Active not recruitingNAINTERVENTIONAL

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

This study aims to find the best way to understand and diagnose problems with the pelvic floor in women. We're focusing on women who experience issues like difficulty with bowel movements or other discomforts, often after childbirth. Researchers are comparing two types of scans: a new, advanced MRI technique called Diffusion Tensor Imaging (DTI), which helps map muscle fibres, and a high-frequency internal ultrasound. The goal is to see if these methods can give doctors a clearer picture of the pelvic floor muscles and any damage, like tears. By finding better ways to see these issues, doctors hope to improve how they care for women with these common problems.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospitals of North Midlands NHS Trust

Enrolment target

Start

12 Apr 2021

Estimated completion

30 Dec 2025

Pelvic Floor Dysfunction

What is this study about?

Imagine your pelvic floor muscles as a hammock supporting your bladder, bowel, and womb. Sometimes, especially after childbirth, these muscles can get weak or damaged, leading to problems like difficulty going to the toilet or other discomforts. Doctors want to understand these issues better so they can provide the best care.

This study is looking at different ways to take pictures of these important muscles. They are trying out a new, detailed type of MRI scan, which is like a very powerful camera that can even track the tiny fibres in your muscles. This advanced MRI is being compared to a special internal ultrasound scan, which uses sound waves to create images. The main aim is to see which of these scanning methods gives the clearest and most helpful information about the pelvic floor muscles and any damage they might have.

By comparing these two types of scans, researchers hope to discover if the new MRI or the special ultrasound can provide a better view of the pelvic floor than current methods. This could lead to more accurate diagnoses and better treatment plans for women who are struggling with pelvic floor problems, helping them feel better and improve their quality of life.

Key takeaways

The study explores better ways to scan pelvic floor muscles.
It compares a new MRI method with a special ultrasound.
Aims to improve diagnosis for women with pelvic floor problems.
Participation involves two scanning appointments.
You must be a woman, aged 18 or over, with pelvic floor symptoms.

Who may be eligible?

This study is looking for women who are experiencing problems with their pelvic floor, especially if they think these issues might be related to childbirth. You might be experiencing symptoms like difficulty with your bowels, or other discomforts in your pelvic area.

To be considered, you must be a woman aged 18 or older. You should be able to understand information given in English, both spoken and written, and be able to give your clear agreement to take part in the study.

However, some women cannot join. This includes if you are pregnant, or if you have certain medical conditions or devices that make having an MRI scan unsafe (like some pacemakers). You also cannot participate if you feel very anxious in small spaces (claustrophobia) and cannot have an MRI, or if you simply don't wish to be involved in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Do you have symptoms of pelvic floor problems?
Are you comfortable with MRI scans (not severely claustrophobic)?
Do you understand spoken and written English?
Are you not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have two main appointments for scans. First, you will have a specific type of MRI scan. This scan involves lying still inside a large machine that takes detailed pictures. You will also have a special internal ultrasound scan. This is similar to other internal ultrasounds, where a small probe is gently inserted to get a clear view of the pelvic floor muscles. Both scans will be done by experts in imaging. You won't be given any new medications as part of this study. The total time for your involvement will primarily be for these two scanning appointments. There are no follow-up visits specifically for the study after your scans are completed.

Potential risks and benefits

Taking part in this study could help doctors better understand pelvic floor problems, potentially leading to improved diagnosis and care for many women in the future. For you personally, the scans might provide more detailed information about your own pelvic floor. However, an MRI scan can feel a bit enclosed, and the ultrasound can sometimes be a little uncomfortable, though both procedures are generally safe. You are free to change your mind and withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital of North Midlands
Verified postcode
Stoke-on-Trent, United Kingdom

Common questions

What exactly is the 'pelvic floor'?

The pelvic floor is a group of muscles and tissues that form a 'hammock' at the bottom of your pelvis, supporting organs like your bladder and bowel.

Why are you looking at these specific scans?

We want to see if a newer type of MRI and a special ultrasound can give us clearer pictures of your pelvic floor muscles to better understand problems.

Will I get results from my scans?

The study aims to improve general understanding, but any findings relevant to your care will be shared with your treating doctor as usual.

Are the scans painful?

The scans are generally not painful. The MRI is just noisy and involves lying still. The internal ultrasound might cause some mild discomfort, similar to a regular gynaecological exam.

How long will it take if I join?

Your involvement will mainly be for the two scanning appointments, which shouldn't take a whole day each. There are no long-term follow-up visits specifically for the study.