Menu
Recruiting NCT07601932

Patient Positioning for Treatment of Proximal Ureteral Stones

No phase Interventional Ureteral Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reverse Trendelenburg Position, T-Tilt Position.
Who it may be relevant to
Registry conditions: Ureteral Stone. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Reverse Trendelenburg Position
    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.
  • Procedure T-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.

Primary outcome measures

  • Total operative time [Time frame: Immediately postoperatively on the day of surgery]
Secondary outcome measures (4)
  • Proportion of participants stone-free [Time frame: From Week 4 to Week 6 postoperatively]
  • Proportion of procedures requiring additional equipment or procedural maneuvers [Time frame: Immediately after completion of surgery on the day of procedure]
  • Proportion of strategy failure [Time frame: Assessed immediately at completion of surgery on the day of procedure]
  • Incidence of Complications [Time frame: Through postoperative day 30]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mount Sinai West — New York

Identifiers

NCT: NCT07601932 · STUDY-26-00168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗