Single-Incision Mini-Slings for Stress Urinary Incontinence in Women.

BACKGROUND: Until recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. METHODS: We performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. RESULTS: A total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, -1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. CONCLUSIONS: Single-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up. (Funded by the National Institute for Health Research.).

Cost-utility analysis of shockwave lithotripsy vs ureteroscopic stone treatment in adults.

OBJECTIVES: To assess the cost-effectiveness, resource use implications, quality-adjusted life-years (QALYs) and cost per QALY of care pathways starting with either extracorporeal shockwave lithotripsy (SWL) or with ureteroscopic retrieval (ureteroscopy [URS]) for the management of ureteric stones. PATIENTS AND METHODS: Data on quality of life and resource use for 613 patients, collected prospectively in the Therapeutic Interventions for Stones of the Ureter (TISU) randomized controlled trial (ISRCTN 92289221), were used to assess the cost-effectiveness of two care pathways, SWL and URS. A health provider (UK National Health Service) perspective was adopted to estimate the costs of the interventions and subsequent resource use. Quality-of-life data were calculated using a generic instrument, the EuroQol EQ-5D-3L. Results are expressed as incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: The mean QALY difference (SWL vs URS) was -0.021 (95% confidence interval [CI] -0.033 to -0.010) and the mean cost difference was -£809 (95% CI -£1061 to -£551). The QALY difference translated into approximately 10 more healthy days over the 6-month period for the patients on the URS care pathway. The probabaility that SWL is cost-effective is 79% at a society's willingness to pay (WTP) threshold for 1 QALY of £30,000 and 98% at a WTP threshold of £20,000. CONCLUSION: The SWL pathway results in lower QALYs than URS but costs less. The incremental cost per QALY is £39 118 cost saving per QALY lost, with a 79% probability that SWL would be considered cost-effective at a WTP threshold for 1 QALY of £30 000 and 98% at a WTP threshold of £20 000. Decision-makers need to determine if costs saved justify the loss in QALYs.

Perinatal deaths and low birthweight in an urban health centre in the Gambia: A prospective cohort study.

Perinatal deaths (stillbirths after 28 weeks gestation and early neonatal deaths) are rarely reported separately but are the deaths most closely associated with complications during pregnancy, birth and the first days of life. We conducted a prospective cohort study to report perinatal deaths, late neonatal deaths and low birthweight babies as they occur. This cohort of birth outcomes from The Gambia was conducted between 2012 and 2016 and followed 1611 women attending a government-supported health center from the first antenatal visit to 28 days post-delivery. The outcome of the pregnancy was known for 1372 women (85.2%) and included 20 stillbirths and 12 early neonatal deaths. Of 1252 singleton babies with known birthweight 85 weighed less than 2500g (6.8%). Using multivariate analysis it was shown that women who attended the antenatal clinic four times or more were less likely to have a low birthweight baby than women who attended less than four times, OR 0.47 (95% CI:0.273-0.799). We conclude that frequent visits to the antenatal clinic are associated with better outcomes.

What influences adherence to guidance for postoperative instillation of intravesical chemotherapy to patients with bladder cancer?

OBJECTIVE: To understand the barriers and facilitators to single instillation of intravesical chemotherapy (SI-IVC) use after resection of non-muscle-invasive bladder cancer (NMIBC) in Scotland and England using a behavioural theory-informed approach. SUBJECTS 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 mitomycin C (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 in operation proforma (four hospitals). Performance targets (with audit and feedback) within a national governance framework were 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 MMC, after NMIBC resection reduces recurrences. This evidence underpins international guidance. The number 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.

Mobile Telephone Follow-Up to Ascertain Birth Outcomes in The Gambia.

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.

Determinants of compliance with the World Health Organisation recommendations for pregnant women in an urban health centre in The Gambia.

In 2001 the World Health Organization drew up recommendations for pregnant women in order to reduce maternal mortality: the first visit to the antenatal clinic to be in the first trimester, at least four visits in total and delivery with a trained birth attendant. This study reports the extent to which pregnant women attending a health centre in The Gambia complied with the recommendations. A cohort of 1611 consecutive pregnant women was recruited. Only 384 (23.9%) women first attended in the first trimester and 568 (41.6%) attended at least four times. Only 15.8% of the women complied with all recommendations. Following multivariate analysis the educational level of the partner was the sole factor associated with both recommendations regarding attendance. This level of compliance reflects widespread ignorance of the value of early antenatal care and frequent visits. Public health programmes require a basic level of education to be effective.

Bipolar versus monopolar transurethral resection of the prostate for lower urinary tract symptoms secondary to benign prostatic obstruction.

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.

Adherence to the European Association of Urology Guidelines: A National Survey among Italian Urologists.

OBJECTIVE: The study aimed to explore adherence to the European Urological Association (EAU) Guidelines (GLs) grade A recommendation among Italian urologists. MATERIALS AND METHODS: A 13-item multiple-choice questionnaire covering oncological and non-oncological urological diseases was e-mailed to all Italian Urologist Society (Società Italiana di Urologia or SIU) members. We asked members to provide an explanation for their answer choice where needed. The quantitative data were tested using the Pearson's chi-square test. For all statistical comparisons, significance was considered as p < 0.05. RESULTS: Of the 2011 invited SIU members, 210 (10.4%) completed the survey. The sample was composed of 22 (10.5%) Academic Urologists (AcUs), 110 (52.4%) Attending Urologists (AtUs), 32 (15.2%) Private Practice Urologists (PPUs), and 41 (19.5%) Residents in Urology (RUs). The mean adherence to the EAU Oncologic GLs ranged from 54.5 to 97.1%, while the adherence to the non-oncologic GLs ranged from 45 to 87.6%. We found that adherence differed across the working categories assessed. CONCLUSION: Our survey showed that professional role, updates, and local facilities seem to be the drivers that influence the non-adherence to the GLs. Urologists who work in university hospital would be more inclined to adopt the GLs compared to those who practice in non-academic centers.

A core outcome set for localised prostate cancer effectiveness trials.

OBJECTIVE: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer. Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio; which is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials. PATIENTS, SUBJECTS AND METHODS: A list of 79 outcomes was derived from a systematic review of published localised prostate cancer effectiveness studies and semi-structured interviews with 15 patients with prostate cancer patients. A two-stage consensus process involving 118 patients and 56 international healthcare professionals (HCPs; cancer specialist nurses, urological surgeons and oncologists) was undertaken, consisting of a three-round Delphi survey followed by a face-to-face consensus panel meeting of 13 HCPs and eight patients. RESULTS: The final COS included 19 outcomes. In all, 12 apply to all interventions: death from prostate cancer, death from any cause, local disease recurrence, distant disease recurrence/metastases, disease progression, need for salvage therapy, overall quality of life, stress urinary incontinence, urinary function, bowel function, faecal incontinence, and sexual function. Seven were intervention-specific: perioperative deaths (surgery), positive surgical margin (surgery), thromboembolic disease (surgery), bothersome or symptomatic urethral or anastomotic stricture (surgery), need for curative treatment (active surveillance), treatment failure (ablative therapy), and side-effects of hormonal therapy (hormone therapy). The UK-centric participants may limit the generalisability to other countries, but trialists should reason why the COS would not be applicable. The default position should not be that a COS developed in one country will automatically not be applicable elsewhere. CONCLUSION: We have established a COS for trials of effectiveness in localised prostate cancer, applicable across all interventions that should be measured in all localised prostate cancer effectiveness trials.

Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial.

BACKGROUND: Meta-analyses of previous randomised controlled trials concluded that the smooth muscle relaxant drugs tamsulosin and nifedipine assisted stone passage for people managed expectantly for ureteric colic, but emphasised the need for high-quality trials with wide inclusion criteria. We aimed to fulfil this need by testing effectiveness of these drugs in a standard clinical care setting. METHODS: For this multicentre, randomised, placebo-controlled trial, we recruited adults (aged 18-65 years) undergoing expectant management for a single ureteric stone identified by CT at 24 UK hospitals. Participants were randomly assigned by a remote randomisation system to tamsulosin 400 µg, nifedipine 30 mg, or placebo taken daily for up to 4 weeks, using an algorithm with centre, stone size (≤5 mm or >5 mm), and stone location (upper, mid, or lower ureter) as minimisation covariates. Participants, clinicians, and trial personnel were masked to treatment assignment. The primary outcome was the proportion of participants who did not need further intervention for stone clearance within 4 weeks of randomisation, analysed in a modified intention-to-treat population defined as all eligible patients for whom we had primary outcome data. This trial is registered with the European Clinical Trials Database, EudraCT number 2010-019469-26, and as an International Standard Randomised Controlled Trial, number 69423238. FINDINGS: Between Jan 11, 2011, and Dec 20, 2013, we randomly assigned 1167 participants, 1136 (97%) of whom were included in the primary analysis (17 were excluded because of ineligibility and 14 participants were lost to follow-up). 303 (80%) of 379 participants in the placebo group did not need further intervention by 4 weeks, compared with 307 (81%) of 378 in the tamsulosin group (adjusted risk difference 1·3% [95% CI -5·7 to 8·3]; p=0·73) and 304 (80%) of 379 in the nifedipine group (0·5% [-5·6 to 6·5]; p=0·88). No difference was noted between active treatment and placebo (p=0·78), or between tamsulosin and nifedipine (p=0·77). Serious adverse events were reported in three participants in the nifedipine group (one had right loin pain, diarrhoea, and vomiting; one had malaise, headache, and chest pain; and one had severe chest pain, difficulty breathing, and left arm pain) and in one participant in the placebo group (headache, dizziness, lightheadedness, and chronic abdominal pain). INTERPRETATION: Tamsulosin 400 µg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review.

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.

Systematic review and meta-analysis of the clinical effectiveness of bipolar compared with monopolar transurethral resection of the prostate (TURP).

To compare monopolar and bipolar transurethral resection of the prostate (TURP) for clinical effectiveness and adverse events. We conducted an electronic search of MEDLINE, Embase, CENTRAL, Science Citation Index, and also searched reference lists of articles and abstracts from conference proceedings for randomised controlled trials (RCTs) comparing monopolar and bipolar TURP. Two reviewers independently undertook data extraction and assessed the risk of bias in the included trials using the tool recommended by the Cochrane Collaboration. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. From the 949 abstracts that were identified, 94 full texts were assessed for eligibility and a total of 24 trials were included in the review. No statistically significant differences were found in terms of International Prostate Symptom Score (IPSS) or health-related quality of life (HRQL) score. Results for maximum urinary flow rate were significant at 3, 6 and 12 months (all P < 0.001), but no clinically significant differences were found and the meta-analysis showed evidence of heterogeneity Bipolar TURP was associated with fewer adverse events including transurethral resection syndrome (risk ratio [RR] 0.12, 95% confidence interval [CI] 0.05-0.31, P < 0.001), clot retention (RR 0.48, 95% CI 0.30-0.77, P = 0.002) and blood transfusion (RR 0.53, 95% CI 0.35-0.82, P = 0.004) Several major methodological limitations were identified in the included trials; 22/24 trials had a short follow-up of ≤1 year, there was no evidence of a sample size calculation in 20/24 trials and the application of GRADE showed the evidence for most of the assessed outcomes to be of moderate quality, including all those in which statistical differences were found. Whilst there is no overall difference between monopolar and bipolar TURP for clinical effectiveness, bipolar TURP is associated with fewer adverse events and therefore has a superior safety profile. Various methodological limitations were highlighted in the included trials and as such the results of this review should be interpreted with caution. There is a need for further well-conducted, multicentre RCTs with long-term follow-up data.

Three-year cost utility analysis of mini versus standard slings: A trial based economic evaluation.

Objective: To report on the cost-effectiveness of adjustable anchored single-incision mini-slings (mini-slings) compared with tension-free standard mid-urethral slings (standard slings) in the surgical management of female stress urinary incontinence (SUI). Patients and Methods: Data on resource use and quality were collected from women aged ≥18 years with predominant SUI undergoing mid-urethral sling procedures in 21 UK hospitals. Resource use and quality of life (QoL) data were prospectively collected alongside the Single-Incision Mini-Slings versus standard synthetic mid-urethral slings Randomised Control Trial (SIMS RCT), for surgical treatment of SUI in women. A health service provider's (National Health Service [NHS]) perspective with 3-year follow-up was adopted to estimate the costs of the intervention and all subsequent resource use. A generic instrument, EuroQol EQ-5D-3L, was used to estimate the QoL. Results are reported as incremental costs, quality adjusted life years (QALYs) and incremental cost per QALY. Results: Base case analysis results show that although mini-slings cost less, there was no significant difference in costs: mini-slings versus standard slings: £-6 [95% CI -228-208] or in QALYs: 0.005 [95% CI -0.068-0.073] over the 3-year follow-up. There is substantial uncertainty, with a 56% and 44% probability that mini-slings and standard slings are the most cost-effective treatment, respectively, at a £20 000 willingness-to-pay threshold value for a QALY. Conclusions: At 3 years, there is no significant difference between mini-slings and standard slings in costs and QALYs. There is still some uncertainty over the long-term complications and failure rates of the devices used in the treatment of SUI; therefore, it is important to establish the long-term clinical and cost-effectiveness of these procedures.

Improving Patient Information and Enhanced Consent in Urology: The Impact of Simulation and Multimedia Tools. A Systematic Literature Review from the European Association of Urology Patient Office.

BACKGROUND AND OBJECTIVE: Discussions surrounding urological diagnoses and planned procedures can be challenging, and patients might experience difficulty in understanding the medical language, even when shown radiological imaging or drawings. With the introduction of virtual reality and simulation, informed consent could be enhanced by audiovisual content and interactive platforms. Our aim was to assess the role of enhanced consent in the field of urology. METHODS: A systematic review of the literature was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, using informed consent, simulation, and virtual reality in urology as the search terms. All original articles were screened. KEY FINDINGS AND LIMITATIONS: Thirteen original studies were included in the review. The overall quality of these studies was deemed good according to the Newcastle-Ottawa Scale. The studies analysed the application of different modalities for enhanced consent: 3D printed or digital models, audio visual multimedia contents, virtual simulation of procedures and interactive navigable apps. Published studies agreed upon a significantly improved effect on patient understanding of the diagnosis, including basic anatomical details, and surgery-related issues such as the aim, steps and the risks connected to the planned intervention. Patient satisfaction was unanimously reported as improved as a result of enhanced consent. CONCLUSIONS AND CLINICAL IMPLICATIONS: Simulation and multimedia tools are extremely valuable for improving patients' understanding of and satisfaction with urological procedures. Widespread application of enhanced consent would represent a milestone for patient-urologist communication. PATIENT SUMMARY: Several multimedia tools can be used to improve patients' understanding of urological conditions and procedures, such as simulation and models. Use of these tools for preoperative discussion enhances knowledge and patient satisfaction, resulting in more realistic patient expectations and better informed consent.

Gambian Mothers Lack Obstetric Danger Sign Knowledge, But Educational Intervention Shows Promise.

Background: The Gambia has the 12th highest maternal mortality rate in the world, with 80% of deaths resulting from avoidable causes. Unawareness of pregnancy danger signs (DS) has been shown to be a barrier to seeking obstetric care, while app-based education intervention has shown promise. Objective: We aim to assess patient awareness of DS, identify barriers to awareness, and evaluate potential for implementing smartphone-based technologies for education. Methods: A cross-sectional semi-structured survey was administered to Gambian women (n = 100) across five hospitals/health centers. Data and informed consent were collected via an online survey portal. Analysis included bivariate analysis and descriptive statistics with p < 0.05 significance level. Recall of 0-2 DS per category was classified as "low" knowledge, 3-5 as "moderate" knowledge, and 6+ as "sufficient" knowledge. Cross-category recall was quantified for overall awareness level (0-6 = "low", 7-12 = "moderate", 13+ = "sufficient". N = 28 total DS). Findings: Although 75% of participants (n = 100) self-perceived "sufficient" knowledge of DS, the average recall was only two (SD = 2, n = 11) pregnancy DS, one labor and delivery DS (SD = 1, n = 8), and one postpartum DS (SD = 1, n = 9). Twenty-one women were unable to recall any danger signs. "Low" awareness was identified in 77% of women, while 23%, and 0% of women showed "moderate" and "sufficient" overall awareness, respectively. Education level was significantly correlated with overall danger sign recall (ρ(98) = .243, p = .015) and awareness level (ρ(98) = .265, p = .008). Monthly income was significantly correlated with awareness level (ρ(97) = .311, p = .002). Smartphone ownership was reported by 76% of women, and 97% expressed interest in using app-based video (94%) or provider (93%) teaching. Conclusions: Women had low knowledge of obstetric danger signs, and true awareness of danger signs was remarkably lower than self-perceived knowledge. However, patients exhibited proper healthcare-seeking behavior when danger signs arose. Findings suggest that video- or messaging-based education from local healthcare providers may be effective DS educational interventions.

Research protocol for an observational health data analysis to assess the applicability of randomized controlled trials focusing on newly diagnosed metastatic prostate cancer using real-world data: PIONEER IMI's "big data for better outcomes" program.

Background: Metastatic prostate cancer (PCa) constitutes ~5% of all new PCa diagnoses in Western countries. For most cases, primary consideration should be given to systemic therapies as the first-line approach based on evidence from randomized controlled trials (RCTs). Despite the importance of RCTs as the pinnacle of evidence in modern medicine, concerns have been raised about their applicability to real-life scenarios. These trials often feature participants who are younger with better performance statuses and prognoses compared to their real-world counterparts. The PIONEER project falls under the Innovative Medicine Initiative's (IMI) "Big Data for Better Outcomes" initiative, aimed at revolutionizing PCa care in Europe. The central focus lies in improving cancer-related outcomes, enhancing health system efficiency, and elevating the quality of health and social care. This study endeavours to evaluate the generalizability of RCT findings concerning newly diagnosed metastatic PCa. Methods: A systematic review of the literature will be conducted to compile patient characteristics from RCTs addressing this subject within the past decade. To create a real-world benchmark, patients with recently diagnosed metastatic PCa from a network of population-based databases will serve as a comparison group. The objective is to assess the applicability of RCT results in two ways. First, a comparison will be made between the characteristics of patients with newly diagnosed metastatic PCa enroled in RCTs and those with the same condition included in our databases which might represent the real-world setting. Second, an evaluation will be undertaken to determine the proportion of real-world patients with newly diagnosed metastatic PCa who meet the criteria for RCT enrolment. This study will rely on extensive observational data, primarily sourced from population-based registries, electronic health records, and insurance claims data. The study cohort is established upon routinely gathered healthcare data, meticulously mapped to the Observational Medical Outcomes Partnership Common Data Model.

ESRU-ESU-YAU_UROTECH Survey on Urology Residents Surgical Training: Are We Ready for Simulation and a Standardized Program?

Background: Currently, the landscape of surgical training is undergoing rapid evolution, marked by the initial implementation of standardized surgical training programs, which are further facilitated by the emergence of new technologies. However, this proliferation is uneven across various countries and hospitals. Objective: To offer a comprehensive overview of the existing surgical training programs throughout Europe, with a specific focus on the accessibility of simulation resources and standardized surgical programs. Design setting and participants: A dedicated survey was designed and spread in May 2022 via the European Association of Urology (EAU) mail list, to Young Urologist Office (YUO), Junior membership, European Urology Residents Education Program participants between 2014 and 2022, and other urologists under 40 yr, and via the EAU Newsletter. Intervention: A 64-item, online-based survey in accordance with the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) using the platform of Survey Monkey (Portland, OR, USA) was realized. Outcome measurements and statistical analysis: The study involved an assessment of the demographic characteristics. Additionally, it explored the type of center, availability of various surgical approaches, presence of training infrastructure, participation in courses, organization of training, and participants' satisfaction with the training program. The level of satisfaction was evaluated using a Likert-5 scale. The subsequent sections delved into surgical training within the realms of open, laparoscopic, robotic, and endoscopic surgery, each explored separately. Finally, the investigation encompassed the presence of a structured training course and the availability of a duly validated final evaluation process. Results and limitations: There were 375 responders with a completion rate of 82%. Among them, 75% were identified as male, 50.6% were young urologists, 31.7% were senior residents, and 17.6% were junior residents. A significant majority of participants (69.6%) were affiliated with academic centers. Regarding the presence of dry lab training facilities, only 50.3% of respondents indicated its availability. Among these centers, 46.7% were primarily focused on laparoscopy training. The availability of virtual and wet lab training centers was even more limited, with rates of 31.5% and 16.2%, respectively. Direct patient involvement was reported in 80.5% of cases for open surgery, 58.8% for laparoscopy, 25.0% for robotics, and 78.6% for endourology. It is worth noting that in <25% of instances, training followed a well-defined standardized program comprising both preclinical and clinical modular phases. Finally, the analysis of participant feedback showed that 49.7% of respondents expressed a satisfaction rating of either 4 or 5 points with respect to the training program. The limitations of our study include the low response rate, predominance of participants from academic centers, and absence of responses from individuals not affiliated with the EAU network. Conclusions: The current distribution of surgical training centers falls short of ensuring widespread access to standardized training programs. Although dry lab facilities are relatively well spread, the availability of wet lab resources remains restricted. Additionally, it appears that many trainees' initial exposure to surgery occurs directly with patients. There is a pressing need for continued endeavors to establish uniform training routes and assessment techniques across various surgical methodologies. Patient summary: Nowadays, the surgical training landscape is heterogeneous across different countries. The implementation of a standardized training methodology to enhance the overall quality of surgical training and thereby improving patient outcomes is needed.

How Can We Improve Patient-Clinician Communication for Men Diagnosed with Prostate Cancer?

Background and objective: The ability of health care professionals to communicate with patients compassionately and effectively is crucial for shared decision-making, but little research has investigated patient-clinician communication. As part of PIONEER-an international Big Data Consortium led by the European Association of Urology to answer key questions for men with prostate cancer (PCa), funded through the IMI2 Joint Undertaking under grant agreement 777492- we investigated communication between men diagnosed with PCa and the health care professional(s) treating them across Europe. Methods: We used the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Communication 26, which was shared via the PIONEER and patient organisations on March 11, 2022. We sought men who spoke French, Italian, Spanish, German, Dutch, or English who were diagnosed with PCa and were undergoing or had already received treatment for their PCa. Results and limitations: A total of 372 men reported that they communicated with their clinician during either the diagnostic or the treatment period. Overall, the majority of participants reported positive experiences. However, important opportunities to enhance communication were identified, particularly with regard to correcting misunderstandings, understanding the patient's preferred approach to information presentation, addressing challenging questions, supporting the patient's comprehension of information, attending to the patient's emotional needs, and assessing what information had already been given to patients about their disease and treatment, and how much of it was understood. Conclusions and clinical implications: These results help us to identify gaps and barriers to shared treatment decision making. This knowledge will help devise measures to improve patient-health care professional communication in the PCa setting. Patient summary: As part of the PIONEER initiative, we investigated the communication between men diagnosed with prostate cancer and their health care professionals across Europe. A total of 372 men from six different countries participated in the study. Most participants reported positive experiences, but areas where communication could be improved were identified. These included addressing misunderstandings, tailoring the presentation of information to the patient's preferences, handling difficult questions, supporting emotional needs, and assessing the patient's understanding of their diagnosis and treatment.