RecruitingPHASE3INTERVENTIONAL

Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser

This study is investigating if a water tablet called Furosemide (given with extra fluids) can help people clear tiny leftover kidney stone fragments after laser surgery. When kidney stones are zapped with a laser during a procedure called flexible ureteroscopy, they break into many small pieces. While some are removed, very tiny bits can remain in the kidney. These tiny fragments might grow into new stones later on. Previous research has shown that using water tablets (diuretics) can help clear stone fragments after a different type of stone treatment, but it hasn't been specifically studied after laser surgery within the kidney. This research aims to see if Furosemide can increase urine flow enough to flush out these microscopic fragments, potentially reducing the chance of new stones forming later.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Tours

Enrolment target

374

Start

04 Jan 2024

Estimated completion

03 Apr 2026

Kidney Stone

What is this study about?

Kidney stones are hard lumps that can form in your kidneys and cause a lot of pain. One common way to treat them is called flexible ureteroscopy, where doctors use a thin, flexible tube to reach the stone and break it up with a laser. The laser turns the stone into tiny pieces, like dust. While doctors try to remove as many pieces as possible, some very small fragments can be left behind in your kidney.

These tiny leftover pieces are a bit like crumbs on a table – you hope they'll disappear on their own. Usually, your body's natural processes, like urine flowing through your kidney, help to wash them away. However, sometimes these tiny fragments can stay put and might even grow into new, bigger stones in the future. This study is exploring a way to help your body get rid of these stubborn small bits.

In the past, for a different type of kidney stone treatment (where sound waves break the stones), doctors found that giving patients a 'water tablet' (a diuretic) with extra fluids, called 'forced diuresis', helped clear pieces. This made more urine flow through the kidneys, flushing out the stone fragments. This study wants to see if the same idea works after laser surgery for kidney stones inside the kidney. They are specifically looking at a common water tablet called Furosemide to see if it can increase urine flow enough to help clear those tiny leftover fragments, hopefully stopping new stones from forming.

Key takeaways

This study evaluates Furosemide to clear kidney stone fragments after laser surgery.
Tiny fragments can remain after surgery and might grow into new stones.
Furosemide is a 'water tablet' increasing urine flow.
The goal is to see if increased urine flow flushes out these small fragments.
This could potentially reduce the chance of new stones forming.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 80 years old, and you must be scheduled to have laser surgery (flexible ureteroscopy) to break up kidney stones. You also need to be covered by the UK social security system (like NHS services) and be able to understand and sign a consent form, showing you agree to take part. It's important that you can follow the study's instructions.

There are certain reasons why you wouldn't be able to join. This includes if you are pregnant, breastfeeding, under 18, or if a court decision means you can't make your own choices. You also can't participate if you have any serious health conditions that would make Furosemide unsafe for you. This includes severe kidney problems, very low potassium or sodium levels, severe dehydration, or serious liver disease. If you're already taking Furosemide regularly, or if you need certain other strong antibiotics (like Aminoside or Vancomycin) around the time of your procedure, you won't be able to join. Finally, if you're already in another study testing a new medicine or medical device, you wouldn't be eligible for this one.

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 between 18 and 80 years old?
Are you scheduled for laser surgery for kidney stones?
Do you have no serious allergies to Furosemide or related medicines?
Do you have no severe kidney or liver problems?
Are you NOT pregnant or breastfeeding?
Are you NOT currently taking Furosemide regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given a water tablet called Furosemide through an injection, along with extra fluids given into your vein (like a drip), after your kidney stone laser surgery. The doctors will then monitor you as part of your standard care. The main focus of the study is observing how well your body clears the tiny stone fragments. There will likely be follow-up appointments and scans to check if any fragments remain in your kidney. The total duration of your involvement in the study would depend on how long these checks are needed to see the full effect of the treatment.

Potential risks and benefits

Potential benefits of taking part could include a better chance of clearing the tiny stone fragments left after surgery, which might reduce the risk of new stones forming in the future. However, there are no guarantees, and this is still being researched. Potential risks are mainly related to the Furosemide medication itself, such as dehydration, changes in your body's salt levels, or specific reactions if you have an allergy, though these risks will be carefully checked for before you receive the medicine. As with any study, you are free to withdraw at any time without giving a reason, and this will not affect your usual medical care.

Locations (9)

CHU d'Angers
Verified postcode
Angers, France· Recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
CHU de Nice
Verified postcode
Nice, France· Recruiting
CHU de Nîmes
Verified postcode
Nîmes, France· Recruiting
CHU de Rennes
Verified postcode
Rennes, France· Recruiting
CHU de Rouen
Verified postcode
Rouen, France· Recruiting
CHU de Toulouse
Verified postcode
Toulouse, France· Recruiting
Clinique La Croix du Sud
Verified postcode
Toulouse, France· Recruiting
CHRU de Tours
Verified postcode
Tours, France· Recruiting

Common questions

What is Furosemide?

Furosemide is a 'water tablet' (a diuretic) that helps your body produce more urine, making you pass water more often.

What is 'forced diuresis'?

This is when doctors give you extra fluids along with a water tablet like Furosemide to significantly increase your urine flow.

Why is this study important?

It could help find a way to clear tiny stone fragments left after kidney stone surgery, possibly preventing new stones from growing later.

Is laser surgery for kidney stones common?

Yes, laser surgery (flexible ureteroscopy) is a very common and effective way to treat kidney stones.

Will I definitely benefit from this treatment?

This is a research study, so we don't know for sure if it will benefit everyone. That's what the study aims to find out.

How to find out more

Marie-Lou LETOUCHE, MD

marielou.letouche@gmail.com +33247474665 Official trial record

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