Kidney StonePhase 3FIREStonesNCT05916963
Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser
A Phase 3 study testing Furosemide 40 mg in people with Kidney Stone, run by University Hospital, Tours at 9 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Furosemide 40 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 9 sitesFrance
- Study dates
- 4 Jan 2024to 3 Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CHU d'Angers
Angers
Pierre BIGOT, +332 41 35 64 94, pibigot@chu-angers.fr
Pierre BIGOT
- Recruiting
Hospices Civils de Lyon
Lyon
Nadia ABID, +33472119675, nadia.abid@chu-lyon.fr
Nadia ABID
- Recruiting
CHU de Nice
Nice
Mathieu DURAND, +33492031637, durand.m@chu-nice.fr
Mathieu DURAND
- Recruiting
CHU de Nîmes
Nîmes
Stéphane DROUPY, +334 66 68 33 53, stephane.droupy@chu-nimes.fr
Stéphane DROUPY
- Recruiting
CHU de Rennes
Rennes
Karim BENSALAH, +332 99 28 42 70, charles-karim.BENSALAH@chu-rennes.fr
Karim BENSALAH
- Recruiting
CHU de Rouen
Rouen
Hugo DUPUIS, +332 32 88 89 90, hugo.dupuis@chu-rouen.fr
Hugo DUPUIS
- Recruiting
CHU de Toulouse
Toulouse
Xavier GAME, +33561323106, game.x@chu-toulouse.fr
Xavier GAME
- Recruiting
Clinique La Croix du Sud
Toulouse
Christophe ALMERAS, +335 32 02 72 02, c.almeras@gmail.com
Christophe ALMERAS
- Recruiting
CHRU de Tours
Tours
Marie-Lou LETOUCHE, +336 74 75 71 13, marielou.letouche@gmail.com
Marie-Lou LETOUCHE
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Stone
- Being tested
- Furosemide 40 mg
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide 40 mgDrug
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Experimental | Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser. Receives: Drug: Furosemide 40 mg |
| Usual care | No intervention | Usual care, without injection of Furosemide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stone free patients
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
Measured: At 3 months
Secondary outcomes (4)
Rate of urinary infection
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.
Measured: From baseline to 30 days
Pain in a scale
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)
Measured: During the hospital stay
Opioid consumption
The use of opioids will be reported
Measured: During the hospital stay, an average of 1 day
Number of participants with adverse events
Number of participants with Furosemide adverse events
Measured: From baseline to 3 months, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start4 Jan 2024
- Primary completion3 Apr 2026 (estimated)
- Study completion3 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916963
- Sponsor's protocol ID
- 2022-502890-40-00
- Other IDs
- DR220258
- Acronym
- FIREStones
- Status last verified
- Nov 2025
- First submitted
- 14 Jun 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Letouche ML, Giraudeau B, Agier MS, Bruyere F. FIRE Stones: impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser-protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation. Trials. 2024 Jul 4;25(1):455. doi: 10.1186/s13063-024-08309-0.
PubMed 38965611
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05916963
- Acronym / sponsor ID
- FIREStones / 2022-502890-40-00
- Conditions
- Kidney Stone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 3 Apr 2026 (estimated)
- Study completion
- 3 Apr 2026 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Experimental | Drug: Furosemide 40 mgInjection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser. |
| Usual care | No intervention | –Usual care, without injection of Furosemide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide 40 mgInjection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser. | Drug | Furosemide |
Primary outcome
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
4 secondary outcomes
Rate of urinary infection
Time frame: From baseline to 30 days
Pain in a scale
Time frame: During the hospital stay
Opioid consumption
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 38965611Letouche ML, Giraudeau B, Agier MS, Bruyere F. FIRE Stones: impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser-protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation. Trials. 2024 Jul 4;25(1):455. doi: 10.1186/s13063-024-08309-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide 40 mg in people with Kidney Stone, run by University Hospital, Tours at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Lou LETOUCHE, MD (+33247474665, marielou.letouche@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of stone free patients (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.