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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

Primary Purpose

Ureteral Stones, Kidney Stones

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symptomatic stone removal
Asymptomatic kidney stones and ureteral stone removed
Sponsored by
Indiana Kidney Stone Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Stones, Kidney Stones focused on measuring kidney stone

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Indiana University Health
  • University of Minnesota
  • University of Washington Medical Center Department of Urology
  • Veterans Administration Puget Sound Heath Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Symptomatic stone removal

Asymptomatic kidney stones and symptomatic stone removed

Arm Description

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

Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 1, 2014
Last Updated
May 18, 2022
Sponsor
Indiana Kidney Stone Institute
Collaborators
University of Washington, VA Puget Sound Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT02210650
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2022 (Actual)
Study Completion Date
May 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana Kidney Stone Institute
Collaborators
University of Washington, VA Puget Sound Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Stones, Kidney Stones
Keywords
kidney stone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic stone removal
Arm Type
Other
Arm Description
Group 1 will receive the standard treatment of having only the symptomatic stone removed
Arm Title
Asymptomatic kidney stones and symptomatic stone removed
Arm Type
Other
Arm Description
Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone
Intervention Type
Procedure
Intervention Name(s)
Symptomatic stone removal
Intervention Description
Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy
Intervention Type
Procedure
Intervention Name(s)
Asymptomatic kidney stones and ureteral stone removed
Intervention Description
Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy
Primary Outcome Measure Information:
Title
Relapse of stone disease on the study side
Description
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
Time Frame
annually up to 5 years after stone removal surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Lingeman, MD
Organizational Affiliation
Indiana University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Washington Medical Center Department of Urology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195 9472
Country
United States
Facility Name
Veterans Administration Puget Sound Heath Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35947709
Citation
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.
Results Reference
derived

Learn more about this trial

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

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