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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210650
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : May 25, 2022
Sponsor:
Collaborators:
University of Washington
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Indiana Kidney Stone Institute

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.

Condition or disease Intervention/treatment Phase
Ureteral Stones, Kidney Stones Procedure: Symptomatic stone removal Procedure: Asymptomatic kidney stones and ureteral stone removed Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : May 2022
Actual Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Symptomatic stone removal
Group 1 will receive the standard treatment of having only the symptomatic stone removed
Procedure: Symptomatic stone removal
Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy

Asymptomatic kidney stones and symptomatic stone removed
Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone
Procedure: Asymptomatic kidney stones and ureteral stone removed
Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy




Primary Outcome Measures :
  1. Relapse of stone disease on the study side [ Time Frame: annually up to 5 years after stone removal surgery ]
    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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210650


Locations
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United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Washington
University of Washington Medical Center Department of Urology
Seattle, Washington, United States, 98195 9472
Veterans Administration Puget Sound Heath Care System
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Indiana Kidney Stone Institute
University of Washington
VA Puget Sound Health Care System
Investigators
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Principal Investigator: James E Lingeman, MD Indiana University Health
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Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT02210650    
Other Study ID Numbers: P01 DK 043881 Project 3
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Keywords provided by Indiana Kidney Stone Institute:
kidney stone
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Ureteral Diseases