Nephrolithiasis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESuctioning-UAS
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.
DEVICENon-suctioning-UAS
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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Surgeon will not be blinded to the UAS type (suctioning vs. non-suctioning) but will be blinded to IRP measurements during the procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and older. * Diagnosed with kidney stones and scheduled for fURS. * Stone burden \> 1 cm and/or multiple stones will be eligible. * Able and willing to provide informed consent.
Exclusion criteria
* Pregnant persons as determined by pre-operative urine pregnancy test (standard of care at our institution) * Untreated UTI * Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney) * Single stone \< 1 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrarenal Pressure (IRP) During Flexible Ureteroscopy | Intraoperative (during procedure) | Continuous measurement of intrarenal pressure using the LithoVue Elite ureteroscope system. |
| Time spent above Intrarenal Pressure (IRP) threshold during Flexible Ureteroscopy | Intraoperative (during procedure) | Time spent above Intrarenal Pressure (IRP) thresholds of 20, 40, 60, 80, and 100 mmHg using the LithoVue Elite ureteroscope system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate (SFR) on Postoperative CT Imaging | 4-8 weeks postoperatively | 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). |
| Postoperative Pain Score (VAS) | In the Post-Anesthesia Care Unit (PACU), prior to discharge on the day of surgery (on average 1.5 hours post operatively) | Visual Analog Scale (VAS) pain score. Scale ranges from 0 (no pain) to 10 (worst pain imaginable); higher scores indicate greater pain intensity. |
| Number of Postoperative Complications | 30 days postoperatively | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMantu Gupta, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed