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

Kidney Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855787
• Other study ID #: URSSTONE
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: November 11, 2025

Study information

• Verified date: July 2023
• Source: Vanderbilt University Medical Center
• Contact: Ryan Hsi, MD
• Phone: 615-343-2036
• Email: ryan.hsi[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 11, 2025
• Est. primary completion date: March 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

Intervention

Procedure:
• Ureteroscopy
Ureteroscopy for 1.5cm or less renal stones.

Locations

Country	Name	City	State
Canada	University of Montreal	Montréal
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Penn State Health	Hershey	Pennsylvania
United States	Indiana University Health Physicians Urology	Indianapolis	Indiana
United States	University of California Los Angeles	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of California Davis	Sacramento	California
United States	University of California San Diego	San Diego	California

Sponsors (8)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Brigham and Women's Hospital, Indiana University, Penn State Health, Université de Montréal, University of California, Davis, University of California, Los Angeles, University of California, San Diego

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	% 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
Secondary	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
Secondary	Number of participants with abnormal imaging findings	Hydronephrosis, hematoma, urinoma on routine postop imaging	4-8 weeks after ureteroscopy