Patient Positioning for Treatment of Proximal Ureteral Stones

NCT07601932 | Recruiting

• 1 other identifier: STUDY-26-00168
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Stone

Outcome Measures

Primary Outcomes (1)

• Total operative time

  Operative time will be used to compare procedural efficiency

  Immediately postoperatively on the day of surgery

Secondary Outcomes (4)

• Proportion of participants stone-free

  From Week 4 to Week 6 postoperatively

• Proportion of procedures requiring additional equipment or procedural maneuvers

  Immediately after completion of surgery on the day of procedure

• Proportion of strategy failure

  Assessed immediately at completion of surgery on the day of procedure

• Incidence of Complications

  Through postoperative day 30

Study Arms (2)

Reverse Trendelenburg Position

EXPERIMENTAL

Participants undergo ureteroscopic lithotripsy in reverse Trendelenburg positioning with attempted in situ treatment of the proximal ureteral stone to minimize proximal migration.

Procedure: Reverse Trendelenburg Position

T-Tilt Position

ACTIVE COMPARATOR

Participants undergo intentional relocation of the proximal ureteral stone into the kidney followed by intrarenal lithotripsy performed in the T-tilt position.

Procedure: T-Tilt Position

Interventions

Reverse Trendelenburg Position PROCEDURE

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.

Reverse Trendelenburg Position

T-Tilt Position PROCEDURE

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.

T-Tilt Position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Mantu Gupta, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mantu Gupta, MD

CONTACT

212-241-1272; mantu.gupta@mountsinai.org

Blair Gallante, MPH

CONTACT

212-241-1272; blair.gallante@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)