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

November 18, 2025 updated by: University Hospital, Tours

FIRESTONES : Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser: a Randomized Controlled Two-parallel Group Multicenter Trial With Blinding Evaluation

In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Flexible ureteroscopy is the most common technique to treat kidney stones and is the treatment of choice in France.

Kidney stones destruction requires its laser pulverization into small fragments in order to remove them through the ureter or improve their spontaneous expulsion along the urinary tract. However, most of the time, all the micro-fragments and dust created during stone destruction cannot be extracted using our surgical tools, and may stay intra-renally at the end of the procedure. Although these micro-fragments are expected to disappear spontaneously by the natural flushing and peristalsis of the upper urinary tract, they remain at risk of stagnation that could be the nest of new aggregation and stone formation.

Adjuvant treatments (such as forced diuresis, inversion or mechanical pressure) were previously described to improve the expulsion of stone fragments after extra-corporeal shock wave lithotripsy.

Nevertheless, the impact of adjuvant treatment after flexible ureteroscopy remains unclear and mainly theoretical.

In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.

Loop diuretics (including Furosemide) significantly increase diuresis, which results in a greater flow of urine into the renal cavities, improving the chances of evacuating the residual fragments of the stone destroyed during flexible ureteroscopy, before they can sediment in the fundus of the renal calices or in the pyelon. Therefore, the investigators hypothesize that a forced diuresis with an injection of Furosemide at the end of ureteroscopy could improve the micro-fragments and stones dust clearance.

Study Type

Interventional

Enrollment (Estimated)

374

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU d'Angers
        • Contact:
        • Principal Investigator:
          • Pierre BIGOT
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Nadia ABID
      • Nice, France
        • Recruiting
        • CHU de Nice
        • Contact:
        • Principal Investigator:
          • Mathieu DURAND
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes
        • Principal Investigator:
          • Stephane DROUPY
        • Contact:
      • Rennes, France
      • Rouen, France
        • Recruiting
        • CHU de Rouen
        • Contact:
        • Principal Investigator:
          • Hugo DUPUIS
      • Toulouse, France
        • Recruiting
        • CHU de Toulouse
        • Principal Investigator:
          • Xavier GAME
        • Contact:
      • Toulouse, France
        • Recruiting
        • Clinique La Croix Du Sud
        • Contact:
        • Principal Investigator:
          • Christophe ALMERAS
      • Tours, France
        • Recruiting
        • CHRU de Tours
        • Contact:
        • Principal Investigator:
          • Marie-Lou LETOUCHE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥ 18 years old and < 80 years old
  • With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
  • Participants covered by or entitled to social security
  • Written informed consent obtained from the participant
  • Ability for participant to comply with the requirements of the study

Exclusion Criteria:

  • Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship)

  • Contra-indication to Furosemide:

    • Hyper-sensitivity to the active substance or one of the excipients
    • Hyper-sensitivity to Sulfonamide
    • Renal failure with oligo-anuria refractory to Furosemide
    • Hypokalemia < 3,5 mmol/L
    • Severe hyponatremia
    • Hypovolemia with or without hypotension or dehydration
    • Ongoing hepatitis, hepatic insufficiency severe and hepatic encephalopathy
  • Patient having Furosemide as usual treatment
  • Patient requiring an injection of Aminoside or Vancomycin before or during the procedure
  • Participation in other interventional research with an investigational drug or medical device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Furosemide
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
Drug: Furosemide 40 mg
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
No Intervention: Usual care
Usual care, without injection of Furosemide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of stone free patients
Time Frame: At 3 months

Rate of stone-free patients 3 months after a flexible ureteroscopy for renal stone laser destruction, evaluated on the low dose abdomino-pelvic CT-Scan.

A centralized review of the images will be performed by two specialized radiologists, in a blind and crossed way to allow a homogenization of the results
At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of urinary infection
Time Frame: From baseline to 30 days

Rate of post-operative urinary tract infection will be assessed within 30 days after surgery on the combination of:

  • Fever higher than 38.5°C and/or,
  • Chills and/or,
  • Clinical symptoms (supra-pubic pain, dysuria, pollakiuria, urgency, urinary burning, back pain radiating to the genitals, hematuria) and/or
  • Positive urine culture with a significant bacteriuria threshold defined as bacteriuria ≥10^5 UFC/mL with one or two bacterial species.
From baseline to 30 days
Pain in a scale
Time Frame: During the hospital stay
Post-operative pain will be assessed on numerical pain scale in the recovery room, in the service and at the discharge. Pain scale is from 0 (no pain) to 10 (as bad as it could be nothing else matters)
During the hospital stay
Opioid consumption
Time Frame: During the hospital stay, an average of 1 day
The use of opioids will be reported
During the hospital stay, an average of 1 day
Number of participants with adverse events
Time Frame: From baseline to 3 months, an average of 1 day
Number of participants with Furosemide adverse events
From baseline to 3 months, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

April 3, 2026

Study Completion (Estimated)

April 3, 2026

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-502890-40-00
  • DR220258 (Other Identifier: Promoter reference)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Stone

Clinical Trials on Furosemide 40 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe