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

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.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05955664
Acronym
EDITUS
Enrollment
20
Registered
2023-07-21
Start date
2021-04-12
Completion date
2025-12-30
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Dysfunction

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.

Interventions

DIAGNOSTIC_TESTMRI 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_TESTPelvic 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

University Hospitals of North Midlands NHS Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparability of MRI to DTI7 hour visit timeAssessing both images independently to assess if possible to view subdivisions of the levator ani muscle.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026