172 Participants Needed

Optimal Ureteral Stent Duration After Surgery

Recruiting at 10 trial locations
AV
Overseen ByAnnabelle Vega
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.36789

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.3491011

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.

Research Team

KS

Karen Stern, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Uncomplicated Ureteroscopy and Stent Placement for 7-9 daysExperimental Treatment1 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 daysActive Control1 Intervention
After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

References

Do ureteric stent extraction strings affect stent-related quality of life or complications after ureteroscopy for urolithiasis: a prospective randomised control trial. [2022]
Ureteric stent dwelling time: a risk factor for post-ureteroscopy sepsis. [2022]
Delays in Ureteroscopy and Shockwave Lithotripsy After Ureteral Stent Placement: Impact on Infectious Complications, Resource Use, and Medical Costs. [2023]
Ureteral stenting after routine ureteroscopy: Is earlier stent removal feasible? [2022]
The Spanish linguistic validation of the ureteral stent symptom questionnaire. [2019]
Outcomes of stenting after uncomplicated ureteroscopy: systematic review and meta-analysis. [2022]
Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. [2022]
Safety of decreasing ureteral stent duration following radical cystectomy. [2021]
Novel Use of the Epic Electronic Medical Record Platform to Identify Lost Ureteral Stents. [2020]
The impact of ureteral stent indwelling time on the treatment of acute infection caused by ureteral calculi. [2018]
Spontaneous fragmentation of a double J stent. [2019]
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