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

NCT ID: NCT02210650

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2022-05-31

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.

Conditions

Ureteral Stones, Kidney Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Symptomatic stone removal

Group 1 will receive the standard treatment of having only the symptomatic stone removed

Group Type: OTHER

Symptomatic stone removal

Intervention Type: PROCEDURE

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

Group Type: OTHER

Asymptomatic kidney stones and ureteral stone removed

Intervention Type: PROCEDURE

Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy

Interventions

Symptomatic stone removal

Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy

Intervention Type: PROCEDURE

Asymptomatic kidney stones and ureteral stone removed

Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

VA Puget Sound Health Care System

FED

Sponsor Role: collaborator

Indiana Kidney Stone Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James E Lingeman, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Health

Locations

Indiana University Health

Indianapolis, Indiana, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Washington Medical Center Department of Urology

Seattle, Washington, United States

Veterans Administration Puget Sound Heath Care System

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35947709 (View on PubMed)

Other Identifiers

P01DK043881

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P01 DK 043881 Project 3

Identifier Type: -

Identifier Source: org_study_id