Optimal Ureteral Stent Duration After Surgery

Recruiting at 10 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

172 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.

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.

Is it safe to use ureteral stents in humans?

Ureteral stents are generally safe for use in humans, but they can cause symptoms that affect quality of life, and prolonged use may lead to complications like infections or blockages. It's important to follow up with healthcare providers to avoid these issues, especially if the stent is placed in an emergency situation. ^{1 2 3 4 5}

How does the ureteral stent treatment differ from other treatments for ureteral conditions?

Ureteral stents are unique because they are placed inside the ureter (the tube connecting the kidney to the bladder) to help urine flow and relieve blockages, unlike other treatments that may involve surgery or external procedures. The optimal duration for keeping a stent in place is still being studied, as prolonged use can lead to complications like infections or stent fragmentation. ^{4 5 6 7 8}

What data supports the effectiveness of the treatment Ureteral Stent?

Research shows that the duration of ureteral stent placement can impact the risk of complications. Keeping the stent for more than 30 days after certain procedures increases the chances of infections and other issues, suggesting that the timing of stent removal is important for effectiveness. ^{4 8 9 10 11}

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. England pubmed.ncbi.nlm.nih.gov

Do ureteric stent extraction strings affect stent-related quality of life or complications after ureteroscopy for urolithiasis: a prospective randomised control trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Ureteric stent dwelling time: a risk factor for post-ureteroscopy sepsis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Delays in Ureteroscopy and Shockwave Lithotripsy After Ureteral Stent Placement: Impact on Infectious Complications, Resource Use, and Medical Costs. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Ureteral stenting after routine ureteroscopy: Is earlier stent removal feasible? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Spanish linguistic validation of the ureteral stent symptom questionnaire. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Outcomes of stenting after uncomplicated ureteroscopy: systematic review and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Safety of decreasing ureteral stent duration following radical cystectomy. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Novel Use of the Epic Electronic Medical Record Platform to Identify Lost Ureteral Stents. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

The impact of ureteral stent indwelling time on the treatment of acute infection caused by ureteral calculi. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Spontaneous fragmentation of a double J stent. [2019]