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

• ClinicalTrials.gov Identifier: NCT02210650
• Recruitment Status: Completed
• First Posted: August 7, 2014
• Last Update Posted: May 25, 2022
• Sponsor: Indiana Kidney Stone Institute
• Collaborators: University of Washington; VA Puget Sound Health Care System
• Information provided by (Responsible Party): Indiana Kidney Stone Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Ureteral Stones, Kidney Stones	Procedure: Symptomatic stone removal; Procedure: Asymptomatic kidney stones and ureteral stone removed	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: November 2014
• Actual Primary Completion Date: May 2022
• Actual Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. Relapse of stone disease on the study side [ Time Frame: annually up to 5 years after stone removal surgery ]
   1. Radiological evidence of significant growth in the size of any pre-existing stone
   2. Return for stone removal surgery on the study side
   3. Passage of a stone with pain symptoms on the study side resulting in an emergency department visit

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Indiana

Indiana University Health

Indianapolis, Indiana, United States, 46202

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

United States, Washington

University of Washington Medical Center Department of Urology

Seattle, Washington, United States, 98195 9472

Veterans Administration Puget Sound Heath Care System

Seattle, Washington, United States, 98195

Sponsors and Collaborators

Indiana Kidney Stone Institute

University of Washington

VA Puget Sound Health Care System

Investigators

• Principal Investigator: James E Lingeman, MD; Indiana University Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Indiana Kidney Stone Institute
• ClinicalTrials.gov Identifier: NCT02210650
• Other Study ID Numbers: P01 DK 043881 Project 3
• First Posted: August 7, 2014
• Last Update Posted: May 25, 2022
• Last Verified: May 2022

Keywords provided by Indiana Kidney Stone Institute:

kidney stone

Additional relevant MeSH terms:

Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Ureteral Diseases