An interventional study of transperineal ultrasound in Pelvic Floor Disorders, sponsored by Assiut University. Status unknown. Open to female participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic
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.
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:
For MRI:
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).
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.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's planned enrollment of 135 is above the median of 64 across 148 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
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
Time frame: 4 years
No study locations are listed for this record.
Start is estimated for Sep 2018; primary completion for Feb 2020, 17 months later.
Of 101 non-industry interventional studies with no phase under Pelvic Floor Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 17 months is close to that.
Counting every sponsor, half of 107 studies reached it within 17 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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