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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Calculi
• Intervention / Treatment: Procedure: Ureteroscopy

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
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada
    • University of Montreal
• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Sacramento, California, United States, 95817
      • University of California Davis
    • San Diego, California, United States, 92121
      • University Of California San Diego
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Physicians Urology
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Brigham and Women's Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Flexible ureteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of complications	Total number of complications - Defined as ER visits related to procedure, unanticipated provider visit, and hospitalization	30 days after ureteroscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a	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.	baseline to 5-10 days after ureteroscopy
WISQOL (Wisconsin Stone Quality of Life Questionnaire)	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.	baseline to 5-10 days after ureteroscopy
Cumulative opiate morphine equivalent dosing (MED)	This will be the calculated morphine equivalent dosage of all opiate medications that are prescribed after surgery to follow-up at 5-10 days.	baseline to 5-10 days after ureteroscopy
% return to work	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.	5-10 days after ureteroscopy
Number of participants with symptomatic urinary tract infection (UTI)	This will be defined as a urine culture positivity (50,000 cfu/mL or more) with urinary symptoms.	Baseline 5-10 days after ureteroscopy
Number of participants with abnormal imaging findings	Hydronephrosis, hematoma, urinoma on routine postop imaging	4-8 weeks after ureteroscopy

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: University of California, San Diego; University of California, Los Angeles; Brigham and Women's Hospital; University of California, Davis; Indiana University; Université de Montréal; Penn State Health
• Investigators: Principal Investigator: Ryan Hsi, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): September 26, 2025
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: February 24, 2019
• First Submitted That Met QC Criteria: February 24, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Urologic Surgical Procedures; Urogenital Surgical Procedures; Diagnostic Techniques, Urological; Ureteroscopy
• Other Study ID Numbers: URSSTONE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No