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Transperineal US on Basis of MRI in Female Pelvic Floor Dysfunction

Primary Purpose

Pelvic Floor Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transperineal ultrasound
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pelvic Floor Disorders

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Trans-perineal ultrasound

    Arm Description

    Transperineal ultrasonography is done by 2D ultrasound machine, curved probe is placed in the perineum, mid sagittal and axial views are obtained Then it's accuracy is assessed according to findings on dynamic pelvic MRI .

    Outcomes

    Primary Outcome Measures

    role of trans-perineal ultrasound in diagnosis of pelvic floor dysfunction
    accuracy of trans-perineal ultrasound in detection and assessment of female pelvic floor dysfunction

    Secondary Outcome Measures

    Full Information

    First Posted
    February 21, 2018
    Last Updated
    August 10, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03456310
    Brief Title
    Transperineal US on Basis of MRI in Female Pelvic Floor Dysfunction
    Official Title
    Role of Transperineal Ultrasonography on Basis of Dynamic Pelvic MRI in Diagnosis of Female Pelvic Floor Dysfunction.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2018 (Anticipated)
    Primary Completion Date
    February 2020 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Pelvic floor failure is a common disorder that can seriously jeopardize a woman's quality of life by causing urinary and 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 magnetic resonance imaging.
    Detailed Description
    Patient: 135 female patients in child bearing period (20-39 yrs) will undergo trans-perineal ultrasound 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: asymptomatic 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 buttocks and move hips towards the heels. For MRI: - Patient is positioned in supine position and using pelvic coil after bladder and bowel emptying. Method: trans-perineal US: B mode capable 2D ultrasound system with cine loop function, a 3.5-6.0 MHz curved array transducer. At women health hospital. A mid-sagittal and axial views is obtained by placing a transducer on the perineum (Parting of the labia can improve image quality). The following measures will be obtained: Hiatus diameter, bladder neck descent, and descent of other pelvic organs in relation to reference line (parallel to lower part of public bone). Dynamic MRI: Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes: analysis of anatomic damage on axial fast spin-echo (FSE) T2-weighted images. then sagittal and coronal (FSE) T2-weighted are obtained. functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation to show descent of pelvic organs and pelvic floor relaxation or weakness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Floor Disorders

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    135 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Trans-perineal ultrasound
    Arm Type
    Experimental
    Arm Description
    Transperineal ultrasonography is done by 2D ultrasound machine, curved probe is placed in the perineum, mid sagittal and axial views are obtained Then it's accuracy is assessed according to findings on dynamic pelvic MRI .
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    transperineal ultrasound
    Other Intervention Name(s)
    dynamic pelvic MRI
    Intervention Description
    trans-perineal US: B mode capable 2D ultrasound system with cine loop function, a 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). Dynamic MRI: Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes: analysis of anatomic damage on axial fast spin-echo (FSE) T2-weighted images. then sagittal and coronal (FSE) T2-weighted are obtained. functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation.
    Primary Outcome Measure Information:
    Title
    role of trans-perineal ultrasound in diagnosis of pelvic floor dysfunction
    Description
    accuracy of trans-perineal ultrasound in detection and assessment of female pelvic floor dysfunction
    Time Frame
    4 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Transperineal US on Basis of MRI in Female Pelvic Floor Dysfunction

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