In shockwave lithotripsy (SWL), bones along the shockwave path can attenuate the energy delivered to the stone and interfere with fragmentation. We conducted a retrospective cohort study to determine whether bony interference identified during SWL is associated with reduced treatment success and increased need for further intervention. Patients receiving SWL as their primary treatment for a renal or ureteral calculus between January and December 2022 were reviewed. Bony interference was identified intra-operatively via fluoroscopy and pre-operatively via x-ray. The treatment outcomes studied were success rate (residual fragments < 2 mm), re-treatment rate, and complication rate. Multivariable logistic regression was used to quantify the association between bony interference and SWL treatment success. This study included 275 SWL patients, and intra-operative bony interference was observed in 41 (14.9%) cases. Intra-operative bony interference was associated with a significantly lower SWL success rate after a single treatment (22% with interference vs. 53% without interference) in univariable (OR = 0.25, p = 0.001) and multivariable (OR = 0.32, p = 0.01) logistic regressions. Intra-operative bony interference was also associated with a significantly higher re-treatment rate (OR = 2.50, p = 0.008). These findings highlight the clinical relevance of bony interference and suggest that patient positioning should be optimized to avoid bony structures. Prospective assessments are warranted to further develop and validate these positioning strategies.

INTRODUCTION:The Revised Cardiac Risk Index (RCRI) and the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) are well-recognized tools to predict 30-day postoperative cardiac events in noncardiac surgeries. However, their predictive accuracy is yet to be assessed in minimally invasive transurethral prostate surgery. We compared the RCRI- and NSQIP-predicted postoperative cardiac outcomes with the actual incidence of cardiac events after transurethral prostate surgery. METHODS:We conducted a retrospective review of patients who underwent transurethral prostate surgery between July and December of 2022. We assessed for postoperative cardiac events within 30 days, as defined by the seminal cardiac VISION study. The RCRI and NSQIP cardiac event predictions were calculated. Fisher's exact test was used for analysis. RESULTS:We included 185 patients with an average age of 73 ± 8.4 (standard deviation) years, 86 of whom (46%) had transurethral resection of the prostate, and 99 underwent Holmium Laser Enucleation of the Prostate (54%). Myocardial injury after noncardiac surgery surveillance was needed for 34 patients (18.4%) as per standard practice. No patient had any intraoperative cardiac events. One patient experienced a nonfatal postoperative cardiac event (asystole) within hours of surgery. The 30-day cardiac event prediction by the RCRI was 4.8% of the patient cohort (n ≈ 9), significantly higher than the observed incidence of 0.5% (p = 0.0198). NSQIP predicted that 0.54% of the patient cohort (n = 1) will have a cardiac complication within 30 days, which is not significantly different from the observed cardiac event incidence (p = 1). CONCLUSION:The RCRI significantly overestimated the 30-day cardiac risk after transurethral prostate surgery, whereas NSQIP predictions and the observed rate of cardiac events were similar. Utilizing more representative predictive tools helps improve risk stratification and will allow patients and surgeons to make better-informed decisions.

Urolithiasis, a condition affecting approximately 10

A tri-layer ureteral stent with novel coating lining the inner and outer surfaces (Tria™) was designed to reduce encrustation. We assessed technical success, complications, and patient symptoms in an international prospective stent registry conducted from 2020 to 2023. Outcomes included technical success, infections, and encrustation rates. Patient-reported PROMIS Pain Intensity (3a) and Pain Interference (6b) scores were obtained at time of index procedure, stent removal, and post-stent removal. Tria stents were compared to non-Tria stents grouped together. Of 359 total patients, 271 had a unilateral stent placed for stone management procedures. Tria vs. non-Tria groups were comparable in age (55.9y vs. 58.7y), gender (57.8

PURPOSE:This study reports on a prospective, multicenter, single-arm, clinical trial utilizing the SonoMotion (San Mateo, California) Break Wave lithotripsy (BWL) device to fragment urinary stones. MATERIALS AND METHODS:Patients with a urinary stone underwent a single treatment of 30 minutes and peak negative pressure of 4.5 to 8 MPa. Subjects were contacted and outcomes assessed at 7, 14, and 35 days after treatment, with clinical follow-up and CT imaging 70 ± 14 days postprocedure. The primary objectives were to assess the safety (hematomas, complications, etc) and effectiveness of BWL (any fragmentation, residual fragments ≤4 mm or ≤2 mm, and completely stone-free rate) as assessed via noncontrast CT-kidneys, ureters, and bladder. RESULTS:Forty-four patients with a ureteral (43%) or renal (57%) stone were treated across 5 centers. Stone fragmentation occurred in 88% of cases; 70% had fragments ≤ 4 and 51% ≤ 2 mm, while 49% were completely stone free on CT; no serious adverse events were reported. Eighty-six percent of patients received either no analgesic medication at all (50%) or minor analgesia (36%). After determining optimal therapy settings, 36 patients were treated and the effectiveness improved exhibiting fragmentation in 92% (33/36), residual fragments ≤ 4 mm in 75% and 58% with fragments ≤ 2 mm with 58% completely stone free. Effectiveness was less in subjects with lower pole stones with 81% fragmentation, 71% having fragments ≤ 4 mm, 29% with fragments ≤ 2 mm, and 29% completely stone free; of distal ureteral stone patients, 89% were completely stone free. CONCLUSIONS:BWL offered safe and effective noninvasive stone therapy requiring little to no anesthesia and was carried out successfully in nonoperative environments. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT03811171.

Background: Residual fragments (RFs) after percutaneous nephrolithotomy (PCNL) have a significant impact on patients' quality of life and clinical course. There is a paucity of studies that evaluate the natural history of RFs after PCNL. The objective of this study is to compare rates of reintervention, complications, stone growth, and passage in patients with RFs >4, & LE;4, and & LE;2 mm after PCNL.Methods: Sites from the Endourologic Disease Group for Excellence (EDGE) research consortium examined data of PCNL patients from 2015 to 2019 with at least 1-year follow-up. RF passage, regrowth, reintervention, and complications were recorded and RFs were stratified into >4 and & LE;4 mm groups, as well as >2 and & LE;2 mm groups. Potential predictors for stone-related events after PCNL were determined using multivariable logistic regression analysis. It was hypothesized that larger RF thresholds would result in lower passage rates, faster regrowth, and greater clinically significant events (complications and reinterventions) than smaller RF thresholds.Results: A total of 439 patients with RFs >1 mm on CT postoperative day 1 were included in this study. For RFs >4 mm, rates of reintervention were found to be significantly higher and Kaplan-Meier curve analysis showed significantly higher rates of stone-related events. Passage and RF regrowth were not found to be significantly different compared with RFs & LE;4 mm. However, RFs & LE;2 mm had significantly higher rates of passage, and significantly lower rates of fragment regrowth (>1 mm), complications, and reintervention compared with RFs >2 mm. On multivariable analysis, older age, body mass index, and RF size were found to be predictive of stone-related events.Conclusions: With the largest cohort to date, this study by the EDGE research consortium further confirms that clinically insignificant residual fragment is problematic for patients after PCNL, particularly in older more obese patients with larger RFs. Our study underscores the importance of complete stone clearance post-PCNL and challenges the use of Clinically insignificant residual fragment (CIFR).

INTRODUCTION:Patients with chronic scrotal content pain (CSCP) lack effective, non-invasive treatment options. We aimed to determine the local and systemic safety, tolerability, pharmacokinetics (PK), and efficacy of a long-lasting local anesthetic in patients with CSCP.METHODS:This was a prospective, single-center, open-label, single-arm, phase 1, dose-escalating trial completed between October 2019 and March 2021. Twelve patients ≥19 years old with unilateral scrotal pain lasting ≥3 months reporting an average maximum pain score over seven days of ≥4 on a 0-10 numerical rating scale (NRS) were included. Patients underwent a test spermatic cord block and those reporting a decrease of ≥2 points were included. The investigational drug, ST-01 (sustained-release lidocaine polymer solution), is a long-acting injection of lidocaine around the spermatic cord. Subjects were provided a NRS dairy and recorded their NRS score until day 28. The Chronic Epididymitis Symptom Index (CESI) was completed on days 0, 7, 14, and 28. All patients underwent an examination and assessment for adverse events (AE) on days 0, 1, 7, 14, and 28. Exploratory statistical hypothesis testing was planned for this study due to its investigative nature.RESULTS:There were no serious adverse events (SAEs) reported. All subjects reported at least one treatment-emergent adverse event (TEAE); 83% of related AEs were injection-site reactions consisting of swelling and bruising. NRS was reduced across all cohorts between baseline and end of study.CONCLUSIONS:This study provides evidence that the novel ST-01 treatment is safe and well-tolerated.

Purpose: We report 5-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia and large-volume prostate glands. Materials and Methods: A total of 101 men with moderate to severe benign prostatic hyperplasia symptoms and prostate volumes between 80 and 150 mL underwent a robotic-assisted Aquablation procedure in a prospective multicenter international trial (NCT03123250). Herein we report the final 5-year results. Results: The study successfully met its safety and efficacy performance goal, which was based upon transurethral resection of the prostate outcomes typically done in smaller prostates, at 3 months. Mean prostate volume was 107 mL (range 80-150) at baseline. Patient symptoms showed a significant improvement where the mean (SD) International Prostate Symptom Score of 22.6 (6.4) at baseline to 6.8 (4.6) at 5 years, resulting in a change score of 15.9 (7.7, P < .001). Uroflowmetry measurements also demonstrated improvement where the mean maximum urinary flow rate increased from 8.6 (SD 3.4) to 17.1 (9.8) mL/s at 5 years, resulting in a change score of 9.2 (11.1) mL/s at 5 years (P < .001). A regression analysis evaluating change in PSA as a function of baseline PSA across all time points out to 5 years resulted in a 50% reduction. A prespecified subgroup analysis using a baseline prostate volume cutoff of 100 mL showed no difference in efficacy outcomes through 5 years. Freedom from a secondary benign prostatic hyperplasia procedure at 5 years was 96.3% based on Kaplan-Meier. Conclusions: At 5-years of prospective follow-up, the Aquablation procedure was shown to be safe with durable efficacy and low rates of retreatment in men with large prostates (80-150 mL).

Benign prostatic hyperplasia affects up to 80% of men in their lifetime. It causes bladder outflow obstruction, leading to lower urinary tract symptoms, which can have a large impact on quality of life. Lifestyle modifications and pharmacotherapy are often offered as first-line treatments for patients. These include alpha blockers, 5-alpha-reductase inhibitors, phosphodiesterase-5 inhibitors, anticholinergics, B3-agonists, and desmopressin. While often well tolerated, these pharmacotherapies do have significant side effects, which both clinicians and patients should understand and discuss in order to make an informed treatment decision among alternatives. The purpose of this review is to provide a current overview of the risks and side effects of commonly used medications in benign prostatic hyperplasia management.

PURPOSE:Treatment of struvite kidney stones requires complete surgical stone removal combined with antibiotic therapy to eliminate urinary tract infections and preventive measures to reduce stone recurrence. The optimal duration of antibiotic therapy is unknown. We sought to determine if 2- or 12-weeks of antibiotics post percutaneous nephrolithotomy (PNL) for infection stones resulted in better outcomes for stone recurrence and positive urine cultures.MATERIAL AND METHODS:This multi-center, prospective randomized trial evaluated patients with the clinical diagnosis of infection stones. Patients were randomized to 2- or 12-weeks of postoperative oral antibiotics (nitrofurantoin or culture-specific antibiotic) and included if residual fragments were ≤4 mm on computed tomography imaging after PNL. Imaging and urine analyses were performed at 3-, 6-, and 12-months post-procedure.RESULTS:Thirty-eight patients were enrolled and randomized to either 2-weeks (n = 20) or 12-weeks (n = 18) of antibiotic therapy post-PNL. Eleven patients were excluded due to residual fragments >4 mm, and 3 patients were lost to follow-up. The primary outcome was the stone-free rate (SFR) at 6 months post-PNL. At 3-, 6-, and 12-months follow-up, SFRs were 72.7% versus 80.0%, 70.0% versus 57.1%, 80.0% versus 57.1% (p = ns), between 2- and 12-week-groups, respectively. At 3-, 6-, and 12-months follow-up, positive urine cultures were 50.0% versus 37.5%, 50.0% versus 83.3%, and 37.5% versus 100% between 2- and 12-week groups, respectively (p = ns).CONCLUSIONS:For patients with stone removal following PNL, neither 2-weeks nor 12-weeks of postoperative oral antibiotics is superior to prevent stones and recurrent positive urine cultures.

of tongue (1), ulcers and diarrhoea (1), nephrotic syndrome (1). 12 of the 63 patients had tried both medications with 8/12 trying penicillamine and when they had side effects switched to tiopronin. Of these 8 patients who were unable to take penicillamine, 4 (50%) who were given tiopronin 2 line tolerated it. Likewise 4 of the 12 patients had tried tiopronin first and when unable to tolerate it had been switched to penicillamine 2 line. 2 of the 4 (50%) were able to tolerate penicillamine. So 6 of the 12 patients (50%) who could not tolerate the first chelating agent they were given went on to successfully tolerate the second line regardless of which order the drugs were given, 50% could not tolerate either drug. CONCLUSIONS: Chelating agents used for cystinuria have a range of troublesome side effects that leads to frequent discontinuation of the medication. However in our series, unlike previous reports, the incidence of these side effects is not markedly different with penicillamine when compared with tiopronin. Our results also demonstrate a benefit in trying the alternative medication if the other is not tolerated regardless of the order in which they are taken.

A retrospective review was conducted to evaluate intraoperative and patient outcomes following simultaneous bilateral percutaneous nephrolithotomy (SB-PCNL). Target stone characteristics, operative time, hospitalization length, post-operative complications, blood loss, opioid use, pain, and stone-free rates were evaluated. In total, 42 patients with large renal stones (>20 mm2) were identified for this study, and 38% of them achieved stone-free status with no residual fragments apparent on post-operative day one CT imaging. The maximum mean residual fragment size was 3.67 mm2 and average number of residual fragments following the procedures was 1.63. The rates of blood loss, post-operative complications, opioid use, and pain from the study cohort were similar to the reported outcomes of studies conducted by others. The potential benefits of a single procedure and anesthesia to treat bilateral stone burdens, lower total pain medication prescribed, and lower hospital costs render SB-PCNL as an attractive option in the treatment of bilateral kidney stones.

You have accessJournal of UrologyCME1 May 2022MP37-14 A DOSE-ESCALATING PHASE I STUDY OF AN INJECTION OF LIDOCAINE PASTE FOR PROLONGED SPERMATIC CORD BLOCK IN MEN WITH CHRONIC SCROTAL CONTENT PAIN Luke Witherspoon, Claudia Kesch, Veronika Schmitt, Graeme Boniface, Colin Lundeen, J. Curtis Nickel, Ryan Paterson, Martin Gleave, and Ryan Flannigan Luke WitherspoonLuke Witherspoon More articles by this author , Claudia KeschClaudia Kesch More articles by this author , Veronika SchmittVeronika Schmitt More articles by this author , Graeme BonifaceGraeme Boniface More articles by this author , Colin LundeenColin Lundeen More articles by this author , J. Curtis NickelJ. Curtis Nickel More articles by this author , Ryan PatersonRyan Paterson More articles by this author , Martin GleaveMartin Gleave More articles by this author , and Ryan FlanniganRyan Flannigan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002591.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Spermatic cord block with local anesthetics provides pain relief in a subset of subjects with chronic scrotal content pain (CSCP), but relief is short-lived due to the rapid elimination of local anesthetics. This Phase I trial assessed the safety, tolerability, pharmacokinetics and efficacy of a long-acting formulation of lidocaine in patients with CSCP. METHODS: This was a prospective, single center, open label, single arm, Phase I dose-escalating trial. Male patients ≥19 years with unilateral scrotal pain lasting ≥3 months who reported an average daily maximum pain score over 7 days of ≥4 on a 0-10 numerical rating scale (NRS) were recruited. The investigational drug ST-01 (sustained-release lidocaine polymer solution for injection) is a long-acting lidocaine injected into the spermatic cord. ST-01 has two inactive ingredients, polyethylene glycol (PEG) and poly(lactic-co-glycolic acid) (PLGA) which slow the release of lidocaine. The study had 3 planned dose-escalating cohorts: cohort I: 2 mL of 140 mg/mL ST-01 (280 mg lidocaine); cohort II: 3 mL of 140 mg/mL ST-01 (420 mg lidocaine); cohort III: 4 mL of 140 mg/mL ST-01 (560 mg lidocaine). Subjects recorded their pain (NRS) three times a day on days 0–14, and once on days 15-27 of the study. The Chronic Epididymitis Symptom Index (CESI) was completed by patients on days 0, 7, 14, and 28 (end of study). RESULTS: Twenty subjects were screened, with 12 subjects being enrolled. NRS (mean, median) was reduced across all cohorts studied. Patients in cohort II (420 mg lidocaine) were identified via the dose escalation protocol. This group reported a baseline mean (median) NRS score of 5.3 (5), compared to an end of study score of 3.3 (3.5). Assessment of CESI score showed reduced scores over the study period with cohort II reporting a baseline mean (median) score of 19.8 (19) and an end of study value of 16.8 (17.5). Serum lidocaine concentrations were measured at 1 hour, 1 day and 7 days. Serum concentrations were similar across all cohorts at day 1 indicating only local release of the medication. There were no serious adverse events (SAE’s) reported in the study. All subjects reported at least one treatment-emergent adverse event (TEAE). Most TEAE’s were mild or moderate and related to bruising or swelling at the injection site. CONCLUSIONS: ST-01 was safely injected in 12 subjects suffering from CSCP with a promising efficacy signal. Source of Funding: This study was conducted with aid from the Vancouver Coastal Health Research Institute Translation and Innovation Award © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e614 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Luke Witherspoon More articles by this author Claudia Kesch More articles by this author Veronika Schmitt More articles by this author Graeme Boniface More articles by this author Colin Lundeen More articles by this author J. Curtis Nickel More articles by this author Ryan Paterson More articles by this author Martin Gleave More articles by this author Ryan Flannigan More articles by this author Expand All Advertisement PDF DownloadLoading ...

You have accessJournal of UrologyStone Disease: Surgical Therapy V (MP65)1 Sep 2021MP65-19 REUSABLE DIGITAL FLEXIBLE URETEROSCOPE VS. A SINGLE-USE FLEXIBLE URETEROSCOPE IN THE TREATMENT OF UROLITHIASIS: AN EDGE CONSORTIUM PROSPECTIVE RANDOMIZED CLINICAL TRIAL Bodo E. Knudsen, , Tasha Posid, Alicia Scimeca, Michael Sourial, K.F. Victor Wong, Ryan F. Paterson, Karen L. Stern, Jonathan P. Moore, Mitchell R. Humphreys, and Ben H. Chew Bodo E. KnudsenBodo E. Knudsen More articles by this author , More articles by this author , Tasha PosidTasha Posid More articles by this author , Alicia ScimecaAlicia Scimeca More articles by this author , Michael SourialMichael Sourial More articles by this author , K.F. Victor WongK.F. Victor Wong More articles by this author , Ryan F. PatersonRyan F. Paterson More articles by this author , Karen L. SternKaren L. Stern More articles by this author , Jonathan P. MooreJonathan P. Moore More articles by this author , Mitchell R. HumphreysMitchell R. Humphreys More articles by this author , and Ben H. ChewBen H. Chew More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002105.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Flexible ureteroscopes are routinely used to treat kidney stones. Both single-use and reusable models are available. The high cost of purchase and repair of reusable ureteroscopes has led to the development of single-use options. This trial compared a single-use digital flexible ureteroscope (LithoVue, Boston Scientific) to a state-of-the art reusable digital flexible ureteroscope (Flex-Xc, Storz) in a multicenter, prospective randomized trial from the EDGE Group. METHODS: Patients were randomized across 3 sites to either the single use flexible ureteroscope (n=53) or a reusable flexible ureteroscope (n=49) (brand new at each site and used only for study cases). Ureteroscopies were performed using a standardized technique in patients with renal stone burdens ranging from 5-20 mm. The reusable ureteroscope was used until it was damaged to the point that a major repair was required. Primary outcomes were stone-free rate 6-10 weeks post-procedure and secondary outcomes included length of surgery, laser time, basketing time, deflection of scope at the beginning and end of the case, and a rating scale of scope handling. RESULTS: The mean age was 57.9 years (±13.2), 53.3% male, 73% Caucasian, and 77.6% non-Hispanic or Latino. Upward and downward deflection was significantly better both at the beginning (p<0.007) and end of the case (p<0.001, Table 1) with LithoVue. Performance was comparable between scopes for all other intraoperative measures (Table 1). However, scope handling as rated by each surgeon favored the reusable ureteroscope for maneuverability (p=0.004), visualization (p<0.001), ability to target the laser on stone (p<0.001), and overall scope rating (p<0.001). There was no difference in stone free rate at 4-10 days or 6-10 weeks). The 3 reusable ureteroscopes failed and required a total of 5 repairs during the trial (2 each at OSU and Mayo, 1 at UBC) and averaged 6.6 uses before repair. CONCLUSIONS: The LithoVue single-use ureteroscope had better deflection angles pre- and post-operatively when compared to the reusable digital Flex-Xc. Surgeons preferred the reusable flexible ureteroscope handling and visualization, although both scopes produced similar stone free rates. The high rate of breakage of reusable ureteroscopes is concerning and the single-use ureteroscope produced equivalent patient outcomes. Source of Funding: Boston Scientific © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1127-e1127 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Bodo E. Knudsen More articles by this author More articles by this author Tasha Posid More articles by this author Alicia Scimeca More articles by this author Michael Sourial More articles by this author K.F. Victor Wong More articles by this author Ryan F. Paterson More articles by this author Karen L. Stern More articles by this author Jonathan P. Moore More articles by this author Mitchell R. Humphreys More articles by this author Ben H. Chew More articles by this author Expand All Advertisement Loading ...