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

ConditionKidney Stone
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Tours

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Hyper-sensitivity to the active substance or one of the excipients

Hyper-sensitivity to Sulfonamide

Renal failure with oligo-anuria refractory to Furosemide

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

374 Participants
are divided into 2 treatment groups
Group A: FurosemideExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
At 3 months

Secondary outcomes

1

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.

Time frame
From baseline to 30 days
2

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)

Time frame
During the hospital stay
3

Opioid consumption

The use of opioids will be reported

Time frame
During the hospital stay, an average of 1 day
4

Number of participants with adverse events

Number of participants with Furosemide adverse events

Time frame
From baseline to 3 months, an average of 1 day

Other outcomes

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