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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

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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

Tracking Information
First Submitted Date  ICMJE August 1, 2014
First Posted Date  ICMJE August 7, 2014
Last Update Posted Date May 25, 2022
Study Start Date  ICMJE November 2014
Actual Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2022)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
Relapse of stone disease on the treated 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. Radiological identification of a new stone that was not visible in the previous scan
  3. Passage of a stone with pain symptoms on the treated side
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ureteral Stones, Kidney Stones
Intervention  ICMJE
  • Procedure: Symptomatic stone removal
    Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy
  • Procedure: Asymptomatic kidney stones and ureteral stone removed
    Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy
Study Arms  ICMJE
  • Symptomatic stone removal
    Group 1 will receive the standard treatment of having only the symptomatic stone removed
    Intervention: Procedure: Symptomatic stone removal
  • 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
    Intervention: Procedure: Asymptomatic kidney stones and ureteral stone removed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2022)
75
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2014)
100
Actual Study Completion Date  ICMJE May 2022
Actual Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02210650
Other Study ID Numbers  ICMJE P01 DK 043881 Project 3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Indiana Kidney Stone Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Indiana Kidney Stone Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Washington
  • VA Puget Sound Health Care System
Investigators  ICMJE
Principal Investigator: James E Lingeman, MD Indiana University Health
PRS Account Indiana Kidney Stone Institute
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP