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NCT Number: NCT05955664

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Midlands

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI indlcuding DTI

Diagnostic Test

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.

Diagnostic Test

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study 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.

Acronym: EDITUS

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jul 21, 2023
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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