Psychometric validation of the German version of the EPIC-26 questionnaire for patients with localized and locally advanced prostate cancer.

PURPOSE: For patients with prostate cancer, validated and reliable instruments are essential for measuring patient-reported outcomes. The aim of this study was to validate the German version of the widely established Expanded Prostate Cancer Index Composite with 26 items (EPIC-26). METHODS: A German translation of the original questionnaire was tested in 3094 patients with localized or locally advanced (any T, any N and M0) prostate cancer with treatment intent (including radical prostatectomy, brachytherapy, active surveillance, watchful waiting). They completed the EPIC-26 questionnaire before treatment. A total of 521 of them also completed a questionnaire 12 months afterward. Internal consistency, sensitivity to change, and construct validity were assessed. RESULTS: The internal consistency of all domains was sufficient (Cronbach's alpha between 0.64 and 0.93). Item-to-scale correlation coefficients showed acceptable associations between items and their domain score (all > 0.30), with the lowest scores for "bloody stools" (r = 0.37) and "breast problems" (r = 0.32). Confirmatory and exploratory factor analysis confirmed the five-dimension structure of the EPIC-26 (comparative fit index 0.95). CONCLUSIONS: Psychometric evaluation suggests that the German version of the EPIC-26 is a well-constructed instrument for measuring patient-reported health-related symptoms in patients with prostate cancer.

Patient Selection in Surgical Centers of Expertise in the Treatment of Patients with Moderate to Severe Male Urinary Stress Incontinence.

OBJECTIVE: To analyze decision-making in patients with male urinary incontinence (SUI) in centers of expertise. The artificial urinary sphincter (AUS) remains the gold standard for male patients with moderate to severe SUI but adjustable male slings are a minimally invasive treatment option with good results, hence without a high level of evidence regarding the optimal patient selection. MATERIALS AND METHODS: In total, 220 patients (88 AUS; 132 adjustable slings) were investigated from the DOMINO database that underwent surgery between 2010 and 2012 in 5 urological departments that offer adjustable sling systems as well as AUS systems for patients with moderate to severe urinary incontinence. For statistical analysis, the Mann-Whitney U test was used to identify differences between both groups. RESULTS: Patients selected for an adjustable male sling were less likely to have a neurological disease (5.3 vs. 9.1%; p = 0.030), a prior urethral stricture (22.7 vs. 50.0%; p = 0.001), a prior incontinence surgery (24.4 vs. 45.5%; p = 0.01), or a prior radiation therapy (26.5 vs. 40.1%; p = 0.001). The severity of preoperative incontinence was higher in patients selected for an AUS with a mean pad usage per day of 7.60 versus 5.80 (p < 0.001). Mean postoperative pad usage and patients' subjective perception were comparable in both groups. CONCLUSION: In centers offering both options, the decision-making is mainly based upon presence of radiation therapy and previous failed incontinence surgery. Despite the more complex patient cohort selected for an AUS implantation with a possible impact on the postoperative outcome, the functional results seem to be comparable indicating a proper preoperative patient assessment and selection in this cohort.

A multicenter paper-based and web-based system for collecting patient-reported outcome measures in patients undergoing local treatment for prostate cancer: first experiences.

PURPOSE: To give an overview of the multicenter Prostate Cancer Outcomes (PCO) study, involving paper-based and web-based collection of patient-reported outcome measures (PROM) in patients undergoing local treatment for prostate cancer in certified centers in Germany. The PCO study is part of the larger Movember-funded TrueNTH Global Registry. The article reports on the study's design and provides a brief progress report after the first 2 years of data collection. METHODS: Prostate cancer centers (PCCs) certified according to German Cancer Society requirements were invited to participate in collecting patient-reported information on symptoms and function before and at least once (at 12 months) after treatment. The data were matched with disease and treatment information. This report describes progress in patient inclusion, response rate, and variations between centers relative to online/paper use, and also data quality, including recruitment variations relative to treatment in the first participating PCCs. RESULTS: PCC participation increased over time; 44 centers had transferred data for 3094 patients at the time of this report. Patient recruitment varied widely across centers. Recruitment was highest among patients undergoing radical prostatectomy. The completeness of the data was good, except for comorbidity information. CONCLUSIONS: The PCO study benefits from a quality improvement system first established over 10 years ago, requiring collection and harmonization of a predefined clinical dataset across centers. Nevertheless, establishing a PROM routine requires substantial effort on the part of providers and constant monitoring in order to achieve high-quality data. The findings reported here may be useful for guiding implementation in similar initiatives.

Secondary Sling Implantation after Failure of Primary Surgical Treatment for Male Stress Urinary Incontinence: A Retrospective Study.

OBJECTIVE: The artificial urinary sphincter (AUS) is the surgical gold standard after previously failed surgical treatment for male urinary stress incontinence. The evidence for a male sling as salvage treatment is poor, but there is a proportion of patients that refuse implantation of an AUS or have a relative contraindication. The goal of our retrospective study was an analysis of outcome and complications of patients with a secondary sling after previously failed surgery for stress urinary incontinence (SUI). MATERIALS AND METHODS: Data on 186 patients who had a prior incontinence surgery were extracted from the DOMINO database. 139 patients (74.7%) received an AUS and 41 patients (22.0%) who had received a secondary sling system between 2010 and 2012 after previously failed surgery for male urinary incontinence could be identified and were further analyzed. RESULTS: Eight patients (19.5%) received a secondary repositioning sling and 33 patients (80.5%) received a secondary adjustable sling system. A prior surgery for urethral stricture was performed in 4 patients (9.8%). No major intraoperative complications were reported. A simultaneous explantation was performed in 12 patients (29.3%). The mean number of pad reductions was 4.93 (p = 0.026). No intraoperative complications and no postoperative surgical revisions were reported. The mean follow-up of the patient cohort with a secondary sling was 16 months. CONCLUSION: We provide the largest cohort of male patients up to date with a secondary sling after primary failure of surgery for male SUI. Although the procedure is a rarely performed surgery and without a high level of evidence, a secondary adjustable male sling system might be a feasible option in selected patients with acceptable complication rates, whereas a valuable outcome regarding continence rates cannot be sufficiently supplied by our data.

Retropubic vs transobturator Argus adjustable male sling: Results from a multicenter study.

AIMS: To comparatively analyse outcomes after ARGUS classic and ArgusT adjustable male sling implantation in a real-world setting. METHODS: Inclusion criteria encompassed: non-neurogenic, moderate-to-severe stress urinary incontinence (≥2 pads), implantation of an ARGUS classic or ArgusT male sling between 2010 and 2012 in a high-volume center (>150 previous implantations). Functional outcomes were assessed using daily pad usage, 24-hour pad testing, and International Consultation on Incontinence (ICIQ-SF) questionnaires. Continence was defined as zero pads per 24 hours. Complications were graded using Clavien-Dindo scale. For multivariate analysis, binary logistic regression models were used (P < .05). RESULTS: A total of 106 patients (n = 74 [ARGUS classic], n = 32 [ArgusT]) from four centers were eligible. Median follow-up was 44.0 months (24-64). Patient cohorts were well-balanced. We observed a statistical trend in favor of ARGUS classic regarding postoperative urine loss based on standardized 24-hour pad test (71 ± 162 g [ARGUS classic] vs 160 ± 180 g [ArgusT]); P = .066]. Dry rates were 33.3% (ARGUS classic) and 11.8% (ArgusT, P = .114). In multivariable analysis, ArgusT male sling could not be confirmed as an independent predictor of decreased success (OR, 0.587; 95% CI; 0.166-2.076, P = .408). There were no Clavien IV and V complications. Inguinal pain was significantly higher after ArgusT implantation (P = .033). Explantation rates were higher for ArgusT compared to ARGUS classic (14.0 vs 23.3%; P = .371). Longer device survival for the ARGUS classic male sling was observed in Kaplan-Meier analysis (P = .198). CONCLUSIONS: In the largest comparative analysis of ARGUS classic and ArgusT male sling with the longest follow-up to date, we observed low continence rates with superior functional outcomes and decreased explantation rates after ARGUS classic implantation.

The impact of perioperative complications on favorable outcomes after artificial urinary sphincter implantation for post-prostatectomy incontinence

ABSTRACT Objective To investigate the effect of perioperative complications involving artificial urinary sphincter (AUS) implantation on rates of explantation and continence as well as health-related quality of life (HRQOL). Materials and methods Inclusion criteria encompassed non-neurogenic, moderate-to-severe stress urinary incontinence (SUI) post radical prostatectomy and primary implantation of an AUS performed by a high-volume surgeon (>100 previous implantations). Reporting complications followed the validated Clavien-Dindo scale and Martin criteria. HRQOL was assessed by the validated IQOL score, continence by the validated ICIQ-SF score. Statistical analysis included Chi (2) test, Mann-Whitney-U test, and multivariate regression models (p <0.05). Results 105 patients from 5 centers met the inclusion criteria. After a median follow-up of 38 months, explantation rates were 27.6% with a continence rate of 48.4%. In the age-adjusted multivariate analysis, perioperative urinary tract infection was confirmed as an independent predictor of postoperative explantation rates [OR 24.28, 95% CI 2.81-209.77, p=0.004). Salvage implantation (OR 0.114, 95% CI 0.02-0.67, p=0.016) and non-prostatectomy related incontinence (OR 0.104, 95% CI 0.02-0.74, p=0.023) were independent predictors for worse continence outcomes. Low visual analogue scale scores (OR 9.999, 95% CI 1,42-70.25, p=0.021) and ICIQ-SF scores, respectively (OR 0.674, 95% CI 0.51-0.88, p=0.004) were independent predictors for increased HRQOL outcomes. Perioperative complications did not significantly impact on continence and HRQOL outcomes. Conclusion Findings show postoperative infections adversely affect device survival after AUS implantation. However, if explantation can be avoided, the comparative long-term functional results and HRQOL outcomes are similar between patients with or without perioperative complications.

The AdVance and AdVanceXP male sling in urinary incontinence: is there a difference?

PURPOSE: To compare the efficacy and perioperative complications of the AdVanceXP with the original AdVance male sling. METHODS: We retrospectively enrolled 109 patients with an AdVance and 185 patients with an AdVanceXP male sling. The baseline characteristics and complication rates were analyzed retrospectively. Functional outcome and quality of life were evaluated prospectively by standardized, validated questionnaires. The Chi2-test for categorical and Mann-Whitney U test for continuous variables were performed to identify heterogeneity between the groups. RESULTS: Regarding operation time, there was no significant difference between the slings (p = 0.146). The complication rates were comparable in both groups except for postoperative urinary retention. This occurred significantly more often in patients with the AdVanceXP (p = 0.042). During follow-up, no differences could be identified regarding ICIQ-SF, PGI or I-QoL or number of pad usage. CONCLUSIONS: The AdVance and AdVanceXP are safe and effective treatment options for male stress urinary incontinence. However, the innovations of the AdVanceXP sling did not demonstrate a superiority over the original AdVance sling regarding functional outcome.

Immunotherapy for kidney cancer: status quo and the future.

PURPOSE OF REVIEW: The treatment landscape in advanced and metastatic renal cell carcinoma (RCC) is moving from the inhibition of tyrosine kinases (TKI) and the mammalian target of rapamycin (mTOR) inhibitors to specific immunooncology agents like immune checkpoint inhibitors (ICI). The review focus on the recent immunooncology developments and available trial results within the last 12 months. RECENT FINDINGS: ICI as monotherapy (nivolumab) or immunooncology and immunooncology combinations (nivolumab and ipilimumab) demonstrated positive results on prolonged overall survival in phase III trials. The combination of ICI (atezolizumab) and bevacizumab provided positive signals in prolonged PFS in the PD-L1 positive subgroup. Combinations of ICI and TKI are promising in early phase I and phase II trials. Results are currently expanded in larger phase III studies. The combination of vaccine and TKI in mRCC has not provided beneficial results so far. SUMMARY: The current treatment landscape in mRCC is shifting towards immunooncology agents, which already gained ground in the clinic as ICI monotherapy (nivolumab) or is likely to do in the near future as ICI combination (nivolumab and ipilimumab). The future will hold promise of new combinations with TKIs and ICI or other immunooncology agents like vaccines and metabolic immune checkpoint inhibitors.

The TiLOOP® Male Sling: Did We Forejudge.

INTRODUCTION: To evaluate the safety and efficacy of the TiLOOP® male sling (pfm medical, Cologne, Germany) used in the treatment for male stress urinary incontinence (SUI). MATERIAL AND METHODS: We retrospectively evaluated a total of 34 patients with a TiLOOP® male sling. Perioperative complication rates were assessed and validated questionnaires were prospectively evaluated to assess quality of life and satisfaction rate. Outcome and complication rates were analysed by using descriptive statistics. Correlation of continence outcome and risk factors was performed with the chi-square test. A p value below 0.05 was considered statistically significant. RESULTS: The majority of patients (70.6%) were diagnosed with mild or moderate male SUI. During surgery, one instance (2.9%) of intraoperative urethral injury was observed. There were no immediate postoperative complications. The mean follow-up time was 44.6 months. An improvement of male SUI was reported by 61.9% of the patients and 38.1% reported no change according the Patient Global Impression of Improvement. The mean perineal pain score was 0.5 according to the international index of pain. CONCLUSIONS: The TiLOOP® is a safe treatment option for male SUI in our cohort with a low complication rate. However, the functional outcome of the TiLOOP® was inferior when compared to the outcome of the AdVance® male sling.

Resection of metastasis and local recurrences of renal cell carcinoma after presurgical targeted therapy: probability of complete local control and outcome.

PURPOSE: To analyse probability of complete local control and outcome in patients with metastases and local recurrences who have a high probability of failure of local therapy and who were treated with presurgical targeted therapy with the intention to reconsider complete resection or other local therapies such as radiotherapy or ablation. METHOD: From two institutional databases, patients with metastatic or locally recurrent RCC were retrospectively identified who received targeted therapy based on a multidisciplinary tumour board decision because of high probability of failure of local control. RESULTS: From January 2007 until November 2014, 34 patients were treated and included in the analysis. Five patients underwent no local therapy due to insufficient downsizing to attempt resection. The probability of proceeding to local therapy was 85.3 %. Median overall survival of 29 patients with local therapy after pretreatment was 67 months (range 9-173, 95 % CI 90.87) with a median disease-free survival of 12 months (range 0-147 months). The probability to achieve complete local therapy and discontinue targeted therapy was 73.5 % (25 of 34 patients). Median time without systemic therapy was 12 months. CONCLUSION: In a retrospective series of patients with a high probability of failure of local therapy, neoadjuvant targeted therapy was associated with successful complete local treatment in approximately 70 % of patients with a time off targeted therapy of ≥1 year in 50 %. Only number of metastatic sites and the disease-free interval after treatment were associated with outcome.

Overactive bladder syndrome: an underestimated long-term problem after treatment of patients with localized prostate cancer?

UNLABELLED: Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? In this study we observed courses of micturition symptoms and differentiated degrees of symptoms for each point in time while also considering the impact of bothersomeness. Our data show that not only significantly more patients who have undergone BT suffer from OAB than those who have undergone RP, but also that those affected show significantly higher values for severity of OAB symptoms throughout the whole observation period of 36 months. Our data analysis further shows that variability of OAB symptoms as well as fluctuation of severity of OAB symptoms vary to a significantly higher degree after BT than after RP. Looking only at mean figures at a given point in time clearly underestimates the underlying problem. This fact is not reflected in the literature. OBJECTIVE: • To look at individual courses of postoperative micturition symptoms, especially urgency, in patients treated either with radical prostatectomy (RP) or with brachytherapy (BT). PATIENTS AND METHODS: • In a prospective longitudinal study we investigated individual changes in micturition symptoms before treatment, and 6, 12, 24 and 36 months after treatment. • All patients received the European Organization for the Research and Treatment of Cancer quality-of-life questionnaire, QLQ-C30, and the International Continence Society male questionnaire at each assessment. • We looked at long-term results as well as changes in time using repeated measures analysis of variance. We further analysed fluctuation of symptoms using sum of changes. RESULTS: • Of the 389 patients treated consecutively in our clinic over the last few years, 99 patients with a mean (sd) age of 65 (6.3) years had completed all five questionnaires and thus were further analysed. Of these, 66 (66.7%) were treated with RP and 33 (33.3%) with BT. • With the exception of age, no significant difference was found between the treatment groups either in physical functioning or in prevalence and severity of overactive bladder (OAB) symptoms. • Adjusted for age and pretreatment symptoms in analysis of covariance, we found that there were statistically more symptoms of OAB 36 months after BT compared with those patients treated with RP (P < 0.025). Whereas 30% of patients complained about severe symptoms of urgency after BT, only 11% did so after RP. • Changes of severity of OAB symptoms over the course of time (P < 0.007) using analysis of repeated measures as well as variability of OAB symptoms (P < 0.033) using the two-sided Wilcoxon t-test were significantly higher in patients treated with BT than in patients treated with RP. CONCLUSIONS: • Independently of age and physical functioning, BT is significantly associated with higher rates of long-term urgency symptoms, even after 3 years. • Repeated measurements show that OAB symptoms are highly fluctuating and that in patients treated with BT, severity of symptoms as well as variability of symptoms was significantly higher than in those patients treated with RP. • Persistent OAB seems to be an underestimated problem after treatment for localized prostate cancer, especially in patients treated with BT.

Percentage of positive biopsies predicts lymph node involvement in men with low-risk prostate cancer undergoing radical prostatectomy and extended pelvic lymphadenectomy.

OBJECTIVE: To evaluate preoperative predictive risk factors associated with lymph node metastases (LNM) in a cohort of low-risk prostate cancer (PCA) patients. PATIENTS AND METHODS: The charts of 499 patients were retrospectively reviewed to identify prognostic risk factors for the presence of LNM. Pathohistological data and Gleason score of the radical prostatectomy (RP) specimen, number of removed nodes, number of positive lymph nodes, and anatomical distribution of LNM were tabulated and evaluated. A correlation between clinical stage, preoperative serum prostate-specific antigen (PSA), biopsy Gleason score, number of biopsies taken, percentage of positive biopsies and the presence of LNM were calculated. All 499 men underwent retropubic RP and extended pelvic lymphadenectomy (EPLND). RESULTS: LNM were identified in 29 (5.8%) patients. A prediction model based on clinical stage, PSA, and biopsy Gleason score had a predictive accuracy of 79.2%. The addition of number of positive biopsies and % positive cores improved its predictive accuracy to 81.5% and 87.8%, respectively. The predicted frequency of LNM by the original nomogram was 7.4% and differed by less than 3% with the actual observation of LNM. The predictive accuracy of the nomogram was 81.5% as compared with 87.8% of the prediction model of this study. CONCLUSIONS: The percentage of positive cores involved with PCA is the most reliable predictor of LNM and indicates the need for EPLND. The Briganti nomogram has been validated and a general applicability for predicting the presence of LNM was proven.

Do alpha-reductase inhibitors prevent prostate cancer? 2008 practice guideline from the American society of clinical oncology and American urological association.

As new guidelines on the use of 5-alpha-reductase inhibitors (5-ARIs) for prostate cancer chemoprevention produced by the American Society of Clinical Oncology (ASCO) and American Urological Association (AUA) have recently been published, the use of 5-ARIs is becoming of increasing interest. We analyzed the current evidence to support the use of 5-ARIs in the prevention of prostate cancer. We therefore compared the new guidelines of the ASCO and AUA with the current data concerning the use of 5-ARIs in the prevention of prostate cancer. At present, there is still an open debate going on whether or not it is advisable to incorporate the use of 5-ARIs as chemopreventive agents in daily practice.

Solitary fibrous tumor of the kidney: a case report.

A solitary fibrous tumor of the kidney is a rare neoplasm that was often misdiagnosed as hemangiopericytoma, until recently. We report a case of a 35-year-old male patient with a solid, 7 cm tumor located centrally in a solitary right kidney. The patient underwent successful bench surgery and autotransplantation.

Interventional management of a renal cell carcinoma by radiofrequency ablation with tagging and cooling.

Over the last few years, percutaneous radiofrequency (RF) ablation has been successfully established as a viable treatment modality for small peripheral renal cell carcinoma (RCC). This technique is limited by central tumor location and tumor size. We report the interventional management of a 5.3 cm mixed RCC with central and exophytic parts by combining the RF ablation with embolization, tagging, and retrograde, as well as anterograde cooling. The potential pitfalls of complex hybrid interventions for treating RCC are discussed.

Endosew: new device for laparoscopic running sutures.

PURPOSE: In 2002, the first completely laparoscopic cystectomy and orthotopic ileal neobladder procedure was reported to take more than 10 hours, with the most time-consuming portion being suturing. Therefore, to improve the quality and reduce the time to place running sutures, we developed a new sewing device for laparoscopic use. MATERIALS AND METHODS: We compared running sutures made by hand with those made by machine in the ilea of six pigs. The tightness of the closures was examined and the suturing time recorded. Two animals each were sacrificed after 3, 6, and 9 days, and then the explanted ilea were examined at both the macroscopic and microscopic levels. RESULTS: No animal died during the course of the experiment and no leaks were found postoperatively. Moreover, no significant differences were seen on macroscopic or microscopic examination in the quality of the two sets of sutures. The time taken to place 1 cm of running suture, including initial preparation, was 7.2 and 3 minutes for hand and machine suturing, respectively. The hand sutures were always initially tight, whereas those placed by machine required adjustment to stop leaks on four occasions. CONCLUSION: Using the Endosew device reduces the time needed to place running sutures by 2.4-fold. The quality of the hand- and machine-made sutures was nearly identical at both the macroscopic and microscopic level. Thus, the functionality of this new sewing device is more than satisfactory, and the amount of time saved by using it far outweighs the need for occasional adjustments to stop suture leakage.

Percutaneous radiofrequency ablation for treatment of recurrent retroperitoneal liposarcoma.

Percutaneous CT-guided radiofrequency ablation (RFA) is becoming more and more established in the treatment of various neoplasms, including retroperitoneal tumors of the kidneys and the adrenal glands. We report the case of RFA in a patient suffering from the third relapse of a retroperitoneal liposarcoma in the left psoas muscle. After repeated surgical resection and supportive radiation therapy of a primary retroperitoneal liposarcoma and two surgically treated recurrences, including replacement of the ureter by a fraction of the ileum, there was no option for further surgery. Thus, we considered RFA as the most suitable treatment option. Monopolar RFA was performed in a single session with a 2-cm umbrella-shaped LeVeen probe. During a 27-month follow-up period the patient remained free of tumor.

Laparoscopic heminephrectomy and resection of ectopic ureter in an adult.

We report a unique case of a duplex kidney and ectopic ureter presenting as a cystic tumor of the seminal vesicle with consecutive dysuria in an adult. The medical history of the patient, the diagnostic pathway and the laparoscopic treatment as well as the key points in laparoscopic surgery are described.

Different types of scaffolds for reconstruction of the urinary tract by tissue engineering.

INTRODUCTION: Tissue engineering is an important and expanding field in reconstructive surgery. The ideal biomaterial for urologic tissue engineering should be biodegradable and support autologous cell growth. We examined different scaffolds to select the ideal material for the reconstruction of the bladder wall by tissue engineering. MATERIALS AND METHODS: We seeded mouse fibroblasts and human keratinocytes in a co-culture model on 13 different scaffolds. The cell-seeded scaffolds were fixed and processed for electron microscopy, hematoxylin and eosin stain, and immunohistochemistry. Cell density and epithelial cell layers were evaluated utilizing a computer-assisted optical measurement system. RESULTS: Depending on the growth pattern, scaffolds were classified into the following three distinct scaffold types: carrier-type scaffolds with very small pore sizes and no ingrowth of the cells. This scaffold type induces a well-differentiated epithelium. Fleece-type scaffolds with fibers and huge pores. We found cellular growth inside the scaffold but no epithelium on top of it. Sponge-type scaffolds with pores between 20 and 40 microm. Cellular growth was observed inside the scaffold and well-differentiated epithelium on top of it. CONCLUSION: To our knowledge, this is the first time three distinct scaffold types have been reported. All types supported the cell growth. The structure of the scaffolds affects the pattern of cell growth.