<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/NCT03241836</url>
  </required_header>
  <id_info>
    <org_study_id>TPUS&amp; MRI female pelvic floor</org_study_id>
    <nct_id>NCT03241836</nct_id>
  </id_info>
  <brief_title>Trans-perineal Ultrasound &amp; Dynamic Pelvic Magnetic Resonance Imaging in Assessment of Pelvic Floor Dysfunction.</brief_title>
  <official_title>Role of Trans-perineal Ultrasonography on Basis of Dynamic Pelvic Magnetic Resonance Imaging in Diagnosis of Female Pelvic Floor Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pelvic floor failure is a common disorder that can seriously jeopardize woman's quality of&#xD;
      life by causing urinary, fecal incontinence, difficult defecation and pelvic pain. Multiple&#xD;
      congenital and acquired risk factors are associated with pelvic floor failure including&#xD;
      altered collagen metabolism, female sex, vaginal delivery, menopause, and advanced age. A&#xD;
      complex variety of fascial and muscular lesions that range from stretching, insertion&#xD;
      detachment, denervation atrophy, and combinations of pelvic floor relaxation to pelvic organ&#xD;
      prolapse may manifest in a single patient.&#xD;
&#xD;
      The prevalence of pelvic floor dysfunction increases with age. It is approximately 9.7% in&#xD;
      child bearing period (20-39 yrs), while it reaches up to 49.7% by 80 yrs and older.&#xD;
&#xD;
      Thorough preoperative assessment of pelvic floor failure is necessary to reduce the rate of&#xD;
      relapse, which is reported to be as high as 30%.&#xD;
&#xD;
      MR imaging is a powerful tool that enables radiologists to comprehensively evaluate pelvic&#xD;
      anatomic and functional abnormalities, thus helping surgeons provide appropriate treatment&#xD;
      and avoid repeat operations.&#xD;
&#xD;
      Real time 2D trans-perineal ultrasound is emerging as an exciting new technique for pelvic&#xD;
      floor assessment. It has advantage of providing a global view of the entire pelvic floor,&#xD;
      from the symphysis to the ano-rectum, and includes the lower aspects of the levator ani&#xD;
      muscle, in addition to its lower costs and greater accessibility; also sonographic imaging is&#xD;
      more useful in the clinical environment, and generally better tolerated than MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      135 female patients in child bearing period (20-39 yrs) will undergo trans-perineal US and&#xD;
      dynamic pelvic MRI; 40 days after vaginal delivery or cesarean section for asymptomatic and&#xD;
      symptomatic cases.&#xD;
&#xD;
      Revision after six months for cases with sonongraphic or MRI findings. after obtaining an&#xD;
      informed written consent and approval of the ethical committee of faculty of medicine of&#xD;
      Assiut University.&#xD;
&#xD;
        -  Inclusion criteria: asmptomatic and symptomatic female Patients in child bearing period&#xD;
           40 days after vaginal delivery and cesarean section.&#xD;
&#xD;
        -  Exclusion criteria: patients with previous pelvic floor surgery.&#xD;
&#xD;
      Patient preparation&#xD;
&#xD;
      For trans-perineal US:&#xD;
&#xD;
      - Patient is positioned in dorsal lithotomy position, with the hips flexed and slightly&#xD;
      abducted and after bladder and bowel emptying. The pelvic tilt can be improved by asking the&#xD;
      patient to place their heels as close as possible to the but¬tocks and move hips towards the&#xD;
      heels.&#xD;
&#xD;
      For MRI:&#xD;
&#xD;
      - Patient is positioned in supine position and using pelvic coil after bladder and bowel&#xD;
      emptying.&#xD;
&#xD;
      Method:&#xD;
&#xD;
        1. trans-perineal US: B mode capable 2D ultrasound system with cine loop function, 3.5-6.0&#xD;
           MHz curved array transducer. A mid-sagittal and axial views is obtained by placing a&#xD;
           transducer on the perineum (Parting of the labia can improve image quality).&#xD;
&#xD;
        2. Dynamic MRI:&#xD;
&#xD;
      Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes:&#xD;
&#xD;
      Analysis of anatomic damage on axial, coronal and sagittal fast spin-echo (FSE) T2-weighted&#xD;
      images.&#xD;
&#xD;
      Functional evaluation using sagittal dynamic single-shot T2-weighted sequences during&#xD;
      straining and defecation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    3Dtransvaginal probe is not available at this time&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 2018</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction</measure>
    <time_frame>four years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Pelvic Floor, Obstetric</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>trans-perineal ultrasonography</intervention_name>
    <description>accuracy of trans perineal ultrasonography in identification of female pelvic floor dysfunction</description>
    <other_name>dynamic pelvic MRI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        female patients in child bearing period (20-39 yrs old) with or without symptoms of pelvic&#xD;
        floor failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Inclusion criteria: asmptomatic and symptomatic female Patients in child bearing&#xD;
             period 40 days after vaginal delivery and cesarean section.&#xD;
&#xD;
          -  Exclusion criteria: patients with previous pelvic floor surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>alzahraa sayed hassan, a.lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>February 24, 2018</last_update_submitted>
  <last_update_submitted_qc>February 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>AShassan</investigator_full_name>
    <investigator_title>principle 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/NCT03241836
org study id: TPUS& MRI female pelvic floor
nct id: NCT03241836
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pelvic floor failure is a common disorder that can seriously jeopardize woman's quality of
      life by causing urinary, fecal incontinence, difficult defecation and pelvic pain. Multiple
      congenital and acquired risk factors are associated with pelvic floor failure including
      altered collagen metabolism, female sex, vaginal delivery, menopause, and advanced age. A
      complex variety of fascial and muscular lesions that range from stretching, insertion
      detachment, denervation atrophy, and combinations of pelvic floor relaxation to pelvic organ
      prolapse may manifest in a single patient.

      The prevalence of pelvic floor dysfunction increases with age. It is approximately 9.7% in
      child bearing period (20-39 yrs), while it reaches up to 49.7% by 80 yrs and older.

      Thorough preoperative assessment of pelvic floor failure is necessary to reduce the rate of
      relapse, which is reported to be as high as 30%.

      MR imaging is a powerful tool that enables radiologists to comprehensively evaluate pelvic
      anatomic and functional abnormalities, thus helping surgeons provide appropriate treatment
      and avoid repeat operations.

      Real time 2D trans-perineal ultrasound is emerging as an exciting new technique for pelvic
      floor assessment. It has advantage of providing a global view of the entire pelvic floor,
      from the symphysis to the ano-rectum, and includes the lower aspects of the levator ani
      muscle, in addition to its lower costs and greater accessibility; also sonographic imaging is
      more useful in the clinical environment, and generally better tolerated than MRI.
135 female patients in child bearing period (20-39 yrs) will undergo trans-perineal US and
      dynamic pelvic MRI; 40 days after vaginal delivery or cesarean section for asymptomatic and
      symptomatic cases.

      Revision after six months for cases with sonongraphic or MRI findings. after obtaining an
      informed written consent and approval of the ethical committee of faculty of medicine of
      Assiut University.

        -  Inclusion criteria: asmptomatic and symptomatic female Patients in child bearing period
           40 days after vaginal delivery and cesarean section.

        -  Exclusion criteria: patients with previous pelvic floor surgery.

      Patient preparation

      For trans-perineal US:

      - Patient is positioned in dorsal lithotomy position, with the hips flexed and slightly
      abducted and after bladder and bowel emptying. The pelvic tilt can be improved by asking the
      patient to place their heels as close as possible to the but¬tocks and move hips towards the
      heels.

      For MRI:

      - Patient is positioned in supine position and using pelvic coil after bladder and bowel
      emptying.

      Method:

        1. trans-perineal US: B mode capable 2D ultrasound system with cine loop function, 3.5-6.0
           MHz curved array transducer. A mid-sagittal and axial views is obtained by placing a
           transducer on the perineum (Parting of the labia can improve image quality).

        2. Dynamic MRI:

      Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes:

      Analysis of anatomic damage on axial, coronal and sagittal fast spin-echo (FSE) T2-weighted
      images.

      Functional evaluation using sagittal dynamic single-shot T2-weighted sequences during
      straining and defecation.
observational model: Case-Only
time perspective: Cross-Sectional
measure: accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction
time frame: four years
intervention type: Diagnostic Test
intervention name: trans-perineal ultrasonography
description: accuracy of trans perineal ultrasonography in identification of female pelvic floor dysfunction
other name: dynamic pelvic MRI
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: No
last name: alzahraa sayed hassan, a.lecturer
role: Principal Investigator
affiliation: Assiut University
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: AShassan
investigator title: principle investigator