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

NCT03855787 | Completed DMC

• 1 other identifier: URSSTONE
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 7

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.

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a

  baseline to 5-10 days after ureteroscopy

• WISQOL (Wisconsin Stone Quality of Life Questionnaire)

  baseline to 5-10 days after ureteroscopy

• Cumulative opiate morphine equivalent dosing (MED)

  baseline to 5-10 days after ureteroscopy

• % return to work

  5-10 days after ureteroscopy

• Number of participants with symptomatic urinary tract infection (UTI)

  Baseline 5-10 days after ureteroscopy

Study Arms (2)

Ureteral stent group

ACTIVE COMPARATOR

A ureteral stent will be placed after ureteroscopy.

Procedure: Ureteroscopy

No ureteral stent group

ACTIVE COMPARATOR

A ureteral stent will not be placed after ureteroscopy.

Procedure: Ureteroscopy

Interventions

Ureteroscopy PROCEDURE

Ureteroscopy for 1.5cm or less renal stones.

Also known as: Flexible ureteroscopy

No ureteral stent group; Ureteral stent group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Université de Montréal: collaborator
• University of California, Davis: collaborator
• University of California, San Diego: collaborator
• Indiana University: collaborator
• Brigham and Women's Hospital: collaborator
• Penn State Health: collaborator
• University of California, Los Angeles: collaborator

Study Sites (7)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

University of California San Diego

San Diego, California, 92121, United States

Location

Indiana University Health Physicians Urology

Indianapolis, Indiana, 46202, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Montreal

Montreal, Canada

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Ryan Hsi, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 27, 2019
• Study Start: November 11, 2019
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CA (1)