Stenting After Kidney Stone Removal
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ureteroscopy with either stent placement or stent omission
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at postoperative day 7-10 and 4-6 weeks
Observational
Participants in the observational cohort complete surveys and treatment is decided by the surgeon intraoperatively
What Are the Treatments Tested in This Trial?
Interventions
- No stent placement
- Standard of care stent placement
- Surveys
No stent placement is already approved in United States, European Union for the following indications:
- Uncomplicated ureteroscopy for nephrolithiasis
- Uncomplicated ureteroscopy for nephrolithiasis
Find a Clinic Near You
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