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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02210650
Enrollment
75
Registered
2014-08-07
Start date
2014-11-30
Completion date
2022-05-31
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Stones, Kidney Stones

Keywords

kidney stone

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.

Interventions

PROCEDURESymptomatic stone removal

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

PROCEDUREAsymptomatic kidney stones and ureteral stone removed

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

Sponsors

University of Washington
CollaboratorOTHER
VA Puget Sound Health Care System
CollaboratorFED
Indiana Kidney Stone Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Relapse of stone disease on the study sideannually up to 5 years after stone removal surgery1. 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026