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This randomized controlled clinical trial evaluated whether furosemide-assisted forced diuresis during flexible ureteroscopy reduced the residual fragment rate and improved the stone-free rate after flexible ureteroscopy for management of medium sized renal stones measuring up to 30 millimeters. Adult patients undergoing flexible ureteroscopy for renal stones were randomized into two parallel groups: an experimental group that received intravenous furosemide during the procedure and a control group that received standard perioperative and postoperative care without furosemide. Stone-free status and residual fragments were assessed using non-contrast computed tomography performed four weeks after the procedure, and residual fragments were classified by fragment size. Secondary outcomes included operative time, length of hospital stay, postoperative complications, total urine output in the first 24 hours, and the need for additional treatments for significant residual stones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide-Assisted Forced Diuresis During Flexible Ureteroscopy | Experimental | During flexible ureteroscopy, participants received intravenous furosemide 40 milligrams total, divided into 20 milligrams administered 5 minutes after induction of anesthesia and 20 milligrams administered 30 minutes after the start of the procedure. |
|
| Standard Care During Flexible Ureteroscopy Without Furosemide | Active Comparator | Participants underwent flexible ureteroscopy and received standard perioperative and postoperative care without receiving intravenous furosemide or any other diuretic medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Intravenous furosemide was administered as a total dose of 40 milligrams during the procedure, divided into 20 milligrams given 5 minutes after induction of anesthesia and 20 milligrams given 30 minutes after the start of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate on non-contrast computed tomography | Stone-free status was assessed using non-contrast computed tomography performed four weeks after the procedure. Residual fragments were classified into four grades: Grade A (no stones), Grade B (0 to 2 millimeters), Grade C (2.1 to 4 millimeters), and Grade D (greater than 4 millimeters, clinically significant residual stones). | Four weeks after flexible ureteroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time was calculated from insertion of the ureteroscope into the urethra until completion of ureteral stent placement. | During procedure |
| Length of hospital stay | Length of hospital stay was calculated from the day of surgery to the day of discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals (Urology Department) | Cairo | Cairo Governorate | 11511 | Egypt |
De-identified individual participant data that underlay the reported results were planned to be shared with other researchers. The shared data were planned to include baseline characteristics, stone characteristics, intraoperative details, stone-free outcome on non-contrast computed tomography at four weeks, and postoperative outcomes including complications, pain scores, urine output in the first 24 hours, and need for auxiliary treatment. A data dictionary was planned to be provided.
The data were planned to become available after completion of the study and acceptance of the thesis or publication of the primary results, and were planned to remain available for five years.
Access was planned to be provided to qualified researchers upon reasonable request, after review of a brief proposal and analysis plan, and after execution of a data use agreement. Data were planned to be shared in a secure electronic format with de-identification applied.
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Participants were randomly assigned in a one-to-one ratio to receive either intravenous furosemide-assisted forced diuresis during flexible ureteroscopy or standard care without furosemide during flexible ureteroscopy.
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| Standard Care After Flexible Ureteroscopy Without Furosemide | Other | Participants received standard perioperative and postoperative management after flexible ureteroscopy without administration of furosemide or any other diuretic medication. |
|
| From end of procedure to hospital discharge (up to 7 days) |
| Postoperative hematuria | Hematuria was recorded after the procedure. | From end of procedure through 4 weeks post-procedure |
| Postoperative urinary tract infection | Postoperative urinary tract infection was assessed within seven days after the procedure using fever with urinary symptoms and or a positive urine culture with significant bacteriuria. | Within 7 days post-procedure |
| Postoperative pain score | Postoperative pain was assessed using a numerical rating scale (NRS) from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain (higher scores = worse pain). Pain was recorded in the recovery room (PACU), on postoperative day 1 (during admission), and at discharge. | Recovery room (PACU), postoperative day 1, and at discharge (up to 7 days) |
| Need for auxiliary treatment for clinically significant residual stones | The need for auxiliary treatment for clinically significant residual stones was recorded, including extracorporeal shock wave lithotripsy or repeat ureteroscopy. | Up to four weeks after flexible ureteroscopy |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |