Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney

Randomized Controlled Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney

Patients with a ureteral or kidney stone that causes symptoms, like pain, frequently have small kidney stones that don't cause symptoms. If these small kidney stones are determined to be asymptomatic (not causing any problems or pain), then most urologists will simply remove the symptomatic ureteral stone and leave the additional stones in the kidneys. However, symptomatic kidney stones started as small stones that didn't cause symptoms. This means that the small stones remaining in the patient's kidney may cause problems later. The purpose of our research is to test if removing small stones from the kidney prevents future stone episodes.

Study Overview

• Status: Completed
• Conditions: Ureteral Stones, Kidney Stones
• Intervention / Treatment: Procedure: Symptomatic stone removal; Procedure: Asymptomatic kidney stones and ureteral stone removed

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Washington
    • Seattle, Washington, United States, 98195 9472
      • University of Washington Medical Center Department of Urology
    • Seattle, Washington, United States, 98195
      • Veterans Administration Puget Sound Heath Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled to undergo surgery (URS or PCNL) for a primary stone.
• Computed tomography (CT) exam within the 90-day pre-operative period
• Small (≤ 6mm) asymptomatic stones in visible on KUB or CT (i.e., calcium stones) in the contralateral kidney for a primary renal stone or ipsilateral kidney for primary ureteral stone.
• Recurrent (having had previous stones) or multiple (simultaneous bilateral stones) stones
• Able to give informed consent
• Age 21 years or older

Exclusion Criteria:

• Inability to give informed consent
• Age less than 21 years
• Stones not visible on KUB or CT
• Patients with systemic disease or renal anatomical disorders (RTA, primary hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)
• Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the
• subject at significant risk, confound the study results, or interfere significantly with the subject's
• participation in the study.
• Unwilling to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Symptomatic stone removal; Group 1 will receive the standard treatment of having only the symptomatic stone removed	Procedure: Symptomatic stone removal; Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy
Other: Asymptomatic kidney stones and symptomatic stone removed; Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone	Procedure: Asymptomatic kidney stones and ureteral stone removed; Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse of stone disease on the study side	Radiological evidence of significant growth in the size of any pre-existing stone; Return for stone removal surgery on the study side; Passage of a stone with pain symptoms on the study side resulting in an emergency department visit	annually up to 5 years after stone removal surgery

Collaborators and Investigators

• Sponsor: Indiana Kidney Stone Institute
• Collaborators: University of Washington; VA Puget Sound Health Care System
• Investigators: Principal Investigator: James E Lingeman, MD, Indiana University Health

Publications and helpful links

General Publications

• Sorensen MD, Harper JD, Borofsky MS, Hameed TA, Smoot KJ, Burke BH, Levchak BJ, Williams JC Jr, Bailey MR, Liu Z, Lingeman JE. Removal of Small, Asymptomatic Kidney Stones and Incidence of Relapse. N Engl J Med. 2022 Aug 11;387(6):506-513. doi: 10.1056/NEJMoa2204253.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: kidney stone
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: P01 DK 043881 Project 3