Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
ID05916963

Impact of Forced Diuresis Using Furosemide Injection After Flexible Ureteroscopy for Kidney Stone Destruction With Laser: A Randomized Controlled Multicenter Trial with Blinded Evaluation

Led by University Hospital, Tours · Updated on 2025-11-24

374

Participants Needed

9

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 9 locations

1

CHU d'Angers

Angers, France

Actively Recruiting

2

Hospices Civils de Lyon

Lyon, France

Actively Recruiting

3

CHU de Nice

Nice, France

Actively Recruiting

4

CHU de Nîmes

Nîmes, France

Actively Recruiting

5

CHU de Rennes

Rennes, France

Actively Recruiting

6

CHU de Rouen

Rouen, France

Actively Recruiting

7

CHU de Toulouse

Toulouse, France

Actively Recruiting

8

Clinique La Croix du Sud

Toulouse, France

Actively Recruiting

9

CHRU de Tours

Tours, France

Actively Recruiting

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Research Team

M

Marie-Lou LETOUCHE, MD

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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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.

M L Letouche, B Giraudeau, M S Agier...

https://pubmed.ncbi.nlm.nih.gov/38965611