Effect of Furosemide on ESWL Outcomes for Renal and Ureteral Calculi

Trial end date:
Target enrollment:
Participant gender:
The minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Despite some promising results, few clinical trials have assessed the impact of furosemide on the outcome of ESWL. This study seeks to determine the effect of furosemide on ESWL outcomes when treating renal and ureteral calculi, hypothesizing that it will result in better outcomes for patients. The present double-blind, randomized clinical trial includes 500 adults aged 18-60 years referring to the ESWL Clinic of Shahid Faghihi Hospital. Using block randomization, the patients are randomly assigned to one of two groups. All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Pain will be checked for all participants via a telephone interview 24 hours later. The outcomes and possible side effects of ESWL will be evaluated for all patients after two and twelve weeks.
Phase 3
Accepts Healthy Volunteers?
Lead Sponsor:
Shiraz University of Medical Sciences
Inclusion Criteria:

- Age 18 to 60 years

- Patients with renal or ureteral calculi referred by attending urologists to the ESWL
Clinic of Shahid Faghihi Hospital, affiliated to Shiraz University of Medical Sciences
(Shiraz, Iran)

Exclusion Criteria:

- An anatomic anomaly in urinary system

- Coagulopathy

- Untreated urinary tract infection

- Prior urologic surgery

- Simultaneous unilateral renal and ureteral stones

- Kidney failure (serum creatinine > 1.8 mg/dl)

- Cardiovascular disease

- Hypertension

- Morbid obesity (BMI > 40 kg/m2)

- History of allergy to furosemide, glibenclamide, hydrochlorothiazide, or

- Pregnancy

- Single kidney