Ureteroscopy is the most common procedure for the surgical management of nephrolithiasis in the United States.¹ At the conclusion of ureteroscopic stone treatment, the urologist must decide whether or not to place a ureteral stent. AUA guidelines recommend stent omission for uncomplicated cases (ie, no ureteric injury, no ureteral stricture, normal contralateral kidney, normal renal function, and no planned secondary ureteroscopy procedure).² Despite this, studies reveal urologists continue to place stents in approximately 80% of all patients after ureteroscopy.^3-5 There is also tremendous variation in this practice. In an analysis of 140 urologists in Michigan, while the average stenting rate was 74%, it ranged from 10% to 100%.⁴

A stent ensures ureteral patency and drainage of the renal unit and can offer security for the surgeon and patient. However, the decision on whether to place a stent can have health-related quality of life consequences for patients. Ureteral stents lead to postoperative pain and urinary symptoms in the majority of patients.⁶ Some will seek additional care for these symptoms, which can drive unplanned health care utilization, such as electronic medical record messages, telephone encounters, and clinic or emergency department visits.^4,7 Thus, the urologist must strike the appropriate balance in each case between the promise of safety offered by stenting, and the improved patient experience offered by stent omission.⁸

Unfortunately, we have poor evidence on which to base these decisions. A recent Cochrane review of the comparative effectiveness of stent placement vs omission after uncomplicated ureteroscopy (16 trials consisting of 1,970 participants), found a trend for stenting to reduce the number of unplanned visits.⁹ However, studies were limited by low confidence of evidence, performance bias, inconsistency, and imprecision, prohibiting clear interpretation of these results. The review concluded that higher-quality and sufficiently large trials are needed to better inform decision-making. Toward that end, the Michigan Urological Surgery Improvement Collaborative (MUSIC) recently launched the Stent Omission after Ureteroscopy and Lithotripsy (SOUL) trial, which is funded by the Patient-Centered Outcomes Research Institute.

Established in 2011, MUSIC is a collaborative quality improvement initiative funded by Blue Cross Blue Shield of Michigan consisting of 46 urology practices in Michigan, representing urologists, advanced practice providers, patient advocates, and other stakeholders. Additional practices outside Michigan have now joined MUSIC, and include the University of North Carolina, the Montefiore Medical Center, New York, and the University of Florida. Members regularly engage with each other through periodic workshops, webinars, ongoing quality improvement initiatives, quality metric-based payer reimbursement incentives, and triannual collaborative-wide symposia. Recently, this unique framework has shown advantages in conducting several randomized clinical trials (RCTs) within MUSIC.

The first RCT in MUSIC was the Genomics in Michigan Impacting Observation or Radiation (G-MINOR) trial (funded by GenomeDx; NCT02783950), using the Decipher classifier to help predict which patients undergoing radical prostatectomy may benefit from postoperative radiotherapy. The second was the Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) trial (NIH funded; NCT04396808), which seeks to determine the clinical impact of gene expression classifier testing in patients with newly diagnosed favorable risk prostate cancer.

Key advantages for conducting RCTs in MUSIC include the preexisting infrastructure, data registry, and community engagement to promote sustained participation. Importantly, the broad variety of participating practices and urologists provides a more accurate representation of the diversity of urologic care across our health care system. MUSIC is able to bring trials to large and small centers, academic or private practices, and urban and rural communities, which is important for generalization. Although this can make the logistics of implementation challenging, it also holds tremendous potential to capture the real-world forces that shape practice. We have found this be helpful in the conduct of our third RCT, assessing silicone vs polyurethane ureteral stents for ureteroscopy on patient-reported outcomes, the Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) trial (funded by Coloplast; NCT05026710).

Figure. Schematic of the SOUL MUSIC trial, assessing outcomes between stent placement vs omission after uncomplicated ureteroscopy, demonstrating the combined randomized and observational study design.

Our most recent trial, SOUL MUSIC (NCT05866081) is a clinical trial of stent omission vs stent placement following uncomplicated ureteroscopy and lithotripsy that aims to address shortcomings of prior trials by assessing patient-reported outcomes, collecting standardized health care–related outcomes, and assessing provider and patient attitudes regarding stenting to inform implementation strategies. Because the trial was designed with the input of patients, it has a unique combined randomized and observational design, the latter for patients who decline randomization (see Figure). The 2 coprimary outcomes are Patient Reported Outcomes Measurement Information System Pain Interference at postoperative day 7-10, and unplanned health care utilization within 30 days. Adult patients with stones ≤1 cm in size in either the ureter or kidney, who are not prestented, are eligible. We plan to recruit approximately 800 patients over 2 years, with one-third being randomized, across 14 centers in the MUSIC network (see Table). The study also includes a qualitative arm, consisting of semistructured interviews with both patients and urologists. These conversations will assess existing opinions and preferences around stenting and stent omission and characterize the barriers and facilitators to stent omission.

SOUL leverages the existing interpersonal and professional networks within MUSIC to strengthen and support the trial’s success. As a multicenter prospective trial, the success of the SOUL study will depend on sustained engagement and participation by investigators and site champions across a broad spectrum of urologic practices throughout Michigan and beyond. This will be achieved in part by utilizing the existing sense of community and regular cadence of both in-person and virtual meetings between members of MUSIC. Investigators and other key personnel from multiple trial performance sites can be refreshed about key aspects of the study, provided with progress updates, and recognized for their contributions at collaborative-organized functions. Similarly, issues that may arise at individual performance sites can be efficiently resolved and solutions quickly disseminated to the broader group through existing networks.

In summary, quality improvement networks are uniquely positioned to support clinical trials that address relevant and impactful knowledge gaps, through their existing infrastructure and community, as well as inherent practice variation. These aspects can strengthen engagement by different centers, and make the trials conducted pragmatic and applicable to diverse real-world practice, with the goal to benefit patients and our field.