Are adverse events during surgery for benign prostatic hyperplasia device related? A review of the MAUDE database.

PURPOSE: The Manufacturer and User Facility Device Experience database contains anonymous, voluntary medical device reports. A review of device-related adverse events associated with Benign Prostatic Hyperplasia surgeries was completed. The objective was to evaluate the occurrence and contributing factors to clinically significant complications in a cohort of patients electing to undergo surgical intervention for Benign Prostatic Hyperplasia. METHODS: The Manufacturer and User Facility Device Experience database was queried for "Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Water Vapor Thermal Therapy, Loop Resection, and Prostatic Urethral Lift" from 2018 through 2021. A complication classification system (Level I-IV) based on the Clavien-Dindo system was used to categorize events. These events were then correlated with procedural technology malfunctions and classified as "device related" and "non-device related." Chi squared analysis was performed to identify associations between procedural technology and complication classification distribution. RESULTS: A total of 873 adverse events were identified. The adverse events were classified into level I (minimal harm) versus levels II-IV (clinically significant). Aquablation (p < 0.017) and Water Vapor Thermal Therapy (p < 0.012) were associated with a higher proportion of reports with Level II-IV complications compared with other procedure types. Level II-IV complications were not associated with a reported device related malfunction. CONCLUSIONS: Aquablation and water vapor thermal therapy demonstrated noteworthy clinically significant complications which were not driven by device-related malfunctions.

Prospective Multicenter Evaluation of Pain Before and After Removal of Nonobstructing Renal Calculi: A CoRE Initiative.

PURPOSE: Flank pain associated with stone disease is typically caused by a stone that obstructs urine flow. However, it is plausible that nonobstructing kidney stones may still cause pain. We performed a multicenter, observational trial to evaluate whether treatment of small nonobstructing calyceal stones improves pain and kidney stone-specific health-related quality of life. MATERIALS AND METHODS: Patients aged 18 years or older with nonobstructing renal stone(s) up to 10 mm in longest diameter and moderate to severe pain were recruited. All participants completed 3 questionnaires: the Brief Pain Inventory (BPI), the Patient-Reported Outcomes Measurement Information System pain interference form 6a, and the Wisconsin Stone Quality of Life questionnaire. Thereafter, all participants underwent ureteroscopy for renal stone treatment. All 3 questionnaires were repeated at 2, 6 to 8, and at 12 weeks postprocedure. The primary outcomes were change in preoperative to 12-week postoperative mean BPI score and worst BPI pain score. RESULTS: A total of 43 patients with nonobstructing kidney stones and associated flank pain were recruited. All stones were removed. Preoperatively, BPI scores for mean pain and worst pain were 5.5 and 7.2, respectively which decreased to 1.8 and 2.8 respectively at 12 weeks postoperatively. Wisconsin Stone Quality of Life questionnaire mean score increased from 70.4 to 115.3 at 12 weeks postoperatively. A total of 86% and 69% of patients had at least a 20% and 50% reduction in their mean pain scores, respectively. CONCLUSIONS: This study determined that patients benefit significantly from the removal of calyceal nonobstructing kidney stones for at least 12 weeks with a reduction in pain and an increase in quality of life. Therefore, surgical removal of these stones in this patient population should be offered as a treatment option.

Quick Sequential Organ Failure Assessment Score Is a Better Predictor of Septic Shock After Percutaneous Nephrolithotomy: A Secondary Analysis of Two Multicenter Prospective Trials.

Introduction: Recent retrospective literature suggests that the quick sequential organ failure assessment (qSOFA) scoring tool is a potentially superior tool over use of the systemic inflammatory response syndrome (SIRS) criteria to predict septic shock after percutaneous nephrolithotomy (PCNL) surgery. Here we examine use of qSOFA and SIRS to predict septic shock within data series collected prospectively on PCNL patients as part of a greater study of infectious complications. Materials and Methods: We performed a secondary analysis of two prospective multicenter studies including PCNL patients across nine institutions. Clinical signs informing SIRS and qSOFA scores were collected no later than postoperative day 1. The primary outcome was sensitivity and specificity of SIRS and qSOFA (high-risk score of greater-or-equal to two points) in predicting admission to the intensive care unit (ICU) for vasopressor support. Results: A total of 218 cases at 9 institutions were analyzed. One patient required vasopressor support in the ICU. The sensitivity/specificity was 100%/72.4% (McNemar's test p < 0.001) for SIRS and was 100%/90.8% (McNemar's test p < 0.001) for qSOFA. Conclusion: Although positive predictive value for both qSOFA and SIRS in prediction of post-PCNL septic shock is low, prospectively collected data demonstrate use of qSOFA may offer greater specificity than SIRS criteria when predicting post-PCNL septic shock.

Ultrasound-Guided PCNL - Why Are We Still Performing Exclusively Fluoroscopic Access?

PURPOSE OF REVIEW: While urologists are traditionally taught to perform percutaneous nephrolithotomy (PCNL) utilizing exclusively fluoroscopy, ultrasound has emerged as a safe alternative. This article showcases the major reasons why ultrasound-guided access should be considered the first-line approach for performing access for PCNL. RECENT FINDINGS: There continues to be a need to further reduce radiation exposure in the management of kidney stone patients. This review showcases how performing ultrasound-guided PCNL has been associated with a shorter learning curve, increased patient safety, and the ability to perform x-ray free PCNL. Ultrasound-guided PCNL is not only an achievable skill for urologists to learn but provides multiple advantages over traditional fluoroscopic access. As every effort should be given to help reduce radiation exposure for kidney stone patients as well as performing surgeons and operating theater personnel, endourologists should strive to add this technique to their armamentarium.

Long-term follow-up on dusting versus basketing during ureteroscopy: a prospective multicenter trial from the EDGE Research Consortium.

In 2018, the Endourology Disease Group for Excellence (EDGE) published a prospective trial comparing dusting versus basketing during ureteroscopy. One hundred fifty-nine patients were included in the original analysis, which found no difference in stone-free rate at 3 months. We report the intermediate and long-term outcomes of patients included in the original trial. Two analyses were performed. At 1-year, a retrospective chart review was performed, and data collected on stone episodes, Emergency Department (ED) visits, hospital admissions and surgical interventions. To obtain long-term outcomes, the four sites with the largest initial accrual were included in a second phase of data collection with updated analyses. The patients from those sites were contacted, re-consented, and data were collected on stone surgical interventions, stone episodes, stone recurrences on imaging, emergency department (ED) visits, and hospital admissions for stone-related care since their original procedure. One-year follow-up data were collected in 111 of the original 159 (69.8%) patients from the nine sites. There were no statistically significant differences in the number of painful episodes, ED visits, hospital admissions, or surgical interventions. 94 patients from four sites were included in the long-term analysis. There were no statistically significant differences in surgical interventions, painful stone episodes, stone recurrence on imaging, ED visits or hospitalizations for stone-related events between the two groups. Long-term outcomes of dusting versus basketing during ureteroscopy indicate that there are no significant differences in clinical outcomes between the two surgical modalities.

Effect of Cannabidiol Oil on Post-ureteroscopy Pain for Urinary Calculi: A Randomized, Double-blind, Placebo-controlled Trial.

PURPOSE: Post-ureteroscopy stent placement carries significant morbidity which can interfere with daily life. This discomfort unfortunately leads to high utilization of opioid pain medications, which have a known risk of addiction. Cannabidiol oil represents an alternative analgesic that has proven anti-inflammatory and antinociceptive effects. The purpose was to evaluate the effect of a Food and Drug Administration-approved cannabidiol oil (Epidiolex) on pain control and opioid usage in the post-ureteroscopy setting. MATERIALS AND METHODS: This was a prospective, randomized, double-blind, placebo-controlled trial at a tertiary care center. Ninety patients undergoing ureteroscopy with stent placement for urinary stone disease were randomized 1:1 to placebo or 20 mg cannabidiol oil daily for 3 days postoperatively. Both groups were prescribed a rescue narcotic, tamsulosin, oxybutynin, and phenazopyridine. Daily pain scores, medication usage, and ureteral stent symptoms using the validated Ureteral Stent Symptom Questionnaire were recorded postoperatively. RESULTS: Both the placebo and cannabidiol oil groups were not different in pre- and perioperative characteristics. There was no difference in pain scores or opioid usage between groups postoperatively. The level of discomfort with ureteral stents was also not different between groups when comparing physical activity, sleep, urination, and activities of daily life. CONCLUSIONS: This randomized, blinded, placebo-controlled trial showed that cannabidiol oil is safe but ineffective when compared to placebo in reducing post-ureteroscopic stent discomfort or opioid usage. Despite the availability of numerous analgesic agents, stent symptoms continue to be a dissatisfier for most patients, suggesting additional work needs to focus on novel interventions and pain control.

Opioids and Kidney Stones.

In recent years, the use of opioids in medical practice has come under significant scrutiny. This, in part, is owing to evidence of overprescription and overuse of opioid medications, as well as the unintended consequences and side effects for patients who take these medications. Here, we review the role of opioids and the responsible use of these medications with respect to kidney stone disease and surgical interventions for kidney stones.

Holmium laser enucleation of the prostate using Moses 2.0 vs non-Moses: a randomised controlled trial.

OBJECTIVES: To compare the enucleation efficiency of Moses 2.0 with non-Moses technology in patients undergoing holmium laser enucleation of the prostate (HoLEP). PATIENTS AND METHODS: A double-blinded, randomised study of patients undergoing HoLEP at the Mayo Clinic in Arizona, using the Lumenis Pulse™ 120H laser system. Patients were randomised to either right lobe enucleation using Moses 2.0 and left lobe enucleation using non-Moses, or the opposite. The primary outcome was individual lobe enucleation efficiency. Secondary outcomes included individual lobe laser time, laser energy, individual enucleation and haemostasis laser energies, and fibre burn back. Two independent reviewers watched videos of the procedures and provided a subjective evaluation of the technologies. RESULTS: A total of 27 patients were included in the study. For the entire cohort, Moses 2.0 had less fibre degradation (3.5 vs 16.8 mm, P < 0.01) compared to non-Moses. When HoLEP procedures were performed by an expert, Moses 2.0 resulted in shorter enucleation time (21 vs 36.7 min, P = 0.016) and higher enucleation efficiency (1.75 vs 1.05 g/min, P = 0.05) compared to non-Moses. When HoLEP was performed by trainees, the Moses 2.0 cohort had a shorter haemostasis laser time (4.1 vs 9 min, P = 0.035) compared to the non-Moses. Fibre degradation was lower with Moses 2.0 compared to non-Moses for both experts and trainees. Moses 2.0 received a higher score than the standard technology for the incision sharpness, fibre control, tissue separation, tissue damage, haemostasis, visibility, and charring. The overall inter-observer correlation coefficient was 0.63. CONCLUSION: Moses 2.0 has higher enucleation efficiency compared to non-Moses when used by experts. The subjective evaluation favoured Moses 2.0.

Does bladder stone composition predict kidney stone composition?

INTRODUCTION Bladder stones have historically been associated with urinary stasis secondary to bladder outlet obstruction (BOO). Recent studies indicate that the role of BOO in bladder stone formation is minor. We evaluate the role of urinary lithogenic factors in bladder stone formation by comparing the compositions of bladder stones and kidney stones in patients with multi-site urinary calculi. MATERIALS AND METHODS: We identified patients who were treated for concomitant bladder stones and kidney stones between 2008-2019, and had both stone compositions available. Patients with bladder stone size < 10 mm, urinary foreign bodies, encrusted stents or tumors were excluded. Data regarding urinary symptoms, residual volumes, stone composition and 24-hours urine data were collected. RESULTS: We identified 40 males with a median age of 72 years (IQR 6-14), median residual volume of 76 mL (IQR 41-200), and a median prostate volume of 52 mL (IQR 32-102). Bladder outlet procedures were performed concomitantly with cystolitholapaxy in 21 (53%) patients. The most common bladder stone and kidney stone compositions were CaOx (47.5% and 65%), uric acid (32.5% and 22.5%), calcium phosphate (15% and 10%), and struvite (5% and 2.5%), respectively. Bladder stone and kidney stone compositions were identical in 70% of patients. Bladder stone composition was predictive of kidney stone composition, regardless of the PVR, bladder stone size, or whether an outlet procedure was performed. CONCLUSION: We found a high concordance between bladder stone and kidney stone composition, suggesting that metabolic abnormalities have a significant role in bladder stone formation. Bladder stone composition can be used to guide surgical and medical treatment for kidney stones in metabolically active stone patients.

The Clinical Implication of Incidental Prostatic Amyloidosis.

OBJECTIVE: To describe the clinicopathologic features of patients with incidental prostatic amyloidosis. PATIENTS AND METHODS: We queried the genitourinary pathology database at Mayo Clinic Arizona for prostate specimens which showed amyloid deposits. Congo red stain was used for the diagnosis of amyloidosis and amyloid subtype was performed analysis using Liquid chromatography tandem mass spectrometry. We reviewed the patient's medical charts for past or subsequent diagnosis of systemic amyloidosis and clinical course. RESULTS: Prostatic amyloidosis was identified in 7 patients between 2008-2018. Median age was 79 years (range 69-84) and median follow-up was 5 years (range 0-11). Benign prostate tissue was found in 4 patients, and prostate cancer was diagnosed in 3 patients. Amyloid subtyping was available in 6 patients and was consistent with Amyloid transthyretin Amyloidosis. Liquid chromatography tandem mass spectrometry did not detect an amino acid sequence abnormality in the transthyretin protein in any of the patients. Five of 6 patients were diagnosed with cardiac amyloidosis, which preceded and followed the diagnosis of prostatic amyloidosis in 1 and 4 patients, respectively. Of these 4 patients, 2 were diagnosed immediately and as a consequence of the diagnosis of prostatic amyloidosis, and the remaining 2 3 and 4 years later. CONCLUSION: Incidental prostatic amyloidosis should prompt systemic and cardiac evaluation for amyloidosis. In patients with suspected cardiac amyloidosis, prior prostate specimens should be reviewed for the presence of amyloidosis.

Retained Foreign Body Presenting as Pouch Stone After Continent Urinary Diversion.

Background: Continent urinary diversion is a procedure commonly performed in patients after cystectomy who wish to not have a urostomy. Well-documented complications after continent urinary diversion include urinary tract infections and formation of urinary stones. However, these are typically late complications, and few reports have described the onset of these urinary symptoms within 12 months of initial continent urinary diversion. Case Presentation: Herein we report a case of a 41-year-old woman with history of cystectomy with continent urinary diversion who presents with recurrent infections and a calculus in the pouch 10 months after the initial procedure. Upon surgical exploration for removal of the stone, it was discovered that the stone was in fact a calcified retained catheter tip. Conclusion: This case further highlights that stone formation within 12 months of a urinary diversion is unusual and should prompt additional work-up for foreign body.

The safety wire with a ureteral access sheath - does it hurt more than it helps?

INTRODUCTION: Studies indicate that with a safety wire in the ureter, an increased amount of force is necessary to advance ureteral access sheaths up to the proximal ureter. Theoretically, the compression of the ureter with the wire could lead to an increase in number and severity of ureteral injuries secondary to placement of a sheath. This prospective study aims to evaluate if there is a correlation between the use of a safety wire and ureteral injury from sheath placement by evaluating the location of the wire in relation to the injury after ureteroscopy. MATERIALS AND METHODS: Fifty-nine consecutive patients underwent ureteroscopy for upper tract urinary stone disease. A 12/14 French ureteral access sheath was used with a safety wire in place. Ureteroscopy during withdrawal of the sheath was video recorded and reviewed by a blinded observer. Visible ureteral injuries were graded per the Traxer ureteral injury scale and the proximity of the wire to the injury was noted. RESULTS: Thirty-one of 59 patients (52.4%) had a ureteral injury secondary to access sheath placement. Eighteen (30.5%) injuries were low-grade, 13 (22.0%) were high-grade (grade 2 and 3) and there were no grade 4 injuries. A total of 10 (32.3%) injuries occurred on the same side as the wire while 67.7% were on the contralateral side of the ureter. Of the injuries that occurred on the same side as the wire, 80% were grade 1 injuries and 2 (20%) were grade 3. Statistical analysis did not show a significant relationship between high/low injury grade and side of injury (p value = 0.088). This suggests that there is no association of between the safety wire and development of high injury. CONCLUSION: There is no association between the location of the safety wire and ureteral injury if injury occurs during the placement of a ureteral access sheath. This suggests that the use of a safety wire does not add significant morbidity to the procedure.

A Prospective Study Analyzing the Association Between High-grade Ureteral Access Sheath Injuries and the Formation of Ureteral Strictures.

OBJECTIVE: To assess the intermediate- and long-term effect of high-grade ureteral injuries from ureteral access sheaths. METHODS: Patients undergoing ureteroscopy for upper tract calculi were prospectively enrolled at 2 sites from 2010 to 2015. A 12/14 French sheath was used and the ureter was inspected with a flexible ureteroscope during withdrawal of the sheath and recorded. The videos were then evaluated by 2 blinded endourologists, and any injuries were graded per the Traxer ureteral injury scale. Only high-grade injuries were included. The primary endpoint was defined as ongoing hydronephrosis without an obstructing stone on follow-up imaging indicating a ureteral stricture. Logistic regression analysis was used to assess the relationship between hydronephrosis, ureteral injury, and other patient variables. RESULTS: Fifty-six patients were identified with high-grade ureteral injuries. Sixteen patients (28.6%) were female. Median age was 56.4 years (range 14-85). Median follow-up was 35.8 months (range 0-88). Three patients (5.5%) had hydronephrosis on follow-up imaging, only 1 of whom developed a de novo ureteral stricture. On univariate analysis, hydronephrosis was associated with a shorter stent duration (P = .11) and older age (P = .17). CONCLUSION: Endoscopically identified high-grade ureteral lesions following ureteral access sheath placement do not lead to clinically significant sequelae on intermediate term follow-up, with a stricture rate comparable to those without visible injuries of 1.8%.

Laser Papillotomy for Chronic Flank Pain: A Reassessment of Efficacy in the Era of Automated Opioid Prescription Monitoring.

INTRODUCTION: We determined whether laser papillotomy for patients with chronic flank pain decreased narcotic pain medication use after surgery. Specifically, the introduction of state specific automated prescription reporting systems offers the opportunity for a more objective longitudinal assessment of outcomes in patients who often use multiple providers for pain management. METHODS: Patients who underwent laser papillotomy for chronic flank pain at a single institution between January 2013 and January 2017 were identified. Narcotic prescription refill information for the 12 months before and 12 months after the surgery was obtained through the Ohio Automated Rx Reporting System and the Pennsylvania Prescription Drug Monitoring Program. RESULTS: Overall 10 patients underwent laser papillotomy for chronic flank pain. Preoperative outpatient narcotic prescriptions filled ranged from 0 to 23, with a mean of 10.5 separate prescriptions per patient. Postoperatively 8 of 10 cases were considered failures. Six patients had multiple narcotic pain medication refills, with the mean number of pills filled recorded as 993.3 in the 12 months after surgery. One patient became a heroin addict postoperatively and another required ongoing care in the chronic pain clinic. CONCLUSIONS: Laser papillotomy for chronic flank pain has a high failure rate, especially in patients who are on narcotic pain medication preoperatively. In the era of automated opioid prescription monitoring, urologists should use such information to make surgical decisions and properly counsel patients.

The Moses holmium system - time is money.

INTRODUCTION: The Moses technology of the holmium laser has been shown to decrease retropulsion in the ureter and procedural time in kidney stones during laser lithotripsy. Theoretically, these improvements could lead to cost savings for the patient. MATERIALS AND METHODS: All patients with total laser energy data recorded who underwent ureteroscopy with laser lithotripsy by a single surgeon at a tertiary care center were included. Total lasing time was calculated from the total laser energy. Sub-analyses were done on stone size and stone composition. The procedure time using Moses technology was projected to be approximately 35% less than procedure time without the Moses technology based on prior in vitro studies. The projected cost savings was then utilized to predict cost-effectiveness of the Moses technology. RESULTS: Forty patients underwent ureteroscopy with laser lithotripsy. Mean stones size was 10.2 mm and mean lasing time was 3.02 minutes. Linear regression showed a positive association between stone size and laser time, p = 0.01. There was no significant correlation between stone composition or stone Hounsfield units and lasing time. On cost analyses, for stones of all sizes the Moses system has a price differential of an increase in $292.36 when compared to the standard Holmium TracTip system. Specifically for stones larger than 10 mm, the price differential is an increase in $253.16 for the Moses technology. CONCLUSION: The decrease in lasing time achieved by the Moses system does not translate into sufficient cost savings to off-set the higher cost of the laser fiber and software.

A New Laser Platform for Holmium Laser Enucleation of the Prostate: Does the Lumenis Pulse 120H Laser Platform Improve Enucleation Efficiency?

OBJECTIVE: To determine whether the recently introduced Lumenis Pulse 120H laser platform, which offers a dual-pedal footswitch and preset energy modes to easily switch among laser settings, facilitates a more efficient process in holmium laser enucleation of the prostate (HoLEP) for surgical treatment of benign prostatic hyperplasia. PATIENTS AND METHODS: Patients at a single institution who underwent HoLEP with the new Lumenis Pulse 120H laser platform were matched 1:2 with patients who underwent the procedure with the previously used 100-watt VersaPulse single-pedal laser platform. Matching was performed by using propensity scores calculated by a logistic model that considered preoperative transrectal ultrasound prostate volume and patient age. The primary outcome was enucleation efficiency of each platform, determined by the weight of prostate tissue resected and enucleation time. The McNemar test and a conditional logistic model were used to associate predictors and cases. RESULTS: Twenty-nine patients who underwent HoLEP with the Lumenis Pulse 120H platform were matched with 58 patients who underwent the procedure with the 100-watt platform. We observed statistically significant differences in operating room total time, procedure time, and enucleation time. Other perioperative and postoperative outcomes were comparable between the 2 groups. Enucleation efficiency was similar between the 2 laser platforms (0.89 g per minute in the control group vs 0.84 g per minute in the Lumenis Pulse 120H group). CONCLUSION: The efficiency of the new Lumenis Pulse 120H laser platform is comparable to the 100-watt VersaPulse laser platform in HoLEP when comparing g of tissue enucleated per minute.

The impact of training on the perioperative and intermediate functional outcomes after holmium laser enucleation of the prostate.

INTRODUCTION: To systemically measure the impact of trainees' participation on the perioperative and functional outcomes after holmium laser enucleation of the prostate (HoLEP). MATERIALS AND METHODS: Benign prostatic hyperplasia patients who underwent HoLEP at our department between January 2007 and January 2013 were classified based on trainee's level. Perioperative outcomes and complications were collected. Functional outcomes were assessed using the Sexual Health Inventory for Men (SHIM), International Prostate Symptom Score (IPSS), and International Continence Society-Short Form (ICSmaleSF) questionnaires. Voiding and incontinence domains of ICSmaleSF were assessed separately. Patients were divided into group 1 if no trainee participated in the operation, group 2 if a senior trainee performed the operation, and group 3 if a junior trainee participated in the operation. The patient's baseline characteristics, complications, and perioperative outcomes were compared. RESULTS: There were no differences in the baseline characteristics. There were significant differences in overall operative and enucleation time (p = 0.0186, p = 0.0047, respectively) with shorter times noticed with more experienced operators. There were no differences in resected tissue weight, hemoglobin change, and transfusion rates. Postoperatively, all patients had a similar length of stay and catheterization. Complications (graded by Clavien grading system) were not different. All patients were followed up at regular intervals starting at 6 weeks, 3 months , 6 months, 1 year, and every year after that and there were no differences in flow rates or post void residual volumes at any time point. There were no differences in SHIM, IPSS, and ICSmale voiding scale among the groups. However, ICSmale continence scale was significantly different where the highest score seen in group 2. CONCLUSION: Trainee participation in HoLEP in a controlled training environment does not compromise the safety of the procedure.