<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/NCT03750604</url>
  </required_header>
  <id_info>
    <org_study_id>obesity in OAB</org_study_id>
    <nct_id>NCT03750604</nct_id>
  </id_info>
  <brief_title>Central Obesity in Cases of OAB</brief_title>
  <official_title>Central Obesity With Relation in OAB: Is it a Matter of Size or Fat Activity?. Prospective Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      Obesity is not a homogeneous condition and that the regional distribution of adipose tissue&#xD;
      is important to understanding the relation of obesity to disturbances in glucose and lipid&#xD;
      metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat.&#xD;
      Regional distribution appears to be an important indicator for metabolic alterations since an&#xD;
      inconstant correlation between body mass index (BMI) and these disturbances have been found.&#xD;
      Visceral obesity is associated with increased adipocytokine production, proinflammatory&#xD;
      activity, deterioration of insulin sensitivity, increased risk of developing diabetes,&#xD;
      &quot;high-triglyceride/low-HDL cholesterol dyslipidemia,&quot; hypertension and atherosclerosis. It&#xD;
      might be more precise to divide central abdominal fat into subcutaneous(S) and visceral (V)&#xD;
      fat surface area and volume and even ratio (S/V); risk factors for cardiovascular disease,&#xD;
      particularly those related to glucose and lipid metabolism and hypertension, being&gt;0.4; with&#xD;
      evaluation of visceral fat functionality by visceral adiposity index (VAI) with integration&#xD;
      with lipid profile. Adding bladder wall thickness with perivesical fat as a factor may impair&#xD;
      bladder function and contribute to dysregulation. The data on the association between central&#xD;
      adiposity with OAB symptoms and Urodynamics is not mature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overactive bladder (OAB) is defined by international continence society (ICS) as urinary&#xD;
      urgency with or without incontinence often associated with frequency and nocturia. As a&#xD;
      chronic, unbearable condition, OAB has a deeply negative impact on QoL, including social,&#xD;
      physical, psychological, occupational and sexual domains. Overactive bladder (OAB) is a&#xD;
      highly prevalent symptom complex that is estimated to affect 12.8% of women and 10.8% of men.&#xD;
&#xD;
      The underlying pathophysiological mechanism of OAB and DO is poorly understood. It is thought&#xD;
      that not only the detrusor muscle but also urothelium, peripheral afferent terminals, and&#xD;
      pelvic blood vessels may play a role.&#xD;
&#xD;
      More recently, overweight and central obesity was found to be an independent risk factor for&#xD;
      overactive bladder (OAB) in women. The most likely explanation is the occurrence of chronic&#xD;
      inflammation in the bladder indicated by increased urinary chemokines. Adipocytes surrounding&#xD;
      the human bladder can be affected, thus leading to inflammation and triggering OAB symptoms.&#xD;
      Other authors showed that OAB is associated with increased BMI and increase of waist&#xD;
      circumference at the upper end of the adiposity distribution for both men and women.&#xD;
&#xD;
      Obesity is not a homogeneous condition and that the regional distribution of adipose tissue&#xD;
      is important to understanding the relation of obesity to disturbances in glucose and lipid&#xD;
      metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat.&#xD;
      Regional distribution appears to be an important indicator for metabolic alterations since an&#xD;
      inconstant correlation between body mass index (BMI) and these disturbances have been found.&#xD;
      Visceral obesity is associated with increased adipocytokine production, proinflammatory&#xD;
      activity, deterioration of insulin sensitivity, increased risk of developing diabetes,&#xD;
      &quot;high-triglyceride/low-HDL cholesterol dyslipidemia,&quot; hypertension and atherosclerosis.&#xD;
&#xD;
      Away from that anthropometric measures as BMI, waist circumference (WC), waist to hip ratio&#xD;
      (WHR) are crude measures for adiposity. WHR has been advocated as a measure of central&#xD;
      obesity because BMI does not describe the distribution of obesity. This measurement, however,&#xD;
      was found to be associated with SUI but not with OAB or mixed urinary incontinence, further&#xD;
      suggesting a non-mechanical mechanism for OAB in obese women. WC is a major clinical&#xD;
      parameter used for the indirect evaluation of increased visceral fat, In addition, WC showed&#xD;
      shared variance with visceral adipose fat up to 75% (42) (38). Nevertheless, WC alone does&#xD;
      not help in distinguishing between subcutaneous and visceral fat mass.&#xD;
&#xD;
      So, it might be more precise to divide central abdominal fat into subcutaneous(S) and&#xD;
      visceral (V) fat surface area and volume and even ratio (S/V); risk factors for&#xD;
      cardiovascular disease, particularly those related to glucose and lipid metabolism and&#xD;
      hypertension, being&gt;0.4; with evaluation of visceral fat functionality by visceral adiposity&#xD;
      index (VAI) with integration with lipid profile. Adding bladder wall thickness with&#xD;
      perivesical fat as a factor may impair bladder function and contribute to dysregulation.&#xD;
&#xD;
      The data on the association between central adiposity with OAB symptoms and Urodynamics is&#xD;
      not mature. So, the investigators intend to conduct this study evaluating the surface area of&#xD;
      both subcutaneous and visceral fat and its functionality with incorporation with lipid&#xD;
      profile and bladder wall thickness and perivesical fat.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>relation between visceral fat and and severity of OAB symptoms.</measure>
    <time_frame>2 years</time_frame>
    <description>using OAB symptoms scores(OABSS) with total score 15(mild&lt;5,mod (5-10),sever&gt;10) in relation to visceral fat surface area in cm2 by NCCT measurement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relation of OAB symptoms to visceral fat function</measure>
    <time_frame>2 years</time_frame>
    <description>using of OABSS total score 15(mild&lt;5, mod(5-10), sever&gt;10) to visceral fat function (VAI)(VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males:VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Urologic Diseases</condition>
  <condition>Overactive Bladder Syndrome</condition>
  <condition>Obesity, Abdominal</condition>
  <arm_group>
    <arm_group_label>patients with OAB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were asked to fill (OABSS) for more accurate evaluation of bothersome degree. Waist Circumference is evaluated. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to CT detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.&#xD;
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL.&#xD;
And in males:&#xD;
VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal variants healthy without symptoms</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>WC is evaluated crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.&#xD;
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males:VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>visceral fat obesity (surface area and function)</intervention_name>
    <description>WC is evaluated at the midpoint between the lower border of the rib cage and the iliac crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels.&#xD;
Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.&#xD;
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL.&#xD;
And in males:&#xD;
VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL WC: waist circumference, BMI: body mass index, TG: triglyceride, HDL: high-density lipoprotein</description>
    <arm_group_label>normal variants healthy without symptoms</arm_group_label>
    <arm_group_label>patients with OAB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with OAB between 18 and 40 years old.&#xD;
&#xD;
          -  normal variant healthy donor as a control.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have any of the following:&#xD;
&#xD;
               -  Age less than 18 or more than 40 years old&#xD;
&#xD;
               -  Neurogenic detrusor overactivity&#xD;
&#xD;
               -  evidence of obstructed flow in absence of prolapse&#xD;
&#xD;
               -  mixed urinary incontinence&#xD;
&#xD;
               -  associated urethral pathology, e.g. Urethral diverticulum&#xD;
&#xD;
               -  Associated bladder pathology e.g. fistula, active urinary tract infection as&#xD;
                  evidenced by positive urine culture&#xD;
&#xD;
               -  previous exposure for anticholinergics or BTX-A injection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mohamed Abdelbaset</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>abdominal obesity</keyword>
  <keyword>OAB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Urologic Diseases</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Abdominal</mesh_term>
  </condition_browse>
  <!-- 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/NCT03750604
org study id: obesity in OAB
nct id: NCT03750604
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity is not a homogeneous condition and that the regional distribution of adipose tissue
      is important to understanding the relation of obesity to disturbances in glucose and lipid
      metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat.
      Regional distribution appears to be an important indicator for metabolic alterations since an
      inconstant correlation between body mass index (BMI) and these disturbances have been found.
      Visceral obesity is associated with increased adipocytokine production, proinflammatory
      activity, deterioration of insulin sensitivity, increased risk of developing diabetes,
      "high-triglyceride/low-HDL cholesterol dyslipidemia," hypertension and atherosclerosis. It
      might be more precise to divide central abdominal fat into subcutaneous(S) and visceral (V)
      fat surface area and volume and even ratio (S/V); risk factors for cardiovascular disease,
      particularly those related to glucose and lipid metabolism and hypertension, being>0.4; with
      evaluation of visceral fat functionality by visceral adiposity index (VAI) with integration
      with lipid profile. Adding bladder wall thickness with perivesical fat as a factor may impair
      bladder function and contribute to dysregulation. The data on the association between central
      adiposity with OAB symptoms and Urodynamics is not mature.
Overactive bladder (OAB) is defined by international continence society (ICS) as urinary
      urgency with or without incontinence often associated with frequency and nocturia. As a
      chronic, unbearable condition, OAB has a deeply negative impact on QoL, including social,
      physical, psychological, occupational and sexual domains. Overactive bladder (OAB) is a
      highly prevalent symptom complex that is estimated to affect 12.8% of women and 10.8% of men.

      The underlying pathophysiological mechanism of OAB and DO is poorly understood. It is thought
      that not only the detrusor muscle but also urothelium, peripheral afferent terminals, and
      pelvic blood vessels may play a role.

      More recently, overweight and central obesity was found to be an independent risk factor for
      overactive bladder (OAB) in women. The most likely explanation is the occurrence of chronic
      inflammation in the bladder indicated by increased urinary chemokines. Adipocytes surrounding
      the human bladder can be affected, thus leading to inflammation and triggering OAB symptoms.
      Other authors showed that OAB is associated with increased BMI and increase of waist
      circumference at the upper end of the adiposity distribution for both men and women.

      Obesity is not a homogeneous condition and that the regional distribution of adipose tissue
      is important to understanding the relation of obesity to disturbances in glucose and lipid
      metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat.
      Regional distribution appears to be an important indicator for metabolic alterations since an
      inconstant correlation between body mass index (BMI) and these disturbances have been found.
      Visceral obesity is associated with increased adipocytokine production, proinflammatory
      activity, deterioration of insulin sensitivity, increased risk of developing diabetes,
      "high-triglyceride/low-HDL cholesterol dyslipidemia," hypertension and atherosclerosis.

      Away from that anthropometric measures as BMI, waist circumference (WC), waist to hip ratio
      (WHR) are crude measures for adiposity. WHR has been advocated as a measure of central
      obesity because BMI does not describe the distribution of obesity. This measurement, however,
      was found to be associated with SUI but not with OAB or mixed urinary incontinence, further
      suggesting a non-mechanical mechanism for OAB in obese women. WC is a major clinical
      parameter used for the indirect evaluation of increased visceral fat, In addition, WC showed
      shared variance with visceral adipose fat up to 75% (42) (38). Nevertheless, WC alone does
      not help in distinguishing between subcutaneous and visceral fat mass.

      So, it might be more precise to divide central abdominal fat into subcutaneous(S) and
      visceral (V) fat surface area and volume and even ratio (S/V); risk factors for
      cardiovascular disease, particularly those related to glucose and lipid metabolism and
      hypertension, being>0.4; with evaluation of visceral fat functionality by visceral adiposity
      index (VAI) with integration with lipid profile. Adding bladder wall thickness with
      perivesical fat as a factor may impair bladder function and contribute to dysregulation.

      The data on the association between central adiposity with OAB symptoms and Urodynamics is
      not mature. So, the investigators intend to conduct this study evaluating the surface area of
      both subcutaneous and visceral fat and its functionality with incorporation with lipid
      profile and bladder wall thickness and perivesical fat.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: relation between visceral fat and and severity of OAB symptoms.
time frame: 2 years
description: using OAB symptoms scores(OABSS) with total score 15(mild<5,mod (5-10),sever>10) in relation to visceral fat surface area in cm2 by NCCT measurement.
measure: Relation of OAB symptoms to visceral fat function
time frame: 2 years
description: using of OABSS total score 15(mild<5, mod(5-10), sever>10) to visceral fat function (VAI)(VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males:VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL)
arm group label: patients with OAB
arm group type: Active Comparator
description: Patients were asked to fill (OABSS) for more accurate evaluation of bothersome degree. Waist Circumference is evaluated. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to CT detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL.
And in males:
VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL
arm group label: normal variants healthy without symptoms
arm group type: Placebo Comparator
description: WC is evaluated crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males:VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL
intervention type: Diagnostic Test
intervention name: visceral fat obesity (surface area and function)
description: WC is evaluated at the midpoint between the lower border of the rib cage and the iliac crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels.
Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL.
And in males:
VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL WC: waist circumference, BMI: body mass index, TG: triglyceride, HDL: high-density lipoprotein
arm group label: normal variants healthy without symptoms
arm group label: patients with OAB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mohamed Abdelbaset
investigator title: principal investigator
mesh term: Urinary Bladder, Overactive
mesh term: Urologic Diseases
mesh term: Obesity
mesh term: Obesity, Abdominal