Evaluation of Diffusion Tensor Imaging and High Frequency 3D Endovaginal Ultrasound

Pelvic Floor Dysfunction Clinical Trial

— EDITUS  

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05955664
• Other study ID #: 2329
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: July 2023
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Dysfunction

Intervention

Diagnostic Test:
• MRI indlcuding DTI
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. We think that MRI with DTI is superior to routine MRI in visualization of LAM.
• Pelvic floor ultrasound.
The patient will be scanned in a supine position and the probe is inserted into the vagina in the neutral position to avoid excessive pressure on surrounding structures to avoid distortion of the anatomy. The 3D data automatic acquisition takes approximately 70 seconds. The analysis of the ultrasound images will be performed on the Trust computers by Radiologists experienced in pelvic floor ultrasound. Participant will be asked to complete a VAS score for the US.

Locations

Country	Name	City	State
United Kingdom	University Hospital of North Midlands	Stoke-on-Trent	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparability of MRI to DTI	Assessing both images independently to assess if possible to view subdivisions of the levator ani muscle.	7 hour visit time