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RecruitingNCT05916963

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

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
374 (estimated)
Sponsor
University Hospital, Tours · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

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

Interventions

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

Timeline

Start date
2024-01-04
Primary completion
2026-04-03
Completion
2026-04-03
First posted
2023-06-23
Last updated
2025-11-24

Locations

9 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05916963. Inclusion in this directory is not an endorsement.