Stenting After Kidney Stone Removal

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Khurshid Ghani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Must not be taking: Opiates

Disqualifiers: Bilateral ureteroscopy, Pregnancy, others

No Placebo Group

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}

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.

Trial 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 (Other)
• Standard of care stent placement (Device)
• Surveys (Other)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Michigan Health System Ann Arbor, MI

University of Michigan Health System Brighton, MI

St. Joseph Mercy Health (Trinity) Chelsea, MI

Who Is Running the Clinical Trial?

University of Michigan Lead Sponsor

Michigan Urological Surgery Improvement Collaborative (MUSIC) Collaborator

Patient-Centered Outcomes Research Institute Collaborator

Michigan Urological Surgery Improvement Collaborative (MUSIC) Collaborator

References

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

Stenting after ureteroscopy for ureteral lithiasis: results of a retrospective study. [2022] Routine ureteral stenting after ureteroscopy for stone removal is common. However ureteral stent negatively impact quality of life and can cause significant morbidity. This study was carried out to report our experience.

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

Stent Omission in Pre-stented Patients Undergoing Ureteroscopy Decreases Unplanned Health Care Utilization. [2023] Despite AUA guidelines providing criteria for ureteral stent omission after ureteroscopy for nephrolithiasis, stenting rates in practice remain high. Because pre-stenting may be associated with improved patient outcomes, we assessed the impact of stent omission vs placement in pre-stented and non-pre-stented patients undergoing ureteroscopy on postoperative health care utilization in Michigan.

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

Practice patterns of ureteral stenting after routine ureteroscopic stone surgery: a survey of practicing urologists. [2022] Controversy exists regarding the need for ureteral stent insertion after routine ureteroscopic stone surgery. We designed a questionnaire to assess and better understand the practice patterns of urologists for stent applications.

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

Multimodal stone therapy for two forgotten and encrusted ureteral stents: a case report. [2021] Ureteral stent placement is a common procedure in daily urologic practice. To manage the problems of forgotten stents for many years needs multimodal stone therapy.

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

Routine ureteral stenting is not necessary after ureteroscopy and ureteropyeloscopy: a randomized trial. [2022] Retrospective studies have suggested that routine stenting can be avoided following ureteroscopy. We prospectively analyzed the need for routine ureteral stent placement in patients undergoing ureteroscopic procedures.

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

Where are the Stents? A Computerized Tracking System to Eliminate the Forgotten Ureteral Stent. [2023] Ureteral stent placement is the main treatment for ureteral obstruction in contemporary urological practice. Meticulous followup is required to confirm ureteral stent removal. Forgotten ureteral stents create significant patient and physician risk. We assessed the efficacy of an electronic spreadsheet tracking system at a VA medical center urology practice to monitor ureteral stent placement and retrieval.

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] We evaluated the necessity and adverse effects of routine ureteral stent placement after ureteroscopic lithotripsy for ureteral stones.

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] Post-ureteroscopy ureteral stent omission remains controversial. Although omission is associated with reduced postoperative discomfort, concern remains for early obstruction. We performed a systematic review and meta-analysis of trials to compare the risk of unplanned visits with vs without a stent following ureteroscopy for nephrolithiasis.

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

Ureteric stenting vs not stenting following uncomplicated ureteroscopic lithotripsy: A prospective randomised trial. [2022] To compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) and to evaluate whether stenting could be eliminated after the procedure, as there is no consensus about whether a ureteric stent should be placed after uncomplicated ureteroscopy for stone retrieval.