Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial.

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.

Quality and cost assessment of Canadian Urological Association microscopic hematuria guidelines in clinical practice: Turning urine into gold.

INTRODUCTION: Asymptomatic microscopic hematuria (AMH) is defined in the Canadian Urological Association (CUA) guideline as >2 red blood cells (RBCs) per high-powered field (HPF). Our objective was to evaluate guideline adherence for AMH at our center. Secondarily, we aimed to identify areas of the guideline that can be optimized. METHODS: We retrospectively reviewed 875 consecutive adults referred to two urologists for hematuria between June 2010 and June 2016. Patient characteristics, risk factors, and outcomes were added to an encrypted Research Electronic Data Capture (REDCap) database. Evaluation of microscopic hematuria reporting was performed by analyzing 681 urine samples reported as 1-5 RBC/HPF. Healthcare costs were obtained from Alberta Health Services (AHS), Data Integration and Management Repository (DIMR), and Alberta Society of Radiologists (ASR). RESULTS: Of the 875 patients referred with hematuria, 400 had AMH. Overall, 96.5% completed evaluation consistent with the CUA guideline. The incidence of pathology requiring surgical intervention was 21/400 (5%) with a 0.8% rate (3/400) of urothelial cell carcinoma (UCC) (non-invasive, low-grade). No malignancy was found in non-smokers with normal cytology, normal imaging and <50 RBC/HPF; 44% had AMH in the 1-5 RBCs/HPF range. Only 41% (279/681) of urine samples categorized as 1-5 RBCs/ HPF had guideline-defined microscopic hematuria. By changing local microscopic hematuria reporting to differentiate 1-2 and 3-5 RBCs/HPF, we estimate $745 000 in annual savings. CONCLUSIONS: At our center, CUA AMH guideline adherence is high. We did not find malignancy in non-smokers with normal cytology, imaging and <50 RBC/HPF. We identified and changed regional microscopic hematuria reporting to fit the CUA definition, eliminating unnecessary investigations and healthcare costs.

A population based assessment of complications following outpatient hydrocelectomy and spermatocelectomy.

PURPOSE: We determine the incidence of complications following outpatient scrotal surgery for the treatment of hydroceles and spermatoceles. MATERIALS AND METHODS: A retrospective study of all patients undergoing hydrocelectomy or spermatocelectomy between April 1, 1997 and March 31, 1999 at 1 institution was performed. The hospital and office charts were reviewed, and postoperative complications (infection, persistent swelling, chronic pain) were recorded. The type of preoperative antiseptic preparation (iodine based versus chlorhexidine) and the presence or absence of surgical drains were also recorded. RESULTS: A total of 161 patients were included in the study with an average age of 53.7 years. The overall complication rate was 19.2%. Infection/scrotal abscess formation occurred in 9.3% of patients, persistent swelling (treatment failure) in 9.3% and chronic pain in 0.6%. There was no significant difference in the complication rate when the preoperative preparations and the presence or absence of surgical drains were compared. CONCLUSIONS: The most common complications following scrotal surgery for hydroceles and spermatoceles are persistent scrotal swelling, inflammation and postoperative infection. Further prospective investigation is required to study factors such as the use of drains, preoperative and/or perioperative antibiotics and the type of surgical preparations, which may have a role in complication rates.