Evaluation of Diffusion Tensor Imaging and High Frequency 3D Endovaginal Ultrasound (EVUS) in Understanding the Anatomy of the Pelvic Floor and Levator Ani Muscle Injury.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comparability of MRI to DTI
研究概览
简要总结
To assess the feasibility of a novel MRI technique- diffusion tensor imaging with fibre tracking in understanding the anatomy of the pelvic floor and levator ani muscle injury. To compare this novel MRI technique with endocavity ultrasound in assessment of pelvic floor anatomy and deficiencies in patients with pelvic floor problems.
详细描述
The study population is females with symptoms of pelvic floor dysfunction, and with suspected anatomical abnormalities of the pelvic floor muscles, for example following obstetric injury. The participants will be recruited to the study through Pelvic Floor and gynaecology Clinics. Each patient will undergo the same imaging investigations, pelvic floor MRI and three-dimensional high frequency internal ultrasound. As the MRI is regarded the gold standard examination in the assessment of the levator ani muscle (LAM), it will be used as reference in our study. A novel technique in MR imaging, which allows tracking of the pelvic floor muscle fibers, Diffusion Tensor Imaging (DTI) will be performed in addition to the standard scanning protocol. The investigator thinks that MRI with DTI is superior to routine MRI in visualization of LAM.
Moreover, every participant will undergo pelvic floor ultrasound (EVUS), which is believed to be comparable with routine MRI in diagnosis of LAM defects. The investigator hypothesize that this type of ultrasound is not inferior to MRI with DTI in visualizing pelvic floor muscles and their abnormalities.
All images will be assessed independently by two radiologists experienced in pelvic floor imaging, who will not be aware of each other's findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with probable previous obstetric injury
- •with symptoms of obstructed defecation
- •other pelvic floor dysfunction
排除标准
- •claustrophobic patients unable to undergo MRI scan
- •patients with general contraindications to MRI
- •patients not willing to take part in the study
- •patients not able to consent
- •pregnant patients
- •patients unable to understand verbal and written English
结局指标
主要结局
Comparability of MRI to DTI
时间窗: 7 hour visit time
Assessing both images independently to assess if possible to view subdivisions of the levator ani muscle.
次要结局
未报告次要终点
