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Ureteral StoneNCT07601932

Patient Positioning for Treatment of Proximal Ureteral Stones

A study testing Reverse Trendelenburg Position and T-Tilt Position in people with Ureteral Stone, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

Ureteroscopic management of proximal ureteral stones presents technical challenges including stone retropulsion, prolonged operative time, and conversion to intrarenal treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ureteral Stone
What is being tested?
Reverse Trendelenburg Position and T-Tilt Position
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
21 May 2026to Dec 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Mount Sinai West

    New York, New York, 10019

    Mantu Gupta, MD, 212-241-1272, Mantu.gupta@mountsinai.org

    Blair Gallante, MPH, 212-241-1272, blair.gallante@mountsinai.org

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Ureteral Stone
Being tested
Reverse Trendelenburg Position, T-Tilt Position
Medical subject headings
Ureterolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reverse Trendelenburg PositionProcedure or surgery

    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.

  • T-Tilt PositionProcedure or surgery

    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.

Study groups in NCT07601932
Study groupRoleWhat they receive
Reverse Trendelenburg PositionExperimentalParticipants undergo ureteroscopic lithotripsy in reverse Trendelenburg positioning with attempted in situ treatment of the proximal ureteral stone to minimize proximal migration.
Receives: Procedure: Reverse Trendelenburg Position
T-Tilt PositionActive comparatorParticipants undergo intentional relocation of the proximal ureteral stone into the kidney followed by intrarenal lithotripsy performed in the T-tilt position.
Receives: Procedure: T-Tilt Position

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total operative time

    Operative time will be used to compare procedural efficiency

    Measured: Immediately postoperatively on the day of surgery

Secondary outcomes (4)
  1. Proportion of participants stone-free

    Proportion of participants without residual stone fragments on postoperative CT imaging

    Measured: From Week 4 to Week 6 postoperatively

  2. Proportion of procedures requiring additional equipment or procedural maneuvers

    Proportion of procedures requiring additional equipment or procedural maneuvers beyond the initially planned operative strategy to complete stone treatment

    Measured: Immediately after completion of surgery on the day of procedure

  3. Proportion of strategy failure

    Proportion of cases in which the randomized operative strategy could not be successfully executed intraoperatively

    Measured: Assessed immediately at completion of surgery on the day of procedure

  4. Incidence of Complications

    Incidence 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.

    Measured: Through postoperative day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start21 May 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07601932
Sponsor's protocol ID
STUDY-26-00168
Status last verified
Jun 2026
First submitted
14 May 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: protecting participant privacy/confidentiality

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