Definition of clinically insignificant residual fragments after percutaneous nephrolithotomy among urologists: a world-wide survey by EAU-YAU Endourology and Urolithiasis Working Group.

Introduction: The aim of this article was to evaluate the current perception of urologists as to what size is considered as a clinically insignificant residual fragment (CIRF). Material and methods: A survey was globally distributed to the members of the Endourological Society via SurveyMonkey. Results: A total of 385 participants responded to the survey on CIRF. Most participants considered 2 mm (29%) as CIRF threshold, followed by 3 mm (24%), 4 mm (22%), 0 mm (14%), 5 mm (8%) and 1 mm (3%). North American urologists considered CIRF to be smaller than urologists from Asia, Eurasia and South America, (p-values ≤0.001, 0.037 and 0.015 respectively). European urologists identified smaller CIRF in comparison to Asian urologists (p-value = 0.001). Urologists mainly using a pneumatic lithotripter accepted larger fragments as CIRF, compared to urologists mainly using ultrasonic devices or a combination of ultrasonic and pneumatic devices (p-value = 0.026 and 0.005 respectively). Similarly, urologists mainly performing X-Ray and ultrasound as post-operative imaging accepted larger fragments as CIRF in comparison to urologists mainly performing non-contrast computed tomography (p-value = 0.001). Conclusions: What is considered as CIRF varies between urologist from different continents and seems to be associated with the lithotripter used and the post-operative imaging modality of preference to assess treatment success.

The SIMULATE ureteroscopy training curriculum: educational value and transfer of skills.

OBJECTIVE: Different simulation modalities may be utilised in a curricular fashion to benefit from the strengths of each training model. The aim of this study is to evaluate a novel multi-modality ureterorenoscopy (URS) simulation curriculum in terms of educational value, content validity, transfer of skills and inter-rater reliability. METHODS: This international prospective study recruited urology residents (n = 46) with ≤ 10 URS experience and no prior simulation training. Participants were guided through each phase of the expert-developed SIMULATE URS curriculum by trainers and followed-up in the operating room (OR). Video recordings were obtained during training. A post-training evaluation survey was distributed to evaluate content validity and educational value, using descriptive statistics. Performance was evaluated using the objective structured assessment of technical skills (OSATS) scale to measure improvement in scores throughout the curriculum. Pearson's correlation coefficient and Cohen's kappa tests were utilised to investigate correlation and agreement between raters. RESULTS: Participants reported gaining OR-transferrable skills (Mean: 4.33 ± 0.67) and demonstrated marked improvement in throughout the curriculum, transferred to the OR for both semi-rigid URS (p = 0.004) and flexible URS (p = 0.007). 70% of participants were successfully followed-up in the OR (n = 32). No differences were identified with the additional use of fresh frozen cadavers (p = 0.85, p = 0.90) and the URO Mentor VR simulator (p = 0.13, p = 0.22). A moderate level of correlation was noted on the video OSATS assessments, between two expert assessors (r = 0.70), but a poor agreement with the live rating. CONCLUSION: The SIMULATE URS training curriculum received high educational value from participants, who demonstrated statistically significant improvement with consecutive cases throughout the curriculum and transferability of skills to the OR in both semi-rigid and flexible URS.

Exploratory analysis on the usage of Pi-score algorithm over endoscopic stone treatment step 1 protocol.

BACKGROUND: The Performance Improvement score (Pi-score) has been proven to be reliable to measure performance improvement during E-BLUS hands-on training sessions. Our study is aimed to adapt and test the score to EST s1 (Endoscopic Stone Treatment step 1) protocol, in consideration of its worldwide adoption for practical training. METHODS: The Pi-score algorithm considers time measurement and number of errors from two different repetitions (first and fifth) of the same training task and compares them to the relative task goals, to produce an objective score. Data were obtained from the first edition of 'ART in Flexible Course', during four courses in Barcelona and Milan. Collected data were independently analyzed by the experts for Pi assessment. Their scores were compared for inter-rater reliability. The average scores from all tutors were then compared to the PI-score provided by our algorithm for each participant, in order to verify their statistical correlation. Kappa statistics were used for comparison analysis. RESULTS: Sixteen hands-on training expert tutors and 47 3rd-year residents in Urology were involved. Concordance found between the 16 proctors' scores was the following: Task 1=0.30 ("fair"); Task 2=0.18 ("slight"); Task 3=0.10 ("slight"); Task 4=0.20, ("slight"). Concordance between Pi-score results and proctor average scores per-participant was the following: Task 1=0.74 ("substantial"); Task 2=0.71 ("substantial"); Task 3=0.46 ("moderate"); Task 4=0.49 ("moderate"). CONCLUSIONS: Our exploratory study demonstrates that Pi-score can be effectively adapted to EST s1. Our algorithm successfully provided an objective score that equals the average performance improvement scores assigned by of a cohort of experts, in relation to a small amount of training attempts.

Percutaneous microwave ablation therapy of renal cancer local relapse after radical nephrectomy: a feasibility and efficacy study.

Renal cell carcinoma (RCC) local recurrence after radical nephrectomy is uncommon. When feasible, surgical removal remains the primary treatment strategy; nevertheless, local RCC relapse management is controversial, and less invasive procedures may represent an attractive option to achieve oncologic control. The aim of our study was to assess the feasibility, safety, and clinical outcomes of image-guided percutaneous microwave ablation (MWA) for RCC local recurrence in patients initially treated with nephrectomy with curative intent. 10 consecutive patients underwent CT-guided percutaneous MWA of a total of 10 retroperitoneal nodules. Inclusion criteria were: histologically verified retroperitoneal metastases, previous radical nephrectomy, lesion no larger than 3 cm, no other metastatic site elsewhere. All the procedures were performed under moderate sedation choosing the most favorable patient decubitus. If deemed necessary, pneumodissection was induced before ablation. After the antenna placement inside the target lesion, thermal ablation was achieved by maintenance of a power of 100 W for a total time between 2 and 4 min. All patients were observed overnight and discharged the following day if clinically stable. Technical success was obtained in 100% of patients. One patient was re-treated to complete oncologic response with repeat MWA. No major complications were observed. No patients demonstrated local recurrence at a mean follow-up of 26 months. MWA is a safe and effective treatment strategy for loco-regional relapse of RCC following radical nephrectomy. This technique may represent a valuable approach for patients who are not eligible for surgery.

Effectiveness of the HoloLens mixed-reality headset in minimally invasive surgery: a simulation-based feasibility study.

BACKGROUND: The advent of Virtual Reality technologies presents new opportunities for enhancing current surgical practice. Studies suggest that current techniques in endoscopic surgery are prone to disturbance of a surgeon's visual-motor axis, influencing performance, ergonomics and iatrogenic injury rates. The Microsoft® HoloLens is a novel head-mounted display that has not been explored within surgical innovation research. This study aims to evaluate the HoloLens as a potential alternative to conventional monitors in endoscopic surgery. MATERIALS AND METHODS: This prospective, observational and comparative study recruited 72 participants consisting of novices (n = 28), intermediate-level (n = 24) and experts (n = 20). Participants performed ureteroscopy, within an inflatable operating environment, using a validated training model and the HoloLens mixed-reality device as a monitor. Novices also completed the assigned task using conventional monitors; whilst the experienced groups did not, due to their extensive familiarity. Outcome measures were procedural completion time and performance evaluation (OSATS) score. A final evaluation survey was distributed amongst all participants. RESULTS: The HoloLens facilitated improved outcomes for procedural times (absolute difference, - 73 s; 95% CI - 115 to - 30; P = 0.0011) and OSAT scores (absolute difference, 4.1 points; 95% CI 2.9-5.3; P < 0.0001) compared to conventional monitors. Feedback evaluation demonstrated 97% of participants agreed or strongly agreed that the HoloLens will have a role in surgical education (mean rating, 4.6 of 5; 95% CI 4.5-4.8). Furthermore, 95% of participants agreed or strongly agreed that the HoloLens is feasible to introduce clinically and will have a role within surgery (mean rating, 4.4 of 5; 95% CI 4.2-4.5). CONCLUSION: This study demonstrates that the device facilitated improved outcomes of performance in novices and was widely accepted as a surgical visual aid by all groups. The HoloLens represents a feasible alternative to the conventional setup, possibly by aligning the surgeon's visual-motor axis.

Evaluation of the Endo-Uro trainer for semi-rigid ureteroscopy training.

BACKGROUND: The aim of this study was to evaluate the validity of evidence of the Endo-Uro Trainer (SAMED, Dresden, Germany) for semi-rigid ureteroscopy. METHODS: Novice (n = 29), intermediate-level (n = 25), and expert (n = 24) urological surgeons were recruited to participate in the study. Novices were allocated randomly to Groups A and B, where A performed two set procedures using the already validated Uro-Scopic Trainer (Limbs and Things, Bristol, UK), and Group B used the Endo-Uro trainer. Subsequently they were crossed over to perform the same two procedures using the other model. Intermediate and expert groups performed the same procedure on the Endo-Uro trainer only. Objective Structured Assessment of Technical Skills (OSATS) and the procedural times were collected and analyzed. All participants were invited to complete a final evaluation survey. RESULTS: The evaluation survey revealed a realism rating in all aspects, with a mean Likert rating of 4.04/5. Significant differences were observed in performance time between novices and experts (p = 0.0014), and between intermediates and experts (p = 0.0113). OSATS scores differed significantly between all groups (p < 0.0001). Group B novices showed statistically significant improvement in performance time (p = 0.0012) and OSATS scores (p = 0.0439) after the crossover. Significant differences in performance time (p = 0.0025) between groups A and B were also observed post-crossover. CONCLUSIONS: This study demonstrated content validity for the Endo-Uro Trainer model. In addition, the model was shown to be capable of differentiating levels of experience, which contributes to the acceptance of the validity hypothesis. Improvement in performance using the model demonstrates its effectiveness for training.

The Antibiofilm Effect of a Medical Device Containing TIAB on Microorganisms Associated with Surgical Site Infection.

Surgical site infections (SSIs) represent the most common nosocomial infections, and surgical sutures are optimal surfaces for bacterial adhesion and biofilm formation. Staphylococcus spp., Enterococcus spp., and Escherichia coli are the most commonly isolated microorganisms. The aim of this research was to evaluate the antibiofilm activity of a medical device (MD) containing TIAB, which is a silver-nanotech patented product. The antibacterial effect was evaluated against Staphylococcus aureus ATCC 29213, Enterococcus faecalis ATCC 29212, and E. coli ATCC 25922 by assessing the minimum inhibitory concentration (MIC) by the Alamar Blue® (AB) assay. The antibiofilm effect was determined by evaluation of the minimum biofilm inhibitory concentration (MBIC) and colony-forming unit (CFU) count. Subsequently, the MD was applied on sutures exposed to the bacterial species. The antimicrobial and antibiofilm effects were evaluated by the agar diffusion test method, confocal laser scanning microscopy (CLSM), and scanning electron microscopy (SEM). The MIC was determined for S. aureus and E. faecalis at 2 mg/mL, while the MBIC was 1.5 mg/mL for S. aureus and 1 mg/mL for E. faecalis. The formation of an inhibition zone around three different treated sutures confirmed the antimicrobial activity, while the SEM and CLSM analysis performed on the MD-treated sutures underlined the presence of a few adhesive cells, which were for the most part dead. The MD showed antimicrobial and antibiofilm activities versus S. aureus and E. faecalis, but a lower efficacy against E. coli. Surgical sutures coated with the MD have the potential to reduce SSIs as well as the risk of biofilm formation post-surgery.

Flower Pollen Extract in Association with Vitamins (Deprox 500®) Versus Serenoa repens in Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Comparative Analysis of Two Different Treatments.

OBJECTIVE: Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is reported in the literature ranging from 1 to 14.2%. The aim of the present study was to assess the impact on patient's quality of life and symptoms of Flower pollen extract in association with vitamins (Deprox 500®) in comparison with Serenoa repens 320 mg (Permixon 320 mg® by Pierre Fabre) in patients with CP/CPPS. METHODOLOGY: All consecutive patients, with a diagnosis of CP/CPPS, referred to our center from January to August 2016, were screened to be enrolled in this single-center, randomized, controlled trial. The main outcome measure was the evaluation of IPSS/NIHCPSI (International Prostatic Symptom Score/NIH-Chronic Prostatitis Symptom Index) score variation and the assessment of the quality of life and symptoms at the end of the therapy. The second outcome measure was the evaluation of the comorbidity role in the CP/CPPS therapy. 63 patients were analyzed; patients were randomized into two groups: 29 patients were treated with Deprox 500® 2 tablets/day for 6 weeks and 34 patients with Serenoa repens 320 mg, 1 tablet/day for 6 weeks. RESULTS: The mean score variation for IPSS was -12.7 ± 4.3 in the Deprox 500® group and -7.8 ± 4.7 in the Serenoa repens group (p=0.0005) while for NIH-CPSI was -17.3±3.1 in the Deprox 500® group and -13.6±4.8 in the Serenoa repens group (p=0.0016). By accounting only the symptoms part of NIH-CPSI questionnaire, the mean score variation reported was -11.5±2.5 in the Deprox 500® group and -9.02±4.0 in the Serenoa repens group (p=0.009321). Furthermore, analyzing the comorbidity subgroups, in patients with hypertension, the mean IPSS score variation was -14.3±3.2 in the Deprox 500® group and - 9.02±4.0 in the Serenoa repens group. CONCLUSION: In conclusion, in patients with CP/CPPS, Deprox 500® improves IPSS and NIH-CPSI scores up to 74.5% and 84.5% respectively. Furthermore, in patients with hypertension, the antioxidant effect of Deprox 500® reduces the mean IPSS score of 82.7%.

Graminex Pollen: Phenolic Pattern, Colorimetric Analysis and Protective Effects in Immortalized Prostate Cells (PC3) and Rat Prostate Challenged with LPS.

Prostatitis, a general term describing prostate inflammation, is a common disease that could be sustained by bacterial or non-bacterial infectious agents. The efficacy of herbal extracts with antioxidant and anti-inflammatory effects for blunting the burden of inflammation and oxidative stress, with possible improvements in clinical symptoms, is under investigation. Pollen extracts have been previously reported as promising agents in managing clinical symptoms related to prostatitis. The aim of the present work was to evaluate the protective effects of Graminex pollen (GraminexTM, Deshler, OH, USA), a commercially available product based on standardized pollen extracts, in rat prostate specimens, ex vivo. In this context, we studied the putative mechanism of action of pollen on multiple inflammatory pathways, including the reduction of prostaglandin E2 (PGE2), nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB), and malondialdehyde (MDA), whose activities were significantly increased by inflammatory stimuli. We characterized by means of chromatographic and colorimetric studies the composition of Graminex pollen to better correlate the activity of pollen on immortalized prostate cells (PC3), and in rat prostate specimens challenged with Escherichia coli lipopolysaccharide (LPS). We found that Graminex pollen was able to reduce radical oxygen species (ROS) production by PC3 cells and MDA, NFκB mRNA, and PGE2 levels, in rat prostate specimens. According to our experimental evidence, Graminex pollen appears to be a promising natural product for the management of the inflammatory components in the prostate.

Trans-Urethral Ureteral Stent Replacement Technique (TRUST): 10-Year Experience in 1168 Patients.

OBJECTIVES: To affirm technical success, clinical success and safety of fluoroscopically guided transurethral replacement of double-J (DJ) ureteral stents. METHODS: From January 2005 to December 2015, in a follow-up period ranging from 9 to 73 months, we replaced 6167 DJ ureteral stents in 3221 procedures in 1168 patients. All the procedures were performed in the angiography suite under fluoroscopic control. RESULTS: Technical success was achieved in 97.5% of the procedures. In eighty procedures, cystoscopic approach was necessary; time from previous procedure and side were significantly associated with technical success. Clinical success was reached in 95.7% of the procedures and was significantly lower in urological and gynaecological tumours (when compared to fibrosis and other causes) and in bilateral stents. No major complications were reported. In 90 cases, self-limiting transient minor haematuria occurred and in 160 procedures urinary tract infection responding to antibiotics were registered. Overall procedure time was 27 min. Mean fluoroscopic time was 6 min and 45 s. Mean radiation dose of the procedure was 38.40 Gy cm2. CONCLUSIONS: In patients that need routine replacement of DJ ureteral stent, transurethral fluoroscopically guided method may be the first choice; only in few cases of technical failure, cystoscopy may be considered.

Use of XenX™, the latest ureteric occlusion device with guide wire utility: results from a prospective multicentric comparative study.

PURPOSE: This is a prospective multicentric comparative study evaluating the performance of XenX-a new dual-purpose device for the prevention of stone fragments migration during ureteroscopic lithotripsy (URS). METHODS: Between March 2014 and January 2015, 41 patients undertaking URS + XenX were matched with 41 patients undergoing standard URS. Patients included had unilateral ureteric stone(s) of 0.5-1.5 cm in maximum size. Demographics, complication rates and surgical outcomes were recorded for comparison. A Likert-like 5-grade scoring system was used for surgeons' evaluation of XenX properties. Cost analysis was performed by comparing weighted mean costs of the relevant procedures. RESULTS: Patients' characteristics between the two groups were comparable. Lasering time was longer for XenX group (13.59 vs. 5.17 min; p = 0.0001) whilst use of basket and need of JJ stent insertion was more frequent in control group (19.5 vs. 97.6 %; p = 0.0001 and 22 vs. 35 %; p = 0.001, respectively). Intra-operative SFR was significantly higher for XenX group (100 vs. 85.4 %; p = 0.0001), but not at 4-week follow-up, after ancillary procedures were needed in 17.1 % of the control group. Surgeons' evaluations for XenX were suboptimal for "Ease of Basketing" (2/5) and "Advancement of double J stent" (3/5). The use of XenX increased costs of procedures, but spared the costs associated to ancillary procedures and stent removals. CONCLUSIONS: XenX confirmed to be a safe and effective device especially for the treatment of upper ureteric tract stones; moreover, XenX may reduce the risk for the need of auxiliary procedures and for the insertion of a JJ stent.

Xenx (Xenolith): preliminary considerations of a new "all-in-one" ureteral guidewire and anti-repulsion device.

A new anti-retropulsion device for the endoscopic treatment of ureteral stones was evaluated for safety and potential efficacy. The Xenx™ (Rocamed, Monaco-Montecarlo) is an anti-retropulsion device that operates as a normal hydrophilic guidewire when "closed" and as a nitinol ureteral mesh when "open". We performed semirigid ureterorenoscopy and Ho:YAG Laser lithotripsy in 15 patients, with a single ureteral stone. For each procedure, the papilla was negotiated with the Xenx™, the radiopaque markers were positioned over the stone via direct visualization and the device was opened under fluoroscopic control. The ureteroscope was then retracted and reinserted beside the Xenx™. At the end of the procedure, the Xenx™ was closed, and a ureteral catheter was coaxially placed and left for 24-48 h post-operation. We evaluated device positioning success with respect to pushability, ease of deployment, full expansion and fitting with the ureteral walls, kink resistance and stone retention capabilities during lithotripsy and device retrieval. Operative time, post-operative complications (Clavien-Dindo scale), ultrasound kidney stone-free rate and the hydronephrosis grade, were also recorded. At 4 weeks post-operation, the stone-free rate was assessed via non-contrast computed tomography with 1-mm slices. All procedures were successfully accomplished without complications according to the Clavien-Dindo scale. In all the cases, Xenx™ was inserted successfully past the stone and opened over it. In 4/15 cases (27%) some difficulties in pushability and kink resistance were recorded. In no case stone fragment basketing was performed. The median operative time was 24 min. At hospital discharge, 14/15 patients (93%) were kidney stone-free. At 4 weeks, the NCCT stone-free rate was 100%. This study demonstrated that the Xenx™ is safe and effective in terms of the stone-free rate, complications and operating time. Moreover, use of the Xenx™ allows the use of a basket or guide wire to be avoided.

Intracavitary immunotherapy and chemotherapy for upper urinary tract cancer: current evidence.

A review of the literature was performed to summarize current evidence regarding the efficacy of topical immunotherapy and chemotherapy for upper urinary tract urothelial cell carcinoma (UUT-UCC) in terms of post-treatment recurrence rates. A Medline database literature search was performed in March 2012 using the terms upper urinary tract, urothelial cancer, bacillus Calmette-Guérin (BCG), and mitomycin C. A total of 22 full-text articles were assessed for eligibility, and 19 studies reporting the outcomes of patients who underwent immunotherapy or chemotherapy with curative or adjuvant intent for UUT-UCC were chosen for quantitative analysis. Overall, the role of immunotherapy and chemotherapy for UUT-UCC is not firmly established. The most established practice is the treatment of carcinoma in situ (CIS) with BCG, even if a significant advantage has not yet been proven. The use of BCG as adjuvant therapy after complete resection of papillary UUT-UCC has been studied less extensively, even if recurrence rates are not significantly different than after the treatment of CIS. Only a few reports describe the use of mitomycin C, making it difficult to obtain significant evidence.