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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Floor Dysfunction
- Sponsor
- University Hospitals of North Midlands NHS Trust
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Comparability of MRI to DTI
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients with probable previous obstetric injury
- •with symptoms of obstructed defecation
- •other pelvic floor dysfunction
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Comparability of MRI to DTI
Time Frame: 7 hour visit time
Assessing both images independently to assess if possible to view subdivisions of the levator ani muscle.