Imagine undergoing a medical procedure to remove kidney stones only to face discomfort because of a stent placed to prevent complications. Each year, thousands of patients undergo ureteroscopy to remove kidney stones, and while the procedure is effective, the placement of ureteral stents post-surgery has been a common practice to ensure ureteral patency and avoid complications.
Background
Ureteral stents are commonly used by urologists after ureteroscopy to maintain ureteral patency and prevent complications. Nevertheless, these stents often result in significant pain and urinary symptoms, which severely affect the quality of life of patients. Despite the guidelines from professional societies recommending the omission of stents after uncomplicated ureteroscopy, stents are still used in over 80% of such cases. This notable inconsistency stems from the low level of evidence supporting the omission of stents and the varying results from past studies about the impact of stents on post-operative pain and complications.
Study Design
The SOUL study is designed as a combined randomized and observational clinical trial with the primary aim of evaluating health-related quality of life (HRQOL), patient-reported outcomes (PROs), and unplanned healthcare utilization that is associated with either the omission or placement of stents following ureteroscopy. By integrating patient input through collaboration with patient partners and harnessing data from multiple centers within the MUSIC network, the study endeavors to offer a thorough and pragmatic assessment of the practices involved.
Objectives
Primary Objectives:
- Compare patient-reported pain interference one week after ureteroscopy between patients who had a stent omitted and those who had a stent placed.
- Evaluate 30-day unplanned healthcare utilization related to stone treatment between these two groups.
Secondary Objectives:
The study also aims to analyze the individual components of 30-day unplanned healthcare utilization, such as intensive care unit care, hospitalization, additional procedures, emergency room visits, unplanned clinic visits, and patient-provider interactions. Additionally, the research will focus on HRQOL, urinary symptoms post-ureteroscopy, treatment satisfaction, and time off work for both patients and caregivers. It will also delve into patient and surgeon preferences and their existing knowledge regarding ureteral stenting.
Methodology
Participants:
Adults aged 18 years and above who are undergoing unilateral ureteroscopy for kidney stones that are 10 mm or smaller are eligible to participate. Those excluded include patients planning bilateral ureteroscopy, individuals with anatomical abnormalities of the urinary tract, and patients with pre-existing conditions such as indwelling ureteral stents.
Intervention:
Participants in the randomized cohort are assigned either to undergo stent omission or stent placement intraoperatively using an online randomization platform. Those unwilling to be randomized enter an observational cohort where the decision whether to use a stent is left to the surgeon’s judgment. Both patient groups engage in preoperative and postoperative PRO assessments, and qualitative interviews with patients and urologists capture additional insights into stent-related decision-making processes and experiences.
Outcome Measures:
The primary outcomes focus on changes in pain interference and 30-day unplanned healthcare utilization. Secondary outcomes analyze detailed components of healthcare utilization, changes in HRQOL, urinary symptoms, treatment satisfaction, and time taken off work. Exploratory outcomes assess daily pain scores, interference with usual activities, pain medication use, and postoperative imaging findings.
Data Management and Analysis
Data will be meticulously collected via a secure clinical registry and analyzed using appropriate statistical methods. The study includes robust quality assurance measures and employs tools such as linear models for PROs and logistic models for healthcare utilization components to ensure accurate analysis and interpretation of results.
Expected Impact
The SOUL study aims to bridge significant gaps identified in previous research by providing high-quality evidence around the practice of stent omission. By adopting a mixed-methods approach and a patient-centered design, the study is anticipated to yield real-world insights that could prompt a seismic shift in clinical practice. Ultimately, this could lead to reduced unnecessary stent placements and associated morbidities, thereby enhancing patient comfort and reducing healthcare costs.
Trial Status
As of May 30, 2024, 162 patients have been enrolled in the study. The anticipated completion date for participant enrollment is set for June 2025.
Conclusion
Imagine going through a medical procedure to remove kidney stones, only to experience discomfort afterward due to a stent placed to prevent complications. Each year, thousands of patients undergo ureteroscopy to eliminate kidney stones. Although this procedure is effective, doctors often insert ureteral stents following the surgery as a standard practice to keep the ureter open and prevent complications.
The placement of these stents, although helpful in preventing problems and ensuring proper ureteral patency, can cause discomfort for many patients. This discomfort can include feelings of pressure, pain, and irritation in the urinary tract. Ureteral stents are small, flexible tubes that help keep the ureter open after surgery, allowing urine to flow from the kidney to the bladder and reducing the risk of infection or blockage. Despite their preventive purpose, the presence of these stents can lead to bothersome and sometimes painful side effects.
Patients often report difficulties and adverse feelings associated with the stents, creating a challenging post-procedure recovery phase.
