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Completed

NCT Number: NCT03855787

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Montreal, Montreal, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ureteroscopy

Procedure

Ureteroscopy for 1.5cm or less renal stones.

Other names: Flexible ureteroscopy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Feb 27, 2019
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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