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

Last updated: July 25, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Stones

Treatment

Ureteroscopy

Clinical Study ID

NCT03855787
URSSTONE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 tractreconstruction

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Ureteroscopy
Phase:
Study Start date:
November 11, 2019
Estimated Completion Date:
November 11, 2025

Study 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

Connect with a study center

  • University of Montreal

    Montréal,
    Canada

    Active - Recruiting

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California San Diego

    San Diego, California 92121
    United States

    Active - Recruiting

  • Indiana University Health Physicians Urology

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02130
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Penn State Health

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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