Transperineal US on Basis of MRI in Female Pelvic Floor Dysfunction

NCT03456310 | Unknown

• 1 other identifier: TPUS MRI PELVIC FLOOR
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• 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

  4 years

Study Arms (1)

Trans-perineal ultrasound

EXPERIMENTAL

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 .

Diagnostic Test: transperineal ultrasound

Interventions

transperineal ultrasound DIAGNOSTIC_TEST

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.

Also known as: dynamic pelvic MRI

Trans-perineal ultrasound

Eligibility Criteria

• Age: 20 Years - 39 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• asmptomatic and symptomatic female Patients in child bearing period 40 days after vaginal delivery and cesarean section.

You may not qualify if:

• patients with previous pelvic floor surgery.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer-radiology department-assiutU

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 7, 2018
• Study Start: September 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2022
• Last Updated: August 14, 2018

Record last verified: 2018-08