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

Kidney Stone Clinical Trial

— FIREStones  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05916963
• Other study ID #: 2022-502890-40-00
• Secondary ID: DR220258
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 15, 2023
• Est. completion date: March 15, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Tours
• Contact: Marie-Lou LETOUCHE, MD
• Phone: +33247474665
• Email: marielou.letouche[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 374
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 3 months
Secondary	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.	From baseline to 30 days
Secondary	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)	During the hospital stay
Secondary	Opioid consumption	The use of opioids will be reported	During the hospital stay, an average of 1 day
Secondary	Number of participants with adverse events	Number of participants with Furosemide adverse events	From baseline to 3 months, an average of 1 day