Diversity, Equity, and Inclusion in Urolithiasis Clinical Trials: Representative Enrollment by Race, Ethnicity, and Sex.

INTRODUCTION: We sought to assess whether participant enrollment is appropriately representative of the overall urolithiasis population in published urolithiasis clinical trials. METHODS: PubMed was queried for urolithiasis US clinical trials published from 2000 to 2022. Trials were evaluated for reporting patient race/ethnicity and sex data. These were then compared to the stone prevalence reported by the National Health and Nutrition Examination Survey from 2015 to 2018. We calculated a representation quotient (RQ) to describe enrollment of patients and then stratified by geographic location, study type, and funding source. RESULTS: Of the 180 urolithiasis trials performed in the US, we identified 40 trials (22%) reporting race or ethnicity and 104 trials (58%) reporting sex. Male and female participants are well represented (RQ 0.97 and 1.02, respectively). Overall, the RQ of Black, Asian American and Pacific Islander, White, Hispanic, and mixed/other participants is 1.84, 1.06, 1.04, 0.46, and 0.34, respectively. Trials completed in the Western Section and multi-institutional trials have the most proportional enrollment, while trials in the South Central and Southeastern Sections have underrepresentation of mixed/other and Hispanic patients. Enrollment was similar among all trial subtypes. Government- and industry-funded trials had more diverse enrollment than academic-funded trials. CONCLUSIONS: Only 1 in 4 published US urolithiasis trials report race or ethnicity enrollment. Mixed race and Hispanic participants are consistently underrepresented, while Black participants are overrepresented. Government- and industry-sponsored multi-institutional trials have the most proportional representation. Investigators should prioritize inclusive recruitment and improve reporting practices to accurately reflect the diversity of the urolithiasis population.

Factors Affecting Holmium Laser Efficiency: Comparison of Laryngeal Mask Airway and Endotracheal Intubation During Ureteroscopy for Renal Stones.

Introduction: Holmium laser lithotripsy is a standard energy source used for treatment of kidney stones during flexible ureteroscopy. Efficiency of laser surgery may be affected by patient and operator characteristics or perioperative management. Here, we sought to examine intraoperative data from patients undergoing high frequency dusting with high-powered holmium laser lithotripsy to evaluate surgical and demographic factors associated with lasing efficiency (LE). Methods: A total of 82 intraoperative reports were analyzed from an ongoing laser lithotripsy clinical trial evaluating the Lumenis Pulse™ 120H holmium laser with renal stones up to 20 mm in diameter with and without Moses 2.0 technology. For each case, the total pause time between lasing activations was corrected to remove lengthy pauses and divided by the total lasing time to calculate an efficiency percentage. This was then compared with patient demographics, anesthesia administration, stone burden, postoperative complications, and stone-free rates using both univariate and multivariate analyses. Results: Of the 82 included patients, 36 received endotracheal tube (ETT) intubation and 46 had a laryngeal mask airway (LMA). Patients with ETT had significantly higher LE (78.7%) compared to those with an LMA (73.3%) in our univariate analysis (p < 0.01) as well as in the multivariate model that adjusted for maximum stone size, number of stones, stone density, and patient body mass index (p < 0.05). There was also significantly higher mean LE in patients with no postoperative complications (76.3%) compared to those with any grade (I-V) Clavien-Dindo complication within 30 days after surgery (70.0%) (p < 0.05). Conclusions: Flexible ureteroscopy and laser lithotripsy cases with higher LE are associated with lower rates of postoperative complications. The data also support the use of ETT over LMA to improve overall LE; however, this remains one consideration among many for choosing anesthesia administration. Clinical Trial Registration number: NCT04505956.

The Role of Routine Ureteral Stenting Following Uncomplicated Ureteroscopic Treatment for Upper Ureteral and Renal Stones: A Randomized Control Trial.

Purpose: Ureteral stenting following uncomplicated ureteroscopy (URS) is common practice. Several studies have proven the safety of omitting routine stent placement following distal ureteral stone treatment. However, there is a paucity of data regarding the utility of stent placement for proximal URS. We designed a prospective, randomized controlled trial to evaluate the role of ureteral stent placement following URS for proximal ureteral and renal stones. Methods: Seventy-two patients with proximal ureteral or renal stones measuring as much as 1.5 cm were prospectively randomized into stented (37) or unstented (35) groups. The surgeon was blinded to the treatment group until after stone treatment. Patients tracked postoperative pain medications and completed validated pain questionnaires on postoperative days 0, 3, 7, and 28. Stents were removed on postoperative day 7. Postoperative follow-up imaging was obtained at 4 weeks. Results: No statistical differences were observed between the two groups in terms of demographics or stone characteristics. The operative time was longer in the stented group (p < 0.03). Patients in the stented group had more irritative urinary symptoms (p < 0.0001) and pain (p < 0.0001), missed more days of work (p < 0.01), and used more narcotics (p < 0.0005) during the first week, but no differences were observed at 30 days. Emergency room visits and overall complication rates were similar between the two groups. Three nonstented patients required stent placement. Two stented patients required early stent removal. Urinary tract infections developed in three stented patients, but not in unstented patients. Postoperative imaging did not reveal any hydronephrosis in either group, and the total stone-free rate was 94%. Conclusions: For most patients undergoing uncomplicated ureteroscopic treatment for proximal ureteral and kidney stones, it may be safe to omit ureteral stents to potentially decrease urinary symptoms and pain while improving short-term quality of life. Further studies with larger patient cohorts may be warranted to confirm our results.

Duration of Ureteral Stenting Following Ureteroscopic Perforation in a Porcine Model.

Objectives: Ureteroscopic ureteral perforations have been reported in up to 6% of cases, with recent studies suggesting a decline to less than 2%. Ureteroscopic perforations are managed with prolonged ureteral stenting of up to 6 weeks based on historical data. We sought to evaluate the time of urothelial healing and duration of ureteral stenting following a ureteroscopic perforation in a porcine model. Materials and Methods: Part A: Ureteral perforation using a semirigid ureteroscope was performed in 37 ureters. The ureters were stented using 4.7F × 22 cm stents for 3, 7, 10, or 14 days, and retrograde pyelograms performed after stent removal. Injured ureteral segments were collected for histologic evaluation. Part B: 8 ureters had endoscopic perforation and stenting for 7 days and then survived for 4 weeks for evaluation of urinary extravasation or hydronephrosis and histologic evaluation. Results: Part A: At 3 days of ureteral stenting, there was urinary extravasation on retrograde pyelograms and gross defect in all ureters; average creatinine increased (1.55-1.75 mg/dL). Starting at 7 days, no evidence of gross urothelial defects or extravasation, and average creatinine was stable. Histologic evaluation revealed urothelial healing by 7 days with ongoing tissue healing. Granulation tissue predominated in early phase of healing. Part B: With only 7 days of ureteral stenting, no extravasation or hydronephrosis developed a month after stent removal. Conclusions: Following ureteroscopic ureteral perforation in a porcine model, the urothelium is functionally intact with 7 days of stenting. These results are sustained without complications for at least 4 weeks after stent removal. While further studies are warranted, these results challenge the current practice of maintaining ureteral stenting for several weeks following ureteral perforation during ureteroscopy.

Type 2 Diabetes Mellitus: Relationships Between Preoperative Physiologic Stress, Gastric Content Volume and Quality, and Risk of Pulmonary Aspiration.

Pulmonary aspiration is a potentially fatal anesthetic complication occurring when gastric contents enter the respiratory system. Fasting guidelines aim to decrease the risk of pulmonary aspiration by recommending a timeframe in which patients abstain from food and drink before surgery. Fasting guidelines recommended for healthy individuals fail to account for patients with type 2 diabetes mellitus (T2DM). Gastroparesis, a common condition associated with T2DM, is exacerbated during stress such as an impending surgery. This study sought to determine whether a relationship exists between stress levels and gastric contents in fasting patients with T2DM presenting for an elective surgical or diagnostic procedure. The quality and quantity of gastric contents and preoperative stress were evaluated using gastric ultrasonography and salivary α-amylase levels. No relationship existed between preoperative stress and gastric contents; however, glycated hemoglobin levels of 7% or greater were associated with increased gastric fluid, which was the most significant finding in this study. In addition, there was a significant difference between the mean gastric volume in healthy individuals and patients with T2DM. Performance of gastric ultrasonography preoperatively provides objective data that could influence the anesthetic plan and decrease the risk of pulmonary aspiration in patients with T2DM.

Semi-rigid ureteroscope as a dilator in renal stone ureteroscopic treatment.

INTRODUCTION: To determine the efficacy and safety of using the semi-rigid ureteroscope as the only ureteral dilator for primary ureteroscopy (URS) in the treatment of renal stones. MATERIALS AND METHODS: A retrospective review of primary URS for renal stone disease was performed on consecutive patients treated by a single provider from 2013 to 2017. Utilizing wire placement under fluoroscopic guidance and direct visual ureteroscopic dilation with a semi-rigid ureteroscope, primary outcome was successful completion of stone treatment. In addition, perioperative safety was evaluated. RESULTS: A total of 126 consecutive cases of primary URS using the semi-rigid ureteroscope as the only ureteral dilator were attempted for renal stone treatment. The renal stones were treated in 124 (98.4%) patients without other forms of active ureteral dilation. Two (1.6%) patients required ureteral stent placement for passive dilation despite attempted other dilating techniques. No intraoperative ureteral perforations were identified. Postoperative radiographic follow up was available for 67% patients with a 91% stone free rate and no hydronephrosis or ureteral strictures were detected. CONCLUSION: Utilizing direct visual semi-rigid ureteroscopic dilation with a semi-ridged ureteroscope prior to flexible ureteroscopy leads to successful primary ureteroscopy for renal stone treatment in most patients. This technique is an effective, safe and possibly cost-effective method of obtaining ureteral access to facilitate primary URS for renal stone treatment.

Genitourinary Injuries Among Female U.S. Service Members During Operation Iraqi Freedom and Operation Enduring Freedom: Findings from the Trauma Outcomes and Urogenital Health (TOUGH) Project.

Introduction: Until recently, female U.S. service members (SMs) have not been permitted to serve in direct combat roles. However, during Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), a large number of female SMs have been wounded while serving in combat support roles. This included an unprecedented number of women with genitourinary (GU) injuries. No previous studies have reported either the incidence or clinical picture of these injuries. The objective of this study is to describe the epidemiology of GU injuries among female U.S. SMs during OIF/OEF and understand the potential for increased female GU injuries in future conflicts and the long-term sequelae from these injury patterns. Materials and Methods: The Department of Defense Trauma Registry was reviewed to identify all U.S. SMs diagnosed with GU injury from 2001 to 2013. The Department of Defense Trauma Registry includes data for wounded SMs treated at any U.S. combat support hospital, the in-theater equivalent of a civilian trauma center. Female SMs with ICD-9-CM diagnosis codes and/or Abbreviated Injury Scale codes for GU injury were included. Data on all females with GU injury were reviewed, including battle injury (BI) and non-BI. Basic demographic and injury characteristics were reported. Results: Among the 1,463 U.S. SMs diagnosed with GU injury while deployed to OIF/OEF, 20 (1.4%) were female (median age: 25 yr; interquartile range 21-27 yr). Of these, nine were BI (45%) and 11 were non-BI (55%). The distribution of injury location was as follows: renal injuries (n = 12), vulvar injuries (n = 3), vaginal injuries (n = 3), perineal injury (n = 1), and bladder injury (n = 1). Median Injury Severity Score was in the severe range of 21 (interquartile range 6-32), and four women (20%) died of their wounds. Important associated injuries included colorectal (n = 5) and lower extremity amputation(s) (n = 2). The most common mechanism of injury among the nine women with GU BI was improvised explosive device blast (n = 6), followed by other explosions (n = 2) and gunshot wound (n = 1). Mechanisms of GU non-BI varied, including gunshot wound (n = 2), fall (n = 2), fire/flame (n = 1), knife wound (n = 1), unintentional machine injury (n = 1), motor vehicle accident (n = 1), sports injury (n = 1), fight (n = 1), and pedestrian injury (n = 1). Conclusion: Female GU injuries comprise a small portion of all GU injuries sustained during OIF/OEF with the most predominant being renal injury. Now that the ground combat exclusion policy has been lifted, these data can be used as a model for the expected injury patterns in future female combatants. Long-term applications for these data include research and development for personal protective equipment and development of a multidisciplinary approach to long-term comprehensive care following GU trauma.