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Contains fulltext : 244306.pdf (Publisher’s version ) (Open Access) Patients are the stewards of their own care and hence their voice is important when designing and implementing research. Patients should be involved not only as participants in research that impacts their care, as the recipients of that care and any associated harms, but also as research collaborators in prioritising important questions from the patient perspective and designing the research and the ways in which is it most appropriate to involve patients. The PIONEER Consortium, an international multistakeholder collaboration lead by the European Association of Urology, has developed a core outcome set (COS) for localised and metastatic prostate cancer relevant to all stakeholders in particular patients. Throughout the work of PIONEER, patient representatives were involved as collaborators in setting the research agenda, and a wider group of patients was involved as participants in developing COSs, for instance in consensus meetings on choosing important outcomes and appropriate definitions. This publication showcases the process for COS development and highlights the most important recommendations to ultimately inform future research projects co-created between patients and other stakeholders. PATIENT SUMMARY: An important step in involving patients in the selection of outcomes for clinical trials, clinical audits, and real-world evidence is the development of a core outcome set (COS) that is relevant to all stakeholders. This report highlights the patient participation throughout our PIONEER COS development. TAKE HOME MESSAGE: An important step in involving patients in the selection of outcomes for clinical trials, clinical audits, and real-world evidence is to develop a core outcome set (COS) that is relevant to all stakeholders. As part of the work of the PIONEER Consortium, we aim to highlight the patient participation throughout our PIONEER COS development.

Background Recommendations against prostate-specific antigen (PSA) testing in 2012 have increased advanced-stage diagnosis and prostate cancer–specific mortality rates. Objective To present the position of the European Association of Urology (EAU) in 2021 and provide recommendations for the use of PSA testing as part of a risk-adapted strategy for the early detection of prostate cancer. Evidence acquisition The authors combined their review of relevant literature, including the EAU prostate cancer guidelines 2021 update, with their own knowledge to provide an expert opinion, representing the EAU’s position in 2021. Evidence synthesis The EAU has developed a risk-adapted early prostate cancer detection strategy for well-informed men based on PSA testing, risk calculators, and multiparametric magnetic resonance imaging, which can differentiate significant from insignificant prostate cancer. This approach largely avoids the overdiagnosis/overtreatment of men unlikely to experience disease-related symptoms during their lifetime and facilitates an early diagnosis of men with significant cancer to receive active treatment. It also reduces advanced-stage diagnosis, thereby potentially reducing prostate cancer–specific mortality and improving quality of life. Education is required among urologists, general practitioners, radiologists, policy makers, and healthy men, including endorsement by the European Commission to adapt the European Council’s screening recommendations in its 2022 plan and requests to individual countries for its incorporation into national cancer plans. Conclusions This risk-adapted approach for the early detection of prostate cancer will reverse current unfavourable trends and ultimately save lives. Patient summary The European Association of Urology has developed a patient information leaflet and algorithm for the early diagnosis of prostate cancer. It can identify men who do not need magnetic resonance imaging or a biopsy and those who would not show any symptoms versus those with more aggressive disease who require further tests/treatment. We need to raise awareness of this algorithm to ensure that all well-informed men at risk of significant prostate cancer are offered a prostate-specific antigen test. Take Home Message A risk-adapted early prostate cancer detection strategy, incorporating prostate-specific antigen testing, multiparametric magnetic resonance imaging, risk calculators, and biomarkers, will avoid overdiagnosis/overtreatment of insignificant cancers and ensure early detection and treatment of significant cancers, thereby improving quality of life and reducing prostate cancer–related deaths.

Objective To understand the barriers and facilitators to single instillation of intravesical chemotherapy (SI-IVC) use following resection of non-muscle-invasive bladder cancer (NMIBC) in Scotland and England using a behavioural theory-informed approach. Materials and methods In a cross-sectional descriptive study of practices at seven hospitals, we investigated care pathways, policies, and interviewed 30 urology staff responsible for SI-IVC. We used the Theoretical Domains Framework (TDF) to organise our investigation and conducted deductive thematic analyses, while inductively coding emergent beliefs. Results Barriers to SI-IVC were present at different organisational levels and professional roles. In four hospitals there was a policy to not instil SI-IVC in theatre. Six hospitals' staff reported delays in MMC ordering and/or local storage. Lack of training, skills and perceived workload affected motivation. Facilitators included access to modern instilling devices (four hospitals) and incorporating reminders operation pro-forma (four hospitals). Performance targets (with audit and feedback) within a national governance framework was present in Scotland but not England. Differences in coordinated leadership, sharing best practices, and disliking being perceived as underperforming, were evident in Scotland. Conclusions High-certainty evidence shows that SI-IVC such as Mitomycin C (MMC), following NMIBC resection reduces recurrences. This evidence underpins international guidance. Numbers of eligible patients receiving SI-IVC is variable indicating suboptimal practice. Improving SI-IVC adherence requires modifications to theatre instilling policies, delivery and storage of MMC, staff training, and documentation. Centralising care with bladder cancer expert leadership and best practices sharing, with performance targets, likely led to improvements in Scotland. National quality improvement, incorporating audit and feedback, with additional implementation strategies targeted to professional role could improve adherence and patient outcomes elsewhere. This process should be controlled to clarify implementation intervention effectiveness.

Introduction Telemedicine provides remote clinical support through technology tools. It can facilitate medical care delivery while reducing unnecessary office visits. The COVID-19 outbreak has caused an abrupt change in our daily urological practice, where teleconsultations play a crucial role. Objective To provide practical recommendations for the effective use of technological tools in telemedicine. Materials and methods A literature search was conducted on Medline until April 2020. We selected the most relevant articles related to “telemedicine” and “smart working” that could provide valuable information. Results Telemedicine refers to the use of electronic information and telecommunication tools to provide remote clinical health care support. Smart working is a working approach that uses new or existing technologies to improve performance. Telemedicine is becoming a useful and fundamental tool during the COVID-19 pandemic and will be even more in the future. It is time for us to officially give telemedicine the place it deserves in clinical practice, and it is our responsibility to adapt and familiarize with all the tools and possible strategies for its optimal implementation. We must guarantee that the quality of care received by patients and perceived by them and their families is of the highest standard. Conclusions Telemedicine facilitates remote specialized urological clinical support and solves problems caused by limited patient mobility or transfer, reduces unnecessary visits to clinics and is useful to reduce the risk of COVID-19 viral transmission.

Background: Papillary urothelial neoplasm of low malignant potential (PUN-LMP) was introduced as a noninvasive, noncancerous lesion and a separate grade category in 1998. Subsequently, PUN-LMP was reconfirmed by World Health Organization (WHO) 2004 and WHO 2016 classifications for urothelial bladder tumors. Objectives: To analyze the proportion of PUN-LMP diagnosis over time and to determine its prognostic value compared to Ta-LG (low-grade) and Ta-HG (high-grade) carcinomas. To assess the intraobserver variability of an experienced uropathologist assigning (WHO) 2004/2016 grades at 2 time points. Materials and methods: Individual patient data of 3,311 primary Ta bladder tumors from 17 hospitals in Europe and Canada were available. Transurethral resection of the tumor was performed between 1990 and 2018. Time to recurrence and progression were analyzed with cumulative incidence functions, log-rank tests and multivariable Cox-regression stratified by institution. Intraobserver variability was assessed by examining the same 314 transurethral resection of the tumorslides twice, in 2004 and again in 2018. Results: PUN-LMP represented 3.8% (127/3,311) of Ta tumors. The same pathologist found 71/314 (22.6%) PUN-LMPs in 2004 and only 20/314 (6.4%) in 2018. Overall, the proportion of PUN-LMP diagnosis substantially decreased over time from 31.3% (1990-2000) to 3.2% (2000-2010) and to 1.1% (2010-2018). We found no difference in time to recurrence between the three WHO 2004/2016 Ta-grade categories (log-rank, P = 0.381), nor for LG vs. PUN-LMP (log-rank, P = 0.238). Time to progression was different for all grade categories (log-rank, P < 0.001), but not between LG and PUN-LMP (log-rank, P = 0.096). Multivariable analyses on recurrence and progression showed similar results for all 3 grade categories and for LG vs. PUN-LMP. Conclusions: The proportion of PUN-LMP has decreased to very low levels in the last decade. Contrary to its reconfirmation in the WHO 2016 classification, our results do not support the continued use of PUN-LMP as a separate grade category in Ta tumors because of the similar prognosis for PUN-LMP and Ta-LG carcinomas. (C) 2019 Elsevier Inc. All rights reserved.

INTRODUCTION AND OBJECTIVE:Several Patient-Reported Outcome Measures (PROMs) have been proposed for Localised Prostate Cancer. However, an accurate measurement of Health-Related Quality of Life can...

Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial. Background: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial. Objective: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management. Design: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts before voting during a consensus conference. Setting: Online Delphi survey and consensus conference. Participants: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management. Outcome measurements and statistical analysis: Statements were ranked by experts according to their level of agreement: 1–3 (disagree), 4–6 (equivocal), 7–9 (agree). A priori (level 1) consensus was defined as 70% agreement and 15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). Results and limitations: Overall, 116 statements were included in the Delphi survey. Of these, 33 (28%) statements achieved level 1 consensus and 49 (42%) statements achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease and the evolving role of checkpoint inhibitor therapy in metastatic disease. Conclusions: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time where further evidence is available to guide our approach, The authors would like to thank Peter E. Clark from Atrium Health, Levine Cancer Institute, Charlotte, NC, USA, for his contribution to the Delphi survey. Angela Corstorphine of Kstorfin Medical Communications Ltd provided medical writing support with the preparation of this manuscript; this support was funded jointly by EAU and ESMO.

Background: In the current European Association of Urology (EAU) non-muscle invasive bladder cancer (NMIBC) guideline, two classification systems for grade are advocated: WHO1973 and WHO2004/2016. Objective: To compare the prognostic value of these WHO systems. Design, setting, and participants: Individual patient data for 5145 primary Ta/T1 NMIBC patients from 17 centers were collected between 1990 and 2019. The median follow-up was 3.9 yr. Outcome measurements and statistical analysis: Univariate and multivariable analyses of WHO1973 and WHO2004/2016 stratified by center were performed for time to recurrence, progression (primary endpoint), cystectomy, and duration of survival, taking into account age, concomitant carcinoma in situ, gender, multiplicity, tumor size, initial treatment, and tumor stage. Harrell's concordance (C-index) was used for prognostic accuracy of classification systems. Results and limitations: The median age was 68 yr; 3292 (64%) patients had Ta tumors. Neither classification system was prognostic for recurrence. For a four-tier combination of both WHO systems, progression at 5-yr follow-up was 1.4% in lowgrade (LG)/G1, 3.8% in LG/G2, 7.7% in high grade (HG)/G2, and 18.8% in HG/G3 (log rank, p < 0.001). In multivariable analyses with WHO1973 and WHO2004/2016 as independent variables, WHO1973 was a significant prognosticator of progression (p < 0.001), whereas WHO2004/2016 was not anymore (p = 0.067). C-indices for WHO1973, WHO2004, and the WHO systems combined for progression were 0.71, 0.67, and 0.73, respectively. Prognostic analyses for cystectomy and survival showed results similar to those for progression. Conclusions: In this large prognostic factor study, both classification systems were prognostic for progression but not for recurrence. For progression, the prognostic value of WHO1973 was higher than that of WHO 2004/2016. The four-tier combination (LG/G1, LG/G2, HG/G2, and HG/G3) of both WHO systems proved to be superior, as it divides G2 patients into two subgroups (LG and HG) with different prognoses. Hence, the current EAU-NMIBC guideline recommendation to use both WHO classification systems remains correct. Patient summary: At present, two classification systems are used in parallel to grade non-muscle-invasive bladder tumors. Our data on a large number of patients showed that the older classification system (WHO1973) performed better in terms of assessing progression than the more recent (WHO2004/2016) one. Nevertheless, we conclude that the current guideline recommendation for the use of both classification systems remains correct, since this has the advantage of dividing the large group of WHO1973 G2 patients into two subgroups (low and high grade) with different prognoses. (c) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Background: The European Association of Urology (EAU) prognostic factor risk groups for non–muscle-invasive bladder cancer (NMIBC) are used to provide recommendations for patient treatment after transurethral resection of bladder tumor (TURBT). They do not, however, take into account the widely used World Health Organization (WHO) 2004/2016 grading classification and are based on patients treated in the 1980s. Objective: To update EAU prognostic factor risk groups using the WHO 1973 and 2004/2016 grading classifications and identify patients with the lowest and highest probabilities of progression. Design, setting, and participants: Individual patient data for primary NMIBC patients were collected from the institutions of the members of the EAU NMIBC guidelines panel. Intervention: Patients underwent TURBT followed by intravesical instillations at the physician's discretion. Outcome measurements and statistical analysis: Multivariable Cox proportional-hazards regression models were fitted to the primary endpoint, the time to progression to muscle-invasive disease or distant metastases. Patients were divided into four risk groups: low-, intermediate-, high-, and a new, very high-risk group. The probabilities of progression were estimated using Kaplan-Meier curves. Results and limitations: A total of 3401 patients treated with TURBT ± intravesical chemotherapy were included. From the multivariable analyses, tumor stage, WHO 1973/2004–2016 grade, concomitant carcinoma in situ, number of tumors, tumor size, and age were used to form four risk groups for which the probability of progression at 5 yr varied from 40%. Limitations include the retrospective collection of data and the lack of central pathology review. Conclusions: This study provides updated EAU prognostic factor risk groups that can be used to inform patient treatment and follow-up. Incorporating the WHO 2004/2016 and 1973 grading classifications, a new, very high-risk group has been identified for which urologists should be prompt to assess and adapt their therapeutic strategy when necessary. Patient summary: The newly updated European Association of Urology prognostic factor risk groups for non–muscle-invasive bladder cancer provide an improved basis for recommending a patient's treatment and follow-up schedule. The updated European Association of Urology prognostic factor risk groups for patients with non–muscle-invasive bladder cancer provide urologists with information that they should take into account when choosing a patient's treatment and scheduling follow-up.

IntroductionAs part of the PIONEER (Prostate Cancer Diagnosis and Treatment Enhancement Through the Power of Big Data in Europe) Consortium, we will explore which diagnostic and prognostic factors (DPFs) are currently being researched to previously defined clinical and patient-reported outcomes for prostate cancer (PCa).Methods and analysisThis research project will follow the following four steps: (1) a broad systematic literature review of DPFs for all stages of PCa, covering evidence from 2014 onwards; (2) discussion of systematic review findings by a multidisciplinary expert panel; (3) risk of bias assessment and applicability with Prediction model Risk Of Bias Assessment Tool criteria, Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and the Quality In Prognosis Studies tool (QUIPS) and (4) additional quantitative assessments if required.Ethics and disseminationWe aim to develop an online tool to present the DPFs identified in this research and make them available across all stakeholders. There are no ethical implications.

Contains fulltext : 244196.pdf (Publisher’s version ) (Closed access) BACKGROUND: Heterogenous outcome reporting in non-muscle-invasive bladder cancer (NMIBC) effectiveness trials of adjuvant treatment after transurethral resection (TURBT) has been noted in systematic reviews (SRs). This hinders comparing results across trials, combining them in meta-analyses, and evidence-based decision-making for patients and clinicians. OBJECTIVE: We aimed to systematically review the extent of reporting and definition heterogeneity. METHODS: We included randomized controlled trials (RCTs) identified from SRs comparing adjuvant treatments after TURBT or TURBT alone in patients with NMIBC (with or without carcinoma in situ) published between 2000-2020. Abstracts and full texts were screened independently by two reviewers. Data were extracted by one reviewer and checked by another. RESULTS: We screened 807 abstracts; from 15 SRs, 57 RCTs were included. Verbatim outcome names were coded to standard outcome names and organised using the Williamson and Clarke taxonomy. Recurrence (98%), progression (74%), treatment response (in CIS studies) (40%), and adverse events (77%) were frequently reported across studies. However, overall (33%) and cancer-specific (33%) survival, treatment completion (17%) and treatment change (37%) were less often reported. Quality of Life (3%) and economic outcomes (2%) were rarely reported. Heterogeneity was evident throughout, particularly in the definitions of progression and recurrence, and how CIS patients were handled in the analysis of studies with predominantly papillary patients, highlighting further issues with the definition of recurrence and progression vs treatment response for CIS patients. Data reporting was also inconsistent, with some trials reporting event rates at various time-points and others reporting time-to-event with or without Hazard Ratios. Adverse events were inconsistently reported. QoL data was absent in most trials. CONCLUSIONS: Heterogenous outcome reporting is evident in NMIBC effectiveness trials. This has profound implications for meta-analyses, SRs and evidence-based treatment decisions. A core outcome set is required to reduce heterogeneity. PATIENT SUMMARY: This systematic review found inconsistencies in outcome definitions and reporting, pointing out the urgent need for a core outcome set to help improve evidence-based treatment decisions.

This is a study protocol for an observational health data analysis, submitted as a preprint to facilitate transparency and open science. Watchful waiting (WW) represents a deferred treatment option for prostate cancer (PCa) patients when curative treatment seems overtreatment right from the outset. Patients are ‘watched’ for the development of local or systemic progression with disease-related symptoms, at which stage they are then treated palliatively according to their symptoms, in order to maintain quality of life. When choosing WW, it is important to adequately assess life expectancy of patients. Although previous studies reported the outcomes of PCa patients managed with WW, which is the impact of individual patient characteristics and comorbidities on long-term outcomes is still largely unknown. The PIONEER, which is a novel project of the Innovative Medicine Initiative’s (IMI’s) “Big Data for Better Outcomes” program with the mission to transform PCa care with particular focus on improving cancer-related outcomes, health system efficiency and the quality of health and social care across Europe, aims at assessing which are the long-term outcomes of PCa patients undergoing WW overall and after stratification according to disease characteristics, comorbidities and life expectancy. Of note, this topic emerged as the second one with the highest agreement score among different stakeholders after an international consensus to identify and prioritize the most important questions in the field of PCa. This study aims to describe demographics, clinical characteristics and estimate outcomes of PCa patients under delayed treatment (WW) across a network of databases in the overall population and subgroups of patients identified by individual disease characteristics, demographics and comorbidities. The study will rely on large observational data, namely population-based registries, electronic health records and insurance claims data. The study will be an observational cohort study based on routinely collected health care data which has been mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM).

Introduction: There remains uncertainty regarding the differences in patient outcomes between monopolar transurethral resection of the prostate (MTURP) and bipolar TURP (BTURP) in the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO). Methods: A systematic literature search was carried out up to March 19, 2019. Methods in the Cochrane Handbook were followed. Certainty of evidence (CoE) was assessed using the GRADE approach. Results: A total of 59 randomized controlled trials (RCTs) with 8924 participants were included. BTURP probably results in little to no difference in International Prostate Symptom Score (IPSS) at 12 months (mean difference -0.24, 95% confidence internal [CI] -0.39–-0.09; participants=2531; RCTs=16; moderate CoE) or health-related quality of life (HRQOL) at 12 months (mean difference -0.12, 95% CI -0.25–0.02; participants=2004, RCTs=11; moderate CoE), compared to MTURP. BTURP probably reduces TUR syndrome (relative risk [RR] 0.17, 95% CI 0.09–0.30; participants= 6,745, RCTs=44; moderate CoE) and blood transfusions (RR 0.42, 95% CI 0.30–0.59; participants=5727, RCTs=38; moderate CoE), compared to MTURP. BTURP may carry similar risk of urinary incontinence at 12 months (RR 0.20, 95% CI 0.01–4.06; participants=751; RCTs=4; low CoE), re-TURP (RR 1.02, 95% CI 0.44–2.40; participants=652, RCTs=6, I2=0%; low CoE) and erectile dysfunction (International Index of Erectile Function [IIEF-5]) at 12 months (mean difference 0.88, 95% CI -0.56–2.32; RCTs=3; moderate CoE), compared to MTURP. Conclusions: BTURP and MTURP probably improve urological symptoms to a similar degree. BTURP probably reduces TUR syndrome and blood transfusion slightly postoperatively. The moderate certainty of evidence available for primary outcomes suggests no need for further RCTs comparing BTURP and MTURP.

Introduction: In the past decade, mobile telephone use has surged in sub-Saharan Africa, creating new opportunities in health care. Mobile telephone interventions have been used in controlled trials to improve perinatal care, but in this first cohort study of birth outcomes from The Gambia, we report the value of mobile telephone follow-up. Methods: Between December 2012 and November 2015, 1,611 women entered the cohort at their first antenatal visit to be followed through pregnancy and beyond. Potential risk factors for adverse birth outcomes were measured throughout the pregnancy. As many women left the health center within a few hours of delivery, delivered elsewhere, or failed to attend the postnatal clinics, mobile telephone follow-up was used to identify stillbirths and neonatal deaths at 7 and 28 days. Results: The immediate birth outcome was known for 968 women who delivered at the health center (60.1%). The known outcomes at birth improved from 60.1% to 85.2% following telephone calls to women who delivered elsewhere. The known outcomes at 7 days improved from 43.6% to 82.5%, and the known outcomes at 28 days improved from 32.8% to 71.5% following a telephone call. Conclusions: Previous cohort studies of birth outcomes in sub-Saharan Africa have not followed the mothers and babies after leaving the birth facility. This cohort is the first to record birth outcomes up to 28 days after the birth. Mobile telephone communications have made an invaluable contribution in intervention studies. This study has shown that mobile telephone follow-up is also an important tool in an observational study.

The authors regret that a co-author was mistakenly missed from the authorship. The following co-author should have been included in the authorship: Peter-Paul M. Willemse Department of Oncological Urology, University Medical Center, Utrecht Cancer Center, Utrecht, The Netherlands

Patients with primary localised prostate cancer (PCa) have a wide choice of curative therapeutic interventions, including active surveillance, surgical, focal and radiation therapies. Based on clinical and oncological characteristics, treatment decisions entail consideration of oncological and functional outcomes with important effects on quality of life. We aimed to highlight evidence surrounding present inconsistencies, the problems this presents to clinicians and patients alike and the rationale for using return to baseline as a more realistic and objective functional outcome measure for assessing sexual function in this particularly sensitive group of men. We performed a non-systematic literature review of numerous non-validated, arbitrary thresholds employed in evaluation of sexual function outcomes in men undergoing intervention for primary localised PCa. The literature presents much heterogeneity in measurement methods and outcome measures, which lack context and present difficulties when counselling patients to make informed, autonomous decisions. These include findings from the most widely used internationally validated tools, such as the International Index of Erectile Function (IIEF), UCLA prostate cancer index and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30). There is a need for standardisation of reporting outcomes following PCa treatment to facilitate evaluation of existing and emerging technologies.

Background Transurethral resection of the prostate (TURP) is a well-established surgical method for treatment of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO). This has traditionally been provided as monopolar TURP (MTURP), but morbidity associated with MTURP has led to the introduction of other surgical techniques. In bipolar TURP (BTURP), energy is confined between electrodes at the site of the resectoscope, allowing the use of physiological irrigation medium. There remains uncertainty regarding differences between these surgical methods in terms of patient outcomes. Objectives To compare the effects of bipolar and monopolar TURP. Search methods A comprehensive systematic electronic literature search was carried out up to 19 March 2019 via CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, PubMed, and WHO ICTRP. Handsearching of abstract proceedings of major urological conferences and of reference lists of included trials, systematic reviews, and health technology assessment reports was undertaken to identify other potentially eligible studies. No language restrictions were applied. Selection criteria Randomised controlled trials (RCTs) that compared monopolar and bipolar TURP in men (> 18 years) for management of LUTS secondary to BPO. Data collection and analysis Two independent review authors screened the literature, extracted data, and assessed eligible RCTs for risk of bias. Statistical analyses were undertaken according to the statistical guidelines presented in the Cochrane Handbook for Systematic Reviews of Interventions. The quality of evidence (QoE) was rated according to the GRADE approach. Main results A total of 59 RCTs with 8924 participants were included. The mean age of included participants ranged from 59.0 to 74.1 years. Mean prostate volume ranged from 39 mL to 82.6 mL. Primary outcomes BTURP probably results in little to no difference in urological symptoms, as measured by the International Prostate Symptom Score (IPSS) at 12 months on a scale of 0 to 35, with higher scores reflecting worse symptoms (mean difference (MD) -0.24, 95% confidence interval (CI) -0.39 to -0.09; participants = 2531; RCTs = 16; I² = 0%; moderate certainty of evidence (CoE), downgraded for study limitations), compared to MTURP. BTURP probably results in little to no difference in bother, as measured by health-related quality of life (HRQoL) score at 12 months on a scale of 0 to 6, with higher scores reflecting greater bother (MD -0.12, 95% CI -0.25 to 0.02; participants = 2004; RCTs = 11; I² = 53%; moderate CoE, downgraded for study limitations), compared to MTURP. BTURP probably reduces transurethral resection (TUR) syndrome events slightly (risk ratio (RR) 0.17, 95% CI 0.09 to 0.30; participants = 6745; RCTs = 44; I² = 0%; moderate CoE, downgraded for study limitations), compared to MTURP. This corresponds to 20 fewer TUR syndrome events per 1000 participants (95% CI 22 fewer to 17 fewer). Secondary outcomes BTURP may carry a similar risk of urinary incontinence at 12 months (RR 0.20, 95% CI 0.01 to 4.06; participants = 751; RCTs = 4; I² = 0%; low CoE, downgraded for study limitations and imprecision), compared to MTURP. This corresponds to four fewer events of urinary incontinence per 1000 participants (95% CI five fewer to 16 more). BTURP probably slightly reduces blood transfusions (RR 0.42, 95% CI 0.30 to 0.59; participants = 5727; RCTs = 38; I² = 0%; moderate CoE, downgraded for study limitations), compared to MTURP. This corresponds to 28 fewer events of blood transfusion per 1000 participants (95% CI 34 fewer to 20 fewer). BTURP may result in similar rates of re-TURP (RR 1.02, 95% CI 0.44 to 2.40; participants = 652; RCTs = 6; I² = 0%; low CoE, downgraded for study limitations and imprecision). This corresponds to one more re-TURP per 1000 participants (95% CI 19 fewer to 48 more). Erectile function as measured by the International Index of Erectile Function score (IIEF-5) at 12 months on a scale from 5 to 25, with higher scores reflecting better erectile function, appears to be similar (MD 0.88, 95% CI -0.56 to 2.32; RCTs = 3; I² = 68%; moderate CoE, downgraded for study limitations) for the two approaches. Authors' conclusions BTURP and MTURP probably improve urological symptoms, both to a similar degree. BTURP probably reduces both TUR syndrome and postoperative blood transfusion slightly compared to MTURP. The impact of both procedures on erectile function is probably similar. The moderate certainty of evidence available for the primary outcomes of this review suggests that there is no need for further RCTs comparing BTURP and MTURP.

Background: There is uncertainty in deferred active treatment (DAT) programmes, regarding patient selection, follow-up and monitoring, reclassification, and which outcome measures should be prioritised. Objective: To develop consensus statements for all domains of DAT. Design, setting, and participants: A protocol-driven, three phase study was undertaken by the European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Association of Urology Section of Urological Research (ESUR)-International Society of Geriatric Oncology (SIOG) Prostate Cancer Guideline Panel in conjunction with partner organisations, including the following: (1) a systematic review to describe heterogeneity across all domains; (2) a two-round Delphi survey involving a large, international panel of stakeholders, including healthcare practitioners (HCPs) and patients; and (3) a consensus group meeting attended by stakeholder group representatives. Robust methods regarding what constituted the consensus were strictly followed. Results and limitations: A total of 109 HCPs and 16 patients completed both survey rounds. Of 129 statements in the survey, consensus was achieved in 66 (51%); the rest of the statements were discussed and voted on in the consensus meeting by 32 HCPs and three patients, where consensus was achieved in additional 27 statements (43%). Overall, 93 statements (72%) achieved consensus in the project. Some uncertainties remained regarding clinically important thresholds for disease extent on biopsy in low-risk disease, and the role of multiparametric magnetic resonance imaging in determining disease stage and aggressiveness as a criterion for inclusion and exclusion. Conclusions: Consensus statements and the findings are expected to guide and inform routine clinical practice and research, until higher levels of evidence emerge through prospective comparative studies and clinical trials. Patient summary: We undertook a project aimed at standardising the elements of practice in active surveillance programmes for early localised prostate cancer because currently there is great variation and uncertainty regarding how best to conduct them. The project involved large numbers of healthcare practitioners and patients using a survey and face-to-face meeting, in order to achieve agreement (ie, consensus) regarding best practice, which will provide guidance to clinicians and researchers. (C) 2019 Published by Elsevier B.V. on behalf of European Association of Urology.

The rate of postoperative complications might vary according to the method used to collect perioperative data. We aimed at assessing the impact of the prospective implementation of the European Association of Urology (EAU) guidelines on reporting and grading of complications in prostate cancer patients undergoing robot-assisted radical prostatectomy (RARP). From September 2016, an integrated method for reporting surgical morbidity based on the EAU guidelines was implemented at a single, tertiary center. Perioperative data were prospectively and systematically collected during a patient interview at 30 d after surgery as recommended by the EAU Guidelines Panel Recommendations on Reporting and Grading Complications. The rate and grading of complications of 167 patients who underwent RARP±pelvic lymph node dissection (PLND) after the implementation of the prospective collection system (Group 1) were compared with 316 patients treated between January 2015 and August 2016 (Group 2) when a system based on patient chart review was used. No differences were observed in disease characteristics and PLND between the two groups (all p≥0.1). Postoperative complications were graded according to the Clavien-Dindo classification system. Overall, the complication rate was higher when the prospective collection system based on the EAU guidelines was used (29%) than when retrospective chart review (10%; p0.001) was used. In particular, a substantially higher rate of grade 1 (8.4% vs 4.7%) and 2 (14% vs 2.8%) complications was detected in Group 1 versus Group 2 (p0.001). Although the rate of complications occurred during hospitalization did not differ (13% vs 10%; p=0.3), 31 (19%) complications after discharge were detected in Group 1. This resulted into a readmission rate of 16%. Conversely, no complications after discharge and readmissions were recorded for Group 2. The implementation of the EAU guidelines on reporting perioperative outcomes roughly doubled the complication rate after RARP and allowed for the detection of complications after discharge in more than 15% of patients that would have been otherwise missed, where patients assessed with the EAU implemented protocol had a threefold higher likelihood of reporting complications.The implementation of the European Association of Urology guidelines on reporting and grading of complications after urologic procedures in prostate cancer patients roughly doubled the complication rate after robot-assisted radical prostatectomy compared to retrospective patient chart review. Moreover, it allowed for the detection of complications after discharge in more than 15% of patients that would have been otherwise missed.

BackgroundAlthough guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial.ObjectiveTo bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management.DesignA steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts prior to voting during a consensus conference.SettingOnline Delphi survey and consensus conference.ParticipantsThe European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management.Outcome measurements and statistical analysisStatements were ranked by experts according to their level of agreement: 1–3 (disagree), 4–6 (equivocal), and 7–9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus).Results and limitationsOverall, 116 statements were included in the Delphi survey. Of these statements, 33 (28%) achieved level 1 consensus and 49 (42%) achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease, and the evolving role of checkpoint inhibitor therapy in metastatic disease.ConclusionsThese consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time when further evidence is available to guide our approach.Patient summaryThis report summarises findings from an international, multistakeholder project organised by the EAU and ESMO. In this project, a steering committee identified areas of bladder cancer management where there is currently no good-quality evidence to guide treatment decisions. From this, they developed a series of proposed statements, 71 of which achieved consensus by a large group of experts in the field of bladder cancer. It is anticipated that these statements will provide further guidance to health care professionals and could help improve patient outcomes until a time when good-quality evidence is available.

Context Most series have suggested better perioperative outcomes of laparoscopic radical nephroureterectomy (RNU) over open RNU. However, the oncological safety of laparoscopic RNU remains controversial. Objective To systematically review all relevant literature comparing oncological outcomes of open versus laparoscopic RNU. Evidence acquisition A systematic literature search using the Medline, Embase, and Cochrane databases and clinicaltrial.gov was performed in December 2014 and updated in August 2016. Randomised controlled trials (RCTs) and prospective or retrospective nonrandomised comparative studies comparing the oncological outcomes of any laparoscopic RNU with those of open RNU were included. The primary outcome was cancer-specific survival. The risk of bias (RoB) was assessed using Cochrane RoB tools. A narrative synthesis of the evidence is presented. Evidence synthesis Overall, 42 studies were included, which accounted for 7554 patients: 4925 in the open groups and 2629 in the laparoscopic groups. Most included studies were retrospective comparative series. Only one RCT was found. RoB and confounding were high in most studies. No study compared the oncological outcomes of robotic RNU with those of open RNU. Bladder cuff excision in laparoscopic groups was performed via an open approach in most studies, with only three studies reporting laparoscopic removal of the bladder cuff. Port-site metastasis rates ranged from 0% to 2.8%. No significant difference in oncological outcomes was reported in most series. However, three studies, including the only RCT, reported significantly poorer oncological outcomes in patients who underwent laparoscopic RNU, especially in the subgroups of patients with locally advanced (pT3/pT4) or high-grade upper tract urothelial carcinoma (UTUC), as well as in instances when the bladder cuff was excised laparoscopically. Conclusions The current available evidence suggests that the oncological outcomes of laparoscopic RNU may be poorer than those of open RNU when bladder cuff is excised laparoscopically and in patients with locally advanced high-risk (pT3/pT4 and/or high-grade) UTUC. Patient summary We reviewed the literature comparing the outcomes of two different surgical procedures for the treatment of upper tract urothelial carcinoma. Open radical nephroureterectomy is a surgical procedure in which the kidney is removed through a large incision in the abdomen, while in laparoscopic radical nephroureterectomy, the kidney is removed through a number of small incisions. Our findings suggest that the outcomes of laparoscopic radical nephroureterectomy may be poorer than those of open radical nephroureterectomy, particularly when the bladder cuff is also required to be removed. Laparoscopic radical nephroureterectomy may also be less effective in patients with locally advanced (pT3/pT4) or high-grade upper tract urothelial carcinomas.

Aims: The treatment of prostate cancer has evolved markedly over the last 40 years, including radiotherapy, notably with escalated dose and targeting. However, the optimal treatment for localised disease has not been established in comparative randomised trials. The aim of this article is to describe the history ofprostate radiotherapy trials, including their quality assurance processes, and to compare these with the ProtecT trial.Materials and methods: The UK ProtecT randomised trial compares external beam conformal radiotherapy, surgery and active monitoring for clinically localized prostate cancer and will report on the primary outcome (disease-specific mortality) in 2016 following recruitment between 1999 and 2009. The embedded quality assurance programme consists of on-site machine dosimetry at the nine trial centres, a retrospective review of outlining and adherence to dose constraints based on the trial protocol in 54 participants (randomly selected, around 10% of the total randomised to radiotherapy, n ¼ 545). These quality assurance processes and results were compared with prostate radiotherapy trials of a comparable era.Results: There has been an increasingly sophisticated quality assurance programme in UK prostate radiotherapy trials over the last 15 years, reflecting dose escalation and treatment complexity. In ProtecT, machine dosimetry results were comparable between trial centres and with the UK RT01 trial. The outliningreview showed that most deviations were clinically acceptable, although three (1.4%) may have been of clinical significance and were related to outlining of theprostate. Seminal vesicle outlining varied, possibly due to several prostate trials running concurrently with different protocols. Adherence to dose constraints inProtecT was considered acceptable, with 80% of randomised participants having two or less deviations and planning target volume coverage was excellent.Conclusion: The ProtecT trial quality assurance results were satisfactory and comparable with trials of its era. Future trials should aim to standardise treatment protocols and quality assurance programmes where possible to reduce complexities for centres involved in multiple trials. 2016 Published by Elsevier Ltd on behalf of The Royal College of Radiologists.

Context The European Association of Urology non-muscle-invasive bladder cancer (NMIBC) guidelines recommend that all low- and intermediate-risk patients receive a single immediate instillation of chemotherapy after transurethral resection of the bladder (TURB), but its use remains controversial. Objective To identify which NMIBC patients benefit from a single immediate instillation. Evidence acquisition A systematic review and individual patient data (IPD) meta-analysis of randomized trials comparing the efficacy of a single instillation after TURB with TURB alone in NMIBC patients was carried out. Evidence synthesis A total of 13 eligible studies were identified. IPD were obtained for 11 studies randomizing 2278 eligible patients, 1161 to TURB and 1117 to a single instillation of epirubicin, mitomycin C, pirarubicin, or thiotepa. A total of 1128 recurrences, 108 progressions, and 460 deaths (59 due to bladder cancer [BCa]) occurred. A single instillation reduced the risk of recurrence by 35% (hazard ratio [HR]: 0.65; 95% confidence interval [CI], 0.58-0.74; p < 0.001) and the 5-yr recurrence rate from 58.8% to 44.8%. The instillation did not reduce recurrences in patients with a prior recurrence rate of more than one recurrence per year or in patients with an European Organization for Research and Treatment of Cancer (EORTC) recurrence score ≥5. The instillation did not prolong either the time to progression or death from BCa, but it resulted in an increase in the overall risk of death (HR: 1.26; 95% CI, 1.05-1.51; p = 0.015; 5-yr death rates 12.0% vs 11.2%), with the difference appearing in patients with an EORTC recurrence score ≥5. Conclusions A single immediate instillation reduced the risk of recurrence, except in patients with a prior recurrence rate of more than one recurrence per year or an EORTC recurrence score ≥5. It does not prolong either time to progression or death from BCa. The instillation may be associated with an increase in the risk of death in patients at high risk of recurrence in whom the instillation is not effective or recommended. Patient summary A single instillation of chemotherapy immediately after resection reduces the risk of recurrence in non-muscle-invasive bladder cancer; however, it should not be given to patients at high risk of recurrence due to its lack of efficacy in this subgroup.

Purpose To systematically evaluate evidence regarding the unmet supportive care needs of men affected by penile cancer and their partners to create a holistic model of care and inform clinical practice guidelines. Methods We searched CINAHL, MEDLINE, PsychINFO, Embase, and the Cochrane Library (CCRT and CDSR) controlled trials databases and clinicaltrial.gov from 1990 to April 2020. This review was reported according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Results 18 articles were included, reporting the results from 17 studies. Included reports used qualitative (seven studies) and survey (ten studies). Across these studies, men reported that the diagnosis and subsequent treatment of penile cancer affected physical, psychological and sexual well-being with each facet impacting and being intertwined with the other at varying degrees. There was varying complexity of unmet needs in men and partners pre-surgery, post-surgery and into survivorship. Conclusions Moderate evidence exists that men affected by penile cancer experience a range of unmet supportive care needs across the international literature. Further work to evaluate the impact of penile cancer on partners is required.

Item does not contain fulltext CONTEXT: Controversy exists regarding the therapeutic value of lymphadenectomy (LND) in patients undergoing radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC). OBJECTIVE: To systematically review the relevant literature assessing the impact of LND on oncologic and perioperative outcomes in patients undergoing RC for MIBC. EVIDENCE ACQUISITION: Medline, Medline In-Process, Embase, the Cochrane Central Register of Controlled Trials, and the Latin American and Caribbean Center on Health Sciences Information (LILACS) were searched up to December 2013. Comparative studies reporting on no LND, limited LND (L-LND), standard LND (S-LND), extended LND (E-LND), superextended LND (SE-LND), and oncologic and perioperative outcomes were included. Risk-of-bias and confounding assessments were performed. EVIDENCE SYNTHESIS: Twenty-three studies reporting on 19 793 patients were included. All but one study were retrospective. Planned meta-analyses were not possible because of study heterogeneity; therefore, data were synthesized narratively. There were high risks of bias and confounding across most studies as well as extreme heterogeneity in the definition of the anatomic boundaries of LND templates. All seven studies comparing LND with no LND favored LND in terms of better oncologic outcomes. Seven of 14 studies comparing (super)extended LND with L-LND or S-LND reported a beneficial outcome for (super)extended LND in at least a subset of patients. No difference in outcome was reported in two studies comparing E-LND and S-LND. The comparative harms of different extents of LND remain unclear. CONCLUSIONS: Although the quality of the data was poor, the available evidence indicates that any kind of LND is advantageous over no LND. Similarly, E-LND appears to be superior to lesser degrees of dissection, while SE-LND offered no additional benefits. It is hoped that data from ongoing randomized clinical trials will clarify remaining uncertainties. PATIENT SUMMARY: The current literature suggests that removal of lymph nodes in bladder cancer surgery is beneficial and might result in better outcomes in terms of prolonging survival; however, the quality of the available studies is poor, and high-quality studies are needed.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of various surgical treatments for localised penile cancer, including oncological efficacy, quality of life and functional impact. (FS: do we need to be more specific than this?) The comparisons of interest are: one type of surgery versus another; ; surgical treatment versus non‐surgical treatment.

Context: Controversy remains over whether adrenalectomy and lymph node dissection (LND) should be performed concomitantly with radical nephrectomy (RN) for locally advanced renal cell carcinoma (RCC) cT3-T4N0M0. Objective: To systematically review all relevant literature comparing oncologic, perioperative, and quality-of-life (QoL) outcomes for locally advanced RCC managed with RN with or without concomitant adrenalectomy or LND. Evidence acquisition: Relevant databases were searched up to August 2012. Randomised controlled trials (RCTs) and comparative studies were included. Outcome measures were overall survival, QoL, and perioperative adverse effects. Risks of bias (RoB) were assessed using Cochrane RoB tools. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Evidence synthesis: A total of 3658 abstracts and 252 full-text articles were screened. Eight studies met the inclusion criteria: six LNDs (one RCT and five nonrandomised studies [NRSs]) and two adrenalectomies (two NRSs). RoB was high across the evidence base, and the quality of evidence from outcomes ranged from moderate to very low. Meta-analyses were not undertaken because of diverse study designs and data heterogeneity. There was no significant difference in survival between the groups, even though 5-yr overall survival appears better for the RN plus LND group compared with the no-LND group in one randomised study. There was no evidence of a difference in adverse events between the RN plus LND and no-LND groups. No studies reported QoL outcomes. There was no evidence of an oncologic difference between the RN with adrenalectomy and RN without adrenalectomy groups. No studies reported adverse events or QoL outcomes. Conclusions: There is insufficient evidence to draw any conclusions on oncologic outcomes for patients having concomitant LND or ipsilateral adrenalectomy compared with patients having RN alone for cT3-T4N0M0 RCC. The quality of evidence is generally low and the results potentially biased. Further research in adequately powered trials is needed to answer these questions. (C) 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Although ureteric injury is relatively uncommon, it is a serious event that can result in intra-abdominal sepsis, renal failure, and loss of the ipsilateral renal unit. Most injuries are iatrogenic and remain undiagnosed until the patient presents with symptoms postoperatively. In addition to compromising patient safety, missed ureteric injuries frequently result in litigation. Over the past 20 years, there has been a rapid uptake of laparoscopic and robotic techniques within urology and other surgical specialties. This trend, coupled with increased use of ureteroscopy, has increased the risk of injury to the ureter. The key to diagnosing and managing a ureteric injury is to have a low threshold for suspecting its presence. Diagnosis can be achieved using retrograde pyelography, ureteroscopy, CT, or intravenous urography. Initial management should involve ureteric stent placement or percutaneous nephrostomy drainage. In selected patients, surgical reconstruction might be the optimal approach. Decisions regarding surgical technique (open, laparoscopic, or robotic) are guided by the clinical situation and surgical expertise available.

Context For the treatment of localised renal cell carcinoma (RCC), uncertainties remain over the perioperative and quality-of-life (QoL) outcomes for the many different surgical techniques and approaches of nephrectomy. Controversy also remains on whether newer minimally invasive nephron-sparing interventions offer better QoL and perioperative outcomes, and whether adrenalectomy and lymphadenectomy should be performed simultaneously with nephrectomy. These non-oncological outcomes are important because they may have a considerable impact on localised RCC treatment decision making. Objective To review systematically all the relevant published literature comparing perioperative and QoL outcomes of surgical management of localised RCC (T1–2N0M0). Evidence acquisition Relevant databases including Medline, Embase, and the Cochrane Library were searched up to January 2012. Randomised controlled trials (RCTs) or quasi-randomised controlled trials, prospective observational studies with controls, retrospective matched-pair studies, and comparative studies from well-defined registries/databases were included. The outcome measures were QoL, analgesic requirement, length of hospital stay, time to normal activity level, surgical morbidity and complications, ischaemia time, renal function, blood loss, length of operation, need for blood transfusion, and perioperative mortality. The Cochrane risk of bias tool was used to assess RCTs, and an extended version was used to assess nonrandomised studies (NRSs). The quality of evidence was assessed using Grading of Recommendations, Assessment, Development, and Evaluation. Evidence synthesis A total of 4580 abstracts and 380 full-text articles were assessed, and 29 studies met the inclusion criteria (7 RCTs and 22 NRSs). There were high risks of bias and low-quality evidence for studies meeting the inclusion criteria. There is good evidence indicating that partial nephrectomy results in better preservation of renal function and better QoL outcomes than radical nephrectomy regardless of technique or approach. Regarding radical nephrectomy, the laparoscopic approach has better perioperative outcomes than the open approach, and there is no evidence of a difference between the transperitoneal and retroperitoneal approaches. Alternatives to standard laparoscopic radical nephrectomy (LRN) such as hand-assisted, robot-assisted, or single-port techniques appear to have similar perioperative outcomes. There is no good evidence to suggest that minimally invasive procedures such as cryotherapy or radiofrequency ablation have superior perioperative or QoL outcomes to nephrectomy. Regarding concomitant lymphadenectomy during nephrectomy, there were low event rates for complications, and no definitive difference was observed. There was no evidence to base statements about concomitant ipsilateral adrenalectomy during nephrectomy. Conclusions Partial nephrectomy results in significantly better preservation of renal function over radical nephrectomy. For tumours where partial nephrectomy is not technically feasible, there is no evidence that alternative procedures or techniques are better than LRN in terms of perioperative or QoL outcomes. In making treatment decisions, perioperative and QoL outcomes should be considered in conjunction with oncological outcomes. Overall, there was a paucity of data regarding QoL outcomes, and when reported, both QoL and perioperative outcomes were inconsistently defined, measured, or reported. The current evidence base has major limitations due to studies of low methodological quality marked by high risks of bias.

Item does not contain fulltext CONTEXT: Renal cell carcinoma (RCC) accounts for 2-3% of adult malignancies. There remain uncertainties over the oncological outcomes for the surgical management of localised RCC. OBJECTIVE: Systematically review relevant literature comparing oncological outcomes of surgical management of localised RCC (T1-2N0M0). EVIDENCE ACQUISITION: Relevant databases including Medline, Embase, and the Cochrane Library were searched up to October 2010, and an updated scoping search was performed up to January 2012. Randomised controlled trials (RCTs) or quasi-RCTs, prospective observational studies with controls, retrospective matched-pair studies, and comparative studies from well-defined registries/databases were included. The main outcomes were overall survival, cancer-specific survival, recurrence, and metastases. The Cochrane risk of bias tool was used to assess RCTs, and an extended version was used to assess nonrandomised studies (NRSs). The quality of evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). EVIDENCE SYNTHESIS: A total of 4580 abstracts and 389 full-text articles were assessed. Thirty-four studies met the inclusion criteria (6 RCTs and 28 NRSs). Meta-analyses were planned but were deemed inappropriate due to data heterogeneity. There were high risks of bias and low-quality evidence across the evidence base. Open radical nephrectomy and open partial nephrectomy showed similar cancer-specific and overall survival, but when both open and laparoscopic approaches are considered together, the evidence showed improved survival for partial nephrectomy for tumours

Study Type – Therapy (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Apart from bladder tumour multiplicity, size, stage, grade and presence of cis, early recurrence following white light TURBT for new bladder tumours is also determined by surgeon experience, completeness of resection and presence or absence of detrusor muscle in the specimen. This study aims to validate surgeon experience and detrusor muscle as independent predictors of early recurrence following apparently complete white light TURBT in new bladder tumours. OBJECTIVE • To validate in patients undergoing first transurethral resection of bladder tumour (TURBT) for non-muscle-invasive bladder cancer (NMIBC), the presence/absence of detrusor muscle (DM) in the specimen and surgeon experience as independent predictors of the quality of TURBT. PATIENTS AND METHODS • Patients with new NMIBC, who had undergone complete first resections were recruited from a prospectively maintained cohort from the 1980s at the Western General Hospital, Edinburgh, UK and a contemporary cohort from the Aberdeen Royal Infirmary, UK. • Tumour size, multiplicity, surgeon category, presence or absence of DM in the specimen, grade, stage, findings at first check cystoscopy and early re-TURBT were evaluated. • Surgeons were stratified into a senior group (consultant and trainees in year five or six) and a junior group (trainees below year five). • Early recurrence, or recurrence rate at the first follow up cystoscopy (RRFFC), was used to measure quality and was defined as finding pathologically confirmed tumour at early re-TURBT or the first check cystoscopy. RESULTS • From a total of 566 patients evaluated from both cohorts, 473 NMIBC specimens were suitable for analysis. • Logistic regression multivariate analysis revealed that the absence of DM was associated with a higher RRFFC (odds ratio [OR]= 3.6, 95% CI = 1.7–7.5, P < 0.001). • Senior surgeons were more likely to resect DM (OR = 4.9, 95% CI = 2.3–10.7, P < 0.001) • Senior surgeons were independently associated with a lower RRFFC (OR = 5.3, 95% CI = 2.1–12.9, P < 0.001). CONCLUSIONS • Detrusor muscle status at the first, apparently complete, TURBT and surgeon's experience independently predict the quality of TURBT. • Documented complete resection by experienced surgeons with DM presence (good quality white-light TURBT) should be considered a benchmark for white-light TURBT in NMIBC.

Background Current orthodoxy suggests that patients need to be provided with full information about their care and that treatment options should be discussed with patients and family members. This imperative is especially challenging when there is a lack of consensus about treatment effectiveness and equivocacy over different types of interventions. In the case of prostate cancer, evidence is contested as to the efficacy of different treatments. Thus, involving patients and their family members in treatment choices is complex and little is known about how patients and their partners process these decisions when there is uncertainty about different outcomes. This paper has reviewed the literature on the way couples approach such decision making in relation to treatment for prostate cancer. Objective A meta-ethnographic synthesis of published qualitative papers that focused on the influences on patients’, and their partners’ treatment decision making for prostate cancer, was conducted in order to identify and understand barriers and facilitators which impact on this process. Results Our synthesis indicates that the couples’ relationship ‘dynamic’ provides a contextual background against which treatment decisions are negotiated and made. Discussion and conclusions We propose that the findings from this synthesis can enhance the potential for shared decision making for patients, and their partners, when facing a treatment decision for prostate cancer. By understanding the couples’ relationship dynamic pre-diagnosis, clinicians may be able to tailor the communication and information provision to both patients and their partners, providing a personalized approach to treatment decision making.

OBJECTIVES To determine whether health and body image are important determinants of quality of life (QoL) for patients undergoing urinary diversion (UD). Patients with advanced bladder cancer who undergo cystectomy and UD face potential serious morbidity (25%-40%) and a small risk of mortality (0%-4%). The systematic review compares QoL and body image for different types of diversions. METHODS One researcher trained in using schedule for evaluation of individual quality of life-direct weighting interviewed 32 consecutive patients undergoing radical cystectomy. The European Organization for Research and Treatment of Cancer QLQ-C30 and the Satisfaction With Life Scale questionnaire were also administered before cystectomy and 9-12 months postcystectomy. All QoL studies reporting on radical cystectomy and UD were reviewed between 1996 and March 2008. RESULTS Family, relationships, health, and finance were the most important determinants of QoL, whereas body image was not mentioned by anyone. On using European Organization for Research and Treatment of Cancer QLQ-C30 and Satisfaction With Life Scale, it was found that there was no difference in QoL of patients pre- and postcystectomy. In our review of published data, 40 studies were identified reporting on 3645 patients. Only 2 studies reported a better QoL in favor of neobladders, whereas 2 other studies suggest a better body image perception in patients with neobladder. CONCLUSIONS This prospective cohort study suggests that health and body image may not always be important to patients for their QoL. Our systematic review suggests an overall good QoL in most studies irrespective of the type of UD, with no significant differences among the different diversion types.

There is no current consensus on what constitutes the ideal management of emphysematous pyelonephritis. We review the current management strategies including the role of nephron preserving percutaneous drainage in the treatment of emphysematous pyelonephritis.We searched MEDLINE, PubMed, EMBASE, CINAHL and the Cochrane Library from 1966 to 2006. Abstracts were reviewed including all types of studies from prospective randomized controlled studies to small retrospective series. All relevant English language articles reporting on at least 5 patients were reviewed.Ten retrospective studies on 210 patients with emphysematous pyelonephritis met the inclusion criteria. There were 167 females and 43 males with a mean age of 57 years (range 24 to 83). Of the patients 96% had diabetes mellitus and 29% had urinary tract obstruction. The diagnostic accuracy of computerized tomography was 100%. Escherichia coli and Klebsiella were the most common causative agents. The mortality from medical management alone was 50%, medical management combined with emergency nephrectomy was 25% and medical management combined with percutaneous drainage was 13.5%. Mortality was significantly less in patients undergoing percutaneous drainage compared to other treatments (Pearson chi-square p0.001). Of the patients who underwent medical treatment with percutaneous drainage a small number (15) underwent elective nephrectomy and mortality was 6.6% (1 of 15).Percutaneous drainage should be part of the initial management strategy for emphysematous pyelonephritis. This strategy is associated with a lower mortality than medical management or emergency nephrectomy. Delayed elective nephrectomy may be required in some patients.

Summary points Lower urinary tract symptoms in older men are common and bothersome, leading to considerable use of healthcare services.1 2 Symptoms may reflect obstructive voiding (weak urine flow, hesitancy, straining, and incomplete emptying) or bladder storage problems (frequency, urgency, and nocturia). Lower urinary tract symptoms are often considered to be due to benign prostatic hyperplasia (BPH) or benign prostatic enlargement. However, such symptoms are common in women, as well as in men with prostate glands that are not enlarged.3 4 The symptoms can be caused by overactivity of the bladder’s detrusor muscle, non-urological conditions, medications, or lifestyle factors. This article provides evidence to guide primary care doctors in the diagnosis of men with lower urinary tract symptoms, with an emphasis on BPH. A second article, to be published soon, will focus on management. The pathophysiology of benign prostatic enlargement involves hyperplasia of the epithelial and stromal components of …

© Queen’s Printer and Controller of HMSO 2015.Background People diagnosed with cancer of the prostate, a sex gland in the pelvis, have a choice of treatment options depending on the severity of disease. For people whose cancer is at medium and low risk of spread, the main options are surgical removal of the prostate, radical prostatectomy (RP), use of external beam radiotherapy (EBRT) to destroy the cancer or delaying treatment until there are signs that the cancer is getting worse [active surveillance (AS)]. RP and radiotherapy are effective at curing the cancer but may also cause long-term urinary incontinence and sexual problems. AS, on the other hand, may be quite difficult for people to cope with as they know that the cancer is still present. Newer treatments aim to target the disease more precisely so that surrounding normal tissues can be preserved, reducing the risk of side effects but still effectively destroying the cancer. These more targeted ablative therapies include cryotherapy, high-intensity focused ultrasound (HIFU), brachytherapy, photodynamic therapy (PDT), radiofrequency interstitial tumour ablation (RITA) and laser therapy, among others. Aims This study aimed to develop clinical care pathways relevant to a UK NHS context review systematically the evidence of the clinical effectiveness and safety of each newer ablative therapy concerning primary and salvage treatment of localised prostate cancer• determine which therapies are most likely to be cost-effective for implementation in the UK NHS identify and prioritise future research needs. Methods Clinical effectiveness review We conducted two discrete systematic reviews: (a) primary ablative treatment of localised prostate cancer compared with AS, RP or EBRT (b) salvage ablative treatment for local prostate cancer relapse after primary EBRT compared with salvage RP. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Bioscience Information Service (BIOSIS), Science Citation Index, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE) and the Health Technology Assessment (HTA) databases were searched to the end of March 2013. Reference lists of all included studies were scanned and experts on our advisory panel were contacted for details of additional reports. Evidence came from randomised controlled trials (RCTs), non-randomised comparative studies (NRCSs) (if no RCT evidence was identified) and single-arm cohort studies (case series) with greater than 10 participants for the ablative procedures only. Conference abstracts or non-English-language reports were excluded. For the primary therapy systematic review, the ablative therapies considered were cryotherapy, HIFU, PDT, RITA, laser ablation and brachytherapy. The comparators were AS, RP and EBRT. For the salvage therapy systematic review, the ablative therapies considered were cryotherapy and HIFU. The comparator was RP. Outcomes were cancer related, adverse effects (functional and procedural) and quality of life. Two reviewers extracted data and carried out quality assessment. For meta-analysis, a Bayesian indirect mixed-treatment comparison was used. Cost-effectiveness The cost-effectiveness of the different treatments and their subsequent care pathways was assessed using a modified Markov individual simulation model, applied to a UK NHS setting. The perspective for the model was a health services perspective. Parameter estimates were derived from the systematic review of clinical effectiveness, a micro-costing exercise, other literature, the expert advisory group and other UK sources. The outputs of the model were costs and quality-adjusted life-years (QALYs) for each procedure, incremental costs and QALYs and incremental cost per QALY over the remaining lifetime. Both costs and QALYs were discounted at 3.5%. An elasticity analysis, together with probabilistic and deterministic sensitivity analyses, were performed to explore the uncertainty surrounding parameter estimates. Results Clinical effectiveness Cryotherapy Data from 3995 patients who received cryotherapy across 19 studies (1 RCT, 4 NRCSs and 14 case series) were included, with most studies considered to be at high risk of bias. In the short term, there was conflicting evidence relating to cancer-specific outcomes when cryotherapy was compared with either EBRT or surgery. The only finding that reached statistical significance was 1-year disease-free survival, which was worse for cryotherapy than for either EBRT or RP. However, none of the other cancer-specific outcomes, such as biochemical failure or overall survival, showed any significant differences between them. The findings in relation to cancer-specific outcomes are best regarded as inconclusive. There was evidence that the rate of urinary incontinence at 1 year was lower for people undergoing cryotherapy than for those undergoing RP [3% vs. 66%; odds ratio (OR) 0.02, 95% credible interval (CrI) < 0.01 to 0.34], but the size of the difference decreased with longer follow-up. There was a general trend for cryotherapy to have fewer procedural complications, apart from urinary retention. The only difference that reached statistical significance was for urethral stricture, which was less frequent after cryotherapy than after RP (1% vs. 8%; OR 0.24, 95% CrI 0.09 to 0.54). High-intensity focused ultrasound Data from 4000 patients who received HIFU across 21 studies (1 NRCS and 20 case series) were included, with all studies considered to be at high risk of bias. There was some evidence that biochemical failure rates were higher at 1 year when using HIFU than when using EBRT, and this was statistically significant. However, the difference was no longer statistically significant at 5 years. Similar findings were observed with regard to disease-free survival at 1 year, with worse outcomes for HIFU than for EBRT, which were statistically significant. The differences were no longer significant at 3 years. The biochemical result was in contrast to overall survival at 4 years, which was higher when using HIFU. There were insufficient data on any urinary incontinence, erectile dysfunction or bowel problems to draw any robust conclusions, although at 1 year HIFU had lower incontinence rates than RP (10% vs. 66%; OR 0.06, 95% CrI 0.01 to 0.48). The safety profile for HIFU was generally good, apart from a potential numerical increase in rates of urinary retention and dysuria. However, HIFU appeared to have a slightly higher incidence of urethral stricture than EBRT, and the difference was statistically significant (8% vs. 1%; OR 5.8, 95% CrI 1.2 to 24.5). Brachytherapy This review considered data from 26,129 patients who received brachytherapy across 40 studies (2 RCTs and 38 NRCSs), with most studies considered to be at high risk of bias. The data for brachytherapy were generally more robust than for other ablative therapies. In the short term, there was some evidence at 5-year follow-up that the rate of biochemical failure was lower for brachytherapy (7%) than for EBRT (13%; OR 0.46, 95% CrI 0.32 to 0.67) or RP (11%; OR 0.35, 95% CrI 0.21 to 0.56). There was also some evidence that disease-free survival was better for brachytherapy at 3-year follow-up. There was evidence that the rate of urinary incontinence up to 5 years after treatment was lower for people undergoing brachytherapy than for RP, but the size of the difference decreased with longer follow-up. There was also a trend towards lower erectile dysfunction rates for brachytherapy than for EBRT or RP and this reached statistical significance at 3 years after treatment (60% vs. 81% for EBRT and 88% for RP). There were insufficient data to draw any conclusions on bowel problems. The findings regarding procedural complications were mixed. Dysuria rates were higher for brachytherapy and this reached statistical significance when compared with RP. Urinary retention was also statistically significantly higher for brachytherapy than for EBRT. Stricture rates for brachytherapy were higher than those for EBRT, but lower than those for RP. The differences for stricture reached statistical significance when compared with RP. For rectal pain, there was evidence that rates were significantly lower for brachytherapy than for EBRT. Acute genitourinary toxicity, though rare, had statistically higher rates for brachytherapy than for EBRT, but acute gastrointestinal toxicity was lower for brachytherapy. Other ablative therapies Only two other ablative therapies were identified in the review: focal laser ablative therapy and PDT. Data were too scarce (a total of 35 participants for these two procedures) for any conclusions. Salvage therapy Data from 400 participants who were treated with salvage therapy following primary EBRT across nine case series were included. Six studies involved salvage RP, two involved salvage cryotherapy and one involved salvage HIFU. In six studies, data were not collected prospectively, and only short-term outcomes were reported. As such, all of the studies were considered as having a high risk of bias. There was no robust evidence that mortality or other cancer-specific outcomes differed between salvage cryotherapy and salvage RP in the short term. There were no data on cancer-specific outcomes for salvage HIFU. In regard to functional and quality of life outcomes, lack of data prevented any conclusions. In terms of adverse event outcomes, salvage cryotherapy had numerically fewer periprocedural complications (especially for bladder neck stenosis) than salvage HIFU or salvage RP, but there was a high level of uncertainty with this observation. Focal ablation Descriptive subgroup assessment within studies reporting the use of focal ablation was limited, but suggested that cancer-specific outcomes were at least comparable with those seen in full-gland therapy studies. Urinary incontinence rates may be lower following focal ablation, but the evidence is weak in light of the poor quality and quantity of the data. Active surveillance Lack of outcome data prevented comparison of the efficacy of ablative therapies with a programme of AS, apart from the rate of erectile dysfunction at 12 months, where there was no statistically significant difference. Cost-effectiveness Assuming equal recurrence in line with the lack of statistical differences from the effectiveness review, EBRT was the least costly (£19,363 per patient) and least effective (3.63 QALYs), whereas HIFU was more costly (£19,860 per patient) and more effective (3.86 QALYs). HIFU was more effective and less costly than the other newer ablative interventions. The lifetime incremental cost per QALY for HIFU compared with EBRT was £2915. There was a 75% chance that HIFU would be considered cost-effective at a £30,000-per-QALY threshold. In a plausible best-and-worst-case analysis, the probability that HIFU would be considered cost-effective varied between 60% and 70%. Strengths and limitations The main strength of the study was the systematic approach taken to review the literature and the inclusion of a relatively large quantity of studies, giving a high total number of participants. The main limitations were the low quantity and poor quality of the data available on cancer-related outcomes and long-term adverse events of urinary incontinence, sexual and bowel dysfunction, and the changing technology over the review period. Many published studies were poorly reported or lacked sufficient detail. Inconsistency in outcome definition, measurement and reporting was also a significant problem, and much of the information available was unsuitable for meta-analysis. Another major limitation resulted from the majority of comparisons being made using case series, with few head-to-head comparisons of ablative therapies against current practice. The estimates were therefore generated using indirect comparisons. Like all analyses, they require assumptions to be made that may or may not be reasonable. Accordingly, the results should be interpreted with a large degree of caution. Despite the considerable efforts to construct a model and seek the best data available, the lack of effectiveness data had implications for the economic evaluation. The limited data meant that there was insufficient evidence to assume that there was any difference between interventions for a number of parameters, a particular issue for biochemical recurrence, which was a key parameter in the evaluation. The impact of these assumptions was explored in sensitivity analyses. Conclusions Implications for health care For primary ablative therapy, neither cryotherapy nor HIFU had sufficiently robust data to enable any definitive conclusions to be made. The effectiveness data on brachytherapy were more robust and there was some evidence that cancer-specific outcomes in the short term were either better or equivalent to either EBRT or RP, with comparable adverse effect profiles apart from a possible increased risk of dysuria and urinary retention. The findings on focal ablative therapy were mostly derived from data on focal cryotherapy, which suggested that cancer-specific outcomes were at least comparable with those of full-gland cryotherapy, and there was a suggestion that the urinary incontinence outcome may be better following focal cryotherapy than whole-gland cryotherapy. The cost-effectiveness analysis confirmed the uncertainty from the clinical review and that there is no technology which appears superior, on the basis of current evidence, in terms of average cost-effectiveness. The probabilistic sensitivity analyses suggest that a number of ablative techniques are worthy of further research. For salvage ablative therapy following primary EBRT, a lack of reliable and robust data prevented any meaningful conclusions from being made, in comparison with salvage RP. The findings from the review indicate that there is insufficient evidence to help inform recommendations on the use of ablative therapies in the UK NHS. Need for further research The main gaps in the evidence base are the lack of direct comparative studies of ablative therapies; the consequent lack of robust data to inform calculations of cost-effectiveness and the role of focal ablative therapies; and the lack of longer-term data on cancer control, such as overall and cancer-specific mortality. The key research recommendations, in order of importance, are as follows: 1. HIFU and brachytherapy seem the most promising newer interventions but they lack high-quality evaluation. Such evaluation should ideally be by multicentre RCT with long-term follow-up, and would include predefined assessment of cancer-specific, dysfunction and health-related quality-of-life measures. Such studies should incorporate economic evaluations and also inform economic modelling.

Prostate cancer prognosis may therefore be improved by maintaining healthy weight through diet and physical activity. This systematic review looked at the effect of diet and exercise interventions on body weight among men treated for prostate cancer. MEDLINE, EMBASE, CINAHL, and Cochrane Library databases were searched from the earliest record to August 2013. Randomized controlled trials of diet and exercise interventions in prostate cancer patients that reported body weight or body composition changes were included. A total of 20 trials were included in the review. Because of the heterogeneity of intervention components, a narrative review was conducted. Interventions were categorized as diet (n = 6), exercise (n = 8), or a combination of both diet and exercise (n = 6). The sample size ranged from 8 to 155 and the duration from 3 wk to 4 yr. Four diet interventions and 1 combined diet and exercise intervention achieved significant weight loss with mean values ranging from 0.8 kg to 6.1 kg (median 4.5 kg). Exercise alone did not lead to weight loss, though most of these trials aimed to increase fitness and quality of life rather than decrease body weight. Diet intervention, alone or in combination with exercise, can lead to weight loss in men treated for prostate cancer.

To present a summary of the 2013 version of the European Association of Urology guidelines on the treatment and follow-up of male lower urinary tract symptoms (LUTS). We conducted a literature search in computer databases for relevant articles published between 1966 and 31 October 2012. The Oxford classification system (2001) was used to determine the level of evidence for each article and to assign the grade of recommendation for each treatment modality. Men with mild symptoms are suitable for watchful waiting. All men with bothersome LUTS should be offered lifestyle advice prior to or concurrent with any treatment. Men with bothersome moderate-to-severe LUTS quickly benefit from α1-blockers. Men with enlarged prostates, especially those >40ml, profit from 5α-reductase inhibitors (5-ARIs) that slowly reduce LUTS and the probability of urinary retention or the need for surgery. Antimuscarinics might be considered for patients who have predominant bladder storage symptoms. The phosphodiesterase type 5 inhibitor tadalafil can quickly reduce LUTS to a similar extent as α1-blockers, and it also improves erectile dysfunction. Desmopressin can be used in men with nocturia due to nocturnal polyuria. Treatment with an α1-blocker and 5-ARI (in men with enlarged prostates) or antimuscarinics (with persistent storage symptoms) combines the positive effects of either drug class to achieve greater efficacy. Prostate surgery is indicated in men with absolute indications or drug treatment-resistant LUTS due to benign prostatic obstruction. Transurethral resection of the prostate (TURP) is the current standard operation for men with prostates 30-80ml, whereas open surgery or transurethral holmium laser enucleation is appropriate for men with prostates >80ml. Alternatives for monopolar TURP include bipolar TURP and transurethral incision of the prostate (for glands

Background There is a lack of information on the long-term outcomes of transobturator tension-free vaginal tape (TO-TVT) in the surgical treatment of female stress urinary incontinence (SUI). Objectives To assess the 3-yr outcomes following TO-TVT and to compare the effectiveness of inside-out versus outside-in approaches. Design, setting, and participants A 3-yr follow-up study of the Evaluation of Transobturator Tapes (E-TOT) trial, a randomised controlled trial (RCT) conducted with women undergoing TO-TVT as a sole procedure between April 2005 and April 2007 in a tertiary urogynaecology centre in the United Kingdom. Intervention Patients ( n =341) were randomised to undergo either TVT-O (Ethicon Inc., Somerville, NJ, USA) for the inside-out approach or TOT-Aris (Coloplast Corp., Minneapolis, MN, USA) for the outside-in approach. Outcome measurements and statistical analysis The primary outcome was patient-reported success rate. Secondary outcomes included further treatment for SUI, improvement in quality of life, late complications, and risk factors for late failures. Categorical variables were compared using the chi-square or Fisher exact test. Within-group comparison was undertaken using Wilcoxon and Mann-Whitney tests. Risk factors for late failures were assessed in a multivariate regression model. All statistical analysis was performed using SPSS v.18.0 (IBM Corp., Armonk, NY, USA). Results and limitations The 3-yr follow-up was completed by 238 of the 341 women (70%). The overall success rate, based on Patient's Global Impression of Improvement response, was 73.1%, with no significant difference between the inside-out and the outside-in TO-TVT (73.18% vs 72.3%; odds ratio: 0.927; 95% confidence interval, 0.552–1.645; p = 0.796). Compared with the 1-yr follow-up, there was a significant reduction in the patient-reported success rate ( p = 0.005); however, no independent risk factors were identified. A clinically significant improvement (≥10 points) was seen in 80% ( n = 191) of women, with no significant difference between both groups ( p = 0.113). Twenty-two women (6%) underwent further surgical treatment within 3 yr. The lack of an objective outcome assessment is a potential limitation of this RCT. Conclusions The E-TOT RCT showed a 73% patient-reported success rate for TO-TVT at 3-yr follow-up, with no significant differences between inside-out and outside-in approaches. There was a significant drop in patient-reported success rates between 1 and 3 yr.