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Trans-perineal Ultrasound & Dynamic Pelvic Magnetic Resonance Imaging in Assessment of Pelvic Floor Dysfunction.

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ClinicalTrials.gov Identifier: NCT03241836
Recruitment Status : Withdrawn (3Dtransvaginal probe is not available at this time)
First Posted : August 8, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
AShassan, Assiut University

Brief Summary:

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.


Condition or disease Intervention/treatment
Pelvic Floor, Obstetric Diagnostic Test: trans-perineal ultrasonography

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Role of Trans-perineal Ultrasonography on Basis of Dynamic Pelvic Magnetic Resonance Imaging in Diagnosis of Female Pelvic Floor Dysfunction
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: trans-perineal ultrasonography
    accuracy of trans perineal ultrasonography in identification of female pelvic floor dysfunction
    Other Name: dynamic pelvic MRI


Primary Outcome Measures :
  1. accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction [ Time Frame: four years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
female patients in child bearing period (20-39 yrs old) with or without symptoms of pelvic floor failure
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241836


Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: alzahraa sayed hassan, a.lecturer Assiut University

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Responsible Party: AShassan, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03241836     History of Changes
Other Study ID Numbers: TPUS& MRI female pelvic floor
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

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