Study on the Effect of Furosemide and Amiloride Hydrochloride on Kidney Stone Fragments After Laser Treatment in Patients Undergoing Flexible Ureteroscopy

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What is this study about?

This clinical trial is focused on studying the treatment of kidney stones, which are hard deposits made of minerals and salts that form inside the kidneys. The treatment being tested involves the use of a medication called Furosemide, which is administered through a slow intravenous injection. The purpose of the study is to determine if injecting 40 mg of Furosemide after a procedure called flexible ureteroscopy, which uses a laser to break down kidney stones, can increase the rate at which patients become stone-free three months after the procedure.

Participants in the study will undergo the flexible ureteroscopy procedure, after which they will receive either Furosemide or a placebo. The study will monitor the stone-free rate at three months using a low-dose CT scan, a type of imaging that helps visualize the inside of the body. Additionally, the study will assess any post-operative urinary tract infections, post-operative pain, and any adverse events related to Furosemide. The effect of prescribing an alpha-blocker, a type of medication that can help relax certain muscles, will also be evaluated in relation to the primary outcome of the study.

The trial aims to provide valuable insights into whether Furosemide can effectively aid in the removal of kidney stone fragments after laser treatment. The results will be reviewed by specialized radiologists to ensure consistency and accuracy. This study is expected to conclude by December 2025, with recruitment having started in September 2023.

1 joining the study

Eligibility is confirmed for individuals aged 18 to 79 who require a procedure called flexible ureteroscopy to remove kidney stones using a laser. Stones must be less than 3 cm in size.

Written consent is obtained, and participants must be affiliated with a French social security system or equivalent.

2 procedure and medication administration

The flexible ureteroscopy procedure is performed to destroy kidney stones with a laser.

After the procedure, an injection of 40 mg of furosemide is administered slowly over 10 minutes through a direct intravenous injection. This aims to increase the rate of being stone-free three months after the procedure.

3 post-operative assessment

Within 30 days after surgery, any post-operative urinary tract infection is assessed. This includes checking for fever above 38.5°C, chills, clinical symptoms like pain or burning during urination, and positive urine culture results.

Post-operative pain is evaluated using a numerical pain scale from 0 to 10 in the recovery room, during the hospital stay, and at discharge.

4 follow-up and evaluation

Three months after the procedure, a low-dose abdomino-pelvic CT scan is performed to evaluate the stone-free rate. The images are reviewed by two specialized radiologists in a blind and crossed manner to ensure consistent results.

The effect of prescribing an alpha-blocker is considered in relation to the primary outcome.

The agreement between the imaging analysis of the urologist and the specialized radiologist is evaluated.

5 adverse events monitoring

Any adverse events related to furosemide are monitored throughout the study.

Who Can Join the Study?

Must be a male or female aged between 18 and 79 years old.
Must need a procedure called flexible ureteroscopy, which is a method to look inside the urinary tract and treat kidney stones using a laser.
Must be part of a French social security system or have an equivalent coverage.
Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.
Must be able to follow the study’s requirements, meaning they can attend appointments and follow instructions.
Must have kidney stones that are less than 3 centimeters in size.

Who Cannot Join the Study?

Patients who are not within the specified age range for the study.
Patients who have medical conditions that are not related to the destruction of kidney stones.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any other health issues that might interfere with the study or its results.
Patients who are unable to follow the study procedures or instructions.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nice	Nice	France
Hospices Civils De Lyon	Lyon	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Capio La Croix Du Sud	Quint-Fonsegrives	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Cxikdi Hxhdrwzxqyu Rxlofdcp Ujumhbianksex Dn Tuczy	Tours	France
Cevmix Heyrqffzlph Rpkakzco Dzfeunquyifezg	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.09.2023

Trial locations

Investigated drugs:

Furosemide is a medication used in this trial to help increase the rate at which patients become stone-free after undergoing a procedure to break down kidney stones with a laser. It is administered through a slow intravenous injection after the procedure. The goal is to see if this medication can help clear out any remaining stone fragments more effectively.

Kidney Stones – Kidney stones are hard deposits made of minerals and salts that form inside the kidneys. They can develop when the urine becomes concentrated, allowing minerals to crystallize and stick together. As the stones grow, they may move into the urinary tract, causing pain and discomfort. The progression of kidney stones can lead to symptoms such as severe pain in the back or side, blood in the urine, and frequent urination. If a stone becomes lodged in the urinary tract, it can block the flow of urine and cause further complications. The size and location of the stone can affect the severity of symptoms and the course of the condition.

Trial ID:

2022-502890-40-00

Protocol code:

DR220258

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Furosemide and Amiloride Hydrochloride on Kidney Stone Fragments After Laser Treatment in Patients Undergoing Flexible Ureteroscopy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?