A call for HoLEP: en-bloc vs. two-lobe vs. three-lobe.

PURPOSE: Holmium Laser Enucleation of the Prostate (HoLEP) is widely accepted as standard laser enucleation technique for patients with benign prostate obstruction (BPO). Initially developed as a three-lobe enucleation technique, several modifications have been published. Comparison of the enucleation techniques is lacking. Therefor we aimed to compare outcomes of three enucleation techniques (en-bloc vs. two-lobe vs. three-lobe). MATERIAL AND METHODS: We prospectively collected data of 600 patients treated between 01/2017 and 12/2017 with HoLEP for BPO. Patients were randomised to either enbloc, two-lobe, or three-lobe enucleation, respectively. Data collection consisted of parameters on operation time, perioperative parameters, and functional outcomes. Univariate and multivariate analyses (ANOVA-test for continuous variables; Chi2-test for categorical variables) were performed regarding differences between the three enucleation techniques. RESULTS: Patient characteristics were not significantly different (all p > 0.05). Significant differences were observed with respect to overall operation time (en-bloc vs. two-lobe vs. three-lobe: 40.5 vs. 40.7 vs. 47.9, respectively; p < 0.001), speed (g/min.) (en-bloc vs. two-lobe vs. three-lobe, 1.82 vs. 1.76 vs. 1.67, respectively; p 0.006), and enucleation time (en-bloc vs. two-lobe vs. three-lobe: 31.7 vs. 32 vs. 37.7, respectively; p < 0.001). When solely comparing en-bloc vs. two-lobe enucleation, differences in terms of enucleation time, operation time, and speed were not significantly different (p 0.8, 0.9, and 0.2, respectively). Postoperative outcomes were not significantly different. CONCLUSION: All three HoLEP enucleation techniques show similar postoperative outcomes. However, enbloc and two-lobe enucleation are significantly faster with respect to enucleation, overall operation time, and speed compared to the three-lobe technique.

Super early detailed assessment of lower urinary tract symptoms after holmium laser enucleation of the prostate (HoLEP): a prospective study.

PURPOSE: To prospectively investigate early and consecutive changes of lower urinary tract symptoms (LUTS), specifically storage symptoms after holmium laser enucleation of the prostate (HoLEP). METHODS: Patients referred for HoLEP completed the International Prostatic Symptom Score (IPSS) the day before, at discharge, and 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 52 weeks after HoLEP. Total IPSS was stratified into mild (score 0-7), moderate (8-19), and severe (20-35) LUTS. Storage symptoms were sub-stratified into storage "negative" and "positive". IPSS changes served as the main postoperative outcome. Mixed linear models identified risk factors affecting postoperative recovery of LUTS. RESULTS: Between December 2010 and 2012, 144 consecutive HoLEP patients were prospectively included in the study. Preoperatively 57.6% of the cohort reported severe storage symptoms (mean total IPSS: 22.6 ± 5.0). Total IPSS decreased significantly immediately after surgery (p < 0.001). Patients with severe LUTS, storage-positive sub-score, and high maximum urinary flow rate were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS. Of these, about 7.4% presented persisting urge complaints. Finally, 12 weeks following HoLEP, the vast majority of patients were symptom-free. Limitations of this study include missing urodynamic workup and a comparative patient cohort. CONCLUSION: Immediately after HoLEP, patients experience a significant decrease of LUTS. Continuous symptom recovery seems to be hampered in patients with severe and storage-positive baseline symptoms. (De-novo) storage symptoms slightly affect postoperative recovery. Quality of life is restored to a stable and significantly improved status 3 months after surgery.

Tumor volume improves the long-term prediction of biochemical recurrence-free survival after radical prostatectomy for localized prostate cancer with positive surgical margins.

PURPOSE: To develop a novel application evaluating the effect of tumor volume (TV) and percentage of high-grade tumor volume (%HGTV) on long-term biochemical recurrence-free survival rate (BCRFS) after radical prostatectomy (RP) in patients with pT2 PCa. METHODS: Retrospective analysis of 903 men with pT2 PCa between 1992 and 2004 at a single European tertiary care center was performed. Cox regression models identified risk factors for BCR. A nomogram was developed to predict the BCRFS at 5, 10 and 15 years after RP. Decision curve analyses were performed to identify the net increase in cases identified by the full model. RESULTS: BCR-free survival rates at 5, 10 and 15 years were 94, 90 and 86 %. In Cox regression analyses, TV, %HGTV and positive surgical margin status (SM) were independent predictors of BCR. Predictive accuracies (PA) at 5, 10 and 15 years of the base model (PSA, Gleason score, SM) were 76.8 % (95 % CI 67.9-78.2 %), 70.5 % (95 % CI 64.9-75.0 %) and 68.1 % (95 % CI 60.6-73.5 %). The full model, including TV and %HGTV, achieved 76.9, 72.4 and 70.7 %. These PA differences were statistically significant at 10 and 15 years (p < 0.001). CONCLUSIONS: TV and %HGTV could potentially serve as valuable measures to stratify patients at high risk of BCR. The use of our nomogram should be considered to counsel patients with pT2 disease and SM and to design appropriate follow-up or treatment regimens.

Management of Anterior Urethral Strictures in Adults: A Survey of Contemporary Practice in Germany.

INTRODUCTION: Treatment methods of anterior urethral strictures in adults have undergone considerable changes in the recent past. Our goal was to determine national practice patterns among German urologists and to compare results with the results of prior international surveys. METHODS: We conducted a survey on the management of urethral strictures among German urologists. RESULTS: Eight hundred forty-five urologists, representing about 14.6% of German urologists, answered the survey. Most common procedures were direct vision internal urethrotomy (DVIU; 87.2%), blind internal urethrotomy (57.5%), dilatation (56.3%), ventral buccal mucosa graft urethroplasty (31.6%) and excision and primary anastomosis (28.9%). In case of a 3.5-cm bulbar stricture and in the case of a 1-cm bulbar stricture after 2 failed DVIUs, a consecutive urethroplasty was significantly more often favoured compared to transurethral treatment options (44.9 vs. 21.3% and 59.4 vs. 8.3%, both p < 0.001). CONCLUSION: Open urethral reconstruction reveals to be a more common method in practice nowadays. Adherence to recommended treatment algorithms improved in comparison to prior surveys.

Outcomes of single- vs double-cuff artificial urinary sphincter insertion in low- and high-risk profile male patients with severe stress urinary incontinence.

OBJECTIVES: To evaluate continence and complication rates of bulbar single-cuff (SC) and distal bulbar double-cuff (DC) insertion in male patients with severe stress urinary incontinence (SUI) according to whether the men were considered low or high risk for unfavourable artificial urinary sphincter (AUS) outcomes. PATIENTS AND METHODS: In all, 180 male patients who underwent AUS implantation between 2009 and 2013 were followed according to institutional standards. Patients with previous pelvic radiation therapy, open bulbar urethral or UI surgery ('high risk') underwent distal bulbar DC (123 patients) insertion, all others ('low risk') had proximal bulbar SC (57) insertion. Primary and secondary endpoints consisted of continence and complication rates. Kaplan-Meier analysis determined explantation-free survival, and Cox regression models assessed risk factors for persistent UI and explantation. RESULTS: The median follow-up was 24 months. Whereas there was no significant difference in pad usage/objective continence after SC vs DC insertion, superior rates of subjective/social continence and less persistent UI were reported by the patients with DC devices (all P ≤ 0.02). Overall, device explantation (erosion, infection or mechanical failure) occurred in 12.8% of patients. While early (<6 weeks) complication rates compared with SC patients were similar (P > 0.05), DC patients had a 5.7-fold higher risk of device explantation during late follow-up (P = 0.02) and significantly shorter explantation-free survival (log-rank, P = 0.003). CONCLUSIONS: Distal bulbar DC insertion in patients with a 'high-risk' profile (previous pelvic radiation, urethral surgery) leads to similar objective continence, but higher explantation rates when compared with patients considered 'low risk' with proximal bulbar SCs. Randomised controlled trials comparing both devices will be needed to determine whether the higher explanations rates are attributable to the DC device or to underlying risk factors.

Psychometric validation of a German language version of a PROM for urethral stricture surgery and preliminary testing of supplementary ED and UI constructs.

PURPOSE: To validate a German language version of the patient-reported outcome measurement (PROM) following urethral stricture surgery (USS) in a cohort of men undergoing one-stage buccal mucosa graft urethroplasty (BMGU) for urethral stricture. Furthermore, to explore the responsiveness of erectile function (EF) and urinary incontinence (UI) constructs in the context of this intervention. METHODS: The USS-PROM captures voiding symptoms (ICIQ-MLUTS) and health-related quality of life (HRQoL) (EQ-5D). To evaluate EF and UI, the IIEF-5 and ICIQ-UI SF were included. Between March 2012 and April 2013, all patients undergoing BMGU at our institution were prospectively enrolled in this study. Psychometric assessment included internal consistency, test-retest reliability, criterion validity and responsiveness. RESULTS: Ninety-three men completed the USS-PROM before and 3 months after surgery, with 40 (43 %) also completing the USS-PROM 6 months after surgery to assess reliability. Internal consistency: for the ICIQ-MLUTS, Cronbach's α was 0.83. The test-retest intraclass correlation coefficient was 0.94. There was a negative correlation between change in ICIQ-MLUTS total score and change in Q max (r = -0.40). All values exceeded our predefined thresholds. Significant improvements of voiding symptoms and HRQoL demonstrate responsiveness to change (all p values <0.001). While ICIQ-UI scores did not change (p > 0.05), IIEF-5 scores improved significantly (p = 0.048). CONCLUSIONS: The German language USS-PROM shows similar psychometric properties to the English language version. This instrument can be improved by assessing EF by the use of IIEF-5. Further studies with larger patient cohorts are needed to evaluate the significance of measuring UI in urethroplasty patients.

Outcomes of Ventral Onlay Buccal Mucosa Graft Urethroplasty in Patients after Radiotherapy.

PURPOSE: We evaluated stricture-free survival and functional outcomes of buccal mucosa graft urethroplasty in patients with urethral stricture disease after radiotherapy. MATERIALS AND METHODS: We reviewed our urethroplasty database for patients with a radiotherapy history who underwent buccal mucosa graft urethroplasty between January 2009 and October 2013. We reviewed patient charts and the institutional, standardized, nonvalidated questionnaires administered to each patient postoperatively. Study end points included 1) the success rate, 2) continence status, 3) erectile function and 4) patient satisfaction postoperatively. Success was defined as stricture-free survival. RESULTS: Of 38 men included in the study prostate cancer was the most common indication for radiotherapy in 35 (92.1%). External beam radiotherapy was performed in 24 cases (64.9%), brachytherapy was done in 8 (21.6%) and a combination of the 2 treatments was performed in 6 (13.5%). Strictures were in the bulbar/bulbomembranous urethra and had a median length of 3.0 cm (range 1.0 to 8.0). The overall success rate was 71.1% at a median followup of 26.5 months (range 1.0 to 50.0). Median time to stricture recurrence was 17.0 months (range 3.0 to 44.0). De novo urinary incontinence was observed in 4 patients (10.5%). Erectile function remained mostly unchanged compared to preoperative status. Study limitations include the small sample size and the lack of validated questionnaires. CONCLUSIONS: At short-term to mid-term followup the success rate of ventral onlay buccal mucosa graft urethroplasty in patients with radiotherapy history seems acceptable. However, patients must be counseled about the increased risk of urinary incontinence. Longer followup is warranted to address long-term outcomes.

Internal urethrotomy in patients with recurrent urethral stricture after buccal mucosa graft urethroplasty.

PURPOSE: To determine the success rate of direct vision internal urethrotomy (DVIU) in the treatment of short stricture recurrence after buccal mucosa graft urethroplasty (BMGU). METHODS: Patients who underwent DVIU for the treatment of short, "veil-like" recurrent urethral strictures (<1 cm) after BMGU between October 2009 and 2013 were retrospectively identified within our urethroplasty database. Stricture recurrence was defined as maximum flow rate (Q max) <15 ml/s and a consecutively verified stricture in a combined retro- and antegrade voiding cystography or cystoscopy at a follow-up visit. The success rate of DVIU was assessed by Kaplan-Meier analysis. Univariable Cox regression analyses evaluated risk factors for stricture recurrence following DVIU. RESULTS: Forty-three patients underwent DVIU for short stricture recurrence after BMGU for bulbar (81.3 %), penile (14.0 %) and membranous (4.7 %) strictures. Relapse had occurred proximally to the buccal mucosa graft in 28 (65.1 %) and distally in 12 (27.9 %) patients, respectively. At a mean follow-up of 11.7 (±9.7) months, stricture recurrence was observed in 48.8 % of our patients. Stricture recurrence was significantly associated with weak urinary stream (9.3 ml/s vs. no recurrence 19.5 ml/s) and patient dissatisfaction (66.7 % vs. no recurrence 18.1 %; both p < 0.001). The overall success rate was 60.5 % 15 months after DVIU. The main limitations of this study are its retrospective design, the small sample size and the short follow-up. CONCLUSIONS: DVIU after BMGU showed a moderate success rate and therefore might be a viable treatment option in selected patients with very short strictures after BMGU. However, longer follow-up is warranted to prove long-term effectiveness.

Percentage of high-grade tumour volume does not meaningfully improve prediction of early biochemical recurrence after radical prostatectomy compared with Gleason score.

OBJECTIVE: To examine whether percentage of tumour volume (%TV) and percentage of high-grade tumour volume (%HGTV) help to better identify men at higher risk of early biochemical recurrence (BCR) after radical prostatectomy (RP) for non-metastatic high-risk prostate cancer, as early BCR after RP might be associated with higher risk of metastases and cancer-specific mortality. PATIENTS AND METHODS: We examined the data of 595 men treated with RP for non-metastatic high-risk prostate cancer between 1992 and 2011 at two European tertiary care centres. Kaplan-Meier analyses were used to graphically depict 2-year BCR-free survival. Multivariable Cox regression models addressed early BCR. We tested whether addition of %TV and %HGTV to a multivariable Cox regression model helps to increase a model's predictive accuracy (PA) for prediction of early BCR. RESULTS: In all, 32 men (10%) with specimen-confined prostate cancer (pT2-pT3a, negative surgical margin, pN0) and 67 men (24%) with non-specimen-confined prostate cancer had early BCR. After stratification according to %HGTV (%HGTV threshold: ≤33.33 vs >33.33%), the 2-year BCR-free survival rates were respectively 93 vs 60% (log-rank P < 0.001). In multivariable Cox regression models %HGTV emerged as an independent predictor of early BCR (P < 0.001), whereas %TV did not (P > 0.05). However, adding %HGTV (regardless of its coding) to other covariates in multivariable Cox regression analysis did not increase the model's PA in a meaningful fashion compared with the use of the detailed Gleason grading system (6 vs 7a vs 7b vs 8 vs 9-10). CONCLUSIONS: In a large cohort of patients with high-risk prostate cancer, %HGTV and %TV did not improve prediction of early BCR after RP substantially, although %HGTV was an independent predictor of early BCR. Therefore, sophisticated TV/HGTV measurements do not seem to have additional benefit for early BCR prediction relative to the use of Gleason grading. However, these results need to be confirmed in larger, prospective studies.

External validation of the updated Briganti nomogram to predict lymph node invasion in prostate cancer patients undergoing extended lymph node dissection.

PURPOSE: We aimed to test accuracy and generalizability of a recently updated nomogram to assess the probability of lymph node invasion (LNI), when applied to a different European cohort of men undergoing radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND). MATERIALS AND METHODS: The study cohort consisted of 1,282 men with clinically localized PCa who underwent RP and ePLND, including removal of obturator, external iliac, and hypogastric lymph nodes, between 01/2007 and 08/2011. Descriptive measurements included preoperative clinical and biopsy variables, such as prostate-specific antigen (PSA), clinical stage (CS), primary and secondary biopsy Gleason pattern, and percentage of positive cores. We used the area under curve (AUC) of the receiver operator characteristic analysis to quantify accuracy of the model to predict LNI. The extent of over- or under-estimation was explored graphically within loess calibration plots. RESULTS: The median number of removed lymph nodes was 15 with an interquartile range of 12-20. Twelve percent (n = 155) of men had LNI. Preoperative clinical and biopsy characteristics differed significantly (all P ≤ 0.002) between men with LNI and those without. External validation of the previously reported updated LNI nomogram showed very good accuracy (AUC: 0.829). A nomogram-derived cut-off of 4% could lead to a reduction of 48% of lymph node dissection, while missing 10% of patients with LNI. CONCLUSIONS: We report the external validation of an updated LNI nomogram, demonstrating accuracy and applicability in a different European cohort. A nomogram-derived cut-off of 4% confirmed good performance characteristics within a different external validation cohort.

Prospective evaluation of an intraoperative urodynamic stress test predicting urinary incontinence after robot-assisted laparoscopic radical prostatectomy.

Introduction: Multiple factors influence postprostatectomy incontinence (PPI). This study evaluates the association between an intraoperative urodynamic stress test (IST) with PPI. Materials and Methods: This is an observational, single-center, prospective evaluation of 109 robot-assisted laparoscopic radical prostatectomies (RALPs) performed between July 2020 and March 2021. All patients underwent an intraoperative urodynamic stress test (IST) in which the bladder is filled up to an intravesical pressure of 40 cm H2O to evaluate whether the rhabdomyosphincter is capable of withstanding the pressure and ensure continence. Early PPI was evaluated using a standardized 1-h pad test performed the day after removal of the urinary catheter. The association of IST and PPI was evaluated using univariate and multivariable logistic regression models. Results: Nearly 76.6% of the patients showed no urine loss during the IST ("sufficient" population group). There was no significant correlation between this group and PPI after catheter removal (P = 0.5). Subgroup analyses of the "sufficient" patient population showed a 3.1 higher risk of PPI when no nerve sparing was performed (95% confidence interval: 1.05-9.70, P = 0.045). Conclusion: A sufficient IST, as a surrogate variable for a fully obtained rhabdomyosphincter, has no significant predictive value on its own but seems to be the optimal prerequisite for continence, since the data shows that the lack of neurovascular supply required for a functioning sphincter leads up to a 3.1 times higher risk for PPI.

Transurethral holmium laser enucleation versus transurethral resection of the prostate and simple open prostatectomy--which procedure is faster?

PURPOSE: The longer operative time of holmium laser enucleation of the prostate compared to transurethral resection of the prostate or simple open prostatectomy reported in the literature might have been biased by the unavailability of a soft tissue morcellator, limited surgical experience with holmium laser prostate enucleation or the fact that significantly more tissue was removed by enucleation than by resection. We objectively compared the resection speed of contemporary holmium laser enucleation vs transurethral resection of the prostate and of holmium laser enucleation vs simple open prostatectomy. MATERIALS AND METHODS: The study cohort consisted of 100 cases of transurethral prostate resection and 60 of simple open prostatectomy from our previous randomized, controlled trials. These cases were subjected to matched pair analysis with greater than 1,000 from our prospective contemporary database on holmium laser prostate enucleation. Exact matches were made for the same amount of resected tissue. In all contemporary holmium laser enucleation cases a mechanical soft tissue morcellator was used. We calculated and compared the specific resection speed in gm per minute and operative time for the same amount of resected tissue. RESULTS: In groups 1 and 2 we matched 99 exact laser enucleation-transurethral resection pairs and 53 exact laser enucleation-simple open prostatectomy pairs, respectively. Resection speed and operative time for laser enucleation were statistically significantly faster than for resection (0.61 vs 0.51 gm per minute and 62 vs 73 minutes, p <0.01) and similar to those of simple open prostatectomy (0.92 vs 1.0 gm per minute and 101 vs 90 minutes, respectively, p ≥0.21). CONCLUSIONS: Resection speed seems to be an objective criterion for comparing the efficacy of prostatic tissue removal. Based on resection speed holmium laser enucleation of the prostate is faster than transurethral resection of the prostate and similar to simple open prostatectomy.

[Contemporary surgical management of benign prostatic obstruction in Germany : A population-wide study based on German hospital quality report data from 2006 to 2019]. / Die operative Therapie des benignen Prostatasyndroms in Deutschland : Eine Darstellung der Versorgungssituation auf Basis der Qualitätsberichte von 2006 bis 2019.

BACKGROUND: The surgical management of benign prostatic obstruction (BPO) has greatly evolved in recent years. OBJECTIVES: The aim of this study is to present contemporary management and trends for surgical BPO therapy in Germany. MATERIALS AND METHODS: Disease and procedure rates were extracted using the online platform reimbursement.INFO that is based on German hospital quality report data. For the diagnosis of benign prostate hyperplasia (BPH), the ICD codes N40 and D29.1 were used. For evaluation of the surgical procedures OPS codes 5­600.0, 5­601, 5­603, 5­609.4 and 5­609.8 including their subcodes were used. In addition to descriptive analyses, trend and correlation analyses were performed. RESULTS: In 2019, a total of 83,687 procedures for BPO in 473 urological departments were performed. The most common (71.7%) surgery was transurethral resection of the prostate (TUR-P). Holmium laser enucleation of the prostate (HoLEP; 9.5%) and surgical adenomectomy (5.6%) were the second and third most common procedures. Less often thulium laser enucleation (ThuLEP; 3.1%), laser vaporisation (2.9%) and electrical vaporisation (2.8%) were performed. All other techniques were performed in < 1%. Rates of HoLEP, ThuLEP and electrovaporisation have increased since 2006 (HoLEP: +42.42%/year, p < 0.001; ThuLEP: +20.6%/year, p = 0.99; electrovaporisation +43.42%/year, p < 0.001), while surgical adenomectomy decreased (-1.66%/year, p < 0.01). In 2019 mean length of hospital stay was 5.1 ± 0.1 days. CONCLUSIONS: TUR­P remains the most often performed surgical treatment for BPO. Laser therapy-especially in centers-is increasing, while surgical adenomectomy continues to abate.

Patterns of Peripheral Blood B-Cell Subtypes Are Associated With Treatment Response in Patients Treated With Immune Checkpoint Inhibitors: A Prospective Longitudinal Pan-Cancer Study.

Background: Immune checkpoint inhibitors (ICIs) have revolutionized systemic anti-tumor treatments across different types of cancer. Nevertheless, predictive biomarkers regarding treatment response are not routinely established yet. Apart from T-lymphocytes, the humoral immunity of B-lymphocytes is studied to a substantially lesser extent in the respective setting. Thus, the aim of this study was to evaluate peripheral blood B-cell subtypes as potential predictors of ICI treatment response. Methods: Thirty-nine cancer patients receiving ICI therapy were included into this prospective single-center cohort study. All had a first blood draw at the date before treatment initiation and a second at the time of first response evaluation (after 8-12 weeks). Seven different B-cell subtypes were quantified by fluorescence-activated cell sorting (FACS). Disease control- (DCR) and objective response rate (ORR) were co-primary study endpoints. Results: Overall, DCR was 48.7% and ORR was 25.6%, respectively. At baseline, there was no significant association of any B-cell subtype with neither DCR nor ORR. At the first response evaluation, an increase in the frequency of CD21- B-cells was a statistically significant negative predictor of response, both regarding DCR (OR=0.05, 95%CI=0.00-0.67, p=0.024) and ORR (OR=0.09, 95%CI=0.01-0.96, p=0.046). An increase of the frequency of switched memory B-cells was significantly associated with reduced odds for DCR (OR=0.06, 95%CI=0.01-0.70, p=0.025). Patients with an increased frequency of naïve B-cells were more likely to benefit from ICI therapy as indicated by an improved DCR (OR=12.31, 95%CI=1.13-134.22, p=0.039). Conclusion: In this study, certain B-cell subpopulations were associated with ICI treatment response in various human cancer types.

Older patients suffer from adverse histopathological features after radical cystectomy.

OBJECTIVES: Radical cystectomy (RC) remains a complex procedure in older patients. Perioperative morbidity can be significant and it can represent a limitation for its indication in this population. The aim of the present study was to evaluate the outcomes of RC in elderly patients from a large single-center cohort. METHODS: A total of 447 patients who underwent RC between 1996 and 2009 at our institution were considered. Patients were stratified by age (≤70 vs >70 years). Logistic regression analyses were carried out comparing both groups regarding clinical, perioperative and histopathological findings, as well as complications according to the modified Clavien system and survival. RESULTS: Data of 390 patients were available for the analysis. Of these, 265 (67.9%) versus 125 (32.1%) patients were <70 versus ≥70 years-of-age. The median age was 61 and 75 years, respectively. In the elderly, ASA score (P < 0.001), delay between transurethral resection of the bladder (TURBT) and RC (P = 0.004), and number of perioperative blood transfusions (P = 0.002) were significantly higher. Additionally, a clear trend towards higher stages (pT3-4) was observed (P = 0.04). However, complications, and overall and cancer-specific mortality were not increased in older patients. Finally, age was identified as a significant risk factor for upstaging (P = 0.04). Upstaging between TURBT and final histopathology in patients <70 versus ≥70 years occurred in 45% versus 58%, respectively (P = 0.03). CONCLUSIONS: RC is equally feasible in older patients without increasing morbidity or mortality. On the contrary, older patients have a higher risk of significant upstaging and advanced stages at final histopathology. These findings suggest that RC should neither be delayed in nor withheld from elderly patients.

The Silent Operation Theatre Optimisation System (SOTOS©) to reduce noise pollution during da Vinci robot-assisted laparoscopic radical prostatectomy.

To reduce noise pollution and consequently stress during robot-assisted laparoscopic radical prostatectomy (RALP) the aim of our study was to evaluate the silent operation theatre optimisation system (SOTOS) in its effectiveness. In the operating room (OR) the noise level is between 80 and 85 decibel (dB). Noise corresponds to a major stress factor for surgical teams and especially surgeons. The use of the da Vinci surgical system entails an additional aspect of noise in the OR. The SOTOS surgical team used wired or wireless headphone/microphone combinations to communicate. We measured sound pressure levels in two different locations in the OR and the heart rate of every surgical team member as an indicator of the stress level. We further captured subjective acceptance of SOTOS as well as perioperative data such as surgical time. We prospectively randomised 32 RALP patients into two study arms. Sixteen surgeries were performed using SOTOS and 16 without (control). Overall, the mean sound pressure level in the SOTOS group was 3.6 dB lower compared to the control (p < 0.001). The highest sound pressure level measured was 96 dB in the control group. Mean heart rates were 81.3 beats/min for surgeons and 90.8 beats/min for circulating nurses. SOTOS had no statistically significant effect on mean heart rates of the operating team. Subjective acceptance of SOTO was high. Our prospective evaluation of SOTOS in RALP could show a significant noise reduction in the OR and a high acceptance by the surgical stuff.

Biochemical recurrence after radical prostatectomy: multiplicative interaction between surgical margin status and pathological stage.

PURPOSE: A positive surgical margin after radical prostatectomy is considered an adverse prognostic feature. However, few groups have explored the potential interaction between surgical margin status and other cancer characteristics, specifically pathological stage. We addressed the first degree of interaction between positive surgical margins and other established adverse predictors of biochemical recurrence after radical prostatectomy. MATERIALS AND METHODS: We used univariate and multivariate analysis to test the effect of surgical margin status on biochemical recurrence in 4,490 patients treated at a single institution between 1992 and 2008. We systematically tested all first-degree interactions between surgical margin status, and pretreatment prostate specific antigen, pT and pN stage, and radical prostatectomy Gleason sum. If interactions were significant, we quantified the effect on the biochemical recurrence rate. RESULTS: Overall 850 patients (18.9%) had positive surgical margins. In those with negative vs positive surgical margins the 5-year biochemical recurrence-free survival rate was 95% vs 83%, 74% vs 62% and 47% vs 29% for pT2, pT3a and pT3b disease, respectively. In multivariate models only the pT stage-surgical margin status interaction achieved independent predictor status (p = 0.003). Negative vs positive surgical margin multivariate HRs were 1 vs 2.9, 2.3 vs 4.3 and 4.1 vs 5.6 in pT2, pT3a and pT3b cases, respectively. CONCLUSIONS: Compared to negative surgical margins, positive surgical margins increase the absolute biochemical recurrence 5-year rate by 12% to 18%. More importantly, positive surgical margins may substantially worsen the prognosis beyond that of the original pathological disease stage.

Prognostic significance of a positive surgical margin in pathologically organ-confined prostate cancer.

OBJECTIVE: To identify risk factors of a positive surgical margin (PSM) and the significance of a PSM after radical prostatectomy (RP) on biochemical recurrence (BCR) in exclusively pathologically confirmed organ-confined (OC) prostate cancer, as despite an excellent prognosis after RP, some patients with pathologically confirmed OC disease have BCR, and the prognostic significance of a PSM in these men remains unclear. PATIENTS AND METHODS: We assessed 932 men with pathologically OC disease who were treated with RP by nine different surgeons between 1992 and 2004. The prognostic significance of clinical and pathological variables, including tumour volume (TV) and percentage of high-grade TV (%HGTV) were assessed. Logistic and Cox regression models were fitted to identify risk factors of a PSM and BCR. BCR was defined as a prostate-specific antigen (PSA) level of 0.1 ng/mL and increasing after an undetectable PSA level. RESULTS: The total PSM rate was 12.9% (120 men); the mean TV (P < 0.001), but not %HGTV (P= 0.2) was significantly higher in patients with PSM. TV, nerve-sparing RP technique and surgical volume were independent risk factors for a PSM (P= 0.03). After a median follow-up of 35 months the overall BCR rate was 8.8% (82 men). Patients with a PSM had significantly higher BCR rates (21.7% vs 6.9%; P < 0.001). In univariable analysis, a high %HGTV (70.4%) was the most informative risk factor of BCR, followed by RP Gleason score (65.8%) and PSM (65.7%). Removal of PSM from a multivariable Cox model decreased the accuracy by 12.1% (P < 0.001). CONCLUSIONS: Our findings show that in OC prostate cancer, the risk of a PSM depends on TV, surgical technique and surgical volume. PSM is a significant risk factor for BCR. However, only 20% men with OC disease and a PSM develop BCR; conversely, 80% of men are cured despite a PSM. Therefore, adjuvant therapy must be considered, with caution to avoid unnecessary overtreatment.

Differences in histopathological and biochemical outcomes in patients with low Gleason score prostate cancer.

STUDY TYPE: Diagnosis (case series). LEVEL OF EVIDENCE: 4. OBJECTIVE: To test whether the number or percentage of positive biopsy cores can be used to discriminate between patients with prostate cancer of a favourable and less favourable Gleason score (GS) < or =3 + 3, as prognostically, not all GS 3 + 3 prostate cancers are the same. PATIENTS AND METHODS: In all, 1106 consecutive patients with a prostate-specific antigen (PSA) level of < or =10 ng/mL and a biopsy GS of < or =3 + 3 or 3 + 4 had an open radical prostatectomy. The number of positive biopsy cores (< or =2 vs > or =3) were stratified into low- vs high-risk groups. Subsequently, we stratified patients according to the GS and the percentage of positive biopsy cores (<50% vs > or =50%). The pathological stage and the 5-year biochemical recurrence (BCR)-free survival rates were examined in univariable and multivariable models. RESULTS: Based on the number of positive cores, the rate of extraprostatic disease was 11.7% and 23.3%, respectively, in the low-and high-risk GS < or =3 + 3 groups (P < 0.001). The 5-year BCR-free survival rates were 95.0%, 77.8%, 81.2% and 66.5% for, respectively, low- and high-risk GS < or =3 + 3 and for low- and high-risk GS 3 + 4 patients. Univariable and multivariable intergroup BCR rate differences were statistically significant between low- vs high-risk GS 3 + 3 patients (P < 0.001), but not significant between high-risk GS < or =3 + 3 vs low-risk GS 3 + 4 patients (P = 0.6). Comparable results were obtained when comparisons were made according to the percentage of positive biopsy cores. CONCLUSIONS: Our results corroborate the finding that not all patients with a biopsy GS of < or =3 + 3 prostate cancer have low-risk disease. High-risk GS < or =3 + 3 patients have a similar risk profile as more favourable GS 3 + 4 patients. This finding warrants consideration when deciding on treatment.

The presence of prostate cancer on saturation biopsy can be accurately predicted.

OBJECTIVE: To improve the ability of our previously reported saturation biopsy nomogram quantifying the risk of prostate cancer, as the use of office-based saturation biopsy has increased. PATIENTS AND METHODS: Saturation biopsies of 540 men with one or more previously negative 6-12 core biopsies were used to develop a multivariable logistic regression model-based nomogram, predicting the probability of prostate cancer. Candidate predictors were used in their original or stratified format, and consisted of age, total prostate-specific antigen (PSA) level, percentage free PSA (%fPSA), gland volume, findings on a digital rectal examination, cumulative number of previous biopsy sessions, presence of high-grade prostatic intraepithelial neoplasia on any previous biopsy, and presence of atypical small acinar proliferation (ASAP) on any previous biopsy. Two hundred bootstraps re-samples were used to adjust for overfit bias. RESULTS: Prostate cancer was diagnosed in 39.4% of saturation biopsies. Age, total PSA, %fPSA, gland volume, number of previous biopsies, and presence of ASAP at any previous biopsy were independent predictors for prostate cancer (all P < 0.05). The nomogram was 77.2% accurate and had a virtually perfect correlation between predicted and observed rates of prostate cancer. CONCLUSIONS: We improved the accuracy of the saturation biopsy nomogram from 72% to 77%; it relies on three previously included variables, i.e. age, %fPSA and prostate volume, and on three previously excluded variables, i.e. PSA, the number of previous biopsy sessions, and evidence of ASAP on previous biopsy. Our study represents the largest series of saturation biopsies to date.