Role of Trans-perineal Ultrasonography on Basis of Dynamic Pelvic Magnetic Resonance Imaging in Diagnosis of Female Pelvic Floor Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Assiut University
- Primary Endpoint
- accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction
Study Overview
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.
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:
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 20 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction
Time Frame: four years
Secondary Outcomes
No secondary outcomes reported
Investigators
AShassan
principle investigator
Assiut University
