Optimal Ureteral Stent Duration After Surgery

Enrolling by invitation at 12 trial locations

Overseen By Annabelle Vega

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Infection, Recurrent UTI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3-9 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal duration for leaving ureteral stents (small tubes placed in the ureter to aid urine flow) after kidney stone surgery. Researchers aim to determine whether removing stents after 3-5 days is safe or if leaving them in for 7-9 days is preferable. Participants should be receiving treatment for kidney stones on only one side, with uncomplicated surgery. As an unphased trial, this study provides participants the opportunity to contribute to important research that could enhance post-surgical care for kidney stone patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that ureteral stent placement is safe?

Research shows that keeping a ureteral stent in for 7-9 days after a procedure causes more pain and urinary problems than removing it sooner. Studies have found that patients feel better when stents are taken out earlier, particularly after just 3 days. Although ureteral stents are commonly used and generally safe, leaving them in longer increases discomfort. Overall, stents are well-tolerated, but the timing of their removal affects patient comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the optimal duration for ureteral stents after surgery because it could significantly improve patient comfort and recovery. Unlike the standard of care, which typically involves leaving stents in place for a variable duration without much consensus, this trial compares specific durations—3-5 days versus 7-9 days—to find the most effective timeframe. By pinpointing the ideal duration, they aim to reduce discomfort, lower the risk of complications, and enhance the overall surgical recovery experience for patients.

What evidence suggests that this stent duration protocol is effective for post-surgery recovery?

This trial will compare different durations for keeping a ureteral stent in place after surgery. Research has shown that the optimal duration for a ureteral stent post-surgery remains unclear. Some studies suggest that keeping it in for three to seven days is generally effective. Ureteral stents help drain urine and reduce the risk of infection after surgery. No consensus exists on how the duration of stent placement affects patient outcomes. However, stents have reduced complications by aiding drainage. More research is needed to determine the best stent duration for optimal recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

Karen Stern, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who have had a straightforward ureteroscopy, which is a procedure to remove stones from the urinary tract. Participants must be undergoing treatment on one side only, even if they have stones in both sides. Pregnant individuals or those with prior stents, complex procedures, infections, recurrent UTIs, no visible stones during surgery, transplant kidneys or unusual kidney anatomy cannot join.

Inclusion Criteria

I am having a ureteroscopy using semi-rigid, flexible, or both types of scopes.

I am having treatment for kidney stones on one side only.

My ureteroscopy procedure went smoothly without complications.

Exclusion Criteria

Pregnancy

I have had complications from a kidney stone removal procedure.

I have had at least 2 UTIs proven by tests in the last 6 months or 3 in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo ureteroscopy and stent placement for 3-5 days or 7-9 days

3-9 days

Follow-up

Participants are monitored for symptoms and complications after stent removal

30 days

Post-operative day 2-3 and 2-3 days after stent removal

What Are the Treatments Tested in This Trial?

Interventions

• Ureteral Stent

Trial Overview The study aims to find out the safest and soonest time to remove ureteral stents after someone has undergone a ureteroscopy for stone removal. It will help determine optimal recovery practices post-surgery.

How Is the Trial Designed?

Group I: Uncomplicated Ureteroscopy and Stent Placement for 7-9 days Experimental Treatment 1 Intervention

After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days

Group II: Uncomplicated Ureteroscopy and Stent Placement for 3-5 days Active Control 1 Intervention

After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11974034/

Optimal stenting duration following ureteroscopy and ... Generally, the panel recommends three to seven days of stenting [5]. However, the ideal duration of stenting is unknown. Also, there is no meta- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28229196/

The Impact of Ureteral Stent Indwelling Time on ... The postoperative complication outcomes were collected and analyzed. Effective drainage obtained from ureteral stenting clearly abated the infection after ...

3. bmcurol.biomedcentral.com bmcurol.biomedcentral.com/articles/10.1186/s12894-025-01765-z

Optimal stenting duration following ureteroscopy and ... The optimal duration for ureteral stent placement following ureteroscopy remains unclear, with no consensus on its impact on patient outcomes.

4. musicurology.com musicurology.com/wp-content/uploads/2024/05/What-Is-the-Optimal-Stenting-Duration-After-Ureteroscopy-and-Stone-Intervention_-Impact-of-Dwell-Time-on-Postoperative-Emergency-Department-Visits.pdf

What-Is-the-Optimal-Stenting-Duration-After-Ureteroscopy- ... Based on these data, we explored stent dwell time outcomes in our quality improve- ment ureteroscopy registry in Michigan.

5. karger.com karger.com/uin/article/107/8/772/854789/Optimal-Dwelling-Time-for-Ureteral-Stents-Placed

Optimal Dwelling Time for Ureteral Stents Placed ... The stone-free rates were observed to increase from 46.4% in the first 2 weeks to 72.9% after the 2nd week, an increase of 1.5-fold.

6. mdpi.com mdpi.com/2075-1729/14/9/1131

Clinical Outcomes and Safety Assessment of Flexible ... Overall stent insertion rates in the Clinical Research Office of Endourological Society (CROES) data on 11,885 cases were 81.5%. Their data ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506927/

Results From the Study to Enhance Understanding of Stent ... In this analysis of the STENTS cohort, there was a greater increase in pain intensity, interference due to pain, and urinary symptoms from ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06045962?cond=Ureteric%20stent&viewType=Table&rank=5

NCT06045962 | Optimal Stent Duration After Ureteroscopy Uncomplicated Ureteroscopy and Stent Placement for 7-9 days. After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5836241/

Pilot Study to Determine Optimal Stent Duration Following ... Leaving a stent for 3 versus 7 days may lead to worse outcomes with regard to post-operative events and fank pain.

10. liebertpub.com liebertpub.com/doi/10.1089/end.2023.0189

Timing of Ureteral Stent Removal After Ureteroscopy on ... Conclusions: Patients with stent removal at 3-day group had better reported urinary, pain, and general health score compared with 7-day group.