Focal high-intensity focused ultrasound therapy for localized prostate cancer: An interim analysis of the multinational FASST study.

BACKGROUND: High-intensity focused ultrasound (HIFU) emerged as a novel approach for the treatment of localized prostate cancer (PCa). However, prospective studies on HIFU-related outcomes and predictors of treatment failure (TF) remain scarce. MATERIALS AND METHODS: We conducted a multinational prospective cohort study among patients undergoing HIFU therapy for localized, low- to intermediate-risk PCa. Follow-up data on serial prostate specific antigen (PSA), multi-parametric magnetic resonance imaging (mpMRI), targeted/systematic biopsies, adverse events and functional outcomes were collected. The primary endpoint was TF, defined as histologically confirmed PCa requiring whole-gland salvage treatment. Uni- and multi-variable adjusted hazard ratios (HRs) were calculated using Cox proportional hazard regression models. RESULTS: At baseline, mean (standard deviation) age was 64.14 (7.19) years, with the majority of patients showing T-stage 1 (73.9%) and International Society of Urological Pathology grading system Grade 2 (58.8%). PSA nadir (median, 1.70 ng/mL) was reached after 6 months. Of all patients recruited, 16% had clinically significant PCa, as confirmed by biopsy, of which 13.4% had TF. Notably, T-stage and number of positive cores at initial biopsy were independent predictors of TF during follow-up (HR [95% CI] 1.27 [1.02-1.59] and 5.02 [1.80-14.03], respectively). Adverse events were minimal (17% and 8% early and late adverse events, respectively), with stable or improved functional outcomes in the majority of patients. CONCLUSIONS: This interim analysis of a multinational study on HIFU therapy for the management of low-to-intermediate-risk PCa reveals good functional outcomes, minimal adverse events and low incidence of TF over the short-term. Data on long-term outcomes, specifically as it relates to oncological outcomes, are awaited eagerly.

Risk of bowel resection in incarcerated inguinal hernia: watch out for ASA score and hernia type.

PURPOSE: Incarcerated inguinal hernias can promote bowel ischemia. Emergent bowel resection is associated with increased postoperative morbidity. Risk factors for bowel resection might identify patients who benefit from elective inguinal hernia repair. METHODS: Sixty-five consecutive patients undergoing emergency inguinal hernia repair between 2012 and 2018 at our institution were entered in a prospective database. Data analysis was approved by the local ethics committee. Patient characteristics, surgery data, and postoperative outcomes were compared between patients with and without bowel resection. Risk factors for bowel resection were assessed with univariate and multivariate analysis. RESULTS: Patients requiring bowel resection were more often female (87%, P = 0.004) and presented in 67% with a femoral hernia. Postoperative complications occurred more often after hernia reduction and bowel resection compared to no resection (67% vs. 36%, P = 0.035). ASA score 3-4 and femoral herniation were independent predictors of bowel resection (P = 0,046 and P = 0,047, respectively). CONCLUSION: Highly comorbid patients can profit from early elective hernia repair to prevent bowel resection.

Prostate volume reduction following pure transurethral bipolar plasma vaporization and conventional transurethral resection of the prostate: a prospective investigation using transrectal 3D ultrasound volumetry.

PURPOSE: To evaluate and compare postoperative changes in prostate volume and clinical outcome after bipolar plasma vaporization (BPV) and conventional transurethral resection of the prostate (TURP). PATIENTS AND METHODS: Consecutive series of patients undergoing BPV or TURP were included in this prospective, nonrandomized study. Planimetric volumetry after transrectal three-dimensional ultrasound of the prostate was performed preoperatively and postoperatively after 6 weeks, 6 months and 12 months. Additionally, changes in clinical outcome parameters were assessed and compared between the groups. The reduction ratio and analysis of covariance were used to compare volume changes between BPV and TURP. Multiple regression analysis was performed to assess a possible interaction between preoperative prostate volume and effect of therapy. RESULTS: A total of 157 patients were included (BPV: n = 68, TURP: n = 89). Median preoperative prostate volume was 43.1 ml in the BPV group and 45.9 ml in the TURP group (p = 0.43). Postoperatively, the prostate volumes decreased significantly in both groups. After catheter removal, the relative residual prostate volume was significantly higher in the BPV group (66.6 vs. 60.8 %; p = 0.02). Thereafter, significant differences were not detectable anymore (12 months: 46.6 vs. 47.1 %; p = 0.82). Regression analysis revealed that tissue ablation after BPV was superior to TURP in prostates <45 ml but inferior in prostates >45 ml. All clinical outcome parameters improved significantly and were not significantly different between the groups. CONCLUSIONS: Volume reduction and short-term clinical outcome following pure BPV was excellent and comparable to conventional TURP. However, volume reduction seems to be limited in patients with larger prostates.

Absorption of irrigation fluid occurs frequently during high power 532 nm laser vaporization of the prostate.

PURPOSE: Absorption of irrigation fluid was not detected during GreenLight™ laser vaporization of the prostate using the first generation 80 W laser. However, data are lacking on intraoperative irrigation fluid absorption using the second generation 120 W high power laser. We assessed whether fluid absorption occurs during high power laser vaporization of the prostate. MATERIALS AND METHODS: We performed this prospective investigation at a tertiary referral center in patients undergoing 120 W laser vaporization for prostatic bladder outlet obstruction. Normal saline containing 1% ethanol was used for intraoperative irrigation. The expired breath ethanol concentration was measured periodically during the operation using an alcometer. The volume of saline absorption was calculated from these concentrations. Intraoperative changes in hematological and biochemical blood parameters were also recorded. RESULTS: Of 50 investigated patients 22 (44%) had a positive breath ethanol test. Median absorption volume in the absorber group was 725 ml (range 138 to 3,452). Ten patients absorbed more than 1,000 ml. Absorbers had a smaller prostate, more capsular perforation, higher bleeding intensity and more laser energy applied during the operation. Three patients (13%) had symptoms potentially related to fluid absorption. Hemoglobin, hematocrit and serum chloride were the only blood parameters that changed significantly in the absorber group. The changes were significantly different than those in nonabsorbers. CONCLUSIONS: Fluid absorption occurs frequently during high power laser vaporization of the prostate. This should be considered in patients who present with cardiopulmonary or neurological symptoms during or after the procedure.

Lateral temperature spread of monopolar, bipolar and ultrasonic instruments for robot-assisted laparoscopic surgery.

OBJECTIVE: To assess critical heat spread of cautery instruments used in robot-assisted laparoscopic (RAL) surgery. MATERIALS AND METHODS: Thermal spread along bovine musculofascial tissues was examined by infrared camera, histology and enzyme assay. Currently used monopolar, bipolar and ultrasonic laparoscopic instruments were investigated at various power settings and application times. The efficacy of using an additional Maryland clamp as a heat sink was evaluated. A temperature of 45 °C was considered the threshold temperature for possible nerve damage. RESULTS: Monopolar instruments exhibited a mean (sem) critical thermal spread of 3.5 (2.3) mm when applied at 60 W for 1 s. After 2 s, the spread was >20 mm. For adjustable bipolar instruments the mean (sem) critical thermal spread was 2.2 (0.6) mm at 60 W and 1 s, and 3.6 (1.3) mm at 2 s. The PK and LigaSure forceps had mean (sem) critical thermal spreads of 3.9 (0.8) and 2.8 (0.6) mm respectively, whereas the ultrasonic instrument reached 2.9 (0.8) mm. Application of an additional Maryland clamp as a heat sink, significantly reduced the thermal spread. Histomorphometric analyses and enzyme assay supported these findings. CONCLUSIONS: All coagulation devices used in RAL surgery have distinct thermal spreads depending on power setting and application time. Cautery may be of concern due to lateral temperature spread, causing potential damage to sensitive structures including nerves. Our results provide surgeons with a resource for educated decision-making when using coagulation devices during robotic procedures.

Ablative efficiency of 532-nm laser vaporization compared to transurethral resection of the prostate: results from a prospective three-dimensional ultrasound volumetry study.

PURPOSE: To assess and compare postoperative prostate volume changes following 532-nm laser vaporization (LV) and transurethral resection of the prostate (TURP). To investigate whether differences in volume reduction are associated with differences in clinical outcome. METHODS: In this prospective, non-randomized study, 184 consecutive patients undergoing 120 W LV (n = 98) or TURP (n = 86) were included. Transrectal three-dimensional ultrasound and planimetric volumetry of the prostate were performed preoperatively, after catheter removal, 6 weeks, 6 and 12 months. Additionally, clinical outcome parameters were recorded. Mann-Whitney U test and analysis of covariance were utilized for statistical analysis. RESULTS: Postoperatively, a significant prostate volume reduction was detectable in both groups. However, the relative volume reduction was lower following LV (18.4 vs. 34.7 %, p < 0.001). After 6 weeks, prostate volumes continued to decrease in both groups, yet differences between the groups were less pronounced. Nonetheless, the relative volume reduction remained significantly lower following LV (12 months 43.3 vs. 50.3 %, p < 0.001). All clinical outcome parameters improved significantly in both groups. However, the maximum flow rate (Q max) and prostate-specific antigen (PSA) reduction were significantly lower following LV. Subgroup analyses revealed significant differences only if the initial prostate volume was >40 ml. Re-operations were necessary in three patients following LV. CONCLUSIONS: The modest but significantly lower volume reduction following LV was associated with a lower PSA reduction, a lower Q max and more re-operations. Given the lack of long-term results after LV, our results are helpful for preoperative patient counseling. Patients with large prostates and no clear indication for the laser might not benefit from the procedure.

The Transabdominal Lumbar Approach (TALA) for Robotic Renal Surgery-A Retrospective Single-Center Comparative Study and Step-by-Step Description of a Novel Approach.

The transperitoneal approach (TP) and the retroperitoneal approach (RP) are two common methods for performing nephrectomy or partial nephrectomy. However, both approaches face difficulties, such as trocar placement and limited working space (RP). TP is impaired in the case of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. A hybrid approach that combines both methods has been previously reported in a case series, but not evaluated systematically. This study proposes a modified hybrid approach, which we call the transabdominal lumbar approach (TALA), involving late robotic docking after elaborating the retroperitoneum using conventional laparoscopy. The study compares the last 20 consecutive patients who underwent RP and the last 20 patients who underwent TALA at our institution. The investigated variables include operative time and amount of blood loss, hospitalization duration, postoperative analgesia requirement, and postoperative complications. The study found no significant difference in operative time, blood loss, ischemia time, or hospital stay between the two groups. The TALA group had fewer complications regarding Clavien-Dindo category 3, but one complication of category 4. In Conclusion, TALA is a safe and promising approach that combines the advantages of RP and TP.

Prospective evaluation of irrigation fluid absorption during pure transurethral bipolar plasma vaporisation of the prostate using expired-breath ethanol measurements.

OBJECTIVES: To investigate if absorption of irrigation fluid occurs during bipolar plasma vaporisation (BPV) of the prostate. To examine the clinical predictors of increased risk of fluid absorption and to assess if changes in serum electrolytes, venous pH, haemoglobin or haematocrit are able to detect intra-operative fluid absorption. PATIENTS AND METHODS: Over a 15-month period, 55 consecutive patients undergoing BPV of the prostate were investigated. The volume of intra-operative fluid absorption was measured using expired-breath ethanol measurements. Intra-operative irrigation was performed with isotonic saline containing 1% ethanol. The breath ethanol concentration was measured every 10 min during the operation and the volume of irrigation fluid absorption was calculated from these concentrations. Data on clinical (age, prostate volume, smoking status) and surgical variables (operation time, irrigation volume, appearance of capsular perforation) as well as intra-operative changes in serum electrolytes, venous pH, haemoglobin and haematocrit were recorded. RESULTS: The median (range) age of the patients was 67 (48-87) years and the median (range) prostate volume was 41 (17-111) mL. Nine patients (16%) showed a positive ethanol breath test during the procedure. The median (range) calculated fluid absorption in these patients was 346 (138-2166) mL. Three patients had a fluid absorption >500 mL. One patient with absorption of >2 L showed clinical symptoms (dyspnoea and agitation) during the operation under spinal anaesthesia. In the group of patients with fluid absorption, capsular perforation or injury to larger vessels was more often detectable. In the group of patients with fluid absorption, only venous pH showed a significant change during the operation (from median 7.41 to median 7.34, P = 0.02). The pH decrease was significantly greater in the fluid absorption group than in the group of patients without fluid absorption (0.09 vs. 0.02, P = 0.005). CONCLUSION: We have demonstrated that significant intra-operative fluid absorption can occur during BPV of the prostate. Care must be taken if using this procedure in patients with significant cardiovascular comorbidities. Respecting the anatomical borders of the prostate seems to play a relevant role in preventing fluid absorption during the procedure. Venous pH could be used to detect potentially dangerous fluid absorption if intra-operative monitoring with breath ethanol measurements is not available.

Assessment of Image Quality in Chest CT With Precision Matrix and Increased Framing Rate Using Single Source CT: A Phantom Study.

BACKGROUND/AIM: The aim was to evaluate the effect of a combined precision matrix and high sampling rate on the delineation of anatomical structures and objective image quality in single source CT in a qualitative approach. MATERIALS AND METHODS: An anthropomorphic thoracic phantom was used to evaluate the objective image quality parameters, including image noise, noise power spectrum, image stepness and Q for different CT scanners including high/standard matrix and framing frequency setups. Scan parameters were standardized over all scanners. Additional subjective quality assessment was also performed. RESULTS: A linear mixed effects model was used to determine the effect of sampling rate and image matrix on objective image quality parameters. Noise power spectrum and image noise were significantly influenced by both framing frequency and image matrix. There were significant differences between high and standard frequency/matrix acquisitions. CONCLUSION: Higher framing frequency and image matrix allows for improved image noise texture and objective image quality in CT.

Evaluation of Image Quality of Overweight and Obese Patients in CT Using High Data Rate Detectors.

BACKGROUND/AIM: To evaluate the impact of high data rate and sampling frequency detector technology compared to standard scan equipment on the image quality in abdominal computed tomography (CT) of overweight and obese patients. PATIENTS AND METHODS: A total of 173 patients were retrospectively included in this study. Objective image quality in abdominal CT was evaluated using comparative analysis with new detector technology prior to market launch and standard CT equipment. Contrast noise ratio (CNR), image noise, volumetric computed tomography dose index (CTDIVol), and figures of merit (Q and Q1) were assessed for all patients. RESULTS: Image quality was superior in the new detector technology for all parameters evaluated. The dose dependent parameters Q and Q1 showed a significant difference (p<0.001). CONCLUSION: A significant increase in objective image quality could be demonstrated using a new generation detector setup with increased frequency transfer in abdominal CT of overweight patients.

Development and In Vitro Assessment of a Novel Vacuum-Based Tissue-Holding Device for Laparoscopic and Robotic Kidney Cancer Operations.

In this paper, we describe the development and evaluation of a novel tissue-holding device (THD) for use during robotic-assisted laparoscopic partial nephrectomy. The THD is a vacuum-based apparatus made of either 3D-printed polyethylene or stainless steel. The proximal end connects to suction tubing routed outside the body, while the distal end is conically shaped and designed to firmly interface with the tumor. Device feasibility studies were performed on six porcine kidneys, two porcine livers, and two embalmed human cadavers. A Likert-scale rating was used to assess device setup, suction, and tissue handling. Additional tests were performed using the daVinci Xi® robotic system. Finally, the holding force of the THD was assessed using different standard vacuum systems and pressure settings. In porcine tissue, the device setup, tissue suction, and handling were rated as "good". THD insertion and removal was uncomplicated. In a simulated transabdominal approach on fixed human cadavers, the device setup, suction, and tissue handling were also rated as "good". No macroscopic tissue compromise or device deterioration was noted. The handling and holding abilities using the daVinci Xi® robotic system were also rated "good". The device was able to successfully hold over 300 g of tissue at a suction pressure of -600 mmHg. The preliminary evaluation of the THD demonstrated satisfactory results.

Quantifying and Statistically Modeling Residual Pneumoperitoneum after Robotic-Assisted Laparoscopic Prostatectomy: A Prospective, Single-Center, Observational Study.

BACKGROUND: Laparoscopic surgery (LS) requires CO2 insufflation to establish the operative field. Patients with worsening pain post-operatively often undergo computed tomography (CT). CT is highly sensitive in detecting free air-the hallmark sign of a bowel injury. Yet, the clinical significance of free air is often confounded by residual CO2 and is not usually due to a visceral injury. The aim of this study was to attempt to quantify the residual pneumoperitoneum (RPP) after a robotic-assisted laparoscopic prostatectomy (RALP). METHODS: We prospectively enrolled patients who underwent RALP between August 2018 and January 2020. CT scans were performed on postoperative days (POD) 3, 5, and 7. To investigate potential factors influencing the quantity of RPP, correlation plots were made against common variables. RESULTS: In total, 31 patients with a mean age of 66 years (median 67, IQR 62-70.5) and mean BMI 26.59 (median 25.99, IQR: 24.06-29.24) underwent RALP during the study period. All patients had a relatively unremarkable post-operative course (30/31 with Clavien-Dindo class 0; 1/31 with class 2). After 3, 5, and 7 days, 3.2%, 6.4%, and 32.3% were completely without RPP, respectively. The mean RPP at 3 days was 37.6 mL (median 9.58 mL, max 247 mL, IQR 3.92-31.82 mL), whereas the mean RPP at 5 days was 19.85 mL (median 1.36 mL, max 220.77 mL, IQR 0.19-5.61 mL), and 7 days was 10.08 mL (median 0.09 mL, max 112.42 mL, IQR 0-1.5 mL). There was a significant correlation between RPP and obesity (p = 0.04665), in which higher BMIs resulted in lower initial insufflation volumes and lower RPP. CONCLUSIONS: This is the first study to systematically assess RPP after a standardized laparoscopic procedure using CT. Larger patients tend to have smaller residuals. Our data may help surgeons interpreting post-operative CTs in similar patient populations.

Prospective observational study of the role of the microbiome in BCG responsiveness prediction (SILENT-EMPIRE): a study protocol.

INTRODUCTION: The human microbiota, the community of micro-organisms in different cavities, has been increasingly linked with inflammatory and neoplastic diseases. While investigation into the gut microbiome has been robust, the urinary microbiome has only recently been described. Investigation into the relationship between bladder cancer (BC) and the bladder and the intestinal microbiome may elucidate a pathophysiological relationship between the two. The bladder or the intestinal microbiome or the interplay between both may also act as a non-invasive biomarker for tumour behaviour. While these associations have not yet been fully investigated, urologists have been manipulating the bladder microbiome for treatment of BC for more than 40 years, treating high grade non-muscle invasive BC (NMIBC) with intravesical BCG immunotherapy. Neither the association between the microbiome sampled directly from bladder tissue and the response to BCG-therapy nor the association between response to BCG-therapy with the faecal microbiome has been studied until now. A prognostic tool prior to initiation of BCG-therapy is still needed. METHODS AND ANALYSIS: In patients with NMIBC bladder samples will be collected during surgery (bladder microbiome assessment), faecal samples (microbiome assessment), instrumented urine and blood samples (biobank) will also be taken. We will analyse the microbial community by 16S rDNA gene amplicon sequencing. The difference in alpha diversity (diversity of species within each sample) and beta diversity (change in species diversity) between BCG-candidates will be assessed. Subgroup analysis will be performed which will lead to the development of a clinical prediction model estimating risk of BCG-response. ETHICS AND DISSEMINATION: The study has been approved by the Cantonal Ethics Committee Zurich (2021-01783) and it is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Study results will be disseminated through peer-reviewed journals and national and international scientific conferences. TRIAL REGISTRATION NUMBER: NCT05204199.

Two Decades of Active Surveillance for Prostate Cancer in a Single-Center Cohort: Favorable Outcomes after Transurethral Resection of the Prostate.

OBJECTIVE: To report the outcomes of active surveillance (AS) for low-risk prostate cancer (PCa) in a single-center cohort. PATIENTS AND METHODS: This is a prospective, single-center, observational study. The cohort included all patients who underwent AS for PCa between December 1999 and December 2020 at our institution. Follow-up appointments (FU) ended in February 2021. RESULTS: A total of 413 men were enrolled in the study, and 391 had at least one FU. Of those who followed up, 267 had PCa diagnosed by transrectal ultrasound (TRUS)-guided biopsy (T1c: 68.3%), while 124 were diagnosed after transurethral resection of the prostate (TURP) (T1a/b: 31.7%). Median FU was 46 months (IQR 25-90). Cancer specific survival was 99.7% and overall survival was 92.3%. Median reclassification time was 11.2 years. After 20 years, 25% of patients were reclassified within 4.58 years, 6.6% opted to switch to watchful waiting, 4.1% died, 17.4% were lost to FU, and 46.8% remained on AS. Those diagnosed by TRUS had a significantly higher reclassification rate than those diagnosed by TURP (p < 0.0001). Men diagnosed by targeted MRI/TRUS fusion biopsy tended to have a higher reclassification probability than those diagnosed by conventional template biopsies (p = 0.083). CONCLUSIONS: Our single-center cohort spanning over two decades revealed that AS remains a safe option for low-risk PCa even in the long term. Approximately half of AS enrollees will eventually require definitive treatment due to disease progression. Men with incidental prostate cancer were significantly less likely to have disease progression.

The Role of New Technologies in the Diagnosis and Surveillance of Non-Muscle Invasive Bladder Carcinoma: A Prospective, Double-Blinded, Monocentric Study of the XPERT© Bladder Cancer Monitor and Narrow Band Imaging© Cystoscopy.

Follow-up is essential for the early detection of recurrent non-muscle invasive bladder cancers (NMIBC). This study investigates the clinical relevance of new diagnostic tools such as an mRNA-based urine test (XPERT© Bladder Cancer Monitor, XBCM) and Narrow Band Imaging© (NBI) and compares them with the established follow-up diagnostics (white-light cystoscopy (WLC) and urine cytology). This was a prospective, double-blind, single-center study that involved patients undergoing NMIBC screening at a tertiary care center. Enrollment occurred between January 2018 and March 2020. In addition to standard care (WLC, cytology, and ultrasound), patients underwent XBCM urine testing and NBI cystoscopy. In total, 301 WLCs were performed; through this, 49 patients demonstrated NMIBC recurrence. NBI cystoscopy was congruent with WLC in all patients. Cytology showed a sensitivity (SE) and specificity (SP) of 27% and 97% (PPV: 65%; NPV 87%), respectively, whereas XBCM showed SE and SP of 58% and 89%, respectively (PPV: 51%; NPV: 92%; AUC: 0.79 (0.716-0.871)). Subgroup analysis showed improved SE and similar SP (PPV, NPV) for high grade (HG) recurrence, with a SE of 74% and SP of 89% (39%, 97%). NBI cystoscopy does not necessarily provide additional benefit over standard WLC. However, the XBCM may provide better SE and a diagnostic advantage in instances of HG disease recurrence.

A Phase 1/2 Single-arm Clinical Trial of Recombinant Bacillus Calmette-Guérin (BCG) VPM1002BC Immunotherapy in Non-muscle-invasive Bladder Cancer Recurrence After Conventional BCG Therapy: SAKK 06/14.

BACKGROUND: VPM1002BC is a genetically modified Mycobacterium bovis bacillus Calmette-Guérin (BCG) strain with potentially improved immunogenicity and attenuation. OBJECTIVE: To report on the efficacy, safety, tolerability and quality of life of intravesical VPM1002BC for the treatment of non-muscle-invasive bladder cancer (NMIBC) recurrence after conventional BCG therapy. DESIGN, SETTING, AND PARTICIPANTS: We designed a phase 1/2 single-arm trial (NCT02371447). Patients with recurrent NMIBC after BCG induction ± BCG maintenance therapy and intermediate to high risk for cancer progression were eligible. INTERVENTION: Patients were scheduled for standard treatment of six weekly instillations with VPM1002BC followed by maintenance for 1 yr. Treatment was stopped in cases of recurrence. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was defined as the recurrence-free rate (RFR) in the bladder 60 wk after trial registration. The sample size was calculated based on the assumption that ≥30% of the patients would be without recurrence at 60 wk after registration. RESULTS AND LIMITATIONS: After exclusion of two ineligible patients, 40 patients remained in the full analysis set. All treated tumours were of high grade and 27 patients (67.5%) presented with carcinoma in situ. The recurrence-free rate in the bladder at 60 wk after trial registration was 49.3% (95% confidence interval [CI] 32.1-64.4%) and remained at 47.4% (95% CI 30.4-62.6%] at 2 yr and 43.7% (95% CI 26.9-59.4%) at 3 yr after trial registration. At the same time, progression to muscle-invasive disease had occurred in three patients and metastatic disease in four patients. Treatment-related grade 1, 2, and 3 adverse events (AEs) were observed in 14.3%, 54.8%, and 4.8% of the patients, respectively. No grade ≥4 AEs occurred. Two of the 42 patients did not tolerate five or more instillations during induction. Limitations include the single-arm trial design and the low number of patients for subgroup analysis. CONCLUSIONS: At 1 yr after treatment start, almost half of the patients remained recurrence-free after therapy with VPM100BC. The primary endpoint of the study was met and the therapy is safe and well tolerated. PATIENT SUMMARY: We conducted a trial of VPM100BC, a genetically modified bacillus Calmette-Guérin (BCG) strain for treatment of bladder cancer not invading the bladder muscle. At 1 year after the start of treatment, almost half of the patients with a recurrence after previous conventional BCG were free from non-muscle-invasive bladder cancer (NMIBC). The results are encouraging and VPM1002BC merits further evaluation in randomised studies for patients with NMIBC.

Lithium triborate laser vaporization of the prostate using the 120 W, high performance system laser: high performance all the way?

PURPOSE: Technical modifications of the 120 W lithium-triborate laser have been implemented to increase power output, and prevent laser fiber degradation and loss of power output during laser vaporization of the prostate. However, visible alterations at the fiber tip and the subjective impression of decreasing ablative effectiveness during lithium-triborate laser vaporization indicate that delivering constantly high laser power remains a relevant problem. Thus, we evaluated the extent of laser fiber degradation and loss of power output during 120 W lithium-triborate laser vaporization of the prostate. MATERIALS AND METHODS: We investigated 46 laser fibers during routine 120 W lithium-triborate laser vaporization in 35 patients with prostatic bladder outflow obstruction. Laser beam power was measured at baseline and after the application of each 25 kJ during laser vaporization. Fiber tips were microscopically examined after the procedure. RESULTS: Mild to moderate degradation at the emission window occurred in all fibers, associated with a loss of power output. A steep decrease to a median power output of 57.3% of baseline was detected after applying the first 25 kJ. Median power output at the end of the defined 275 kJ lifespan of the fibers was 48.8%. CONCLUSIONS: Despite technical refinements of the 120 W lithium-triborate laser fiber degradation and significantly decreased power output are still detectable during the procedure. Laser fibers are not fully appropriate for the high power delivery of the new system. There is still potential for further improvement in the laser performance.

Electrical microcurrent to prevent conditioning film and bacterial adhesion to urological stents.

Long-term catheters remain a significant clinical problem in urology due to the high rate of bacterial colonization, infection, and encrustation. Minutes after insertion of a catheter, depositions of host urinary components onto the catheter surface form a conditioning film actively supporting the bacterial adhesion process. We investigated the possibility of reducing or avoiding the buildup of these naturally forming conditioning films and of preventing bacterial adhesion by applying different current densities to platinum electrodes as a possible catheter coating material. In this model we employed a defined environment using artificial urine and Proteus mirabilis. The film formation and desorption was analyzed by highly mass sensitive quartz crystal microbalance and surface sensitive atomic force microscopy. Further, we performed bacterial staining to assess adherence, growth, and survival on the electrodes with different current densities. By applying alternating microcurrent densities on platinum electrodes, we could produce a self regenerative surface which actively removed the conditioning film and significantly reduced bacterial adherence, growth, and survival. The results of this study could easily be adapted to a catheter design for clinical use.

Thermal spread of vessel-sealing devices evaluated in a clinically relevant in vitro model.

INTRODUCTION: Bipolar vessel-sealing devices (VSDs) have advantages in urological surgeries (less hemorrhage, shorter operating time). However, these instruments can cause thermal injuries, which can result in neural damage and necrosis. The objectives of this study were to establish a reproducible in vitro model for standardized assessment of electrosurgical devices and to evaluate whether optimized placement of surgical instruments can reduce the thermal spread. METHODS: We evaluated thermal spread of two VSDs in vitro using thin bovine muscle strips. Thermal injury was measured using an infrared camera, temperature probes and histology. The recordings were made with the VSD alone and with a rectangular clamp next to the VSD. RESULTS: Both instruments showed a significant temperature spread of 2.5 mm lateral to the VSD. The placement of a metal clamp next to the VSD significantly reduced the temperature spread. Histological examinations were able to underline these findings. CONCLUSIONS: In this study we describe a straightforward clinically relevant in vitro model for the evaluation of future electrosurgical instruments. We demonstrated that the thermal spread of VSD could be further reduced by optimized placement of an additional surgical instrument. Our results could help surgeons protect sensitive structures like nerves in the vicinity of the VSD.