Kidney CalculiNCT03855787
Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
A study testing Ureteroscopy in people with Kidney Calculi, run by Vanderbilt University Medical Center at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 11 Nov 2019to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02130
Indiana University Health Physicians Urology
Indianapolis, Indiana, 46202
University of California Los Angeles
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of California Davis
Sacramento, California, 95817
University of California San Diego
San Diego, California, 92121
About this study
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.
Read the 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
- Being tested
- Ureteroscopy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UreteroscopyProcedure or surgery
Also called Flexible ureteroscopy
Ureteroscopy for 1.5cm or less renal stones.
| Study group | Role | What they receive |
|---|---|---|
| Ureteral stent group | Active comparator | A ureteral stent will be placed after ureteroscopy. Receives: Procedure: Ureteroscopy |
| No ureteral stent group | Active comparator | A ureteral stent will not be placed after ureteroscopy. Receives: Procedure: Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of complications
Total number of complications - Defined as ER visits related to procedure, unanticipated provider visit, and hospitalization
Measured: 30 days after ureteroscopy
Secondary outcomes (6)
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.
Measured: baseline to 5-10 days after ureteroscopy
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.
Measured: baseline to 5-10 days after ureteroscopy
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.
Measured: baseline to 5-10 days after ureteroscopy
% 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.
Measured: 5-10 days after ureteroscopy
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.
Measured: Baseline 5-10 days after ureteroscopy
Number of participants with abnormal imaging findings
Hydronephrosis, hematoma, urinoma on routine postop imaging
Measured: 4-8 weeks after ureteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 Nov 2019
- Primary completion26 Sep 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, University of California, Davis, University of California, San Diego, Indiana University, Brigham and Women's Hospital, Penn State Health, University of California, Los Angeles
- Responsible party
- Principal investigator, Ryan Hsi, Vanderbilt University Medical Center
- Investigators
- Ryan Hsi, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855787
- Sponsor's protocol ID
- URSSTONE
- Status last verified
- May 2026
- First submitted
- 24 Feb 2019
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03855787
- Acronym / sponsor ID
- URSSTONE
- Conditions
- Kidney Calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Université de Montréal, University of California, Davis, University of California, San Diego, Indiana University, Brigham and Women's Hospital, Penn State Health, University of California, Los Angeles
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ureteral stent group | Active comparator | Procedure: UreteroscopyA ureteral stent will be placed after ureteroscopy. |
| No ureteral stent group | Active comparator | Procedure: UreteroscopyA ureteral stent will not be placed after ureteroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy
Key exclusion criteria (8 listed)
- age < 18 years
- pregnancy status
- ureteral stone
- preoperative hydronephrosis
- indwelling nephrostomy tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UreteroscopyAlso: Flexible ureteroscopyUreteroscopy for 1.5cm or less renal stones. | Procedure or surgery | No ureteral stent group, Ureteral stent group |
Primary outcome
Total number of complications
Time frame: 30 days after ureteroscopy
Total number of complications - Defined as ER visits related to procedure, unanticipated provider visit, and hospitalization
6 secondary outcomes
PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a
Time frame: baseline to 5-10 days after ureteroscopy
WISQOL (Wisconsin Stone Quality of Life Questionnaire)
Time frame: baseline to 5-10 days after ureteroscopy
Cumulative opiate morphine equivalent dosing (MED)
Time frame: baseline to 5-10 days after ureteroscopy
% return to work
Time frame: 5-10 days after ureteroscopy
Number of participants with symptomatic urinary tract infection (UTI)
Time frame: Baseline 5-10 days after ureteroscopy
Number of participants with abnormal imaging findings
Time frame: 4-8 weeks after ureteroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Hsi, MD principal investigator
Vanderbilt University Medical Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopy in people with Kidney Calculi, run by Vanderbilt University Medical Center at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of complications (time frame: 30 days after ureteroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.