跳至主要内容
临床试验/NCT03456310
NCT03456310Unknown不适用

Role of Transperineal Ultrasonography on Basis of Dynamic Pelvic MRI in Diagnosis of Female Pelvic Floor Dysfunction.

Assiut University0 个研究点目标入组 135 人开始时间: 2018年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
135
主要终点
role of trans-perineal ultrasound in diagnosis of pelvic floor dysfunction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • patients with previous pelvic floor surgery.

研究组 & 干预措施

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 .

干预措施: transperineal ultrasound (Diagnostic Test)

结局指标

主要结局

role of trans-perineal ultrasound in diagnosis of pelvic floor dysfunction

时间窗: 4 years

accuracy of trans-perineal ultrasound in detection and assessment of female pelvic floor dysfunction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AShassan

Assistant lecturer-radiology department-assiutU

Assiut University

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