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

• ClinicalTrials.gov Identifier: NCT02210650
• Recruitment Status: Completed
• First Posted: August 7, 2014
• Last Update Posted: May 25, 2022
• Sponsor: Indiana Kidney Stone Institute
• Collaborators: University of Washington; VA Puget Sound Health Care System
• Information provided by (Responsible Party): Indiana Kidney Stone Institute

Tracking Information

• First Submitted Date: August 1, 2014
• First Posted Date: August 7, 2014
• Last Update Posted Date: May 25, 2022
• Study Start Date: November 2014
• Actual Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ureteral Stones, Kidney Stones

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 18, 2022): 75
• Original Estimated Enrollment (submitted: August 4, 2014): 100
• Actual Study Completion Date: May 2022
• Actual Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02210650
• Other Study ID Numbers: P01 DK 043881 Project 3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Indiana Kidney Stone Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Indiana Kidney Stone Institute
• Original Study Sponsor: Same as current

Collaborators

• University of Washington
• VA Puget Sound Health Care System

Investigators

• Principal Investigator: James E Lingeman, MD; Indiana University Health

• PRS Account: Indiana Kidney Stone Institute
• Verification Date: May 2022