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
2 other identifiers
interventional
75
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 7, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMay 25, 2022
May 1, 2022
7.5 years
August 1, 2014
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse of stone disease on the study side
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
annually up to 5 years after stone removal surgery
Study Arms (2)
Symptomatic stone removal
OTHERGroup 1 will receive the standard treatment of having only the symptomatic stone removed
Asymptomatic kidney stones and symptomatic stone removed
OTHERGroup 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone
Interventions
Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy
Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Kidney Stone Institutelead
- University of Washingtoncollaborator
- VA Puget Sound Health Care Systemcollaborator
Study Sites (4)
Indiana University Health
Indianapolis, Indiana, 46202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Washington Medical Center Department of Urology
Seattle, Washington, 98195 9472, United States
Veterans Administration Puget Sound Heath Care System
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 35947709DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James E Lingeman, MD
Indiana University Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2014
First Posted
August 7, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
May 25, 2022
Record last verified: 2022-05