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

Not Applicable

Completed

• Conditions: Ureteral Stones, Kidney Stones
• Interventions: Procedure: Asymptomatic kidney stones and ureteral stone removed; Procedure: Symptomatic stone removal

• Registration Number: NCT02210650
• Lead Sponsor: Indiana Kidney Stone Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-07
• Study Start: 2014-11
• Status Verified: 2022-05
• Primary Completion: 2022-05
• Study Completion: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asymptomatic kidney stones and symptomatic stone removed	Asymptomatic kidney stones and ureteral stone removed	Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone
Symptomatic stone removal	Symptomatic stone removal	Group 1 will receive the standard treatment of having only the symptomatic stone removed

Primary Outcome Measures

Name	Time	Method
Relapse of stone disease on the study side	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

Trial Locations

Locations (4)

Veterans Administration Puget Sound Heath Care System; 🇺🇸 Seattle, Washington, United States

University of Washington Medical Center Department of Urology; 🇺🇸 Seattle, Washington, United States

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States