Objective: To assess and compare stent-associated symptoms after unilateral vs bilateral ureteroscopy with ureteral stent placement for stone treatment. Methods: Participants enrolled in the Study to Enhance Understanding of Stent-Associated Symptoms (STENTS), a multicenter, prospective, observational cohort study, completed validated questionnaires and patient-reported outcome measures to assess stent-associated symptoms postoperatively. Patient-Reported Outcomes Measurement Information System (PROMIS) tools were used to measure pain intensity and interference due to pain, while the Ureteral Stent Symptom Questionnaire (USSQ) and Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10) were used to measure urinary symptoms. These data were used determine symptom intensity and course, comparing outcomes after bilateral vs unilateral ureteroscopy. Results: Of the 484 participants who enrolled in STENTS, 60 underwent a bilateral procedure. Patients in the bilateral group reported greater increases in pain intensity and pain interference beginning on POD 3 (P = .017 and .022, respectively), continuing through POD 7-9, with no difference in interference 30 days after stent removal, compared to the unilateral group. Urinary symptoms were worse following a bilateral compared to unilateral procedure at all time points, except similar urinary symptoms 30 days following stent removal. Conclusion: Patients undergoing bilateral compared to unilateral ureteroscopy report higher pain intensity, pain interference and urinary symptoms. Although exploratory, this analysis provides the most informative description of the patient experience with bilateral stents to date and may be useful in counseling patients considering bilateral stone treatment and in managing expectations.

A large dataset of pediatric US measurements and natural language processing was used to calculate kidney length and volume percentiles, resulting in increased normative value precision and highlighting growth patterns.

OBJECTIVE:To examine item-level changes in PROMIS pain interference and ability to participate in social roles and activities following ureteroscopy (URS). MATERIALS AND METHODS:A prospective cohort study was conducted at a single academic center from 2020 to 2022. Adults undergoing URS for nephrolithiasis completed the PROMIS pain interference (computer-adaptive test, 15 subdomains) and ability to participate in social roles and activities (short-form 8a, 8 subdomains) at baseline and at postoperative days (POD) 1, 7, 14, and 30. The primary outcome was a minimal clinically important difference (≥5 points) in T-score from baseline to POD 1. Pairwise comparisons were assessed for change from baseline to each POD using linear mixed-effects models. RESULTS:A total of 178 participants were enrolled. For pain interference, only 2 of 15 items-work around the home and day-to-day activities-demonstrated a statistically and clinically significant worsening at POD 1 (change +5.9 and +5.7, respectively; both P <.01), persisting through POD 7 before recovering by POD 30. In contrast, 6 of 8 social participation items worsened significantly at POD 1 (change -5.2 to -6.8 points; all P <.01), with full recovery by POD 30. CONCLUSION:URS produces a specific, task-limited impact on pain interference but a comprehensive reduction in social participation both in and outside the home. These item-level findings offer actionable targets for patient counseling and anticipatory guidance prior to surgery.

BACKGROUND:Increased fluid intake is universally recommended to decrease the risk of recurrent urinary stones; however, adherence is challenging. The effectiveness of interventions to maintain high fluid intake has not been well studied. We sought to determine whether a multicomponent behavioural intervention programme to promote high fluid intake reduces symptomatic stone recurrence, compared with a control. METHODS:In this randomised clinical trial, participants aged 12 years and older with a history of urinary stone disease and low 24 h urine volumes based on current guidelines were enrolled at six academic medical centres in the USA. Participants were randomly assigned in a 1:1 ratio to a multicomponent behavioural intervention designed to promote increased fluid intake or to the control group receiving guideline-concordant care. The intervention consisted of a fluid prescription, financial incentives to adhere to fluid prescription, health coaching to overcome barriers to consuming more fluids, and patient-selected approaches such as text messaging to maintain increased fluid intake. Randomisation assignment was computer-generated remotely, and investigators, treating physicians, outcome assessors, and adjudicators were masked to group assignment. The primary outcome was symptomatic stone recurrence defined as stone passage or procedural intervention for stone(s) during a 2-year follow-up period, analysed in the intention-to-treat population. Secondary outcomes included change in 24 h urine volume, urinary symptoms, radiographic stone recurrence or growth, and a composite outcome of symptomatic stone recurrence, new stone formation, and growth of existing stone(s); hyponatremia requiring hospitalisation was the safety endpoint. This trial is registered with ClinicalTrials.gov, NCT03244189. FINDINGS:Between Oct 26, 2017, and Feb 18, 2022, 1658 participants were randomly assigned to intervention (n=826) and control (n=832) groups (median age 44 years [IQR 29-59]; 946 [57%] female). At a median follow-up of 738 days (IQR 711-778), symptomatic stone events occurred in 154 (19%) participants in the intervention group and 165 (20%) in the control group (hazard ratio 0·96, 95% CI 0·77-1·20). Among these 1658 participants, 1104 (66·6%) were recurrent stone formers. 24 h urine volume increased from baseline in both groups and was higher in the intervention group at months 6, 12, 18, and 24 compared with the control group. Urinary storage symptoms of frequency, urgency, and nocturia were greater in the intervention group versus control at months 6 and 12 but not at other timepoints. There was no difference in stone growth of at least 2 mm or new stones between groups from baseline to end-of-study imaging, and the composite outcome of symptomatic stone recurrence, new stone formation, or stone growth of at least 2 mm was also not statistically different between groups. No episodes of hyponatremia requiring hospitalisation (safety endpoint) were reported; 12 (1%) participants in the intervention group had asymptomatic hyponatraemia versus two (<1%) participants in the control group. INTERPRETATION:A behavioural intervention programme to promote fluid intake for secondary stone prevention did not reduce recurrent stone events but modestly increased urine volume compared with guideline-based care during a 2-year follow-up period. FUNDING:National Institute of Diabetes and Digestive and Kidney Diseases.

Importance Most children and adolescents with kidney and ureteral stones are treated with ureteroscopy, despite the uncertainty and equal weight of guideline recommendations for ureteroscopy or shockwave lithotripsy. Objective To compare stone clearance and patient-reported outcomes among children and adolescents after ureteroscopy or shockwave lithotripsy. Design, Setting, and Participants This nonrandomized clinical trial enrolled patients between March 16, 2020, and July 31, 2023, at 31 medical centers in the US and Canada. Patients aged 8 to 21 years with kidney stones, ureteral stones, or both were included. Follow-up was completed on October 15, 2023. Interventions Ureteroscopy or shockwave lithotripsy. Main Outcomes and Measures The primary outcome was stone clearance assessed by standardized ultrasonography 6 (+/- 2) weeks after surgery. Using inverse probability weighting and random intercepts for site, stone clearance was evaluated per kidney or ureter using logistic regression and estimated stone clearance rates were generated for each procedure. Results This study included 1142 patients (690 females [60.4%]), with a median age of 15.6 years (IQR, 12.6-17.3 years). In terms of race and ethnicity, 41 patients (3.6%) were Black, 130 (11.4%) were Hispanic, and 884 (77.4%) were White. A total of 124 urologists treated 1069 and 197 kidneys or ureters with ureteroscopy and shockwave lithotripsy (n = 953 and n = 189 patients), respectively, with a median stone size of 6.0 mm (IQR, 4.0-9.0 mm). Ureteral stents were placed at time of index surgery for 841 procedures for 767 patients (80.4%) receiving ureteroscopy and for 6 procedures for 5 patients (2.6%) receiving shockwave lithotripsy. Stone clearance occurred in 474 patients who underwent ureteroscopy (71.2% [95% CI, 63.8%-78.5%]) and in 105 patients who underwent shockwave lithotripsy (67.5% [95% CI, 61.0%-74.1%]), a difference that was not statistically significant (risk difference, 3.6% [95% CI, -6.2% to 13.5%]). Compared with shockwave lithotripsy, ureteroscopy resulted in greater pain interference (T-score difference, 5.0 [95% CI, 2.3-7.8]) and urinary symptoms (symptom score difference, 3.9 [95% CI, 1.2-6.7]) 1 week after surgery. Patients who had ureteroscopy missed more school (risk difference, 21.3% [95% CI, 9.7%-32.8%]) and caregivers missed more work (risk difference, 23.0% [95% CI, 11.0%-35.0%]) in the week after surgery. Conclusions and Relevance In this study of 1142 children and adolescents with kidney and ureteral stones, there was no clinically meaningful difference in stone clearance with ureteroscopy vs shockwave lithotripsy. Shockwave lithotripsy was associated with better patient-reported outcomes. These findings raise questions about the preference for ureteroscopy in practice.Trial RegistrationClinicalTrials.gov Identifier: NCT04285658

Importance:Based on expert opinion, clinical guidelines recommend percutaneous nephrolithotomy or shockwave lithotripsy for children and adolescents with kidney stones 20 mm or larger, without mention of ureteroscopy as an alternative. Objective:To compare clinical and patient-reported outcomes for percutaneous nephrolithotomy vs ureteroscopy in children and adolescents with kidney and/or ureteral stones. Design, Setting, and Participants:This prospective cohort study was performed at 31 medical centers in the US and Canada. Participants included patients aged 8 to 21 years undergoing surgery for kidney and/or ureteral stones between March 16, 2020, and July 31, 2023. Exposures:Percutaneous nephrolithotomy vs ureteroscopy. Main Outcomes and Measures:Stone clearance assessed by ultrasonography 6 (±2) weeks postoperatively. Secondary outcomes included patient-reported outcomes 1 week after surgery. Results:The study enrolled 1039 eligible patients (median age, 15.6 [IQR, 12.5-17.3] years; 629 female [60.5%]; 40 Black [3.8%]; 128 Hispanic [12.3%]; and 792 White [76.2%]). One hundred twenty-six urologists performed percutaneous nephrolithotomy for 98 kidneys and/or ureters and ureteroscopy for 1069, including 36 undergoing percutaneous nephrolithotomy and 43 undergoing ureteroscopy for stones larger than 15 mm. Stone clearance was 67.2% (95% CI, 46.0%-88.4%) for percutaneous nephrolithotomy and 73.4% (95% CI, 69.4%-77.4%) for ureteroscopy, a difference that was not statistically significant (risk difference, -6.2%; 95% CI, -27.7% to 15.4%). For stones larger than 15 mm, stone clearance was 94.0% (95% CI, 83.3%-100%) for percutaneous nephrolithotomy and 55.0% (95% CI, 32.9%-77.1%) for ureteroscopy, a statistically significant difference (risk difference, 39.0%; 95% CI, 14.4%-63.5%). Compared with ureteroscopy, percutaneous nephrolithotomy had significantly lower pain intensity (T score difference, -5.42; 95% CI, -10.38 to -0.46), pain interference (T score difference, -5.88; 95% CI, -11.02 to -0.75), anxiety (T score difference, -5.74; 95% CI, -9.26 to -2.22), psychological stress experiences (T score difference, -7.90; 95% CI, -13.13 to -2.67), sleep disturbance (T score difference, -5.57; 95% CI, -8.56 to -2.58), and urinary symptoms (symptom score difference, -6.37; 95% CI, -11.71 to -1.03) 1 week after surgery. Conclusions and Relevance:Compared with ureteroscopy, percutaneous nephrolithotomy had similar stone clearance and better lived experiences for children and adolescents and was associated with greater stone clearance of kidney stones larger than 15 mm. A future adequately powered prospective clinical trial is needed to reaffirm these results.

Introduction and Objective: Kidney stone growth and new stone formation are common clinical trial endpoints and are associated with future symptomatic events. To date, a manual review of CT scans has been required to assess stone growth and new stone formation, which is laborious. We validated the performance of a software algorithm that automatically identified, registered, and measured stones over longitudinal CT studies. Methods: We validated the performance of a pretrained machine learning algorithm to classify stone outcomes on longitudinal CT scan images at baseline and at the end of the 2-year follow-up period for 62 participants aged >18 years in the Prevention of Urinary Stones with Hydration (PUSH) randomized controlled trial. Stones were defined as an area of voxels with a minimum linear dimension of 2 mm that was higher in density than the mean plus 4 standard deviations of all nonnegative HU values within the kidney. The four outcomes assessed were: (1) growth of at least one existing stone by ≥2 mm, (2) formation of at least one new ≥2 mm stone, (3) no stone growth or new stone formation, and (4) loss of at least one stone. The accuracy of the algorithm was determined by comparing its outcomes to the gold standard of independent review of the CT images by at least two expert clinicians. Results: The algorithm correctly classified outcomes for 61 paired scans (98.4%). One pair that the algorithm incorrectly classified as stone growth was a new renal artery calcification on end-of-study CT. Conclusions: An automated image analysis method validated for the prospective PUSH trial was highly accurate for determining clinical outcomes of new stone formation, stone growth, stable stone size, and stone loss on longitudinal CT images. This method has the potential to improve the accuracy and efficiency of clinical care and endpoint determination for future clinical trials.

Selection of optimal treatment modalities for patients with kidney and/or ureteral stones is determined by patient factors, urinary tract anatomy, and stone characteristics and are guided by shared decision-making that additionally takes into account patient goals and preferences, resource availability, and physician expertise. This Guideline serves as a resource for clinicians and patients to provide the best available evidence on which to base discussions with patients in a shared decision-making process to arrive at appropriate treatment decisions.

PURPOSE:We developed prediction models for severe pain and urinary symptoms after ureteroscopy with ureteral stent placement. MATERIALS AND METHODS:The development cohort included 424 adults and adolescents enrolled in the multicenter STENTS prospective cohort study who underwent ureteroscopy with stent placement for urinary stones. The validation cohort was an independent prospective cohort of 115 adults. The outcomes were severe pain intensity and pain interference, measured by the Patient-Reported Outcomes Measurement Information System, and severe urinary symptoms, measured by the Ureteral Stent Symptom Questionnaire. The top quartile of symptoms on postoperative days 1 and 3 was defined as severe. Generalized estimating equation models were used to predict severe symptoms on postoperative days 1, 3, 5, and 7 to 9 in the development cohort and severe pain interference on days 1 and 7 in the validation cohort. RESULTS:Female sex, younger age, higher BMI, baseline pain interference, number of chronic pain conditions, renal stone location, and history of anxiety predicted severe pain. In the development cohort, the C statistics were 0.83 (95% CI 0.80-0.85) for severe pain interference and 0.82 (95% CI 0.79-0.84) for severe pain intensity. A model in which baseline urinary symptoms replaced pain interference had excellent discrimination for severe urinary symptoms (C statistic 0.83; 95% CI 0.81-0.85). In the validation cohort, the C statistic was 0.7 for severe pain interference (95% CI 0.54-0.78). CONCLUSIONS:Preoperative characteristics accurately predicted severe pain and urinary symptoms after ureteroscopy with stent placement. On further validation, these models could guide clinical decisions to improve surgical outcomes.

Most children and adolescents with kidney and ureteral stones are treated with ureteroscopy, despite the uncertainty and equal weight of guideline recommendations for ureteroscopy or shockwave lithotripsy. To compare stone clearance and patient-reported outcomes among children and adolescents after ureteroscopy or shockwave lithotripsy. This nonrandomized clinical trial enrolled patients between March 16, 2020, and July 31, 2023, at 31 medical centers in the US and Canada. Patients aged 8 to 21 years with kidney stones, ureteral stones, or both were included. Follow-up was completed on October 15, 2023. Ureteroscopy or shockwave lithotripsy. The primary outcome was stone clearance assessed by standardized ultrasonography 6 (±2) weeks after surgery. Using inverse probability weighting and random intercepts for site, stone clearance was evaluated per kidney or ureter using logistic regression and estimated stone clearance rates were generated for each procedure. This study included 1142 patients (690 females [60.4%]), with a median age of 15.6 years (IQR, 12.6-17.3 years). In terms of race and ethnicity, 41 patients (3.6%) were Black, 130 (11.4%) were Hispanic, and 884 (77.4%) were White. A total of 124 urologists treated 1069 and 197 kidneys or ureters with ureteroscopy and shockwave lithotripsy (n = 953 and n = 189 patients), respectively, with a median stone size of 6.0 mm (IQR, 4.0-9.0 mm). Ureteral stents were placed at time of index surgery for 841 procedures for 767 patients (80.4%) receiving ureteroscopy and for 6 procedures for 5 patients (2.6%) receiving shockwave lithotripsy. Stone clearance occurred in 474 patients who underwent ureteroscopy (71.2% [95% CI, 63.8%-78.5%]) and in 105 patients who underwent shockwave lithotripsy (67.5% [95% CI, 61.0%-74.1%]), a difference that was not statistically significant (risk difference, 3.6% [95% CI, −6.2% to 13.5%]). Compared with shockwave lithotripsy, ureteroscopy resulted in greater pain interference (T-score difference, 5.0 [95% CI, 2.3-7.8]) and urinary symptoms (symptom score difference, 3.9 [95% CI, 1.2-6.7]) 1 week after surgery. Patients who had ureteroscopy missed more school (risk difference, 21.3% [95% CI, 9.7%-32.8%]) and caregivers missed more work (risk difference, 23.0% [95% CI, 11.0%-35.0%]) in the week after surgery. In this study of 1142 children and adolescents with kidney and ureteral stones, there was no clinically meaningful difference in stone clearance with ureteroscopy vs shockwave lithotripsy. Shockwave lithotripsy was associated with better patient-reported outcomes. These findings raise questions about the preference for ureteroscopy in practice. ClinicalTrials.gov Identifier: NCT04285658

Growth in the field of medical imaging research has revealed a need for larger volume and variety in available data. This need could be met using curated clinically acquired data, but the process for getting this data from the scanners to the scientists is complex and lengthy. We present a manifest-driven modular Extract, Transform, and Load (ETL) process named Locutus designed to appropriately handle difficulties present in the process of reusing clinically acquired medical imaging data. The design of Locutus was based on four foundational assumptions about medical data, research data, and communication. All parts of a workflow must communicate with each other and be adaptable to unique data delivery requests. In addition, the workflow must be robust to possible errors and uncertainties in clinically-acquired data, which may require human intervention to resolve. With these assumptions in mind,Locutus presents a five-phase workflow for downloading, deidentifying, and delivering unique requests for imaging data. The phases include initialization, data preparation, extraction of data from the research server to a pre-deidentification data warehouse, transformation into deidentified space, and loading into post-deidentification data warehouse. To date, this workflow has been used to process 32,962 imaging accessions for research use. This number is expected to grow as technical challenges are addressed and the role of humans is expected to shift from frequent intervention to regular monitoring.