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Patient Positioning for Treatment of Proximal Ureteral Stones

Optimal Patient Positioning and Strategy for the Treatment of Proximal Ureteral Stones

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07601932
Enrollment
54
Registered
2026-05-22
Start date
2026-05-01
Completion date
2027-12-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Stone

Brief summary

Ureteroscopic management of proximal ureteral stones presents technical challenges including stone retropulsion, prolonged operative time, and conversion to intrarenal treatment. Reverse Trendelenburg positioning has been shown to reduce proximal stone migration and operative time in ureteral stones, while the T-tilt position improves intrarenal stone clearance. The optimal strategy for proximal ureteral stones (treating stones in situ using reverse Trendelenburg versus pushing stones into the kidney followed by intrarenal treatment in T-tilt) remains unknown. This randomized controlled trial compares these two strategies, with primary focus on operative time as a measure of procedural efficiency. A total of 54 patients (27 per arm) will be enrolled at Mount Sinai West.

Detailed description

Ureteroscopy has become a primary modality for the management of ureteral and renal calculi due to its high efficacy, minimally invasive nature, and favorable safety profile. Despite advances in flexible ureteroscopy, laser lithotripsy, and access technologies, proximal ureteral stones remain technically challenging, largely due to their tendency to migrate retrograde into the kidney, leading to prolonged operative time, increased need for flexible ureteroscopy, and lower procedural efficiency. Stone retropulsion is influenced by laser energy, irrigation flow, ureteral anatomy, and gravitational forces. Several mechanical and laser-based strategies have been explored to mitigate migration, though results have been variable. Patient positioning represents a simple and cost-neutral intervention that may alter stone behavior intraoperatively without requiring additional devices. Reverse Trendelenburg positioning has recently been shown to reduce proximal stone migration and improve operative efficiency during ureteroscopic treatment of ureteral stones. In a randomized controlled trial, patients positioned in reverse Trendelenburg experienced lower rates of retropulsion, reduced need for conversion to flexible ureteroscopy, and shorter operative times compared with standard positioning. However, this study included stones across multiple ureteral segments and did not focus specifically on proximal ureteral stones, which may have distinct anatomical and migration characteristics. Conversely, T-tilt positioning has been investigated in the context of intrarenal stone treatment. Prior randomized evidence demonstrated that T-tilt positioning during retrograde intrarenal surgery resulted in higher stone-free rates, likely due to improved gravitational alignment of calyces and enhanced fragment clearance. These findings suggest that positioning may also optimize intrarenal lithotripsy efficiency once stones migrate into the kidney. For proximal ureteral stones, two competing operative strategies are commonly used in clinical practice: (1) in situ ureteral treatment with efforts to prevent migration, potentially optimized by reverse Trendelenburg positioning, or (2) intentional pushback of the stone into the kidney followed by intrarenal lithotripsy under positioning conditions favorable for fragment clearance, such as T-tilt. The decision to use one strategy over another is based on surgeon preference. Currently, there are no guidelines or standards favoring either approach. To date, no randomized study has directly compared these two positioning-based strategies for proximal ureteral stones. Given that operative time is strongly associated with anesthesia exposure, procedural cost, complication risk, and resource utilization, it represents a clinically meaningful and objective primary endpoint to evaluate procedural efficiency between approaches. This study seeks to address an important gap in endourologic practice by determining the optimal positioning strategy for proximal ureteral stone management, with the goal of improving operative efficiency, reducing procedural burden, and informing evidence-based surgical decision-making.

Interventions

Patients will be positioned in reverse Trendelenburg at a 20 degree incline with the use of a digital protractor. Lithotripsy will be performed within the ureter with attempts to prevent proximal migration and until all fragments are removed.

PROCEDURET-Tilt Position

Stone will be intentionally relocated into the kidney when feasible, followed by intrarenal lithotripsy in T-tilt position. In the T-tilt position the table is angled 15-degree Trendelenburg and 15-degree airplane away from the surgical side kidney with the use of a digital protractor. This allows fragments to rest in a superior and medial position away from the lower pole to facilitate removal.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

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 the institution) * Untreated UTI * Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney) * Single stone \< 1 cm

Design outcomes

Primary

MeasureTime frameDescription
Total operative timeImmediately postoperatively on the day of surgeryOperative time will be used to compare procedural efficiency

Secondary

MeasureTime frameDescription
Proportion of participants stone-freeFrom Week 4 to Week 6 postoperativelyProportion of participants without residual stone fragments on postoperative CT imaging
Proportion of procedures requiring additional equipment or procedural maneuversImmediately after completion of surgery on the day of procedureProportion of procedures requiring additional equipment or procedural maneuvers beyond the initially planned operative strategy to complete stone treatment
Proportion of strategy failureAssessed immediately at completion of surgery on the day of procedureProportion of cases in which the randomized operative strategy could not be successfully executed intraoperatively
Incidence of ComplicationsThrough postoperative day 30Incidence of postoperative complications, defined as any Clavien-Dindo complications, emergency department visits, or readmission related to the procedure. Outcome is recorded as the occurrence of a complication event (yes or no). Each participant is counted once, and the outcome is recorded as a binary variable indicating whether any of these events occurred or did not occur.

Countries

United States

Contacts

CONTACTMantu Gupta, MD
mantu.gupta@mountsinai.org212-241-1272
CONTACTBlair Gallante, MPH
blair.gallante@mountsinai.org212-241-1272
PRINCIPAL_INVESTIGATORMantu Gupta, MD

Icahn School of Medicine at Mount Sinai

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026