Clinical trial NCT03855787: Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Official title: Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Calculi
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: University of California, Davis
name: University of California, San Diego
name: Indiana University
name: Brigham and Women's Hospital
name: Penn State Health
name: University of California, Los Angeles
First posted: 2019-02-27
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Total number of complications
timeFrame: 30 days after ureteroscopy
Secondary outcomes:
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a
timeFrame: baseline to 5-10 days after ureteroscopy
measure: WISQOL (Wisconsin Stone Quality of Life Questionnaire)
timeFrame: baseline to 5-10 days after ureteroscopy
measure: Cumulative opiate morphine equivalent dosing (MED)
timeFrame: baseline to 5-10 days after ureteroscopy
measure: % return to work
timeFrame: 5-10 days after ureteroscopy
measure: Number of participants with symptomatic urinary tract infection (UTI)
timeFrame: Baseline 5-10 days after ureteroscopy
measure: Number of participants with abnormal imaging findings
timeFrame: 4-8 weeks after ureteroscopy
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Indianapolis
country: United States
facility: Indiana University Health Physicians Urology
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Montréal
country: Canada
facility: University of Montreal
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ryan Hsi, MD
role: PRINCIPAL_INVESTIGATOR
References: