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

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.

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Key information

Conditions

Ureteral Stones, Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health, Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symptomatic stone removal

Procedure

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

Asymptomatic kidney stones and ureteral stone removed

Procedure

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

Primary outcomes

Relapse of stone disease on the study side

Time frame: annually up to 5 years after stone removal surgery
- 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

Sponsors and collaborators

Lead sponsor

Indiana Kidney Stone Institute

Other

Collaborators

University of Washington
VA Puget Sound Health Care System

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2022
Study completion: 2022
First posted: Aug 7, 2014
Registry last updated: May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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