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Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03855787
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : July 8, 2021
Sponsor:
Collaborators:
MaineHealth
Université de Montréal
University of California, Davis
University of California, San Diego
Indiana University
Information provided by (Responsible Party):
Ryan Hsi, Vanderbilt University Medical Center

Brief Summary:
The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively.

Condition or disease Intervention/treatment Phase
Kidney Calculi Procedure: Ureteroscopy Not Applicable

Detailed Description:

Kidney stones affect 9% individuals within the United States, and the prevalence is increasing. Over the last few decades, ureteroscopy has become the most commonly performed stone procedure. However the complication rate after ureteroscopy is not insignificant. Reducing morbidity after ureteroscopy would improve patient outcomes and reduce health care utilization.

A major contributor to patient morbidity after ureteroscopy is the ureteral stent, which is placed at the time of surgery and left in place 1-2 weeks after surgery. The rationale for utilizing stents is to prevent urinary obstruction from edema or stone fragments. On the other hand, stents cause hematuria, pain, and lower urinary tract symptoms. Additionally, stent-related symptoms are often misdiagnosed as urinary tract infections leading to unnecessary antibiotic use.

The clinical utility of ureteral stents after ureteroscopy has not been well studied, specifically a stone located in the kidney. Prior studies on stent-less ureteroscopic procedures have focused on treatment of ureteral stones and not stones located in the kidney, have had restrictive inclusion and exclusion criteria, are primarily from single center institutions, and most being performed ~15 years ago. Surgical techniques and device innovations have changed the procedure since that time. To date, there have been only 2 studies that included stone located in the kidney showing no difference in unplanned hospital revisits, however both combined analyses with ureteral stones and selection bias was an issue for both studies. In addition, there is a lack of studies assessing opiate use, impact of quality of life with stent placement, and loss of work related to stent placement

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : March 11, 2023
Estimated Study Completion Date : November 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: Ureteral stent group
A ureteral stent will be placed after ureteroscopy.
Procedure: Ureteroscopy
Ureteroscopy for 1.5cm or less renal stones.
Other Name: Flexible ureteroscopy

Active Comparator: No ureteral stent group
A ureteral stent will not be placed after ureteroscopy.
Procedure: Ureteroscopy
Ureteroscopy for 1.5cm or less renal stones.
Other Name: Flexible ureteroscopy




Primary Outcome Measures :
  1. Total number of complications [ Time Frame: 30 days after ureteroscopy ]
    Total number of complications - Defined as ER visits related to procedure, unanticipated provider visit, and hospitalization


Secondary Outcome Measures :
  1. PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a [ Time Frame: baseline to 5-10 days after ureteroscopy ]
    This survey assesses self-reported consequences of pain on relevant aspects of one's life, including engagement with social, cognitive, emotional, physical, and recreational activities. There are 6 questions on the survey. The survey score uses at T-score metric with a mean of 50 and a standard deviation of 10 in a referent population. A higher score denotes greater pain interference in one's life.

  2. WISQOL (Wisconsin Stone Quality of Life Questionnaire) [ Time Frame: baseline to 5-10 days after ureteroscopy ]
    This is a disease specific quality-of-life instrument designed to assess the impact on patients of stones in the urinary tract. The survey is a 28-item instrument with a 5-point LIkert scale for each item. There are a total of 140 points total, and a difference of 10 points can be considered clinically significant.

  3. Cumulative opiate morphine equivalent dosing (MED) [ Time Frame: baseline to 5-10 days after ureteroscopy ]
    This will be the calculated morphine equivalent dosage of all opiate medications that are prescribed after surgery to follow-up at 5-10 days.

  4. % return to work [ Time Frame: 5-10 days after ureteroscopy ]
    This is the number of participants that have returned to work at the time of follow-up at 5-10 days divided by the total participants in the group.

  5. Number of participants with symptomatic urinary tract infection (UTI) [ Time Frame: Baseline 5-10 days after ureteroscopy ]
    This will be defined as a urine culture positivity (50,000 cfu/mL or more) with urinary symptoms.

  6. Number of participants with abnormal imaging findings [ Time Frame: 4-8 weeks after ureteroscopy ]
    Hydronephrosis, hematoma, urinoma on routine postop imaging



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy

Exclusion Criteria:

  • age < 18 years
  • pregnancy status
  • ureteral stone
  • preoperative hydronephrosis
  • indwelling nephrostomy tube
  • planning bilateral ureteroscopy or subsequent staged ureteroscopy
  • solitary kidney or eGFR <60 mL/min (CKD stage 3 or greater)
  • variant anatomy including horseshoe kidney, pelvic kidney, prior urinary tract reconstruction

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): NCT03855787


Contacts
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Contact: Ryan Hsi, MD 615-343-2036 ryan.hsi@vumc.org

Locations
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United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Noah Canvasser, MD         
University of California San Diego Recruiting
San Diego, California, United States, 92121
Contact: Seth Bechis, MD         
United States, Indiana
Indiana University Health Physicians Urology Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Marcelino Rivera, MD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Johann Ingimarsson, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact: Daniel A Wollin         
United States, Pennsylvania
Penn State Health Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: John Knoedler, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Ryan Hsi, MD         
Canada
University of Montreal Recruiting
Montréal, Canada
Contact: Naeem Bhojani         
Sponsors and Collaborators
Vanderbilt University Medical Center
MaineHealth
Université de Montréal
University of California, Davis
University of California, San Diego
Indiana University
Investigators
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Principal Investigator: Ryan Hsi, MD Vanderbilt University Medical Center
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Responsible Party: Ryan Hsi, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03855787    
Other Study ID Numbers: URSSTONE
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi