Stenting After Kidney Stone Removal

Recruiting at 2 trial locations

Overseen By Sabrina Clark

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Opiates

Disqualifiers: Bilateral ureteroscopy, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

792 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent. Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission. Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants. The study team hypothesizes that: * Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts. * Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you use opiate medication daily for more than 3 months, you may not be eligible to participate.

What data supports the effectiveness of the treatment 'No stent placement' after kidney stone removal?

Research suggests that routine ureteral stenting after kidney stone removal may not be necessary, as studies have shown that omitting the stent can reduce unplanned health care visits and improve patient quality of life without increasing complications. ^{1 2 3 4 5}

Is ureteral stenting after kidney stone removal safe?

Ureteral stenting after kidney stone removal is common, but it can negatively impact quality of life and cause significant discomfort. Omission of stents may reduce discomfort but could increase the risk of early obstruction, leading to unplanned medical visits. ^{1 3 6 7 8}

How does the treatment of stenting after kidney stone removal differ from other treatments?

The treatment of stenting after kidney stone removal involves either placing a ureteral stent or omitting it. Omitting the stent can reduce postoperative discomfort and healthcare visits, but there is a concern about the risk of early obstruction. This approach is unique because it challenges the routine practice of stenting, which can negatively impact quality of life. ^{1 2 4 8 9}

Research Team

Khurshid Ghani, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals undergoing ureteroscopy and lithotripsy for kidney stones no larger than 10mm, who can communicate with the study team and complete surveys in English. It excludes those with certain anatomical abnormalities, chronic opiate users, pregnant women, or those with a solitary kidney.

Inclusion Criteria

Adequate independent cognitive function and English language proficiency to complete study surveys

I am having a procedure for kidney stones on one side; the other side has stones but doesn't need treatment now.

Written informed consent

Exclusion Criteria

I am scheduled for a procedure to examine both of my ureters.

I have been using opiate medication daily for over 3 months for pain management.

I have a unique kidney shape or position.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopy with either stent placement or stent omission

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at postoperative day 7-10 and 4-6 weeks

6 weeks

2 visits (in-person)

Observational

Participants in the observational cohort complete surveys and treatment is decided by the surgeon intraoperatively

6 weeks

Treatment Details

Interventions

• No stent placement
• Standard of care stent placement
• Surveys

Trial Overview The trial examines patient outcomes after kidney stone removal by comparing two approaches: one where a stent is placed post-surgery versus one without stent placement. Participants will either be randomly assigned to a treatment or observed based on physician's choice.

Participant Groups

Group I: Randomized cohort- Stent placement Experimental Treatment 2 Interventions

Participants that are eligible and consent for the randomization cohort trial will have a stent placed. If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study. In randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.

Group II: Randomized cohort- No stent placement Experimental Treatment 2 Interventions

Participants that are eligible and consent for the randomization cohort of the trial will not have a stent placed. If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study. In randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.

Group III: Observational participants - not randomized Experimental Treatment 1 Intervention

Patients that do not consent to the randomization trial that elect to be on the observational cohort. Stent placement in the observational cohort will be decided by the surgeon intraoperatively, as per routine clinical practice.

No stent placement is already approved in United States, European Union for the following indications:

Approved in United States as Stent omission for:

• Uncomplicated ureteroscopy for nephrolithiasis

Approved in European Union as Stent omission for:

• Uncomplicated ureteroscopy for nephrolithiasis

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Michigan Urological Surgery Improvement Collaborative (MUSIC)

Collaborator

Trials

2

Recruited

1,100+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Michigan Urological Surgery Improvement Collaborative (MUSIC)

Collaborator

Trials

2

Recruited

1,100+

Findings from Research

In a study of 529 patients undergoing ureteroscopy for ureteral stones, routine stenting was found to be necessary to prevent postoperative pain and fever, with no significant differences in complications observed between stented and non-stented patients at 24 hours post-treatment.

However, at 4 weeks, patients with double J stents experienced higher rates of lower urinary tract symptoms (LUTS), hematuria, and pain requiring hospital care compared to those with mono J stents, despite both groups having similar stone-free rates and low incidence of ureteral stricture formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stenting after ureteroscopy for ureteral lithiasis: results of a retrospective study. Merlo, F., Cicerello, E., Mangano, M., et al.[2022]

In a study of 6,266 ureteroscopy cases, pre-stented patients had a significantly higher rate of stent omission (47.3%) compared to non-pre-stented patients (26.3%), indicating that pre-stenting may facilitate better outcomes.

Stent placement in pre-stented patients was linked to increased emergency department visits and hospitalizations within 30 days, suggesting that omitting stents in these patients could reduce unplanned health care utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stent Omission in Pre-stented Patients Undergoing Ureteroscopy Decreases Unplanned Health Care Utilization. DiBianco, JM., Daignault-Newton, S., Dupati, A., et al.[2023]

A survey of 173 urologists revealed that while 97.7% perform ureteroscopic stone surgery, there is significant variability in stent placement practices, with 68% considering their procedures routine.

Despite evidence suggesting that stent insertion may not always be necessary, many urologists still opt to place stents, particularly after ureteral dilation, indicating a need for further education on best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice patterns of ureteral stenting after routine ureteroscopic stone surgery: a survey of practicing urologists. Auge, BK., Sarvis, JA., L'esperance, JO., et al.[2022]

A 26-year-old woman had two ureteral stents forgotten for 48 months, leading to severe encrustation and requiring a combination of advanced urologic techniques for removal.

The successful treatment involved multimodal stone therapy, including extracorporeal shock wave lithotripsy and percutaneous nephrolithotomy, demonstrating that tailored approaches can effectively manage complex cases of forgotten stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal stone therapy for two forgotten and encrusted ureteral stents: a case report. Ecke, TH., Hallmann, S., Ruttloff, J.[2021]

In a study of 55 patients undergoing ureteroscopy, routine placement of ureteral stents was found unnecessary for those who did not require ureteral dilation, leading to shorter operative times (43 minutes vs. 55 minutes).

Patients who did not receive stents reported significantly less flank discomfort and fewer urinary symptoms on postoperative days, indicating that avoiding stent placement can reduce patient morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine ureteral stenting is not necessary after ureteroscopy and ureteropyeloscopy: a randomized trial. Byrne, RR., Auge, BK., Kourambas, J., et al.[2022]

The implementation of an electronic spreadsheet tracking system at a VA medical center resulted in a 100% retrieval rate of ureteral stents, effectively preventing the risks associated with forgotten stents.

Out of 379 stents placed in 335 patients, 369 were removed within 180 days, demonstrating the efficacy of meticulous follow-up and monitoring in ensuring patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where are the Stents? A Computerized Tracking System to Eliminate the Forgotten Ureteral Stent. Larkin, S., Preston, D.[2023]

A systematic review of 16 randomized controlled trials involving 1,573 patients found that routine ureteral stent placement after ureteroscopic lithotripsy does not improve outcomes such as stone-free rates or reduce complications like urinary tract infections.

Patients with ureteral stents experienced significantly more lower urinary tract symptoms and pain compared to those without stents, suggesting that stenting may be unnecessary after uncomplicated procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The results of ureteral stenting after ureteroscopic lithotripsy for ureteral calculi: a systematic review and meta-analysis. Pengfei, S., Yutao, L., Jie, Y., et al.[2022]

Patients who did not receive a ureteral stent after ureteroscopy for kidney stones were more likely to have unplanned medical visits compared to those who did receive a stent, indicating a potential risk associated with stent omission (OR 1.63).

However, unstented patients experienced shorter surgery times and reported less dysuria, suggesting that while stent omission may lead to more follow-up visits, it can also reduce postoperative discomfort and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Omission of Ureteral Stents Increase Risk of Unplanned Return Visit? A Systematic Review and Meta-Analysis. Pais, VM., Smith, RE., Stedina, EA., et al.[2022]

In a study of 105 patients undergoing uncomplicated ureteroscopic lithotripsy, those who did not receive a ureteric stent (Group 3) experienced significantly less postoperative pain and discomfort compared to those who had stents placed (Groups 1 and 2).

The findings suggest that placing a double pigtail ureteric stent may be unnecessary for uncomplicated procedures, as it does not improve outcomes and can lead to longer operative times and increased pain, while the stent with an extraction string offers some benefits in terms of easier removal and symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ureteric stenting vs not stenting following uncomplicated ureteroscopic lithotripsy: A prospective randomised trial. Al Demour, S., Alrabadi, A., AlSharif, A., et al.[2022]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Stenting after ureteroscopy for ureteral lithiasis: results of a retrospective study. [2022]

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

Stent Omission in Pre-stented Patients Undergoing Ureteroscopy Decreases Unplanned Health Care Utilization. [2023]

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

Practice patterns of ureteral stenting after routine ureteroscopic stone surgery: a survey of practicing urologists. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Multimodal stone therapy for two forgotten and encrusted ureteral stents: a case report. [2021]

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

Routine ureteral stenting is not necessary after ureteroscopy and ureteropyeloscopy: a randomized trial. [2022]

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

Where are the Stents? A Computerized Tracking System to Eliminate the Forgotten Ureteral Stent. [2023]

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

The results of ureteral stenting after ureteroscopic lithotripsy for ureteral calculi: a systematic review and meta-analysis. [2022]

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

Does Omission of Ureteral Stents Increase Risk of Unplanned Return Visit? A Systematic Review and Meta-Analysis. [2022]

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

Ureteric stenting vs not stenting following uncomplicated ureteroscopic lithotripsy: A prospective randomised trial. [2022]