Clinical trial NCT02210650: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Stones, Kidney Stones
Keywords: kidney stone
Lead sponsor: Indiana Kidney Stone Institute
Sponsor class: OTHER
Collaborators: name: University of Washington
name: VA Puget Sound Health Care System
First posted: 2014-08-07
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Relapse of stone disease on the study side
timeFrame: annually up to 5 years after stone removal surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Seattle
country: United States
facility: University of Washington Medical Center Department of Urology
state: Washington
city: Seattle
country: United States
facility: Veterans Administration Puget Sound Heath Care System
state: Washington
Study officials:
affiliation: Indiana University Health
name: James E Lingeman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.