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Background Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking. Objective We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery. Design This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference. Setting The trial was set in 28 UK urological centres in the NHS. Participants Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation. Interventions We compared male synthetic sling with artificial urinary sphincter. Main outcome measures The clinical primary outcome measure was men’s reports of continence (assessed from questions 3 and 4 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) at 12 months post randomisation (with a non-inferiority margin of 15%). The primary economic outcome was cost-effectiveness (assessed as the incremental cost per quality-adjusted life-year at 24 months post randomisation). Results In total, 380 men were included in the randomised controlled trial (n = 190 in each group), and 99 out of 100 men were included in the non-randomised cohort. In terms of continence, the male sling was non-inferior to the artificial urinary sphincter (intention-to-treat estimated absolute risk difference –0.034, 95% confidence interval –0.117 to 0.048; non-inferiority p = 0.003), indicating a lower success rate in those randomised to receive a sling, but with a confidence interval excluding the non-inferiority margin of –15%. In both groups, treatment resulted in a reduction in incontinence symptoms (as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Between baseline and 12 months’ follow-up, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score fell from 16.1 to 8.7 in the male sling group and from 16.4 to 7.5 in the artificial urinary sphincter group (mean difference for the time point at 12 months 1.30, 95% confidence interval 0.11 to 2.49; p = 0.032). The number of serious adverse events was small (male sling group, n = 8; artificial urinary sphincter group, n = 15; one man in the artificial urinary sphincter group experienced three serious adverse events). Quality-of-life scores improved and satisfaction was high in both groups. Secondary outcomes that showed statistically significant differences favoured the artificial urinary sphincter over the male sling. Outcomes of the non-randomised cohort were similar. The male sling cost less than the artificial sphincter but was associated with a smaller quality-adjusted life-year gain. The incremental cost-effectiveness ratio for male slings compared with an artificial urinary sphincter suggests that there is a cost saving of £425,870 for each quality-adjusted life-year lost. The probability that slings would be cost-effective at a £30,000 willingness-to-pay threshold for a quality-adjusted life-year was 99%. Limitations Follow-up beyond 24 months is not available. More specific surgical/device-related pain outcomes were not included. Conclusions Continence rates improved from baseline, with the male sling non-inferior to the artificial urinary sphincter. Symptoms and quality of life significantly improved in both groups. Men were generally satisfied with both procedures. Overall, secondary and post hoc analyses favoured the artificial urinary sphincter over the male sling. Future work Participant reports of any further surgery, satisfaction and quality of life at 5-year follow-up will inform longer-term outcomes. Administration of an additional pain questionnaire would provide further information on pain levels after both surgeries. Trial registration This trial is registered as ISRCTN49212975. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 36. See the NIHR Journals Library website for further project information.

AIMS: Mounting evidence from experimental animal and human studies suggests that cross-sensitization exists between different organs. Lower urinary tract (LUT) and bowel dysfunction commonly overlap, and the role of cross-sensitization between pelvic visceral organs is uncertain.METHODS: At the International Consultation on Incontinence Research Society (ICI-RS) meeting in 2018, a panel of clinicians participated in a discussion on bladder and bowel interactions in the context of pelvic organ cross-sensitization.RESULTS: Bladder and bowel problems commonly co-occur in adults and children across different disorders, and the mechanism responsible for overlapping dysfunction is uncertain in most instances. At a neuronal level, cross-sensitization occurs as a result of afferent signaling from the LUT and lower bowel through different central and peripheral mechanisms. Studies in animals and humans have demonstrated evidence for cross-organ sensitization following experimental inflammation or distension of the lower bowel, affecting the LUT. Nerve stimulation is an effective treatment for different functional LUT and bowel disorders, and whether this treatment may influence cross-organ sensitization remains uncertain. The role of physiologically dormant C-fibers, the bladder-gut-brain axis, and gut microbiome in cross-sensitization are speculative.CONCLUSION: Recommendations for research were made to explore the role of cross-organ sensitization in the pathogenesis of co-occurring LUT and bowel dysfunction in humans.

Lower urinary tract symptoms (LUTS), consisting storage, voiding and post-micturition symptoms, is a comprehensive definition involving symptoms that may occur due to several causes. Instead of simply focusing on the enlarged prostate, more attention has to be paid to the entire urinary tract as well as multiple system comorbidities. Therefore, prostate surgery alone does not necessarily provide adequate management and cross-disciplinary collaborations are sometimes required. Based on current literature, this paper proposes the “3Bs” concept for managing non-neurogenic male LUTS, namely, “beyond prostate”, “beyond surgery” and “beyond urology”. The clinical application of the “3Bs” enables urologists to carry out integrated, individualized and precise medical care for each non-neurogenic male LUTS patient. Keywords: Male, Lower urinary tract symptoms, Benign prostatic hyperplasia, Benign prostatic obstruction, Detrusor overactivity, Detrusor underactivity, Prostate surgery, Comorbidities

Aims SYNERGY II was a 12‐month phase III trial in patients with overactive bladder (OAB) symptoms that investigated the safety and efficacy of the combination of mirabegron and solifenacin in comparison with each monotherapy. This analysis evaluated the trial findings using four age subgroups (1 bpm were noted in the combination and mirabegron younger age groups only. No clinically significant findings were observed in the other safety parameters. The efficacy variables improved with all treatments and the greatest improvements were typically observed with combination therapy. Conclusions Mirabegron and solifenacin combination therapy was a well‐tolerated and effective treatment for patients with OAB symptoms irrespective of their age.

BackgroundStress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking.ObjectiveTo compare the outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery.Design, setting, and participantsA noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries.InterventionParticipants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group.Outcome measurements and statistical analysisThe primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after surgery.Results and limitationsA total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval {CI} –11.6 to 4.6], pNI = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2–2.6], p = 0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS.ConclusionsUsing a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS.Patient summaryUrinary incontinence after prostatectomy has considerable effect on men’s quality of life. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having an artificial urinary sphincter have better outcomes than those who have a sling.

ObjectiveProstate surgery can improve lower urinary tract symptoms (LUTS) by relieving bladder outlet obstruction (BOO). However, surgery is less effective without BOO, or if detrusor underactivity (DU) is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking. UPSTREAM (Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods) evaluated whether a carepathway including UDS would reduce surgery without increasing urinary symptoms.Design, setting and participantsUPSTREAM is a pragmatic, non-inferiority randomised controlled trial in 26 hospitals in England (ISRCTN56164274) in men with bothersome LUTS where surgery was an option. InterventionParticipants were randomised (1:1) to routine care (RC) diagnostic tests, or routine care plus urodynamics (UDS).Outcome measuresThe primary outcome was International Prostate Symptom Score (IPSS; patient reported outcome scale from 0 to 35 points) 18-months post-randomisation, with a non-inferiority margin of one point. Urological surgery rates were a key secondary outcome.Statistical analysisThe primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis.Results and limitationsBetween October 2014 and December 2016, 820 men (median age 68 years) were randomised (393 and 427 in RC and UDS arms, respectively). The UDS arm showed noninferiority of mean IPSS scores (UDS 12·6; RC 13.1; adjusted difference at 18 months -0·33 (95% CI -1·47, +0·80)). In the UDS arm, 153/408 (38%) received surgery compared with 138/384 (36%) for RC (adjusted OR 1·05; 95% CI 0·77, 1·43). 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms, and 11 unrelated deaths.Conclusion In this population, the UDS randomised group was non-inferior to RC for IPSS but did not reduce surgical rates. The study shows that routine use of UDS in evaluation of uncomplicated LUTS has a limited role and should be used selectively. Patient summaryFor men with uncomplicated lower urinary tract symptoms, the symptom improvements after treatment and the number of operations done are similar, whether or not urodynamic tests aredone in addition to routine tests. Accordingly, routine use of UDS has a limited role in this population group.

Background Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery. Objectives The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome. Design This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research. Setting Urology departments of 26 NHS hospitals in England. Participants Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised. Interventions Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm). Main outcome measures The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness. Results A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (–0.33, 95% CI –1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43–44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS. Limitations The trial met its predefined recruitment target, but surgery rates were lower than anticipated. Conclusions Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS. Future work Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy. Trial registration Current Controlled Trials ISRCTN56164274. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 42. See the NIHR Journals Library website for further project information.

INTRODUCTION The quality of urodynamic measurements in clinical practice has been debated as a matter of concern. It is considered plausible that this has a direct bearing on patient care and the perceived value of urodynamic testing. METHODS This is a report of the proceedings of the Think Tank: "Is the value of urodynamics undermined by poor technique?" from the Annual International Consultation on Incontinence-Research Society, which took place in June 2018 in Bristol, UK. The Think Tank discussed the evidence for deficiencies in urodynamic test quality and considered the implications of improvements for clinical diagnosis and practice. RESULTS There is evidence that technique affects urodynamic quality, and that urodynamic practice is variable. Factors such as team skill set, technologies used, and training received will also affect the quality of urodynamic service. Questions exist regarding the influence of technique on the utility and perceived value of urodynamics. CONCLUSIONS We suggest research questions that will provide the necessary evidence on the link between technique, reporting, and outcome, and clarify the role of good practice in the utility of urodynamic testing.

AimsThe Think Tank aimed to discuss the pitfalls and advantages of current definitions in terms of research and management of underactive bladder (UAB). UAB broadly defines a symptom complex of bladder emptying problems and does not indicate a specific pathology. Detrusor underactivity (DU) is a urodynamic diagnosis from pressure-flow studies. The correlation of UAB with DU remains to be precisely determined. MethodsThe presentations and subsequent discussion, leading to research recommendations during the Think Tank of the International Consultation on Incontinence Research Society in Bristol, 2017, are summarized. ResultsTo develop more specific individualized management strategies, the Think Tank panel proposed (i) that, since defining a single type of index patient to represent all UAB will not fulfill all clinical research needs, several index patients should be defined by phenotyping of patients with UAB, including, children, young men and women, elderly male and female patients with co-existing DU and detrusor overactivity, and neurological patients with UAB; (ii) prospective longitudinal studies to assess the natural history of UAB, in the different target populations, based on different UAB phenotypes, should be initiated; (iii) DU should be precisely defined by urodynamic parameters; and (iv) work to develop validated specific questionnaires combined with non-invasive tests for screening, diagnosis and follow up, needs to be continued. ConclusionsThe precise relationship of UAB to DU remains to be defined. Phenotyping patients with UAB/DU, performing prospective trials of natural history, and developing symptom questionnaires and diagnostic investigations will improve our ability to identify and treat UAB/DU.

ObjectiveDietary factors and physical activity may alter prostate cancer progression. We explored the feasibility of lifestyle interventions following radical prostatectomy for localised prostate cancer.DesignPatients were recruited into a presurgical observational cohort; following radical prostatectomy, they were offered randomisation into a 2×3 factorial randomised controlled trial (RCT).SettingA single National Health Service trust in the South West of England, UK.ParticipantsThose with localised prostate cancer and listed for radical prostatectomy were invited to participate.RandomisationRandom allocation was performed by the Bristol Randomised Trial Collaboration via an online system.InterventionsMen were randomised into both a modified nutrition group (either increased vegetable and fruit, and reduced dairy milk; or lycopene supplementation; or control) and a physical activity group (brisk walking or control) for 6 months.BlindingOnly the trial statistician was blind to allocations.Primary outcome measuresPrimary outcomes were measures of feasibility: randomisation rates and intervention adherence at 6 months. Collected at trial baseline, three and six months, with daily adherence reported throughout. Our intended adherence rate was 75% or above, the threshold for acceptable adherence was 90%.Results108 men entered the presurgical cohort, and 81 were randomised into the postsurgical RCT (randomisation rate: 93.1%) and 75 completed the trial. Of 25 men in the nutrition intervention, 10 (40.0%; 95% CI 23.4% to 59.3%) adhered to the fruit and vegetable recommendations and 18 (72.0%; 95% CI 52.4% to 85.7%) to reduced dairy intake. Adherence to lycopene (n=28), was 78.6% (95% CI 60.5% to 89.8%), while 21/39 adhered to the walking intervention (53.8%; 95% CI 38.6% to 68.4%). Most men were followed up at 6 months (75/81; 92.6%). Three ‘possibly related’ adverse events were indigestion, abdominal bloating and knee pain.ConclusionsInterventions were deemed feasible, with high randomisation rates and generally good adherence. A definitive RCT is proposed.Trial registration numberISRCTN 99048944.

Background Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies). Objective To report participants’ sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and surgery rates are lower if UDS is included. Design, setting, and participants A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments. Intervention Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm). Outcome measurements and statistical analysis The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick’s test, and questionnaire items were compared using Pearson’s correlation coefficient. Results and limitations Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure. Conclusions Men being considered for surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function. Patient summary We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.

Storage lower urinary tract symptoms (LUTS) are characterized by an altered bladder sensation, increased daytime frequency, nocturia, urgency and urgency incontinence. Some evidence underlines the role of metabolic factors, pelvic ischemia, prostatic chronic inflammation and associated comorbidities in the pathophysiology of storage LUTS. A detailed evaluation of the severity of storage LUTS, and the concomitance of these symptoms with voiding and postmicturition symptoms, is mandatory for improving the diagnosis and personalizing treatment. A detailed medical history with comorbidities and associated risk factors, a physical examination, a comprehensive analysis of all the features of LUTS, including their impact on quality of life, and a frequency–volume chart (FVC) or bladder diary, are recommended for men with storage LUTS. Several drugs are available for the treatment of LUTS secondary to benign prostatic obstruction (BPO). Alpha-blockers (α-blockers), 5-α-reductase inhibitors and phosphodiesterase type 5 inhibitors are commonly used to manage storage LUTS occurring with voiding symptoms associated with BPO. Muscarinic receptor antagonists and Beta 3-agonists (β3-agonists) alone, or in combination with α-blockers, represent the gold standard of treatment in men with predominant storage LUTS. There is no specific recommendation regarding the best treatment options for storage LUTS after prostatic surgery.

BACKGROUND: Underactive bladder (UAB) is considered the symptom complex associated with the urodynamic diagnosis of detrusor underactivity.OBJECTIVE: The aim of this research was to investigate the patient reported experience of the symptoms, signs, and impact of UAB. This research is also part of the initial qualitative phase for the development of a new patient reported outcome measure for the assessment of UAB.DESIGN, SETTING, AND PARTICIPANTS: Qualitative methods were used to understand the experience of UAB from a patient perspective, in a purposive sample of male (n=29) and female (n=15) patients aged 27-88 yr (mean: 64 yr), diagnosed with a primary diagnosis of detrusor underactivity, with or without coexisting urological conditions. Semistructured interviews were conducted in Bristol, UK.RESULTS: Male and female patients reported a variety of lower urinary tract symptoms and associated impact on quality of life. Storage symptoms of nocturia, increased daytime frequency, and urgency, and the voiding symptoms of slow stream, hesitancy, and straining were reported by over half of the patients. A sensation of incomplete emptying and postmicturition dribble were also frequently described. Most had a post void residual >30ml (n=34, 77%, median: 199ml) with many reporting urinary tract infections, a history of self-catheterisation, and some experiencing occasional acute retention episodes. These symptoms and signs can have a broad impact on quality of life including having to plan their daily activities around the location of toilets, disruption to sleep, social life, and associated effect on family and friends.CONCLUSIONS: Knowledge of the lived experience of UAB obtained in the current study will be used for the development of a new patient reported outcome measure and help inform the current working definition of UAB.PATIENT SUMMARY: The symptoms, signs, and impact on quality of life of underactive bladder are described by patients with the condition.

INTRODUCTIONUrethral function, as well as anatomy, play a significant role in voiding reflex and abnormalities in one or both contribute to the pathophysiology of Lower Urinary Tract Dysfunction (LUTD). We have several diagnostic tools to assess the urethral function or dysfunction but the question remains, are these adequate?METHODSThis is a report of the proceedings of Think Tank P1: Do we assess urethral function adequately in LUTD and NLUTD?' from the annual International Consultation on IncontinenceResearch Society, which took place September 22-24, 2014 in Bristol, UK.RESULTSWe have collected and discussed, as a committee, the evidence with regard to the urethra and the available relevant methods of testing urethral function, with the emphasis on female and male voiding dysfunction. We looked into previous research and clinical studies and compiled summaries of pertinent testing related to urethral function. The discussion has focused on clinical applications and the desirability of further development of functional tests and analyses in this field.CONCLUSIONSThere are limitations to most of the urethral function tests. Future perspectives and research should concentrate on further development of functional testing and imaging techniques with emphasis on standardization and clinical application of these tests. Neurourol. Urodynam. 36:935-942, 2017. (c) 2017 Wiley Periodicals, Inc.

The diagnosis of bladder outlet obstruction (BOO) in the male is dependent on measurements of pressure and flow made during urodynamic studies. The procedure of urodynamics and the indices used to delineate BOO are well standardized largely as a result of the work of the International Continence Society. The clinical utility of the diagnosis of BOO is however, less well defined and there are several shortcomings and gaps in the currently available medical literature. Consequently the International Consultation on Incontinence Research Society (ICI-RS) held a think tank session in 2015 entitled Male bladder outlet obstruction: Time to re-evaluate the definition and reconsider our diagnostic pathway? This manuscript details the discussions that took place within that think tank setting out the pros and cons of the current definition of BOO and exploring alternative clinical tests (alone or in combination) which may be useful in the future investigation of male patients with lower urinary tract symptoms. The think tank panel concluded that pressure-flow studies remain the diagnostic gold-standard for BOO although there is still a lack of high quality evidence. Newer, less invasive, investigations have shown promise in terms of diagnostic accuracy for BOO but similar criticisms can be levelled against these tests. Therefore, the think tank suggests further research with regard to these alternative indicators to determine their clinical utility.

Detrusor underactivity (DU) is an increasingly recognised cause of lower urinary tract symptoms in both men and women. There has been a lack of research into all aspects of this dysfunction, and as yet, no effective treatments exist. DU can be diagnosed at present only on the basis of an invasive urodynamic study. An international consensus group met at the International Consultation on Incontinence–Research Society and International Continence Society annual meetings in 2014 to consider the feasibility of developing a working definition of a symptom complex associated with DU. Drawing an analogy to detrusor overactivity (urodynamic diagnosis) and overactive bladder (symptom complex), the aim of this process is to help identify affected patients and facilitate further clinical and epidemiological research. Patient summary Bladder underactivity is an underresearched but important cause of urinary symptoms in men and women. In this paper, an international expert group presents a working definition for the symptoms that characterise bladder underactivity, with the aim of facilitating further research in this area.

This is the protocol for a review and there is no abstract. The objectives are as follows: The objective of this review is to determine the effects of drug treatment of nocturia in adults. The following hypotheses will be tested: 1. a drug is better than no intervention ; 2. a drug is better than a placebo drug; 3. one drug is better than another one; 4. combined drug treatment is better than a single drug.

AIMS: To assess the equivalence of touch-screen (hand-held iPad) and telephone completion of patient-completed International Consultation on Incontinence Questionnaire (ICIQ) modules by comparison with corresponding data collected using conventional paper-and-pencil methods.METHODS: Men and women, attending urology outpatients complaining of LUTS, were randomised to one of three groups which determined the order in which they completed three administrations of the same questionnaire: paper, iPad and telephone. Four ICIQ questionnaires were evaluated: ICIQ-MLUTS, ICIQ-LUTSqol, ICIQ-OABqol and ICIQ-UI SF.RESULTS: From August 2012 to October 2014 a total of 448 out of 491 (91%) recruits completed the first two administrations and were included in the analysis. Three hundred forty-eight out of 491 (71%) completed the phone administration. The intra-class correlation coefficient (ICC) and Kappa statistic were calculated where appropriate between completed pairs of administrations. Mean ICC correlations were high (>0.8) between paper and iPad administrations. Paired paper and phone administrations were less well correlated, although still high (mean ICC>0.75). This may be partly due to the practical limitation that the phone interview was completed up to a week later than the initial two administrations. There was no evidence that potential moderator effects (gender, age and experience with computers or touch screen devices) significantly affected overall reliability of scores between administrations.CONCLUSIONS: We can recommend the interchangeable use of ICIQ electronic or paper based questionnaires in a clinical or research setting. Self-report is preferable to telephone delivery where possible. Neurourol. Urodynam. 9999:XX-XX, 2016. © 2016 Wiley Periodicals, Inc.

Background: A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures. Methods/design: The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation). Discussion: The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity interventions post-surgery. Prostate Cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) is registered on the ISRCTN registry, ref number ISRCTN99048944. Date of registration 17 November 2014.

Context Nocturia is a common urologic symptom that has been covered in a variety of reported studies in the literature but is not specifically covered in current guidelines. Objective To comprehensively review the literature pertaining to the definition, etiologies, and consequences of nocturia and assess the evidence supporting the use of conservative medical and interventional therapy. Evidence acquisition A literature search was conducted using the keyword nocturia , restricted to articles in the English language, after 2000 and before April 2012, in PubMed/Medline, Embase, Scopus, Web of Science, and Cochrane Library databases. Regarding treatment modalities, studies were included only if nocturia was a primary end point and if the studies were designed as randomized controlled trials without limit of date. When suitable, a meta-analysis was conducted. Papers covering treatment options for nocturia specifically related to nonurologic conditions were excluded. Evidence synthesis Nocturia is still defined as the symptom of wakening from sleep once or more often to void. The prevalence is high in both genders and increases with age. Frequency–volume charts, which are the pivotal tool of clinical assessment, detect 24-h polyuria, nocturnal polyuria (NP), or reduced nocturnal bladder capacity and help to target specific nonurologic etiologies. Nocturia is a morbid condition that significantly affects quality of life and increases mortality. Besides behavioral measures, validated treatment options include oral desmopressin, which is superior to placebo in treating NP. While the level of evidence for desmopressin is high, limited data support the use of α 1 -blockers and antimuscarinics; however, only rarely has nocturia been a primary end point when studying these drug classes, and studies have not consistently controlled for the effect of NP. Conclusions Our knowledge of nocturia, its etiology, and its management has substantially improved in recent years. The evidence available on the management of nocturia remains limited; contributory factors include (1) the complexity of associated conditions, (2) the underuse of objective evaluation tools, and (3) the lack of specific focus on nocturia in clinical trials.

The Nocturia Think Tank (TT) met during the 2010 meeting of the International Consultation on Incontinence-Research Society to discuss present knowledge and future directions in care and research of this prominent component of the spectrum of lower urinary tract symptoms. Questions raised included whether nocturia should be re-defined as a function of its bother, effects on quality of life, and economic impact upon society. At issue is the need to delineate the determinants of successful nocturia management. The multifactorial nature of nocturia requires that progress in its treatment will be dependent upon the cooperative investigation on the part of urologists, urogynecologists, geriatricians, epidemiologists, medical economists and pharma. Areas for future avenues of research were outlined at the conclusion of the meeting. Wiley-Liss, Inc.

Objectives To assess the clinical effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence (SUI) through systematic review and economic modelling. Data sources The Cochrane Incontinence Group Specialised Register, electronic databases and the websites of relevant professional organisations and manufacturers, and the following databases: CINAHL, EMBASE, BIOSIS, Science Citation Index and Social Science Citation Index, Current Controlled Trials, ClinicalTrials.gov and the UKCRN Portfolio Database. Study selection The study comprised three distinct elements. (1) A survey of 188 women with SUI to identify outcomes of importance to them (activities of daily living; sex, hygiene and lifestyle issues; emotional health; and the availability of services). (2) A systematic review and meta-analysis of non-surgical treatments for SUI to find out which are most effective by comparing results of trials (direct pairwise comparisons) and by modelling results (mixed-treatment comparisons - MTCs). A total of 88 randomised controlled trials (RCTs) and quasi-RCTs reporting data from 9721 women were identified, considering five generic interventions [pelvic floor muscle training (PFMT), electrical stimulation (ES), vaginal cones (VCs), bladder training (BT) and serotonin-noradrenaline reuptake inhibitor (SNRI) medications], in many variations and combinations. Data were available for 37 interventions and 68 treatment comparisons by direct pairwise assessment. Mixed-treatment comparison models compared 14 interventions, using data from 55 trials (6608 women). (3) Economic modelling, using a Markov model, to find out which combinations of treatments (treatment pathways) are most cost-effective for SUI. Data extraction Titles and abstracts identified were assessed by one reviewer and full-text copies of all potentially relevant reports independently assessed by two reviewers. Any disagreements were resolved by consensus or arbitration by a third person. Results Direct pairwise comparison and MTC analysis showed that the treatments were more effective than no treatment. Delivering PFMT in a more intense fashion, either through extra sessions or with biofeedback (BF), appeared to be the most effective treatment [PFMT extra sessions vs no treatment (NT) odds ratio (OR) 10.7, 95% credible interval (CrI) 5.03 to 26.2; PFMT + BF vs NT OR 12.3, 95% CrI 5.35 to 32.7]. Only when success was measured in terms of improvement was there evidence that basic PFMT was better than no treatment (PFMT basic vs NT OR 4.47, 95% CrI 2.03 to 11.9). Analysis of cost-effectiveness showed that for cure rates, the strategy using lifestyle changes and PFMT with extra sessions followed by tension-free vaginal tape (TVT) (lifestyle advice-PFMT extra sessions-TVT) had a probability of greater than 70% of being considered cost-effective for all threshold values for willingness to pay for a QALY up to 50,000 pounds. For improvement rates, lifestyle advice-PFMT extra sessions-TVT had a probability of greater than 50% of being considered cost-effective when society's willingness to pay for an additional QALY was more than 10,000 pounds. The results were most sensitive to changes in the long-term performance of PFMT and also in the relative effectiveness of basic PFMT and PFMT with extra sessions. Limitations Although a large number of studies were identified, few data were available for most comparisons and long-term data were sparse. Challenges for evidence synthesis were the lack of consensus on the most appropriate method for assessing incontinence and intervention protocols that were complex and varied considerably across studies. Conclusions More intensive forms of PFMT appear worthwhile, but further research is required to define an optimal form of more intensive therapy that is feasible and efficient for the NHS to provide, along with further definitive evidence from large, well-designed studies.

Drug companies market drugs for BPH (benign prostatic hyperplasia). However, this is a misuse of the term, which all dictionaries define as a histological term and not related to gross anatomical change. It is therefore disappointing that the BMJ has commissioned review articles on BPH .1 Several important organisations have accepted the arguments presented in the …

To assess the efficacy and safety of duloxetine in women with stress urinary incontinence.Randomised double-blind, placebo-controlled clinical trial.Fort-six centres in seven European countries and Canada.Four hundred and ninety-four women aged 24-83 years identified as having predominant symptoms of stress urinary incontinence using a clinical algorithm that was 100% predictive of urodynamic stress urinary incontinence in a subgroup of 34 women.The case definition included a predominant symptom of stress urinary incontinence with a weekly incontinence episode frequencyor =7, the absence of predominant symptoms of urge incontinence, normal diurnal and nocturnal frequencies, a bladder capacityor =400 mL and both a positive cough stress test and positive stress pad test. Subjects completed two urinary diaries prior to randomisation and three diaries during the active treatment phase of the study, each completed during the week prior to monthly visits. Subjects also completed quality of life questionnaires at each visit. Safety was assessed by the evaluation of treatment-emergent adverse events, discontinuation of treatment because of adverse events, serious adverse events, vital sign measurements, electrocardiograms (ECG) and clinical laboratory tests.After a two-week placebo lead-in, women received placebo or duloxetine 40 mg BD for 12 weeks.The percentage decrease in incontinence episode frequency and the change in the Incontinence Quality of Life (I-QOL) questionnaire total score were prespecified as co-primary outcome variables in the protocol.Incontinence episode frequency decreased significantly with duloxetine compared with placebo (median decrease of 50%vs 29%; P= 0.002) with comparable improvements in the more severely incontinent subgroup (those experiencing at least 14 incontinence episodes per week at baseline; 56%vs 27% decreases; P0.001). The primary analysis of I-QOL scores did not reveal a significant difference between treatment groups, due primarily to the carrying forward of low scores from patients who discontinued treatment very early due to duloxetine-associated adverse events. The increase in I-QOL scores was significantly greater for duloxetine than for placebo at each of the three postrandomisation visits after 4, 8, and 12 weeks of treatment. Discontinuation rates for adverse events were higher for duloxetine (22%vs 5%; P0.001) with nausea being the most common reason for discontinuation (5.3%). Nausea tended to be mild to moderate, not progressive, and transient.The findings support duloxetine as a potential treatment for women with stress urinary incontinence.

We evaluated the efficacy and safety of tamsulosin in patients with neurogenic lower urinary tract dysfunction secondary to suprasacral spinal cord lesions in a 4-week randomized controlled trial (RCT) followed by a 1-year, open label, long-term study.A total of 263 patients were randomized to 4-week double-blind therapy with placebo, or 0.4 or 0.8 mg tamsulosin once daily. Of these, 244 patients completed the RCT, 186 continued long-term tamsulosin therapy (0.4 or 0.8 mg once daily) and 134 completed 1-year treatment. The primary efficacy parameter was maximum urethral pressure (MUP).Although the mean decrease in MUP at 4 weeks in the RCT did not reach statistical significance over the placebo, it was more pronounced with 0.4 (-12.2 cm H2O or -10%) and 0.8 mg (-9.6 cm H2O or -9%) tamsulosin than placebo (-6.5 cm H2O or -3%). In the long-term study there was a statistically significant mean decrease in MUP (-18.0 cm H2O, p0.001 or -15%) from baseline to end point. In the long-term study tamsulosin also decreased maximum urethral closure pressure, improved several cystometry parameters related to bladder storage and emptying, and increased to a statistically significantly degree, from baseline to end point, mean voided volume based on the micturition diary. There was statistically significant improvement for the International Prostate Symptom Score Quality of Life, as well as several questions about symptoms related to urinary leakage, and 1 question on bladder emptying and frequency, bother and severity of symptoms of autonomic dysreflexia. Finally, 71% of patients improved according to investigators (44% slightly and 27% much improved). Both doses were effective and well tolerated.Long-term tamsulosin treatment (0.4 and 0.8 mg once daily) seems to be effective and well tolerated in patients with neurogenic lower urinary tract dysfunction. The results suggest that it improves bladder storage and emptying, and decreases symptoms of autonomic dysreflexia.

EDITOR—The government's intended reorganisation of postgraduate medical education received little mention in the BMJ until Pereira Gray's editorial,1 which outlined the proposals2 but gave little analysis. By contrast, the analysis in an editorial in the British Journal of General Practice —whose view we agree with—was extremely critical.3 The new Medical Education Standards Board, half of whose 24 members are intended to be lay members, will be the single body overseeing curriculums, standards, and the registration of …

We investigated the international differences in the reporting of lower urinary tract symptoms and related bother in patients with symptoms suggestive of bladder outlet obstruction. Multiple logistic regression analysis was used to evaluate international differences in the reporting of lower urinary tract symptoms and related bother in 1,271 patients from 12 countries who participated in the International Continence Society "benign prostatic hyperplasia" study. Country of origin was significantly associated with the prevalence of a large number of lower urinary tract symptoms (10 of 20), even after adjusting for potentially confounding variables, including physical and socio-demographic factors. Country of origin was also significantly associated with the reporting of bother but for a much smaller number of symptoms (2). In different countries lower urinary tract symptoms may be reported to different extents. Therefore, the results of studies in particular countries may not be generally applicable to other countries. It is likely that symptom scores will conceal this variation, necessitating consideration of individual symptoms (as in the International Continence Society "benign prostatic hyperplasia" study) or the development of country specific scoring systems. An alternative would be to focus on bother, which appeared to be much less sensitive to international differences

Extraordinary interest currently exists in the treatment of men over 45 who are referred with the label “prostatism.” This has been generated partly by commercial interest and patients' increased awareness and expectations and partly by the advent of new treatments. Several new drugs to relieve bladder outflow obstruction, including (alpha) adrenergic blockers and 5-(alpha) reductase inhibitors, have been or are about to be licensed. Drug companies have expended huge efforts in increasing patients' and doctors' awareness of prostatic disease. New techniques to destroy part or all of the prostate have been developed, including thermotherapy, thermal ablation, high intensity focused ultrasonography, transurethral needle ablation, and laser prostatectomy. Added to this are the techniques of intraurethral prostatic stenting and balloon dilatation of the prostate.1 Surveys have shown that urinary symptoms are very common in older men, with prevalences varying from 11% for straining up to 78% for nocturia.2 Interestingly, British and American research has suggested that symptoms are also very common in elderly women.3,4 Historically, we have used the terms “prostatism” and “symptoms of benign prostatic hyperplasia” to describe lower urinary tract symptoms in men. Yet because these …