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

• ClinicalTrials.gov Identifier: NCT03855787
• Recruitment Status: Recruiting
• First Posted: February 27, 2019
• Last Update Posted: July 12, 2022
• Sponsor: Vanderbilt University Medical Center
• Collaborators: Université de Montréal; University of California, Davis; University of California, San Diego; Indiana University; Brigham and Women's Hospital; Penn State Health; University of California, Los Angeles
• Information provided by (Responsible Party): Ryan Hsi, Vanderbilt University Medical Center

Tracking Information

• First Submitted Date: February 24, 2019
• First Posted Date: February 27, 2019
• Last Update Posted Date: July 12, 2022
• Actual Study Start Date: November 11, 2019
• Estimated Primary Completion Date: March 11, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 24, 2019)

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

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

Descriptive Information

• Brief Title: Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
• Official Title: Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
• 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.

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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Kidney Calculi

Intervention

Procedure: Ureteroscopy

Ureteroscopy for 1.5cm or less renal stones.

Other Name: Flexible ureteroscopy

Study Arms

• Active Comparator: Ureteral stent group
  A ureteral stent will be placed after ureteroscopy.
  Intervention: Procedure: Ureteroscopy
• Active Comparator: No ureteral stent group
  A ureteral stent will not be placed after ureteroscopy.
  Intervention: Procedure: Ureteroscopy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 24, 2019): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 11, 2023
• Estimated Primary Completion Date: March 11, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Participant eligibility is based on self-representation of gender identity.

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Canada, United States
• Removed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT03855787
• Other Study ID Numbers: URSSTONE
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ryan Hsi, Vanderbilt University Medical Center
• Original Responsible Party: Ryan Hsi, Vanderbilt University Medical Center, Assistant Professor
• Current Study Sponsor: Vanderbilt University Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Université de Montréal
• University of California, Davis
• University of California, San Diego
• Indiana University
• Brigham and Women's Hospital
• Penn State Health
• University of California, Los Angeles

Investigators

• Principal Investigator: Ryan Hsi, MD; Vanderbilt University Medical Center

• PRS Account: Vanderbilt University Medical Center
• Verification Date: July 2022