Pelvic Floor DysfunctionEDITUSNCT05955664
Evaluation of Diffusion Tensor Imaging and High Frequency 3D Endovaginal Ultrasound
A study testing MRI indlcuding DTI and Pelvic floor ultrasound. in people with Pelvic Floor Dysfunction, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Dysfunction
- What is being tested?
- MRI indlcuding DTI and Pelvic floor ultrasound.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Apr 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with probable previous obstetric injury
- with symptoms of obstructed defecation
- other pelvic floor dysfunction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of North Midlands
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
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.
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.
Read the 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.
- Conditions
- Pelvic Floor Dysfunction
- Being tested
- MRI indlcuding DTI, Pelvic floor ultrasound.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI indlcuding DTIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: MRI indlcuding DTI; Diagnostic Test: Pelvic floor ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparability of MRI to DTI
Assessing both images independently to assess if possible to view subdivisions of the levator ani muscle.
Measured: 7 hour visit time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start12 Apr 2021
- Primary completion31 Oct 2023
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955664
- Sponsor's protocol ID
- 2329
- Acronym
- EDITUS
- Status last verified
- Jul 2025
- First submitted
- 27 Jan 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05955664
- Acronym / sponsor ID
- EDITUS / 2329
- Conditions
- Pelvic Floor Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI including DTI | Placebo comparator | Diagnostic Test: MRI indlcuding DTI, Diagnostic Test: Pelvic floor ultrasound.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. |
| Pelvic floor ultrasound. | Active comparator | Diagnostic Test: MRI indlcuding DTI, Diagnostic Test: Pelvic floor ultrasound.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with probable previous obstetric injury
- with symptoms of obstructed defecation
- other pelvic floor dysfunction
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI indlcuding DTIA 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 | MRI including DTI, Pelvic floor ultrasound. |
| 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. | Diagnostic test | MRI including DTI, Pelvic floor ultrasound. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI indlcuding DTI and Pelvic floor ultrasound. in people with Pelvic Floor Dysfunction, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparability of MRI to DTI (time frame: 7 hour visit time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.