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

NCT05955664 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-03

No results posted yet for this study

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

Interventions

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • University Hospitals of North Midlands NHS Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2023-10-31
Completion
2025-12-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05955664 on ClinicalTrials.gov