Interest in monitoring intrarenal pressure (IRP) during flexible ureteroscopy (fURS) has grown, especially due to its potential association with improved postoperative efficiency and safety. A prominent technique for managing IRP during fURS is the use of ureteral access sheaths (UAS), which are known to reduce IRP. Suction-equipped access sheaths provide additional benefits by continuously evacuating dust and stone fragments during the procedure, potentially enhancing stone-free rates. However, IRP during suctioning procedures has yet to be thoroughly investigated. The aim of this study is to compare the IRP during fURS using UAS with and without suctioning technique.
Interest in monitoring intrarenal pressure (IRP) during flexible ureteroscopy (fURS) has grown, especially due to its potential association with improved postoperative efficiency and safety. With advances in technology, precise tools like the LithoVue™ Elite now enables continuous IRP measurement, facilitating accurate data collection throughout the procedure. A prominent technique for managing IRP during fURS is the use of ureteral access sheaths (UAS), which are known to reduce IRP. Suction-equipped access sheaths provide additional benefits by continuously evacuating dust and stone fragments during the procedure, potentially enhancing stone-free rates (SFR). However, IRP during suctioning procedures has yet to be thoroughly investigated. This study is a randomized controlled trial comparing continuous intrarenal pressure (IRP) measurements during flexible ureteroscopy (fURS) using a suctioning ureteral access sheath (UAS) versus a non-suctioning UAS. The study will be conducted over an 18-month period and will include all patients over 18 years of age who are scheduled to undergo fURS for a stone burden greater than 1 cm and/or multiple stones. Patients who are pregnant, have an untreated urinary tract infection (UTI), urinary tract anomalies such as urinary diversion, ureteral reconstruction, or horseshoe kidney, or who have a single stone smaller than 1 cm will be excluded from participation. All procedures will take place at Mount Sinai West, with patients enrolled from the practices of two endourology-trained specialists, Dr. William Atallah and Dr. Mantu Gupta. Participants will be randomized to either the suctioning-UAS arm using the ClearPETRA Flexible and Navigable Suction UAS or the non-suctioning-UAS arm using the BSC Navigator device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
21
Participants undergoing flexible ureteroscopy (fURS) will receive a suctioning ureteral access sheath using the ClearPETRA Flexible and Navigable Suction UAS. Continuous intrarenal pressure (IRP) measurements will be recorded throughout the procedure using the LithoVue Elite ureteroscope system.
Participants undergoing flexible ureteroscopy (fURS) will receive a standard non-suctioning ureteral access sheath using the BSC Navigator device. Continuous intrarenal pressure (IRP) measurements will be recorded throughout the procedure using the LithoVue Elite ureteroscope system.
Mount Sinai West
New York, New York, United States
Intrarenal Pressure (IRP) During Flexible Ureteroscopy
Continuous measurement of intrarenal pressure using the LithoVue Elite ureteroscope system.
Time frame: Intraoperative (during procedure)
Time spent above Intrarenal Pressure (IRP) threshold during Flexible Ureteroscopy
Time spent above Intrarenal Pressure (IRP) thresholds of 20, 40, 60, 80, and 100 mmHg using the LithoVue Elite ureteroscope system.
Time frame: Intraoperative (during procedure)
Stone-Free Rate (SFR) on Postoperative CT Imaging
Rate of stone-free status assessed by non-contrast CT scan using a 4-grade scale (Grade A: completely stone-free; Grade B: residual fragments \<2 mm; Grade C: residual fragments 2-4 mm; Grade D: residual fragments \>4 mm).
Time frame: 4-8 weeks postoperatively
Postoperative Pain Score (VAS)
Visual Analog Scale (VAS) pain score. Scale ranges from 0 (no pain) to 10 (worst pain imaginable); higher scores indicate greater pain intensity.
Time frame: In the Post-Anesthesia Care Unit (PACU), prior to discharge on the day of surgery (on average 1.5 hours post operatively)
Number of Postoperative Complications
Number of any postoperative complications occurring within 30 days of the procedure (as defined by the study protocol and standard Clavien-Dindo classification or similar).
Time frame: 30 days postoperatively
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