Impact of Forced Diuresis Using Furosemide After Flexible Ureteroscopy to Improve Clearance of Kidney Stone Fragments A Randomized Controlled Phase 3 Trial
Led by University Hospital, Tours · Updated on 2025-11-24
374
Participants Needed
9
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Flexible ureteroscopy is a common technique used to treat kidney stones by breaking them into small fragments with a laser for removal or natural expulsion. However, some tiny fragments may remain in the kidney after the procedure, potentially leading to new stone formation. Researchers are studying whether forced diuresis, achieved by injecting Furosemide combined with intravenous hydration, can help clear these residual fragments more effectively. This approach has shown positive results in other kidney stone treatments but has not yet been specifically studied with flexible ureteroscopy.
Participants in this study will be randomly assigned to receive either an injection of 40 mg of Furosemide over 10 minutes right after the flexible ureteroscopy procedure or usual care without the injection. The trial is designed as a randomized controlled study with blinding of the evaluation. The aim is to determine if this forced diuresis method improves the clearance of stone fragments from the kidney.
During the study, researchers will monitor the rate of patients who are stone-free at three months after treatment as the primary outcome. Secondary outcomes include rates of urinary infection within 30 days, pain levels and opioid use during hospital stay, and the number of participants experiencing any adverse events up to three months. Participants will be followed closely during the hospital stay and for three months after their procedure to assess these outcomes and ensure safety.
CONDITIONS
Brief Title
Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser
Research Team
M
Marie-Lou LETOUCHE, MD
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Patients aged 18 years or older and younger than 80 years
Need for flexible ureteroscopy with laser destruction of kidney stones
Covered by or entitled to social security
Written informed consent obtained
Ability to comply with study requirements
You will not qualify if you...
Protected persons including pregnant women, nursing mothers, minors, persons deprived of liberty, or under legal protection
Contraindication to Furosemide such as hypersensitivity to Furosemide or Sulfonamide
Renal failure with oligo-anuria refractory to Furosemide
Hypokalemia below 3.5 mmol/L
Severe hyponatremia
Hypovolemia with or without hypotension or dehydration
Ongoing severe liver disease including hepatitis or hepatic encephalopathy
Current Furosemide treatment
Need for Aminoside or Vancomycin injection before or during procedure
Participation in other interventional research with investigational drugs or devices
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Hospital stay, approximately 1 day
Participants undergo flexible ureteroscopy with laser to destroy kidney stones. After the procedure, some participants receive an injection of 40 mg of Furosemide over 10 minutes to promote forced diuresis, while others receive usual care without the injection.
1 treatment visit (in-person)
Follow-up
Duration - Up to 3 months
Participants are monitored for stone clearance, urinary infections, pain, opioid use, and adverse events after treatment.
Approximately 2 to 3 follow-up visits
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Impact of Forced Diuresis Using Furosemide After Flexible Ureteroscopy to Improve Clearance of Kidney Stone Fragments A Randomized Controlled Phase 3 Trial
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Published Research Related To This Trial
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.