinence. Exclusion criterias of study were male gender, pregnancy, alcohol
      intake, bladder cancer history, previous incontinence surgery history, presence of
      neurological disease, urinary infection or bladder stone and pelvic radiotherapy history.
observational model: Other
time perspective: Cross-Sectional
measure: Visceral adiposity index
time frame: 1 day
description: Group 1(lower visceral adiposity index score) has lower over active bladder questionnaire scores than group 2(higher visceral adiposity index score)
arm group label: Group 1:VAI levels <7,55
description: 7,55 value was calculated as cut-off level for VAI by ROC analyse and area under curve was calculated as 0,487 Group 1 was defined as VAI levels <7,55
arm group label: group 2:VAI levels >=7,55
description: 7,55 value was calculated as cut-off level for VAI by ROC analyse and area under curve was calculated as 0,487 group 2 was defined as VAI levels >=7,55
intervention type: Other
intervention name: overactive bladder
description: Association between groups and over active bladder symptoms
arm group label: Group 1:VAI levels <7,55
arm group label: group 2:VAI levels >=7,55
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female patients with overactive bladder symptoms
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Recep Tayyip Erdogan University Training and Research Hospital
investigator full name: Mustafa Ozan HORSANALI
investigator title: Recepteutrh
mesh term: Urinary Bladder, Overactive
mesh term: Obesity
sharing ipd: No