Association between PRO 160/120 prescriptions and incidence of benign prostatic hyperplasia complications in Germany: a retrospective cohort study.

The present study aims to analyze the impact of PRO 160/120 prescriptions on the incidence of urinary incontinence, polyuria (including nocturia), urinary retention, and erectile dysfunction in a real-world setting in Germany and to compare these data with data for the 5-ARIs finasteride and dutasteride, and the α1-adrenoceptor antagonists tamsulosin and tamsulosin/dutasteride fixed-dose combination. This retrospective study was based on the IQVIA Disease Analyzer database and included male patients with an initial prescription of PRO 160/120, finasteride, dutasteride, tamsulosin, or tamsulosin/dutasteride fixed-dose combination between January 2010 and September 2020. Multivariable logistic regression analyses adjusted for age, health insurance, specialty, and relevant co-diagnoses were performed to estimate the association between PRO 160/120 prescriptions and incidence of pre-defined outcomes. A total of 77,923 patients were included in the study, 3,035 of whom received PRO 160/120. PRO 160/120 was significantly associated with reduced incidence of urinary incontinence (OR: 1.48; 95% CI: 1.10-1.98) and urinary retention compared to tamsulosin (OR: 3.39; 95% CI: 1.75-6.57 and tamsulosin/dutasteride (OR: 2.81; 95% CI: 1.35-5.82). Furthermore, PRO 160/120 significantly reduced the incidence of erectile dysfunction compared to dutasteride (OR: 2.79; 95% CI: 1.49-5.25). At the same time, patients receiving PRO 160/120 showed the same incidence of the remaining complications as those taking the reference substances. In conclusion, we observed a significant association between PRO 160/120 prescription and reduced incidence of urinary incontinence and urinary retention compared to tamsulosin and tamsulosin/dutasteride, as well as reduced incidence of erectile dysfunction compared to dutasteride.

[A (new) revolution in the treatment of benign prostatic hyperplasia? Aqua-ablation and prostate embolization]. / (Wieder) eine Revolution in der Therapie des benignen Prostatasyndroms? Aquaablation und Prostataembolisation.

Surgical treatment of benign prostatic obstruction (BPO) is one of the most common procedures in urology. Numerous alternative methods have been developed in recent years to overcome the potential limitations of transurethral resection of the prostate (TURP) while providing comparable effectiveness and less morbidity. In a randomized study with a currently available follow-up of 3 years, the Aquabeam® system has shown comparable functional results with a lower rate of adverse events compared to TURP. Sufficient functional results were also found in a cohort study in patients with prostate volumes up to 150 ml. However, the rate of transfusions raises the question of optimal coagulation. Further cohort studies with short-term follow-up confirmed the results of the randomized studies. Prostate artery embolization (PAE) has been compared to TURP in several randomized trials. In randomized studies, the reduction of BPO-associated symptoms after PAE is only slightly inferior to that after TURP. In contrast, the improvement of functional parameters after embolization is inferior to that after TURP. This is primarily due to the inferior desobstruction. In addition, long-term results from randomized studies are lacking, so that no final assessment has yet been possible with regard to the durability of the desobstruction. In summary, both Aquabeam® and PAE are potential alternatives to standard methods, which-in case of adequate patient selection-can supplement the operative armamentarium in the wider concept of an individualized therapy of BPO.

[Surgical treatment of benign prostatic hyperplasia-resection, vaporization or enucleation?] / Operative Therapie des benignen Prostatasyndroms ­ resezieren, vaporisieren oder enukleieren?

BACKGROUND: Benign prostatic hyperplasia (BPH) is the most common condition affecting the male lower urinary tract. Besides transurethral resection of the prostate (TURP), vaporization of the prostate and endoscopic enucleation of the prostate are available. OBJECTIVES: To provide an overview of the current status of surgical therapies for BPH. MATERIALS AND METHODS: Narrative review of the literature on the surgical treatment of BPH. RESULTS: Besides TURP, which still can be regarded as the reference technique for surgical treatment of BPH in men with a prostate volume <80 cc, greenlight laser vaporization of the prostate (GLV) and endoscopic enucleation of the prostate (EEP) are established and evidence-based alternatives. A multitude of prospective randomized trials could show comparable functional outcomes of GLV or EEP in comparison to TURP. Based on lower comorbidity and comparable outcomes, bipolar TURP rather than monopolar TURP should be regarded as the surgical reference technique. In patients with ongoing oral anticoagulation of thrombocyte aggregation inhibition, GLV provides high intra- und postoperative safety. Endoscopic enucleation of the prostate is the only transurethral surgical method which provides high level evidence concerning safety and efficacy in patients with prostates >80 cc. CONCLUSIONS: Choice of surgical treatment of BPH should be individualized and based on prostate size, comorbidities and surgical experience.

[Diagnostic procedures and diagnostic strategy for lower urinary tract symptoms/benign prostatic hyperplasia : An overview]. / Diagnostik und diagnostische Strategie beim benignen Prostatasyndrom : Ein Überblick.

BACKGROUND: Lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) is the most common condition affecting the lower urinary tract of men. Evidence-based assessment is the basis for an ideal treatment approach. OBJECTIVES: To provide an overview of the current status of diagnostic measures for LUTS/BPH. MATERIALS AND METHODS: Descriptive review of the literature on the diagnosis of LUTS/BPH. RESULTS: A medical history inquiring about LUTS/BPH symptoms and burden as well as a standardized and validated symptom questionnaire such as the International Prostate Symptom Score (IPSS) are the basis of the assessment. A physical examination including a rectal exam and the ultrasonography of the lower and upper urinary tract are also part of the basic diagnostic workup. Prostate size is ideally measured by transrectal ultrasound. Serum prostate-specific antigen measurement may help to estimate the prostate size and the risk fo progression. It can also be helpful in the detection of prostate cancer. Urine dipstick or sediment is used to exclude urinary tract infection, hematuria, or glucosuria. Voiding dysfunction can be detected by uroflowmetry. In addition to the aforementioned examinations, further tests such as frequency-voiding charts, multichannel urodynamic evaluation, measurement of detrusor wall thickness and X­ray imaging of the upper urinary tract as well as a cystoscopy may be offered if needed. CONCLUSIONS: Diagnostics of LUTS/BPH consist of basic exams as well as optional exams and can be used to assess the progression risk, to identify complications and to offer the ideal treatment.

Aquablation of the prostate: single-center results of a non-selected, consecutive patient cohort.

PURPOSE: Aquablation of the prostate using the AquaBeam™ system promises equivalent functional outcomes, reduced learning curve, and improved sexual function compared to transurethral prostate resection as shown in prospective randomized trials. This prospective cohort study aims to evaluate if published results can be transferred into the clinical routine in a non-selected patient collective. METHODS: This study includes all patients treated between September 2017 and June 2018 with Aquablation of the prostate. Patients have been evaluated prospectively for the perioperative course and early follow-up. Besides voiding parameter and symptom score, TRUS-volume change, ejaculatory function, and adverse events have been recorded. RESULTS: 118 consecutive patients have been treated in the given time. Aquablation could be carried out successfully in all patients. IPSS, QoL, Qmax, and PVR improved significantly after the procedure and continued to improve during 3-month follow-up. Mean OR time was 20 min, TRUS volume decreased by 65%, and 73% of the patients retained antegrade ejaculation. Thirteen adverse events (> Clavien-Dindo I) occurred in 10 patients. CONCLUSION: The surgical ablation of the prostate using Aquablation achieved significant and immediate improvement of functional voiding parameters Qmax and PVR as well as symptomatic improvement of IPSS and QoL. Aquablation seems to be safe and effective with a low perioperative complication profile even in a non-selected group of patients.

[Long-term results after prostate vaporisation : GreenLight™ laser vaporisation of the prostate and electrovaporisation]. / Langzeitergebnisse nach Vaporisation der Prostata : GreenLight™-Laservaporisation der Prostata und Elektrovaporisation.

BACKGROUND: Various minimally invasive techniques are available for the surgical treatment of benign prostatic obstruction. Besides resection and enucleation, vaporization of the prostate is an attractive alternative. OBJECTIVES: The aim of the present article is to provide a comprehensive literature review on long-term results of GreenLight™ laser vaporisation and electrovaporisation of the prostate. MATERIALS AND METHODS: A literature search on long-term (≥5 years) results of GreenLight™ laser vaporization of the prostate and electrovaporisation of the prostate. RESULTS: Laser vaporization of the prostate with the GreenLight™ laser leads to an immediate and long-lasting improvement of voiding symptoms beyond 5 years. Currently, no long-term data of the 180 W laser model are available. With the former 80 W laser, an increased rate of reoperation due to recurrent obstruction has been described. As reoperation mainly occurs within the first 2 postoperative years, this suggests insufficient tissue ablation. Electrovaporisation of the prostate also leads to an improvement of voiding symptoms. However, only few studies on long-term results are available which report a relatively high rate of treatment failure. In addition, these studies have limitations in study design. CONCLUSIONS: Laser vaporisation of the prostate with the GreenLight™ laser seems to be an effective minimally invasive treatment alternative for BPO. However, long-term results of the current 180 W laser are still awaited. Based on limited data, electrovaporisation of the prostate currently cannot be recommended as an established treatment alternative.

Evaluation of perioperative complications in open and laparoscopic surgery for renal cell cancer with tumor thrombus involvement using the Clavien-Dindo classification.

OBJECTIVE: To identify risk factors for perioperative complications and morbidity in renal cell cancer (RCC) surgery with tumor thrombus invasion (TTI). PATIENTS AND METHODS: Retrospective single-center analysis of 128 patients who underwent open (n = 97) or laparoscopic (n = 31) radical nephrectomy (NT) for RCC between 1999 and 2010. TTI was at Mayo-Level 0, I, II, III, IV in 88, 7, 10, 4, and 19 cases, respectively. Cavotomy was performed in 27, liver mobilisation in 20, and cardiovascular bypass in 17 patients. RESULTS: The rate of any early postoperative complication (PC) by Clavien-Dindo classification was 58.6%, while the severe early PC rate was 29.7%. There was a statistically significant difference in multivariate analysis in the incidence of any early PC and of severe early PC by Charlson score (OR:1.584 (95%CI:1.141-2.199), p = 0.006; OR:3.065 (95%CI:1.218-7.714), p = 0.017) and by tumor thrombus level TNM-UICC 2010 T3a/T3c (OR:10.668 (95%CI:1.266-89.871), p = 0.029; OR:10.502 (95%CI:2.981-36.992), p < 0.001). In pT3a cases open NT was associated with a higher early (57.9% vs. 25.8%) and severe (24.6% vs. 9.7%) PC rate compared to laparoscopic NT. The 30-day mortality rate was 0%. The 90-day mortality rate was 6.3% but 100% cancer-related. In Cox regression analysis tumor thrombus level was not predictive for overall survival. CONCLUSIONS: The strongest risk factor for early and severe PC in patients with TTI is a supradiaphragmatic tumor thrombus. In cases with severe PC, this fact persists when comparing Mayo-Levels II-III and Level IV. In pT3a cases open NT shows a 2-fold higher early PC rate compared to laparoscopic NT.

Clinical nodal staging scores for prostate cancer: a proposal for preoperative risk assessment.

BACKGROUND: Pelvic lymph node dissection in patients undergoing radical prostatectomy for clinically localised prostate cancer is not without morbidity and its therapeutical benefit is still a matter of debate. The objective of this study was to develop a model that allows preoperative determination of the minimum number of lymph nodes needed to be removed at radical prostatectomy to ensure true nodal status. METHODS: We analysed data from 4770 patients treated with radical prostatectomy and pelvic lymph node dissection between 2000 and 2011 from eight academic centres. For external validation of our model, we used data from a cohort of 3595 patients who underwent an anatomically defined extended pelvic lymph node dissection. We estimated the sensitivity of pathological nodal staging using a beta-binomial model and developed a novel clinical (preoperative) nodal staging score (cNSS), which represents the probability that a patient has lymph node metastasis as a function of the number of examined nodes. RESULTS: In the development and validation cohorts, the probability of missing a positive lymph node decreases with increase in the number of nodes examined. A 90% cNSS can be achieved in the development and validation cohorts by examining 1-6 nodes in cT1 and 6-8 nodes in cT2 tumours. With 11 nodes examined, patients in the development and validation cohorts achieved a cNSS of 90% and 80% with cT3 tumours, respectively. CONCLUSIONS: Pelvic lymph node dissection is the only reliable technique to ensure accurate nodal staging in patients treated with radical prostatectomy for clinically localised prostate cancer. The minimum number of examined lymph nodes needed for accurate nodal staging may be predictable, being strongly dependent on prostate cancer characteristics at diagnosis.

Association of perioperative blood transfusion with oncologic outcomes after radical nephroureterectomy for upper tract urothelial carcinoma.

BACKGROUND: To test the hypothesis that perioperative blood transfusion (PBT)impacts oncologic outcomes of patients treated with radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC). METHODS: Retrospective analysis of 2492 patients with UTUC treated at 23 institutions with RNU between 1987 and 2007.Cox regression models addressed the association of PBT with disease recurrence, cancer-specific mortality and any-cause mortality. RESULTS: A total of 510 patients (20.5%) patients received PBT. Within a median follow-up of 36 months (Interquartile range: 55 months), 663 (26.6%) patients experienced disease recurrence, 545 patients (21.9%) died of UTUC and 884 (35.5%) patients died from any cause. Patients who received PBT were at significantly higher risk of disease recurrence, cancer-specific mortality and overall mortality than patients not receiving PBT in univariable Cox regression analyses. In multivariable Cox regression analyses that adjusted for the effects of standard clinicopathologic features, PBT did not remain associated with disease recurrence (HR: 1.11; 95% CI 0.92-1.33, p = 0.25), cancer-specific mortality (HR: 1.09; 95% CI 0.89-1.33, p = 0.41) or overall mortality (HR: 1.09; 95% CI 0.93-1.28, p = 0.29). CONCLUSIONS: In patients undergoing RNU for UTUC, PBT is associated with disease recurrence, cancer-specific survival or overall survival in univariable, but not in multivariable Cox regression analyses.

[Renal aspergilloma: retroperitoneoscopic resection as a minimally invasive organ preservation treatment option]. / Renales Aspergillom: Retroperitoneoskopische Exzision als minimal-invasive organerhaltende Therapieoption.

Aspergillus infections frequently affect immunocompromised patients and are associated with high mortality. We report the case of a renal aspergilloma in a bone marrow transplant recipient. Treatment is challenging and requires a combination of systemic antifungal therapy and surgery. In the present case, a minimally invasive retroperitoneoscopic resection of the aspergilloma was performed.

Diabetes mellitus without metformin intake is associated with worse oncologic outcomes after radical nephroureterectomy for upper tract urothelial carcinoma.

AIMS: Evidence suggests a detrimental effect of diabetes mellitus (DM) on cancer incidence and outcomes. To date, the effect of DM and its treatment on prognosis in upper tract urothelial carcinoma (UTUC) remains uninvestigated. We tested the hypothesis that DM and metformin use impact oncologic outcomes of patients treated with radical nephroureterectomy (RNU) for UTUC. METHODS: Retrospective analysis of 2492 patients with UTUC treated at 23 institutions with RNU without neoadjuvant therapy. Cox regression models addressed the association of DM and metformin use with disease recurrence, cancer-specific mortality and any-cause mortality. RESULTS: A total of 365 (14.3%) patients had DM and 194 (7.8%) patients used metformin. Within a median follow-up of 36 months, 663 (26.6%) patients experienced disease recurrence, 545 patients (21.9%) died of UTUC and 884 (35.5%) patients died from any cause. Diabetic patients who did not use metformin were at significantly higher risk of disease recurrence and cancer-specific death compared to non-diabetic patients and diabetic patients who used metformin. In multivariable Cox regression analyses, DM treated without metformin was associated with worse recurrence-free survival (HR: 1.44, 95% CI 1.10-1.90, p = 0.009) and cancer-specific mortality (HR: 1.49, 95% CI 1.11-2.00, p = 0.008). CONCLUSIONS: Diabetic UTUC patients without metformin use have significantly worse oncologic outcomes than diabetics who used metformin and non-diabetics. The possible mechanism behind the impact of DM on UTUC biology and the potentially protective effect of metformin need further elucidation.

Impact of statin use on biochemical recurrence in patients treated with radical prostatectomy.

BACKGROUND: The impact of statin use on biochemical recurrence (BCR) in patients treated with radical prostatectomy (RP) remains controversial. METHODS: We retrospectively evaluated 6842 patients who underwent RP for clinically localized prostate cancer (PC) between 2000 and 2011. Uni- and multivariable cox regression models addressed the association of statin use with BCR. RESULTS: Overall, 2275 (33.3%) patients used statins. Statin users were older and had a higher rate of positive surgical margins than patients not using statins (P-values 0.05). Within a median follow-up of 25 months (interquartile range: 8-42 months), 778 (11.4%) patients experienced BCR. Actuarial estimate 5-years BCR-free survival was 82%±1 for patients without statin use and 84±1% for patients using statins (P=0.05); statin use was not associated with BCR (hazard ratio: 0.88, 95% confidence interval: 0.76-1.03, P=0.10) after adjusting for the effects of standard clinicopathologic features. CONCLUSIONS: In PC patients undergoing RP, statin use was not independently associated with lower risk of BCR.

[Areas of application of isothermal microcalorimetry in urology: an overview]. / Anwendungsbereiche der isothermalen Mikrokalorimetrie in der Urologie : Eine Übersicht.

Isothermal microcalorimetry (IMC) is a nonspecific analytical tool for measurement of heat. With sensitivity in the order of 0.2 µW, IMC can detect very small amounts of heat produced by only a small number of microorganisms or eukaryotic cells. This report is intended to introduce IMC to the urological audience and to give an overview about the past, present and future of this cutting edge technology in the urological context.

[Laservaporization of the prostate: current status of the greenlight and diode laser]. / Laservaporisation der Prostata : Aktueller Stellenwert des Greenlight- und Diodenlasers.

In the last decade laser vaporization of the prostate has emerged as a safe and effective alternative to transurethral resection of the prostate (TURP). This was facilitated in particular by the introduction of photoselective vaporization of the prostate (PVP) with a 532 nm 80 W KTP laser in 2002. Prospective randomized trials comparing PVP and TURP with a maximum follow-up of 3 years mostly demonstrated comparable functional results. Cohort studies showed a safe application of PVP in patients under oral anticoagulation and with large prostates. Systems from various manufacturers with different maximum power output and wavelengths are now available for diode laser vaporization of the prostate. Prospective randomized trials comparing diode lasers and TURP are not yet available. In cohort studies and comparative studies PVP diode lasers are characterized by excellent hemostatic properties but functional results vary greatly with some studies reporting high reoperation rates.

Increasing prevalence of ciprofloxacin resistance in extended-spectrum-ß-lactamase-producing Escherichia coli urinary isolates.

PURPOSE: To describe the incidence and drug susceptibility profiles of uropathogenic extended-spectrum-ß-lactamase-producing Escherichia coli (ESBL-EC) during a 10-year period and to identify differences in resistance patterns between urological and non-urological ESBL-EC isolates. METHODS: Retrospective analysis of 191,564 urine samples obtained during 2001 to 2010 at the University Hospital Basel, Switzerland. The computerized database of the Clinical Microbiology Laboratory and the Division of Infectious Diseases and Hospital Epidemiology was used to identify ESBL-EC positive urine samples. ESBL-EC isolates were stratified according their origin into two groups: Urology and non-Urology isolates. RESULTS: The rate of ESBL-EC positive urine samples increased significantly during the study period (3 in 2001 compared to 55 in 2010, p < 0.05). The most active agents were imipenem, meropenem, and fosfomycin (100%), followed by amikacin (99.1%) and nitrofurantoin (84%). The least active substances were ampicillin-clavulanate (20%), sulfamethoxazole (28%), and ciprofloxacin (29.6%). ESBL-EC isolates from urological and non-urological patients showed similar susceptibility profiles. However, ESBL-EC isolates from urological patients were significantly less susceptible to ciprofloxacin compared to non-urological isolates (14.7 vs. 32.7%, p < 0.05). CONCLUSIONS: The rate of urinary ESBL-EC isolates is increasing. Their susceptibility to nitrofurantoin, fosfomycin, and carbapenems is excellent, whereas ampicillin-clavulanate, sulfamethoxazole, and ciprofloxacin demonstrate only low susceptibility. In particular, the use of ciprofloxacin should be strictly avoided in urologic patients with suspicion for an ESBL-EC urinary tract infection as well as routine antibiotic prophylaxis prior to urological interventions if not explicit indicated by current international guidelines or local resistance patterns.

Comparison of the roll-plate and sonication techniques in the diagnosis of microbial ureteral stent colonisation: results of the first prospective randomised study.

BACKGROUND: Microbial ureteral stent colonisation (MUSC) is one leading risk factor for complications associated with ureteral stent placement. As MUSC remains frequently undetected by standard urine cultures, its definitive diagnosis depends on microbiological investigation of the stent. However, a standard reference laboratory technique for studying MUSC is still lacking. MATERIALS AND METHODS: A total of 271 ureteral stents removed from 199 consecutive patients were investigated. Urine samples were obtained prior to device removal. Stents were divided into four parts. Each part was separately processed by the microbiology laboratory within 6 h. Ureteral stents were randomly allocated to roll-plate or sonication, respectively, and analysed using standard microbiological techniques. Demographic and clinical data were prospectively collected using a standard case-report form. RESULTS: Overall, roll-plate showed a higher detection rate of MUSC compared with sonication (35 vs. 28 %, p < 0.05) and urine culture (35 vs. 8 %, p < 0.05). No inferiority of Maki's technique was observed even when stents were stratified according to indwelling time below or above 30 days. Compared with roll-plate, sonication commonly failed to detect Enterococcus spp., coagulase-negative staphylococci (CoNS) and Enterobacteriaceae. In addition, sonication required more hands-on time, more equipment and higher training than roll-plate in the laboratory. CONCLUSIONS: This prospective randomised study demonstrates the superiority of Maki's roll-plate technique over sonication in the diagnosis of MUSC and that urine culture is less sensitive than both methods. The higher detection rate, simplicity and cost-effectiveness render roll-plate the methodology of choice for routine clinical investigation as well as basic laboratory research.

Microbial ureteral stent colonization in renal transplant recipients: frequency and influence on the short-time functional outcome.

Ureteral stent insertion at the time of renal transplantation significantly decreases complications of urine leakage and obstruction, but bears an intrinsic risk of microbial colonization. Associated urinary tract infection (UTI) may pose a significant risk for graft infection and subsequent graft failure, in particular, during high-level immunosuppression in the early phase after transplantation. The aims of this prospective study were (i) to assess the frequency of microbial ureteral stent colonization (MUSC) in renal transplant recipients by sonication, (ii) to compare the diagnostic value of sonication with that of conventional urine culture (CUC), (iii) to determine biofilm forming organisms, and (iv) to investigate the influence of MUSC on the short-time functional outcome. A total of 80 ureteral stents from 78 renal transplant recipients (deceased donors n = 50, living donors n = 28) were prospectively included in the study. CUC was obtained prior to renal transplantation and at ureteral stent removal. In addition, a new stent sonication technique was performed to dislodge adherent microorganisms. CUCs were positive in 4% of patients. Sonicate-fluid culture significantly increased the yield of microbial growth to 27% (P < 0.001). Most commonly isolated microorganisms by sonication were Enterococcus species (31%), coagulase-negative staphylococci (19%), and Lactobacillus species (19%), microorganisms not commonly observed in UTIs after renal transplantation. The median glomerular filtraton rate (GFR) of the study population increases from 39 mL/min immediately after transplantation (time point A) to 50 mL/min 6 month post transplantation (time point B). In patients without MUSC, the GFR improves from 39 mL/min (A) to 48 mL/min (B) and in patients with MUSC from 39 mL/min (A) to 50 mL/min (B), respectively. In summary, MUSC in renal transplant recipients is common and remains frequently undetected by routine CUC, but colonization had no measurable effect on renal function.