Project Summary
What is the research about?
Kidney stones are a common occurrence that causes severe pain in patients. Ureteroscopy is the most common surgery used to remove kidney stones in the United States. After ureteroscopy, ureteral stents (long flexible hollow tubes) are commonly placed for a short period of time to help with drainage of urine from the kidney. However, ureteral stents themselves can cause severe pain, blood in the urine, and discomfort that can result in trips to the hospital to seek care, time off work, and inability to take part in social activities. Despite guidelines recommending not to place a stent when ureteroscopy goes well, 80 percent of all patients undergoing ureteroscopy have a stent inserted because of the preference of their surgeon. One major reason this happens is that urologists do not have great confidence in the studies so far which assessed outcomes in patients who did or did not have a stent placed after ureteroscopy. The verdict on whether avoiding a stent is beneficial for patients is not clear.
The Stent Omission after Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC) trial aims to understand patient health-related quality of life and patient-reported outcomes after ureteroscopy. It will also seek to understand the effectiveness of this procedure with and without ureteral stents, as well as factors that influence a surgeon to decide to place a stent or not.
Who can this research help?
Urologists can use results from this study to decide whether to give their patients a stent after ureteroscopy. Patients and families can use the study results as they are considering the safety and outcomes of ureteroscopy with and without stents and decide on treatment which will best meet the patient’s needs.
What is the research team doing?
The research team is working with 11 urology practices across the State of Michigan to collect data on 678 patients that undergo kidney stone surgery with ureteroscopy. The team is assigning patients that have uncomplicated surgeries to two groups and the assignment will be made randomly. Patients will include adults with kidney and ureteral stones who will benefit from ureteroscopy and will be enrolled in the study as they decide on treatment. A unique aspect of this study is that those patients who do not want to be randomized will still be offered the chance to be in the study, so that doctors learn about their procedure, as well. Patients will be enrolled into the Michigan Urological Surgery Improvement Collaborative (MUSIC) clinical registry and followed through patient-reported outcomes and the electronic medical record for 60 days after their surgery. The team will track any unplanned clinic or hospital visits because of the surgery and follow up doctor visits.
The research team is working with three patient partners who have had kidney stones, a team of healthcare providers that have experience in urology and research, and the MUSIC team for three years, to learn how to better manage and improve the lives of patients undergoing ureteroscopy