Ureteral StentNCT06045962
Optimal Stent Duration After Ureteroscopy
A study testing Ureteral stent in people with Ureteral Stent, run by Mayo Clinic at 11 sites in 2 countries.
Trial summary
The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stent
- What is being tested?
- Ureteral stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Nov 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants undergoing unilateral stone treatment. Patients may have stones present bilaterally, but must only be having unilateral intervention.
- The ureteroscopy must be uncomplicated
- Patients undergoing semi-rigid ureteroscopy only, flexible ureteroscopy only, or a combination
Who cannot join
- Pregnancy
- A stent or nephrostomy tube placed prior to surgery
- Complex ureteroscopy - ureteral injury, ureteral perforation, ureteral stricture, impacted stone
- Infection or struvite stones
- Recurrent Urinary Tract Infection (UTI): 2 culture proven UTI in 6 months or 3 culture proven UTIs in one year
- No stone evident on ureteroscopic evaluation of ureter or kidney
- Transplant kidney
- Variant anatomy (horseshoe, pelvic kidney)
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Johns Hopkins University
Baltimore, Maryland, 21206
University of North Carolina
Chapel Hill, North Carolina, 27514
Cleveland Clinic
Cleveland, Ohio, 44195
Vanderbilt University
Nashville, Tennessee, 37203
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
University of California San Diego
San Diego, California, 92122
Montefiore Medical Center
The Bronx, New York, 10467
University of Arizona
Tucson, Arizona, 85712
Canada2 sites
University of Montreal
Montreal, Quebec, H3C3J7
University of British Columbia
Vancouver, British Columbia, V6T1K2
About this study
Official title: Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms
The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.
Read the detailed description
The rationale for this study is to determine if there is a difference in symptoms or complications among patients undergoing uncomplicated ureteroscopy for stone removal with shorter indwelling stent duration. Currently there are only a few small studies exploring the optimal duration of stent placement after stent placement and no multicenter randomized control trials. The investigation aim is to determine if earlier ureteral stent removal will reduce urinary symptoms after stent removal and improve quality of life without increasing risk of negative side effects. Using questionnaires for stent related symptoms the researchers will assess stent indwelling time effect on patient reported side effects.
- Conditions
- Ureteral Stent
- Being tested
- Ureteral stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral stentDevice
Used to open the ureter and help the kidney drain
| Study group | Role | What they receive |
|---|---|---|
| Uncomplicated Ureteroscopy and Stent Placement for 3-5 days | Active comparator | After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days Receives: Device: Ureteral stent |
| Uncomplicated Ureteroscopy and Stent Placement for 7-9 days | Experimental | After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days Receives: Device: Ureteral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Symptom Scores
The urinary symptoms will be assessed using the self-reported Canadian Endourology Group Stent Symptom Score. Seven item questionnaire to assess urinary stent symptoms using a 5-point Likert scale; higher score indicated worse outcome.
Measured: Post-operative day 2-3 and 2-3 days after stent removal
Secondary outcomes (4)
Change in Pain Scores
Pain score as indicated in the self-reported Canadian Endourology Group Stent Symptom Score questionnaire with a scale of 0-10 (10 being the worst)
Measured: Post-operative day 2-3 and 2-3 days after stent removal
Change in Quality of life
Change as calculated using the Wisconsin "Living With Kidney Stones" Questionnaire, which is a validated document assessing the quality of life of kidney stone patients. Likert scale 1-5 on 28 items total score range 28-140, with a lower score being associated with a lower quality of life.
Measured: Post-operative day 2-3 and 2-3 days after stent removal
Return to work
Number of days participants return to work
Measured: 30 days
Complications
Number of subjects to experience complications assessed by telephone, epic messages, ER visits related to procedure, unanticipated provider visits, and hospitalizations.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen L. Stern, Mayo Clinic
- Investigators
- Karen Stern, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045962
- Sponsor's protocol ID
- 22-011586
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms
- ClinicalTrials.gov ID
- NCT06045962
- Acronym / sponsor ID
- 22-011586
- Conditions
- Ureteral Stent
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Sep 2023 (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 purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.
Detailed description
The rationale for this study is to determine if there is a difference in symptoms or complications among patients undergoing uncomplicated ureteroscopy for stone removal with shorter indwelling stent duration. Currently there are only a few small studies exploring the optimal duration of stent placement after stent placement and no multicenter randomized control trials. The investigation aim is to determine if earlier ureteral stent removal will reduce urinary symptoms after stent removal and improve quality of life without increasing risk of negative side effects. Using questionnaires for stent related symptoms the researchers will assess stent indwelling time effect on patient reported side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncomplicated Ureteroscopy and Stent Placement for 3-5 days | Active comparator | Device: Ureteral stentAfter standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days |
| Uncomplicated Ureteroscopy and Stent Placement for 7-9 days | Experimental | Device: Ureteral stentAfter standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants undergoing unilateral stone treatment. Patients may have stones present bilaterally, but must only be having unilateral intervention.
- The ureteroscopy must be uncomplicated
- Patients undergoing semi-rigid ureteroscopy only, flexible ureteroscopy only, or a combination
Key exclusion criteria (8 listed)
- Pregnancy
- A stent or nephrostomy tube placed prior to surgery
- Complex ureteroscopy - ureteral injury, ureteral perforation, ureteral stricture, impacted stone
- Infection or struvite stones
- Recurrent Urinary Tract Infection (UTI): 2 culture proven UTI in 6 months or 3 culture proven UTIs in one year
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 |
|---|---|---|
| Ureteral stentUsed to open the ureter and help the kidney drain | Device | Uncomplicated Ureteroscopy and Stent Placement for 3-5 days, Uncomplicated Ureteroscopy and Stent Placement for 7-9 days |
Primary outcome
Change in Urinary Symptom Scores
Time frame: Post-operative day 2-3 and 2-3 days after stent removal
The urinary symptoms will be assessed using the self-reported Canadian Endourology Group Stent Symptom Score. Seven item questionnaire to assess urinary stent symptoms using a 5-point Likert scale; higher score indicated worse outcome.
4 secondary outcomes
Change in Pain Scores
Time frame: Post-operative day 2-3 and 2-3 days after stent removal
Change in Quality of life
Time frame: Post-operative day 2-3 and 2-3 days after stent removal
Return to work
Time frame: 30 days
Complications
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Karen Stern, MD principal investigator
Mayo Clinic
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteral stent in people with Ureteral Stent, run by Mayo Clinic at 11 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 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Urinary Symptom Scores (time frame: Post-operative day 2-3 and 2-3 days after stent removal). 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 17 Sep 2026.