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NCT Number: NCT05916963

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide 40 mg

Drug

Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.
  2. 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)

  3. Opioid consumption

    Time frame: During the hospital stay, an average of 1 day

    The use of opioids will be reported

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Lou LETOUCHE, MD

CONTACT

[email protected]

+33247474665

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: FIREStones

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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