Finding the optimal candidate for shock wave lithotripsy: external validation and comparison of five prediction models.

We aimed to externally validate five previously published predictive models (Ng score, Triple D score, S3HoCKwave score, Kim nomogram, Niwa nomogram) for shock wave lithotripsy (SWL) single-session outcomes in patients with a solitary stone in the upper ureter. The validation cohort included patients treated with SWL from September 2011 to December 2019 at our institution. Patient-related variables were retrospectively collected from the hospital records. Stone-related data including all measurements were retrieved from computed tomography prior to SWL. We estimated discrimination using area under the curve (AUC), calibration, and clinical net benefit based on decision curve analysis (DCA). A total of 384 patients with proximal ureter stones treated with SWL were included in the analysis. Median age was 55.5 years, and 282 (73%) of the sample were men. Median stone length was 8.0 mm. All models significantly predicted the SWL outcomes after one session. S3HoCKwave score, Niwa, and Kim nomograms had the highest accuracy in predicting outcomes, with AUC 0.716, 0.714 and 0.701, respectively. These three models outperformed both the Ng (AUC: 0.670) and Triple D (AUC: 0.667) scoring systems, approaching statistical significance (P = 0.05). Of all the models, the Niwa nomogram showed the strongest calibration and highest net benefit in DCA. To conclude, the models showed small differences in predictive power. The Niwa nomogram, however, demonstrated acceptable discrimination, the most accurate calibration, and the highest net benefit whilst having relatively simple design. Therefore, it could be useful for counselling patients with a solitary stone in the upper ureter.

Factors influencing stone-free rate of Extracorporeal Shock Wave Lithotripsy (ESWL); a cohort study.

OBJECTIVE: To evaluate the success rate of Extracorporeal Shock Wave Lithotripsy (ESWL) therapy and identify relevant treatment-specific factors affecting stone-free rate (SFR) after ESWL. MATERIALS AND METHODS: All ESWL treatments in the years 2016-2019, in Ängelholm Hospital, Skåne, Sweden were analysed retrospectively. Primary outcome was stone-free rate (SFR) at 3 months. Univariate logistic regression was used followed by multivariable regression. Lasso analysis was made to adjust for treatment-specific factors such as age, stone size, skin-to-stone distance (SSD), stone attenuation, number of treatments, stone location and presence of a urinary stent. RESULTS: Factors affecting successful ESWL treatment were lower age (p < 0.001), smaller stone size and volume (both p = 0.001). SSD, stone attenuation, sex, laterality and drainage did not have an effect on SFR in this study. After the first ESWL treatment session, 46.7% of the patients were stone-free. CONCLUSION: Results indicate that stone size and age are the most predictive factors for ESWL outcome. Based on this, we present a simple model for prediction of SFR after ESWL, to be used when counseling patients before ESWL treatment.

Doppler ultrasound improves diagnostic accuracy for testicular torsion.

BACKGROUND: Doppler ultrasound can diagnose testicular torsion with high sensitivity and specificity but may delay surgical treatment. This study aims to assess whether the use of doppler ultrasound, in cases with intermediate clinical suspicion of testicular torsion, can improve diagnostic accuracy compared to clinical assessment alone. METHODS: We implemented a new clinical algorithm where patients with intermediate suspicion of testicular torsion undergo doppler ultrasound within 60 min. This study compared the patients that presented within one year prior to the implementation (group 1) to the patients who presented within one year after the implementation (group 2). The primary outcome measure was failure to confirm testicular torsion upon surgical exploration (negative surgical exploration). Missed testicular torsion was one of the secondary endpoints. RESULTS: 590 consecutive patients were included. 322 (55%) in group 1 and 268 (45%) in group 2. There were 9 (2.8%) testicular torsions in group 1 vs 9 (3.4%) in group 2 (p = 0.69) and 2 (0.6%) missed testicular torsions in group 1 vs 0 in group 2 (p = 0.50). Doppler ultrasound was performed in 65 patients (24.2%) in group 2 vs 0 in group 1 (p < 0.01). Negative surgical exploration was performed in 27 (8.4%) patients in group 1 vs 8 (3.0%) in group 2 (p < 0.01). CONCLUSION: Doppler ultrasound assessment of patients at intermediate clinical risk of testicular torsion significantly reduced the frequency of negative surgical explorations without increased rate of missed testicular torsions.

Rate and characteristics of infection after transrectal prostate biopsy: a retrospective observational study.

OBJECTIVES: The aim of this study was to assess the incidence of infection after transrectal prostate biopsy (TRbx). Secondary objectives were to describe infection characteristics, antibiotic resistance patterns, ICD-10 coding, and costs. METHODS: TRbx carried out at the hospitals of Ängelholm and Helsingborg, Scania, Sweden, between October 2017 and March 2019, were identified based on the NOMESCO Classification of Surgical Procedures code for TRbx, TKE00. All patients received per oral antibiotic prophylaxis, usually 750 mg ciprofloxacin at biopsy. Other preventative measures were not used. Medical care within 30 days of the biopsy was evaluated through a manual retrospective medical chart review. Data on patient and infection characteristics were collected. The costs of infections causing hospitalization were estimated. RESULTS: After 36 (5.4%) of 670 biopsies, the patient developed post-biopsy infection within 30 days after TRbx. Twenty-six patients (3.9%) required hospitalization for an average of 6 days, at an estimated direct cost of USD 9174 (EUR 8031) per patient. Nine patients (1.3%) had a complicated infection leading to intensive care, multiple hospitalizations or emergency department visits. The inpatient care episodes for the 26 hospitalized patients were categorized with 15 different ICD-codes. In 6 episodes no ICD-code related to infection was used. CONCLUSIONS: In this study, we found an infection rate of 5.4% after TRbx; 3.9% of the patients were hospitalized for a post-TRbx infection and 1.3% had complicated infections. A specific ICD code for post-TRbx infections would facilitate evaluation and monitoring of this common, costly, and sometimes serious complication.

Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsy - a novel needle design with the objective to reduce the risk of post-biopsy infection.

BACKGROUND: Transrectal prostate biopsy (TRbx) transfers colonic bacteria into prostatic tissue, potentially causing infectious complications, including sepsis. Our objective was to determine whether biopsy needle shape, surface properties and sampling mechanism affect the number of bacteria transferred through the colon wall, and evaluate a novel needle with improved properties. METHODS: The standard Tru-Cut biopsy needle used today was evaluated for mechanisms of bacterial transfer in a pilot study. A novel Tru-Cut needle (Forsvall needle prototype) was developed. TRbx was simulated using human colons ex-vivo. Four subtypes of the prototype needle were compared with a standard Tru-Cut needle (BARD 18 G). Prototype and standard needles were used to puncture 4 different colon specimens in 10 randomized sites per colon. Needles were submerged into culture media to capture translocated bacteria. The media was cultured on blood agar and then the total amount of transferred bacteria was calculated for each needle. The primary outcome measure was the percent reduction of bacteria translocated by the prototype needles relative to the standard needle. Secondary outcome measures were the effects of tip design and coating on the percent reduction of translocated bacteria. RESULTS: Prototype needles reduced the number of translocated bacteria by, on average, 96.0% (95% confidence interval 93.0-97.7%; p < 0.001) relative to the standard needle. This percent reduction was not significantly affected by prototype needle tip style or surface coating. CONCLUSIONS: The Forsvall needle significantly reduces colonic bacterial translocation, suggesting that it could reduce infectious complications in prostate biopsy. A clinical trial has been initiated.

Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial.

BACKGROUND: Transrectal prostate biopsy (TRbx) carries an increasing risk of infection. The Forsvall Needle Prototype (FNP) is a novel biopsy needle that reduces bacterial load brought across the rectum and may therefore reduce infection risk. The objective of this study was to compare biopsy length, quality and patient experience for the FNP Version 2 (FNP2) versus a standard Tru-Cut needle. METHODS: We conducted a randomized, parallel-group, non-inferiority trial with twenty consecutive patients eligible for TRbx. Participants were randomized to undergo TRbx using either FNP2 or a standard Tru-Cut needle. The primary outcome was difference in mean biopsy lengths measured by the pathologist. FNP2 biopsy lengths ≤1.35 mm of the standard needle length were considered non-inferior. Secondary outcomes were biopsy length in the needle chamber and immediately after removal, biopsy quality, biopsy fragmentation, patient discomfort/pain, and complications (immediate and after 14 and 30 days). RESULTS: Mean pathologist-measured FNP2 biopsy length was non-inferior compared to the standard Tru-Cut needle (0.02 mm longer, 95%CI-0.73 to 0.76 mm). Biopsy length in the needle chamber and immediately after removal were also non-inferior. Biopsy quality and patient discomfort were not significantly different for the FNP2 and the standard Tru-Cut needle. Biopsy fragmentation was more common in the FNP2 group. CONCLUSIONS: The FNP2 biopsy needle is non-inferior to the Tru-Cut needle in terms of biopsy length and not significantly different in terms of biopsy quality and patient experience. Future studies will evaluate the Forsvall needle design's effect on post-biopsy infection risk.

COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. TRIAL DESIGN: Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. PARTICIPANTS: Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. INTERVENTION AND COMPARATOR: Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. MAIN OUTCOMES: The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). RANDOMISATION: Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + "standard of care": "standard of care"). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) BLINDING (MASKING): This is an open-label trial. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. TRIAL STATUS: The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021. TRIAL REGISTRATION: Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601 , registered June 8, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Percutaneous nephrolithotomy and modern aspects of complications and antibiotic treatment.

Objective: The incidence of urinary stones is increasing across the globe. Surgical treatment includes extracorporal shock-wave lithotripsy (ESWL), ureterolithotripsy (URS), percutaneous nephrolitotomy (PCNL) and rarely open surgery. This single center study describes complications to PCNL focusing on infections, bacterial growth/resistance and antibiotic prophylaxis/treatment.Materials and methods: All patients treated for kidney stones with PCNL at Ängelholm Hospital in north-western Scania, Sweden from January 2009 to December 2015 were included. A dipstick test and a bacterial culture was made on all patients. Kidney stones were analysed for composition and cultured for bacteria.Results: In total, 186 patients underwent PCNL, all receiving perioperative antibiotics. Thirty percent (56/186) had a positive urinary culture taken before surgery and 33.3% (62/186) had positive stone culture. The concordance between urinary and stone culture was 57.1%. Both positive stone and urinary culture increased the risk of complications after surgery (p = 0.002 and p = 0.017, respectively). Complications occurred in 16% (30/186). Eight patients (4.3%) developed sepsis. The most common bacteria in urine were Enterococcus faecalis and Escherichia coli, both 20%. The most common stone-bacteria reported was Enterococcus faecalis (26%).Conclusion: This study has a total complication rate of 16%, approximately 10% of those are severe. The most common complication to PCNL was infection (60%), followed by bleeding (5.4%), reoperation (1.6%) and pain (0.5%). The high prevalence of E. faecalis might need to be considered, however the results should be validated in a larger cohort, possibly with a higher rate of antibiotic resistance, before a change of guidelines regarding prophylactic antibiotics could be proposed.

Ureteroscopy: a population based study of clinical complications and possible risk factors for stone surgery.

INTRODUCTION: The aim of this study was to describe the complications of ureteroscopy (URS) and to investigate whether performing URS outside normal working hours leads to increased risk for clinically significant complications. MATERIAL AND METHODS: A cohort of 486 consecutive patients treated with URS, with a total of 567 sessions between 2009 and 2015 at Helsingborg/Ängelholm Hospital, Sweden, was analyzed. Outcome was complications within 14 days after URS treatment. RESULTS: We found no increased risk of complications related to URS performed outside normal working hours. Stone-free rate (SFR) in the distal third of the ureter was 95.2% (315/331), in the middle ureter 92.8% (90/97), in the proximal ureter 84.0% (63/75) and 69.0% (40/58) in renal pelvis. The overall complication rate was 10.6% (n = 60). None of the potential risk factors for complications showed any significance when adjusted for age and gender. We found an inverse relationship between stenting and SFR (p = 0.002). The most common preoperatively cultured bacteria was Escherichia coli. With adequate antibiotics, there was no increased risk of complications. There was an increased risk of complications after URS related to age, but not with gender. CONCLUSIONS: URS in modern setting provides excellent results with adequate SFR and low morbidity. Time of day, the presence of urological specialized operating nurses did not affect the risk of complications and we found no other significant risk factors for complications. Escherichia coli was the most commonly found bacteria in preoperative cultures. The risk of complications increases with age. For patients >65 years old, this should be considered in preoperative counseling.

Perigenital necrotizing soft tissue infection caused by Aerococcus urinae.

Aerococcus urinae can cause severe invasive infections emanating from the urinary tract especially in older males with comorbidities. Here we describe a case of an 80 year-old man with multiple comorbidities presenting with a peri-penile abscess and signs of severe infection. Upon incision A. urinae was isolated in pure culture and the infection was cured by a combination of drainage and antimicrobials. This case demonstrates the potential of A. urinae to cause severe soft tissue infections in predisposed individuals.

Complications in extracorporeal shockwave lithotripsy: a cohort study.

OBJECTIVE: The aim of this study was to evaluate clinically relevant complications within 14 days after extracorporeal shockwave lithotripsy (ESWL) in a modern setting. MATERIALS AND METHODS: Consecutive ESWL treatments between 2009 and 2015 in Ängelholm Hospital, Sweden, were analyzed retrospectively. The primary outcome was complications in patients seeking medical attention within 14 days after ESWL. Multivariable analysis was used to adjust for confounders such as diabetes, stone size and location, and presence of a urinary stent. RESULTS: In total, 1838 stones were treated: 1185 (64.4%) localized in the renal pelvis, and 415 (22.5%) in the upper two-thirds and 205 (11.1%) in the lower third of the ureter. Overall, 116 out of 1838 cases (6.4%) needed medical attention within 14 days after ESWL and 75 (4%) crequired hospital care. Infection was found in 44 cases (2.4%), with a positive urine culture in 33 cases. Invasive/operative interventions were performed in 41 cases (2.2%). Distal stones had a lower risk of complications (p = 0.02) with ESWL. Diabetes (p = 0.02), larger stones (11-20 mm, p = 0.03; 21-30 mm, p = 0.009) and a need for antiemetics during treatment (p = 0.02) were significantly associated with an increased risk of complications. CONCLUSIONS: Few complications are associated with modern ESWL treatment. A frequency of 1 Hz should be used to reduce complications (p = 0.025). Diabetes and larger stone size increase the risk of complications. The need for antiemetics during ESWL requires special consideration and further study. Distal stones seem to carry a lower risk of complications (p = 0.017).