792 Participants Needed

Stenting After Kidney Stone Removal

Recruiting at 13 trial locations
ES
SC
Overseen BySabrina Clark
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether using a stent (a tube to keep the urinary tract open) after kidney stone surgery affects pain and healthcare visits. Some participants will receive a stent, while others will not, to compare outcomes. Individuals who undergo surgery for a kidney stone up to 10 millimeters and can communicate with the study team may be suitable candidates. Participants can also opt for observation, allowing the doctor to decide about the stent during surgery. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ureteral stents are often used after kidney stone removal procedures. These stents keep the pathway between the kidney and bladder open, allowing it to heal properly. One study found that stents were used in 60% of patients after kidney stone treatment and 80% after other similar procedures. This indicates that using stents is a common practice and is generally well-tolerated by patients.

Studies also suggest that for many people with straightforward procedures, skipping the stent might be safe. This can help avoid the discomfort or irritation that stents sometimes cause. However, when stents are used, they usually don't cause serious problems.

In summary, both using a stent and not using one are generally safe options, depending on the specific situation. Most people manage well with stents, but individual experiences can vary.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether avoiding the use of stents after kidney stone removal could be beneficial for patients. Typically, after removing kidney stones, a stent is placed in the ureter to help with urine flow and healing, but stents can cause discomfort and other side effects. This trial is investigating if skipping the stent could reduce these side effects without compromising recovery. If successful, this method could lead to a less invasive approach with fewer complications for patients undergoing kidney stone removal.

What evidence suggests that this trial's treatments could be effective for kidney stone removal?

This trial will compare the effects of using a ureteral stent versus not using one after kidney stone removal. Studies have shown that a ureteral stent, a small tube, can keep the passage between the kidney and bladder open, preventing blockages and other issues. In this trial, some participants will be randomized to receive a stent. Other research suggests that not using a stent can increase comfort and reduce pain after surgery without raising the risk of complications. Participants may also be randomized to not receive a stent. Patients who did not have a stent reported feeling better and experienced fewer issues like pain and discomfort. Both options offer benefits, so consider how each might affect recovery and comfort.13678

Who Is on the Research Team?

KG

Khurshid Ghani, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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
See 2 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Randomized cohort- Stent placementExperimental Treatment2 Interventions
Group II: Randomized cohort- No stent placementExperimental Treatment2 Interventions
Group III: Observational participants - not randomizedExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Stent omission for:
🇪🇺
Approved in European Union as Stent omission for:

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Ureteral stent versus no ureteral stent for ureteroscopy in the ...One evaluation of stent placement revealed that stents are placed in 60% of patients after treatment for ureteral stones and in 80% of patients after treatment ...
Stent Omission after Ureteroscopy and Lithotripsy (SOUL) in ...Ureteral stents are placed by urologists to ensure ureteral patency in the postoperative period following ureteroscopy to treat kidney stones, ...
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.
Stent omission after ureteroscopy is safe, improves patient- ...Omitting stents post-ureteroscopy improves patient-reported outcomes, including pain and quality of life, without increasing complications. The ...
Preliminary Outcomes of Different Tactics of Ureteral Stent ...Twelve months after stent removal, the overall success rate was 55.9%, and the success rates of the three groups were 51.9%, 48.6%, and 70.7%, ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36401514/
The Role of Routine Ureteral Stenting Following ...Conclusions: For most patients undergoing uncomplicated ureteroscopic treatment for proximal ureteral and kidney stones, it may be safe to omit ureteral stents ...
Kidney Stones: Surgical Management GuidelineIn such cases, placement of a ureteral stent typically results in passive dilation of the ureter, thus permitting access at the time of the next attempted URS.
Ureteral Stenting After Ureteroscopy for Stone Treatment, A ...Objective: To analyse the postoperative ureteral stenting strategy in clinical practice looking at the indication, type of stents used and the duration of ...
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