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

NCT ID: NCT03855787

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2025-01-01

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

Conditions

Kidney Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ureteral stent group

A ureteral stent will be placed after ureteroscopy.

Group Type: ACTIVE_COMPARATOR

Ureteroscopy

Intervention Type: PROCEDURE

Ureteroscopy for 1.5cm or less renal stones.

No ureteral stent group

A ureteral stent will not be placed after ureteroscopy.

Group Type: ACTIVE_COMPARATOR

Ureteroscopy

Intervention Type: PROCEDURE

Ureteroscopy for 1.5cm or less renal stones.

Interventions

Ureteroscopy

Ureteroscopy for 1.5cm or less renal stones.

Intervention Type: PROCEDURE

Other Intervention Names

Flexible ureteroscopy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Penn State Health

UNKNOWN

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ryan Hsi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Hsi, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

University of California Los Angeles

Los Angeles, California, United States

University of California Davis

Sacramento, California, United States

University of California San Diego

San Diego, California, United States

Indiana University Health Physicians Urology

Indianapolis, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Montreal

Montreal, , Canada

Countries

United States; Canada

Other Identifiers

URSSTONE

Identifier Type: -

Identifier Source: org_study_id