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

NCT05955664 | Active Not Recruiting

• 1 other identifier: 2329
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MRI including DTI

PLACEBO COMPARATOR

MR imaging will be performed on 3T MRI scanner (Skyra, Avanto) in supine position with no rectal contrast. The patients will undergo pelvic MRI with additional diffusion tensor (DTI) sequences dedicated for assessment of the fibres in the pelvic floor muscles. DTI will be processed with the use of special software. The images will be assessed separately by two clinicians who will not know patients' symptoms or results of the US.

Diagnostic Test: MRI indlcuding DTI; Diagnostic Test: Pelvic floor ultrasound.

Pelvic floor ultrasound.

ACTIVE COMPARATOR

Internal pelvic floor ultrasound will be performed with the use of high-frequency transducers with automatic 3D image acquisition by one of the Consultant Radiologists involved in the study. No preparation is required. No vaginal or rectal contrast is used. 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.

Diagnostic Test: MRI indlcuding DTI; Diagnostic Test: Pelvic floor ultrasound.

Interventions

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.

MRI including DTI; Pelvic floor ultrasound.

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.

MRI including DTI; Pelvic floor ultrasound.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Due to nature of examinations
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with probable previous obstetric injury
• with symptoms of obstructed defecation
• other pelvic floor dysfunction

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospital of North Midlands

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

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: July 21, 2023
• Study Start: April 12, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)