Two single-arm, multicentre unblinded first-in-human trials, including two phases and a qualitative substudy investigating a novel ureteric stent in kidney stone patients and oncology patients to determine the reduction of encrustation, biofilm deposition and complications compared to a conventional JJ stent (CASSETTE)
We are testing a new ureteric stent for the first time in people. Stents are small tubes placed in your body to help urine flow from your kidney to your bladder when there’s a blockage, often caused by kidney stones or cancer. Sometimes, these stents can get blocked by calcium (like limescale) or bacteria, leading to infections or needing another operation. Researchers have designed a new stent with special holes to help stop these blockages. This study wants to find out if this new stent is safe, comfortable for patients, and whether it really does prevent blockages better than older types of stents. We hope it will mean fewer hospital visits and a better quality of life for patients.
At a glance
What is this study about?
Imagine your body’s drainage system for urine; sometimes, a tube called a ureteric stent is needed to keep things flowing, especially if you have kidney stones or certain types of cancer. The problem is that these stents can get clogged up over time, a bit like a drain getting blocked with gunk. This build-up can be from things like calcium, similar to limescale in a kettle, or from bacteria that cause infections.
When a stent gets blocked, it can cause urine infections that need antibiotics. If this happens often, these infections can become harder to treat. In more serious cases, a completely blocked stent means you might need another hospital visit for an operation to replace it. This can be really disruptive and uncomfortable for patients.
Now, scientists at the University of Southampton have created a brand-new type of stent. This new design has special holes that they hope will make it less likely to get blocked by calcium or bacteria. We believe this could mean the stents last longer, patients might need fewer hospital visits for replacements, and overall, people could feel much better. This study is the very first time we're testing this new stent in people, and we need to check if it's safe, if patients find it comfortable, and if it works as well as we hope.
Key takeaways
- This study tests a new ureteric stent design.
- It aims to prevent blockages from calcium and bacteria.
- The goal is fewer infections and less frequent stent changes.
- It's the first time this new stent is being used in people.
- The study includes questionnaires and optional interviews about your experience.
- Potential benefits include a better quality of life and fewer hospital visits.
Who may be eligible?
This study is looking for volunteers who are 18 years old or older. You must need a ureteric stent because of kidney stones or cancer in your tummy area, and you should have had a ureteric stent before.
It's important that you are waiting to have a stent put in or replaced, and that you are able to understand the study information and fill out any forms and questionnaires. You also need to be able to speak enough English to complete these documents.
You won't be able to join if you are expected to live for less than 4 months, if you are not well enough for a stent operation, if you can't follow the study's instructions, or if you are pregnant before the stent is put in. Also, if your stent is planned to be removed at a different hospital than where it's put in, you won't be able to take part.
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 18 years old or older?
- Do you need a ureteric stent for kidney stones or cancer?
- Have you had a ureteric stent before?
- Are you able to speak and understand English to complete questionnaires?
- Are you well enough for a stent operation?
- Are you not currently pregnant?
What does participation involve?
If you decide to join this study, you will have the new type of stent put in, and then it will be removed later on, just like a standard stent procedure. During the study, you'll be asked to fill out several questionnaires at different times to tell us about your experience.
There's also a chance to take part in an optional interview where you can talk more deeply about your experiences with the stent, and doctors might also share their thoughts. The study plans to start around August 2024 and is expected to run until December 2026.
Potential risks and benefits
Locations (2)
- University Hospital Southampton NHS Foundation TrustCity onlySouthampton, United Kingdom
- University College London Hospitals NHS Foundation TrustCity onlyLondon, United Kingdom
Common questions
What is a ureteric stent?
It's a small, flexible tube placed in your body to help urine flow from your kidney to your bladder, usually if there's a blockage.
Why is a new stent needed?
Existing stents can get blocked by calcium or bacteria, leading to infections or needing to be replaced often. This new stent aims to reduce those blockages.
Will I have more hospital visits for this study?
You'll have the stent inserted and removed as usual, plus a few follow-up questionnaires. We hope the new stent will mean *fewer* hospital visits in the long run.
What if the new stent causes problems?
The risks are expected to be the same as with a standard stent. Your doctors will treat any problems just as they would normally. You can also leave the study at any time.
Who is paying for this research?
The study is funded by the National Institute for Health and Care Research (NIHR), a UK government organisation that supports health research.
How to find out more
Ali Mosayyebi
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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