RecruitingNAINTERVENTIONAL

Impact of CMG vs VCMG in Recurrent Stress Incontinence- A Pilot Study

This study is for women who still experience bladder leaks (stress incontinence) even after having surgery for it. Doctors often use tests called urodynamics (UDS) or videourodynamics (VUDS) to understand why this is happening. However, it's not clear which test is best or if they always help improve treatment outcomes. This pilot study aims to figure out if it's practical to conduct a larger trial comparing these two tests. Researchers at UCLH will involve 30 women, giving them either the UDS or VUDS test before planning their medical or surgical treatment. The main thing they want to find out is how well these tests help improve symptoms, looking at things like patient experience and costs. This will help doctors decide when to use each test for better care.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

06 Oct 2025

Estimated completion

06 Jun 2027

Stress Incontinence Female Urodynamic Exam Urodynamic Stress Incontinence

What is this study about?

When women have bladder leaks, especially after previous surgery for the same problem (this is called recurrent stress urinary incontinence), doctors often try to find out why. Two main tests are commonly used: urodynamics (UDS) and videourodynamics (VUDS). Both tests involve placing small tubes into the bladder and back passage to measure how the bladder works, but videourodynamics also uses X-rays to see what's happening inside.

While these tests are used a lot, doctors aren't completely sure if one is better than the other, or if they always lead to better treatment results. Sometimes, what a patient feels as a problem doesn't always show up clearly in these tests. This study is a small, initial step (a 'pilot' study) to see if it's realistic and worthwhile to carry out a much larger study. The aim is to compare how well UDS and VUDS help doctors decide on the best treatments and ultimately improve how women feel.

Researchers at University College London Hospitals (UCLH) will invite 30 women to take part. Each woman will have either the UDS or VUDS test. Based on the test results, they will then receive medical or surgical treatment tailored to their specific problem. The study will carefully track how much the women's symptoms improve, their experience, and even consider things like X-ray exposure and costs. This will help doctors understand which test might be more helpful for different women and when these tests should or shouldn't be used.

Key takeaways

This study compares two common bladder tests for women with returning bladder leaks.
It aims to see which test helps doctors pick the best treatment and improve symptoms.
Participation involves either a UDS or VUDS test followed by tailored treatment.
Your feedback on symptoms and experience is important for the study.
The study helps improve future care for women with stress incontinence.

Who may be eligible?

This study is looking for women aged 18 or older who are experiencing bladder leaks (stress urinary incontinence) that have come back after previously having surgery for the condition. You need to be able to understand the study and agree to take part.

However, there are certain situations where you wouldn't be able to join. This includes if you are pregnant, or if your overall health isn't good enough to have an operation. Also, if you have a very high body weight (a BMI over 35), or if you've had radiation treatment to your pelvic area, or certain nerve conditions that affect your bladder, you wouldn't be eligible.

The research team will discuss all these points with you to make sure the study is right for you and that you meet all the necessary requirements to participate safely.

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 bladder leaks (stress incontinence) that have come back after surgery?
Are you able to understand the study and agree to take part?
Are you not pregnant and generally fit enough for potential surgery?
Do you have a BMI under 35 (not severely overweight)?
Have you not had radiotherapy to your pelvis or certain nerve conditions affecting your bladder?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a discussion with the research team to ensure you understand everything and are a good fit. You would then be asked to give your consent. Following that, you would undergo either a standard urodynamic test (UDS) or a videourodynamic test (VUDS), which involves placing small tubes into your bladder and back passage. The VUDS test also involves some X-rays. These tests are carried out at University College London Hospitals (UCLH) by a specialised team.

After the test, the doctors will use the results to tailor your medical or surgical treatment for your bladder leaks. You will be asked to complete questionnaires to track your symptoms and your experience throughout the study. The study doesn't involve any new or experimental medications; instead, it focuses on which diagnostic test better guides existing treatments. The total duration of your participation will depend on the course of your treatment and follow-up assessments.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as receiving specific attention and tailored treatment for your recurrent bladder leaks from specialist teams at UCLH. Your participation will also help doctors better understand the best ways to diagnose and treat this condition for future patients. Potential risks are generally associated with the urodynamic or videourodynamic tests themselves, which are routine procedures but can sometimes cause discomfort, mild infection, or, in the case of VUDS, a small amount of X-ray exposure. The research team will discuss all potential risks with you in detail. Remember, deciding to participate is entirely voluntary, and you are free to withdraw from the study at any time without affecting your future medical care.

Locations (1)

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

University College Hospital at Westmoreland Street
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'stress incontinence'?

It's when you leak urine when you cough, sneeze, laugh, or exercise, due to pressure on your bladder.

What is a 'recurrent' condition?

It means the condition has come back after you've already had treatment (like surgery) for it before.

What's the difference between UDS and VUDS?

Both test your bladder function, but VUDS also uses X-rays to see how your bladder and urethra are working.

Will I get new medicine in this study?

No, this study is about which test (UDS or VUDS) helps doctors choose the best existing treatments for you.

Who is running this study?

This study is being conducted by specialist teams at University College London Hospitals (UCLH).

How to find out more

Bogdan Toia, MD (Romania)

bogdan.toia1@nhs.net +447864707846 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.