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

NCT03241836 | Withdrawn

• 1 other identifier: TPUS& MRI female pelvic floor
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Floor, Obstetric

Outcome Measures

Primary Outcomes (1)

• accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction

  four years

Interventions

trans-perineal ultrasonography DIAGNOSTIC_TEST

accuracy of trans perineal ultrasonography in identification of female pelvic floor dysfunction

Also known as: dynamic pelvic MRI

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

female patients in child bearing period (20-39 yrs old) with or without symptoms of pelvic floor failure

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• alzahraa sayed hassan, a.lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 8, 2017
• Study Start: May 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2022
• Last Updated: February 27, 2018

Record last verified: 2018-02