<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/NCT03825653</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/001885</org_study_id>
    <nct_id>NCT03825653</nct_id>
  </id_info>
  <brief_title>Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopausal Women</brief_title>
  <official_title>Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopasual Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study will be conducted to assess biomechanical alignment of lower limb as a predictor&#xD;
      for the stress urinary incontinence in the postmenopausal women. 300 postmenopausual women&#xD;
      will be selected suffering from stress unrinary incontinence . Their age ranges from 60 to 70&#xD;
      years old. Their BMI is not exceeding 30 kg/m2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      in this study 300 postmenopausual women will be selected suffering from stress unrinary&#xD;
      incontinence. Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2.&#xD;
      different methods of assessment will be used as : Data recording sheet, Weight-Height scale,&#xD;
      Goniometer ,x ray radiography ,Transabdominal ultrasound and Perineal ultrasound. Data&#xD;
      recording sheet: It will be used to record data of each woman before starting this study.&#xD;
      Weight-Height scale: It will be used to measure weight and height of each woman before&#xD;
      starting this study. Goniometer: it will be used to document the initial and the subsequent&#xD;
      range of motion for ankle joint for each woman. Transabdominal ultrasound: it will be used&#xD;
      for measurement of Post-void residual volume PVR for each woman which is the volume of urine&#xD;
      left in the bladder after micturition . Perineal ultrasound: it will be used to assess the&#xD;
      posterior urethrovesical angle for each woman . X-ray radiography: lateral pelvic radiographs&#xD;
      will be taken for each woman in order to objectify the individual pelvic tilt. Inclusion&#xD;
      criteria include : Subjects will be postmenopausal women complaining from stress urinary&#xD;
      incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2.&#xD;
      Exclusion criteria: previous history of cancer and radiotherapy, any disease that could&#xD;
      interfere with the participation, lower urinary tract infections( Manshadi F. etal )&#xD;
      musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases;&#xD;
      diabetes mellitus, a body mass index &gt;30 kg/m2; intraureterine device implantation, pelvic&#xD;
      organ prolapse and menopause (Cerruto M etal.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 29, 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post-void residual volume PVR</measure>
    <time_frame>30 minutes for every patient</time_frame>
    <description>Transabdominal ultrasound&#xD;
it will be used for measurement of Post-void residual volume PVR for each woman which is the volume of urine left in the bladder after micturition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>posterior urethrovesical angle</measure>
    <time_frame>30 minutes for every patient</time_frame>
    <description>perineal ultrasound will be used to assesse the posterior urethrovesical angle for each woman</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pelvic tilt</measure>
    <time_frame>30 minutes for every patient</time_frame>
    <description>lateral pelvic radiographic xray will be taken for each woman in order to objectify the individual pelvic tilt</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ankle range of motion</measure>
    <time_frame>10 minutes for every patient</time_frame>
    <description>goniometer will be used to measure the range of motion for ankle joint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>10 minutes for every patient</time_frame>
    <description>weight height scale will be used to measure weight and height of each woman before starting this study</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>one group</arm_group_label>
    <description>This study will be carried out on three hundred postmenopausal.They will be selected from gynecological outpatient clinic of (Oum El Masryn Hospital).&#xD;
their age will range from 60-70 years.Their BMI will not exceed 30 kg/m2. They are complaining from stress urinary incontinence.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        300 postmenopausal women suffering from stress urinary incontinence Participants age will&#xD;
        range from 60-70 years.Their BMI will not exceed 30 kg/m2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects will be 300 postmenopausal women suffering from stress urinary incontinence&#xD;
        Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous history of cancer and radiotherapy, any disease that could interfere with the&#xD;
             participation, lower urinary tract infections( Manshadi F. etal ) musculoskeletal&#xD;
             problems; previous major abdominal or pelvic surgery; severe diseases; diabetes&#xD;
             mellitus, a body mass index &gt;30 kg/m2; intraureterine device implantation, pelvic&#xD;
             organ prolapse and menopause (Cerruto M etal.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female</gender_description>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>yara n zaki, M sc.</last_name>
    <phone>01010446044</phone>
    <email>ynz.yara@gmail.com</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>HAhmed</investigator_full_name>
    <investigator_title>lecturer of biomechanics</investigator_title>
  </responsible_party>
  <keyword>stress urinary incontinence</keyword>
  <keyword>pelvic tilt</keyword>
  <keyword>ankle position</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>
  <!-- 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/NCT03825653
org study id: P.T.REC/012/001885
nct id: NCT03825653
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to assess biomechanical alignment of lower limb as a predictor
      for the stress urinary incontinence in the postmenopausal women. 300 postmenopausual women
      will be selected suffering from stress unrinary incontinence . Their age ranges from 60 to 70
      years old. Their BMI is not exceeding 30 kg/m2.
in this study 300 postmenopausual women will be selected suffering from stress unrinary
      incontinence. Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2.
      different methods of assessment will be used as : Data recording sheet, Weight-Height scale,
      Goniometer ,x ray radiography ,Transabdominal ultrasound and Perineal ultrasound. Data
      recording sheet: It will be used to record data of each woman before starting this study.
      Weight-Height scale: It will be used to measure weight and height of each woman before
      starting this study. Goniometer: it will be used to document the initial and the subsequent
      range of motion for ankle joint for each woman. Transabdominal ultrasound: it will be used
      for measurement of Post-void residual volume PVR for each woman which is the volume of urine
      left in the bladder after micturition . Perineal ultrasound: it will be used to assess the
      posterior urethrovesical angle for each woman . X-ray radiography: lateral pelvic radiographs
      will be taken for each woman in order to objectify the individual pelvic tilt. Inclusion
      criteria include : Subjects will be postmenopausal women complaining from stress urinary
      incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2.
      Exclusion criteria: previous history of cancer and radiotherapy, any disease that could
      interfere with the participation, lower urinary tract infections( Manshadi F. etal )
      musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases;
      diabetes mellitus, a body mass index >30 kg/m2; intraureterine device implantation, pelvic
      organ prolapse and menopause (Cerruto M etal.)
observational model: Other
time perspective: Prospective
measure: Post-void residual volume PVR
time frame: 30 minutes for every patient
description: Transabdominal ultrasound
it will be used for measurement of Post-void residual volume PVR for each woman which is the volume of urine left in the bladder after micturition
measure: posterior urethrovesical angle
time frame: 30 minutes for every patient
description: perineal ultrasound will be used to assesse the posterior urethrovesical angle for each woman
measure: pelvic tilt
time frame: 30 minutes for every patient
description: lateral pelvic radiographic xray will be taken for each woman in order to objectify the individual pelvic tilt
measure: ankle range of motion
time frame: 10 minutes for every patient
description: goniometer will be used to measure the range of motion for ankle joint
measure: BMI
time frame: 10 minutes for every patient
description: weight height scale will be used to measure weight and height of each woman before starting this study
arm group label: one group
description: This study will be carried out on three hundred postmenopausal.They will be selected from gynecological outpatient clinic of (Oum El Masryn Hospital).
their age will range from 60-70 years.Their BMI will not exceed 30 kg/m2. They are complaining from stress urinary incontinence.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: No
last name: yara n zaki, M sc.
phone: 01010446044
email: ynz.yara@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: HAhmed
investigator title: lecturer of biomechanics
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress