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Symptom improvement following therapies for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) is associated with a decrease in Bladder Outlet Obstruction Index (BOOI). Surgical therapies for LUTS/BPH provide greater BOOI and symptom improvement than medical therapies. Symptomatic benefit and urodynamic obstruction relief represent relevant outcomes of therapies for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). We summarized evidence from studies concurrently assessing variations in terms of symptoms severity and invasive urodynamic measures of obstruction following medical and surgical therapies for LUTS/BPH. We performed a systematic review of PubMed, Scopus, and Web of Science in June 2023. We identified 29 publications: 14 (872 patients) and 15 (851 patients) studies addressing medical and surgical therapies, respectively. The mean percentage total International Prostate Symptom Score (IPSS) improvements ranged from −2.5% to 56.3% and from 35.1% to 82.1% following medical and surgical therapies, respectively. The corresponding mean percentage Bladder Outlet Obstruction Index (BOOI) improvements ranged from 7.8% to 53.5% and from 22.4% to 138.6%, respectively. Holmium laser enucleation of the prostate (HoLEP) provided IPSS improvements in the higher range and the greatest BOOI reduction. Globally, based on available evidence, more pronounced symptomatic benefits are observed following treatments providing greater deobstructive effect. In detail, patients undergoing surgery exhibit greater IPSS and BOOI improvements than those receiving medical therapy. [ABSTRACT FROM AUTHOR]

Clinicians treating young people with continence problems should be aware of their increased vulnerability to mental health disorders.Clear and effective care pathways to child and adolescent mental health services are required to address their mental health needs. Adolescents with continence problems experience unique threats to their psychological well-being, but long-term mental health sequelae are unknown. To examine prospective relationships between incontinence/lower urinary tract symptoms (LUTS) and mental health problems in young people. A prospective cohort study of young people (n = 7332: 3639 males and 3693 females) from a population-based sample was conducted. We estimated the association between incontinence/LUTS and mental health outcomes using multivariable regression models adjusted for sex, socioeconomic position, developmental level, intelligence quotient, stressful life events, maternal psychopathology, body mass index, and emotional/behavioural problems. Daytime wetting and voiding postponement showed the greatest number of associations with mental health problems. All incontinence subtypes/LUTS were associated with increased odds of generalised anxiety disorder (eg, odds ratio for daytime wetting = 3.01, 95% confidence interval [1.78, 5.09], p < 0.001) and/or higher anxiety scores. There was also evidence of associations with common mental disorder (eg, voiding postponement: 1.88 [1.46, 2.41], p < 0.001), depression (eg, urgency: 1.94 [1.19, 3.14], p = 0.008), depressive symptoms (eg, daytime wetting: 1.70 [1.13, 2.56], p = 0.01), self-harm thoughts (eg, voiding postponement: 1.52 [1.16, 1.99], p = 0.003), and disordered eating (eg, nocturia 1.72 [1.27, 2.34], p = 0.001). We are unable to generalise our results to minority ethnic groups, less affluent populations, and non-UK samples. Young people with incontinence/LUTS are at an increased risk of mental health problems. Further research is needed to establish the direction of causality. We looked at the association between continence problems and mental health outcomes in young people from a large population-based cohort. Young people with continence problems at the age of 14 yr were more likely to suffer from a range of mental health problems at the age of 18 yr, including common mental disorder, depression, anxiety, self-harm thoughts, and disordered eating. Paediatric continence clinics should address the mental health needs of young people and provide clear and effective care pathways to child and adolescent mental health services. [ABSTRACT FROM AUTHOR]

Prostatic artery embolisation (PAE) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (LUTS/BPO) still remains under investigation. To compare the efficacy and safety of PAE and transurethral resection of the prostate (TURP) in the treatment of LUTS/BPO at 2 yr of follow-up. A randomised, open-label trial was conducted. There were 103 participants aged ≥40 yr with refractory LUTS/BPO. PAE versus TURP. International Prostate Symptoms Score (IPSS) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated. Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests. The mean reduction in IPSS after 2 yr was 9.21 points after PAE and 12.09 points after TURP (difference of 2.88 [95% confidence interval 0.04–5.72]; p = 0.047). Superiority of TURP was also found for most other patient-reported outcomes except for erectile function. PAE was less effective than TURP regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of –6.33 [–10.12 to –2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31–240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70–31.38]; p = 0.005). Adverse events were less frequent after PAE than after TURP (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar. Ten patients (21%) who initially underwent PAE required TURP within 2 yr due to unsatisfying clinical outcomes, which prevented further assessment of their outcomes and, therefore, represents a limitation of the study. Inferior improvements in LUTS/BPO and a relevant re-treatment rate are found 2 yr after PAE compared with TURP. PAE is associated with fewer complications than TURP. The disadvantages of PAE regarding functional outcomes should be considered for patient selection and counselling. Prostatic artery embolisation is safe and effective. However, compared with transurethral resection of the prostate, its disadvantages regarding subjective and objective outcomes should be considered for individual treatment choices. A marked improvement of lower urinary tract symptoms secondary to benign prostatic obstruction can be found 24 mo after prostatic artery embolisation (PAE), and the procedure is associated with fewer adverse events than transurethral resection of the prostate (TURP). However, improvements of subjective and objective outcomes are superior after TURP, and PAE might not represent a definitive treatment for a relevant proportion of patients. This should be considered for patient selection and counselling. [ABSTRACT FROM AUTHOR]

In the algorithm of treatment of benign prostatic obstruction (BPO), the shift from medical therapy to surgery is steep in terms of invasiveness. Recently, a lively interest has developed on alternative micro-invasive options. Transperineal interstitial laser ablation (TPLA) was recently proposed for BPO treatment. This work aims to illustrate feasibility, efficacy and safety profile of TPLA in BPO treatment. We prospectively analyzed the results of TPLA performed between September 2018 and March 2019 for LUTS due to BPO, in men with prostate volume <100 ml. TPLA was performed in OR, under local anesthesia, using Soracte Lite-EchoLaserX4. Diode laser light is conveyed through 300 μm optical fibers introduced transperineally by 21 Ga needles and placed at a security distance from urethra and bladder neck. EchoLaser Smart Interface eases needle positioning and increases the safety. The primary endpoint was the variation of Qmax and IPSS at 1, 3 and 6 months. We also assessed the ejaculatory function and recorded complications. These outcomes were further investigated at 12 months by phone call. 21 men with prostate volume of 43.5 ± 8.5 ml underwent TPLA. All were discharged after 24 h, keeping the transurethral catheter for 8.7 ± 2.5d. At one month all patients but one discontinued medical therapy, showing significant advantage in Qmax (+3.4 ± 5.7 ml/s; p < 0.01) and IPSS (-5.6 ± 7.0; p < 0.01). Functional results were still progressing at 6 months, with Qmax (+4.7 ± 6.0 ml/s; p < 0.01) and IPSS improvement (-13.1 ± 4.7; p < 0.01). The ejaculatory function was preserved as the MSHQ-EjD increased (p < 0.05). The only complication was a prostatic abscess, treated with transperineal drainage and antibiotic. TPLA is a micro-invasive treatment for BPO showing good functional and safety outcomes. This work illustrates the results of TPLA to treat LUTS due to BPO, showing high efficacy, preservation of the ejaculation, and low complication rate. Transperineal interstitial laser ablation of the prostate (TPLA) was recently proposed for the treatment of BPO. It is a microinvasive approach, which has no need for anesthesia, low risk of complications and does not cause ejaculation dysfunction. TPLA causes rapid-onset and long-lasting positive effects on LUTS. [ABSTRACT FROM AUTHOR]

Understanding men's values and preferences in the context of personal, physical, emotional, relational, and social factors is important in optimising patient counselling, facilitating treatment decision-making, and improving guideline recommendations. To systematically review the available evidence regarding the values, preferences, and expectations of men towards the investigation and treatment (conservative, pharmacological, and surgical) of male lower urinary tract symptoms (LUTS). We searched electronic databases until August 31, 2020 for quantitative and qualitative studies that reported values and preferences regarding the investigation and treatment of LUTS in men. We assessed the quality of evidence and risk of bias using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) and GRADE Confidence in the Evidence from Reviews of Qualitative Research (CERQual) approaches. We included 25 quantitative studies, three qualitative studies, and one mixed-methods study recruiting 9235 patients. Most men reported urodynamic testing to be acceptable, despite discomfort or embarrassment, as it significantly informs treatment decisions (low certainty evidence). Men preferred conservative and less risky treatment options, but the preference varied depending on baseline symptom severity and the risk/benefit characteristics of the treatment (moderate certainty). Men preferred pharmacological treatments with a low risk of erectile dysfunction and those especially improving urgency incontinence (moderate certainty). Other important preference considerations included reducing the risk of acute urinary retention or surgery (moderate certainty). Men prefer lower-risk management options that have fewer sexual side effects and are primarily effective at improving urgency incontinence and nocturia. Overall, the evidence was rated to be of low to moderate certainty. This review can facilitate the treatment decision-making process and improve the trustworthiness of guideline recommendations. We thoroughly reviewed the evidence addressing men's values and preferences regarding the management of urinary symptoms and found that minimising adverse effects is particularly important. Further research to understand other factors that matter to men is required. When considering treatment options for lower urinary tract symptoms, men prefer lower-risk strategies that primarily improve urgency incontinence and nocturia, and that have a low risk of side effects. Men also value treatments that reduce the risk of acute urinary retention and surgery. [ABSTRACT FROM AUTHOR]

The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce. The aim of this systematic review was to evaluate the evidence on treatment options beyond antimuscarinics in men with OAB. A search of PubMed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases was performed for relevant articles published between January 2000 and October 2020, using the following Medical Subject Headings: "male/man," "LUTS," "overactive bladder," "storage symptoms," "urgency," "nocturia," "incontinence," "beta-3 agonist," "PDE-5 inhibitors," "botulinum toxin," "sacral nerve stimulation/neurostimulation," "percutaneous/transcutaneous tibial nerve stimulation," "PTENS," and "combination therapy." Evidence acquisition was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. PROSPERO registration number is CRD42020201223. Overall, 24 studies were retrieved. In male OAB, mirabegron (MIRA) is the most intensively investigated pharmacological option. A pooled analysis of five randomized clinical trials (RCTs), including 1187 patients, concluded that MIRA 50 mg was associated with a greater reduction in frequency versus placebo (–0.37, 95% confidence interval [CI]: –0.74, –0.01, p < 0.05). A pooled analysis of three RCTs, including 1317 male patients, has also shown that the addition of MIRA 50 mg in men receiving the α 1 -blocker tamsulosin improved the mean number of micturitions per day (–0.27, 95% CI: –0.46 to –0.09, p < 0.05), urgency episodes (–0.50, 95% CI: –0.77 to –0.22, p < 0.05), total OAB symptom score (–0.66, 95% CI: –1.00 to –0.38, p < 0.05), and mean volume voided (+10.76 ml, 95% CI: 4.87–16.64, p < 0.05). MIRA treatment is well tolerated in men. Other pharmacological treatment options, such as phosphodiesterase-5 (PDE-5) inhibitors, should be considered investigational. BTX-A seems to be effective as third-line treatment in male OAB patients. A higher rate of intermittent self-catheterization (5–42%) is observed in male than in female patients. Data on nerve stimulation are scarce. MIRA has the most robust data in terms of safety and efficacy in this patient population. Preliminary data in men suggest that BTX-A is indicated as an interventional treatment. Evidence for PDE-5 inhibitors and nerve stimulation is too limited to provide recommendations. Future studies in this population should aim to better define the best treatment sequence and to identify predictors for treatment response and failure, to determine a therapeutic approach tailored to patients' characteristics. Overactive bladder is highly prevalent in men. Mirabegron 50 mg is the treatment option supported by the highest level of evidence when antimuscarinics failed. Botulinum toxin A injections seems to be an effective treatment as interventional option. Roles of nerve stimulation and phosphodiesterase inhibitors in male OAB patients are still to be defined. Literature on pharmacological treatment of male patients with overactive bladder is scarce. Most of the available evidence is on mirabegron, which is effective and well tolerated. Phosphodiesterase-5 inhibitors, botulinum toxin A, and neuromodulation are still to be considered investigational treatments. [ABSTRACT FROM AUTHOR]

BackgroundData describing urinary health in elderly, community-dwelling prostate cancer (PCa) survivors are limited.ObjectiveTo elucidate the prevalence of lower urinary tract symptoms, urinary bother, and incontinence in elderly PCa survivors compared with peers without PCa.Design, setting, and participantsA cross-sectional analysis of 5990 participants in the Osteoporotic Fractures in Men Research Group, a cohort study of community-dwelling men ≥ 65 yr.Outcome measurements and statistical analysisWe characterized urinary health using self-reported urinary incontinence and the American Urological Association Symptom Index (AUA-SI). We compared urinary health measures according to type of PCa treatment in men with PCa and men without PCa using multivariate log-binomial regression to generate prevalence ratios (PRs).Results and limitationsAt baseline, 706 men (12%) reported a history of PCa, with a mean time since diagnosis of 6.3 yr. Of these men, 426 (60%) reported urinary incontinence. In adjusted analyses, observation (PR: 2.11; 95% confidence interval [CI], 1.22-3.65; p=0.007), surgery (PR: 4.41; 95% CI, 3.79-5.13; p

Prostate 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 is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking. Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods (UPSTREAM) aimed to evaluate whether a care pathway including UDS would reduce surgery without increasing urinary symptoms. UPSTREAM is a pragmatic, noninferiority, randomised controlled trial in men with bothersome LUTS, in whom surgery was an option, in 26 hospitals in England (ISRCTN56164274). Participants were randomised (1:1) to routine care (RC) diagnostic tests, or RC plus UDS. The primary outcome was the International Prostate Symptom Score (IPSS; patient-reported outcome scale from 0 to 35 points) 18 mo after randomisation, with a noninferiority margin of 1 point. Urological surgery rates were a key secondary outcome. The primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis. Between October 2014 and December 2016, 820 men (median age 68 yr) were randomised (393 and 427 in the RC and UDS arms, respectively). The UDS arm showed noninferiority of the mean IPSSs (UDS 12.6; RC 13.1; adjusted difference at 18 mo −0.33 [95% confidence interval {CI} −1.47, +0.80]). In the UDS arm, 153/408 (38%) received surgery compared with 138/384 (36%) in the RC arm (adjusted odds ratio 1.05; 95% CI 0.77, 1.43). A total of 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms and 11 unrelated deaths. In this population, the UDS randomised group was noninferior to RC for the IPSS but did not reduce surgical rates. This study shows that routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively. For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests. Accordingly, routine use of urodynamics has a limited role in this population group. The inclusion of urodynamics (UDS) in the diagnostic tests for male lower urinary tract symptoms (LUTS) resulted in a noninferior symptom outcome (International Prostate Symptom Score) to routine care, 18 mo after randomisation. However, there was no reduction in the rates of surgery for treating bladder outlet obstruction. Accordingly, the findings show that routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively. [ABSTRACT FROM AUTHOR]

Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking. To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH. A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45 yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study. Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period. An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively. Mean age was 63.8 ± 6.0 yr, baseline IPSS 26.4 ± 3.87, and QoL score 4.43 ± 0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2–16.2, p < 0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57–2.68, p < 0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6 ± 9.19 (p < 0.0001) and 2.05 ± 1.71 (p < 0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia. This randomised clinical trial comparing prostate arterial embolisation with a sham procedure for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) showed a marked and sustained improvement in symptoms and functional parameters far superior to those due to the placebo effect with mostly mild adverse events, supporting its role in the treatment of LUTS/BPH. [ABSTRACT FROM AUTHOR]

The majority of patients with overactive bladder (OAB) are aged >65 yr. There has been no prospectively designed study assessing treatment efficacy with the β3-adrenoreceptor agonist, mirabegron, specifically in this age group. A phase IV study comparing flexibly dosed mirabegron versus placebo in elderly patients with OAB and urgency incontinence. Community-dwelling patients aged ≥65 yr with OAB for ≥3 mo. Following a 2-wk placebo run in, patients with one or more incontinence episodes, three or more urgency episodes, and an average of eight or more micturitions/24 h were randomised 1:1 to double-blind 25 mg/d mirabegron or matched placebo, for 12 wk. After week 4 or 8, the dose could be increased to 50 mg/d mirabegron/matched placebo based on patient and investigator discretion. Coprimary endpoints: change from baseline to end of treatment (EOT) in the mean numbers of micturitions/24 h and incontinence episodes/24 h. Secondary endpoints: change from baseline to EOT in the mean volume voided/micturition, mean number of urgency episodes/24 h, and mean number of urgency incontinence episodes/24 h. Analysis of covariance (ANCOVA) was used for the mean number of micturitions/24 h, mean volume voided/micturition, and mean number of urgency episodes/24 h. Stratified rank ANCOVA was used for the mean numbers of incontinence episodes/24 h and urgency incontinence episodes/24 h. Statistically significant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24 h, mean number of incontinence episodes/24 h, mean volume voided/micturition, mean number of urgency episodes/24 h, and mean number of urgency incontinence episodes/24 h. Safety and tolerability were consistent with the known mirabegron safety profile. Mirabegron efficacy, safety, and tolerability over 12 wk were confirmed in patients aged ≥65 yr with OAB and incontinence. We examined the effect of mirabegron compared with placebo in people aged 65 yr or older with overactive bladder and incontinence. Mirabegron improved the symptoms of overactive bladder compared with placebo. Side effects were similar to those already known for mirabegron. PILLAR, the first randomised controlled trial of mirabegron in patients with overactive bladder (OAB) aged ≥65 yr, demonstrated the efficacy of mirabegron for OAB symptoms. The safety and tolerability were consistent with the known safety profile of mirabegron. [ABSTRACT FROM AUTHOR]

Context Alpha-blockers (ABs) and 5-alpha reductase inhibitors have an established role in treating male lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Recently, newer drugs have shown promise for this indication. Objective To assess the comparative effectiveness and adverse effects (AEs) of newer drugs to treat LUTS attributed to BPH through a systematic review and meta-analysis. Evidence acquisition Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, and Ovid Embase bibliographic databases (through June 2016) were hand searches for references of relevant studies. Eligible studies included randomized controlled trials published in English of newer ABs, antimuscarinics, a beta-3 adrenoceptor agonist, phosphodiesterase type-5 inhibitors, or combination therapy with one of these medications as an active comparator. Observational studies of the same agents with a duration ≥1 yr that reported AEs were also included. Evidence synthesis We synthesized evidence from 43 randomized controlled trials as well as five observational studies. Based on improvement of mean International Prostate Symptom Score and quality of life scores, the effectiveness of the newer ABs was not different from the older ABs (moderate strength of evidence [SOE]), but had more AEs (low SOE). Antimuscarinics/AB combination therapy had similar outcomes as AB monotherapy (all moderate SOE), but often had more AEs. Phosphodiesterase type-5 inhibitors alone or in combination with ABs had similar or inferior outcomes than ABs alone. Evidence was insufficient for the beta-3 adrenoceptor agonist. For all newer agents, the evidence was generally insufficient to assess long-term efficacy, prevention of symptom progression, or AEs. Conclusions None of the drugs or drug combinations newly used to treat LUTS attributed to BPH showed outcomes superior to traditional AB treatment. Given the lack of superior outcomes, the studies’ short time-horizon, and less assurance of their safety, their current value in treating LUTS attributable to BPH appears low. Patient summary In this paper, we reviewed the evidence of newer drugs to treat men with urinary problems attributable to an enlarged prostate. We found none of the new drugs to be better but there was more concern about side effects. [ABSTRACT FROM AUTHOR]

Context Several noninvasive tests have been developed for diagnosing bladder outlet obstruction (BOO) in men to avoid the burden and morbidity associated with invasive urodynamics. The diagnostic accuracy of these tests, however, remains uncertain. Objective To systematically review available evidence regarding the diagnostic accuracy of noninvasive tests in diagnosing BOO in men with lower urinary tract symptoms (LUTS) using a pressure-flow study as the reference standard. Evidence acquisition The EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Central, Google Scholar, and WHO International Clinical Trials Registry Platform Search Portal databases were searched up to May 18, 2016. All studies reporting diagnostic accuracy for noninvasive tests for BOO or detrusor underactivity in men with LUTS compared to pressure-flow studies were included. Two reviewers independently screened all articles, searched the reference lists of retrieved articles, and performed the data extraction. The quality of evidence and risk of bias were assessed using the QUADAS-2 tool. Evidence synthesis The search yielded 2774 potentially relevant reports. After screening titles and abstracts, 53 reports were retrieved for full-text screening, of which 42 (recruiting a total of 4444 patients) were eligible. Overall, the results were predominantly based on findings from nonrandomised experimental studies and, within the limits of such study designs, the quality of evidence was typically moderate across the literature. Differences in noninvasive test threshold values and variations in the urodynamic definition of BOO between studies limited the comparability of the data. Detrusor wall thickness (median sensitivity 82%, specificity 92%), near-infrared spectroscopy (median sensitivity 85%, specificity 87%), and the penile cuff test (median sensitivity 88%, specificity 75%) were all found to have high sensitivity and specificity in diagnosing BOO. Uroflowmetry with a maximum flow rate of <10 ml/s was reported to have lower median sensitivity and specificity of 68% and 70%, respectively. Intravesical prostatic protrusion of >10 mm was reported to have similar diagnostic accuracy, with median sensitivity of 68% and specificity of 75%. Conclusions According to the literature, a number of noninvasive tests have high sensitivity and specificity in diagnosing BOO in men. However, although the majority of studies have a low overall risk of bias, the available evidence is limited by heterogeneity. While several tests have shown promising results regarding noninvasive assessment of BOO, invasive urodynamics remain the gold standard. Patient summary Urodynamics is an accurate but potentially uncomfortable test for patients in diagnosing bladder problems such as obstruction. We performed a thorough and comprehensive review of the literature to determine if there were less uncomfortable but equally effective alternatives to urodynamics for diagnosing bladder problems. We found that some simple tests appear to be promising, although they are not as accurate. Further research is needed before these tests are routinely used in place of urodynamics. [ABSTRACT FROM AUTHOR]

Context The correlation among metabolic syndrome, lower urinary tract symptoms (LUTS), and cardiovascular disease (CVD) is well established. In particular, CVD has been proposed as a potential risk factor for both LUTS progression and severity. Objective To evaluate whether LUTS severity can be considered as a significant risk factor of major adverse cardiac events (MACE) in the male population. Evidence acquisition A systematic literature search was performed using PubMed, Google Scholar, and Scopus. The combination of the following keywords was adopted in a free-text strategy: benign prostatic hyperplasia (BPH) or lower urinary tract symptoms (LUTS) and cardiovascular, cardio, major adverse cardiac events, MACE, heart disease, heart, myocardial infarction, myocardial, infarction, stroke, ischemic events, ischemic, cardiac death, coronary syndrome . We included all cross-sectional and longitudinal trials enrolling men and comparing the prevalence or incidence of MACE in men with moderate to severe LUTS compared with those without LUTS or with mild LUTS. The studies in which only nocturia was evaluated were excluded from the analysis. Evidence synthesis Of 477 retrieved articles, 5 trials longitudinally reported the incidence of MACE in patients with moderate to severe LUTS in comparisons to those with mild or no LUTS and 10 studies reported the prevalence of history of MACE at enrollment. All were included in the present meta-analysis. Among cross-sectional studies, 38 218 patients and 2527 MACE were included in the meta-analysis. The mean age of enrolled patients was 62.2 ± 8.0 yr. Presence of moderate to severe LUTS significantly increased the risk of reported history of MACE ( p < 0.001). Metaregression analyses showed that the risk of MACE was lower in older patients and higher in those with diabetes. The association between LUTS-related MACE and diabetes was confirmed in a multivariate regression model after adjusting for age (adjusted r = 0.498; p < 0.0001). Longitudinal trials included 25 494 patients and 2291 MACE. The mean age of enrolled patients was 52.5 ± 5.5 yr, and mean follow-up was 86.8 ± 22.1 mo. Presence of moderate to severe LUTS was associated with an increased incidence of MACE compared with the rest of the sample (odds ratio: 1.68; 95% confidence interval, 1.13–2.50; p = 0.01). Conclusions Men with moderate to severe LUTS seem to have an increased risk of MACE. A holistic approach in considering the morbidities of aging men should be strongly encouraged and represents an important role for the practicing urologist. Patient summary We evaluated whether the severity of lower urinary tract symptoms could be considered as a significant risk factor for major adverse cardiac events (MACE) in the male population. We demonstrated that men with moderate to severe LUTS have an increased risk of MACE. [ABSTRACT FROM AUTHOR]

Context Although vital for decision-making about management, the natural history of nocturia remains uncertain. A systematic review would clarify the issue, but because natural history reviews are uncommon it would require methodological innovations. Objective To estimate the incidence and remission of nocturia, and refine methods for meta-analyses assessing natural history. Evidence acquisition We conducted a comprehensive search of PubMed, Scopus, and Cumulative Index of Nursing and Allied Health Literature databases and abstracts of major urologic meetings as far as August 31, 2015. Random effects meta-analyses addressed incidence/remission rates of nocturia; meta-regression explored potential determinants of heterogeneity. Studies were categorized as either low or high risk of bias using a novel instrument specifically designed for longitudinal symptom studies aimed at the general population. Evidence synthesis Of 4165 potentially relevant reports, 16 proved eligible. Pooled estimates from 13 studies (114 964 person-years of follow-up) demonstrated that annual incidence was strongly associated with age: 0.4% (0–0.8%) for adults aged < 40 yr; 2.8% (1.9–3.7%) for adults aged 40–59 yr; and 11.5% (9.1–14.0%) for adults aged ≥ 60 yr. Of those with nocturia, each year 12.1% (9.5–14.7%) experienced remission. Conclusions The available evidence suggests that nocturia onset is strongly associated with age, with much higher rates in those over 60 yr; remission occurs in approximately 12% each year. These estimates can aid with management decisions and counseling related to nocturia. Patient summary We reviewed all previous studies of progression of night-time urination (nocturia). We found that in any given year 0.4% of adults aged < 40 yr, 3% of adults aged 40–59 yr, and 12% of adults aged ≥ 60 yr will develop nocturia, while overall 12% of those with nocturia will improve. These findings may be helpful in making decisions about coping with or treating nocturia. [ABSTRACT FROM AUTHOR]

Context Several preclinical reports, randomized controlled trials, systematic reviews, and posthoc analyses corroborate the role of phosphodiesterase type 5 inhibitors (PDE5-Is) in the treatment of men with lower urinary tract symptoms (LUTS) associated with benign prostatic enlargement (BPE). Objective Update of the latest evidence on the mechanisms of action, evaluate the current meta-analyses, and emphasize the results of pooled data analyses of PDE5-Is in LUTS/BPE. Evidence acquisition Literature analysis of basic researches on PDE5-Is, systematic literature search in PubMed and Scopus until May 2015 on reviews of trials on PDE5-Is, and collection of pooled data available on tadalafil 5 mg. Evidence synthesis Latest evidences on the pathophysiology of LUTS/BPE has provided the rationale for use of PDE5-Is: (1) improvement of LUT oxygenation, (2) smooth muscle relaxation, (3) negative regulation of proliferation and transdifferentiation of LUT stroma, (4) reduction of bladder afferent nerve activity, and (5) down-regulation of prostate inflammation are the proven mechanisms of action of PDE5-Is. Data from eight systematic reviews demonstrated that PDE5-Is allow to improve LUTS (International Prostate Symptom Score mean difference vs placebo: 2.35–4.21) and erectile function (International Index of Erectile Function mean difference vs placebo: 2.25–5.66), with negligible change in flow rate (Q max mean difference vs placebo: 0.01–1.43). Pooled data analyses revealed that tadalafil 5 mg once daily allows the clinically-meaningful improvement of LUTS and nocturnal voiding frequency independent of both erectile dysfunction severity and improvement. Conclusions PDE5-Is are safe and effective in improving both LUTS and erectile function in appropriately selected men with LUTS/BPE. Data on the reduction of disease progression, long-term outcomes, and cost-effectiveness analyses are still lacking. Patient summary We reviewed recent literature on phosphodiesterase type 5 inhibitors in men with lower urinary tract symptoms associated with prostatic enlargement. We found evidence to confirm that phosphodiesterase type 5 inhibitors are a valid treatment option for men affected by bothersome urinary symptoms with or without erectile dysfunction. [ABSTRACT FROM AUTHOR]

Context The urodynamic outcomes for α1-blockers (ABs) treatment in patients with lower urinary tract symptoms related to benign prostatic enlargement (LUTS/BPE) is a matter of debate. Objective To perform a systematic review and meta-analysis of studies evaluating the ABs urodynamic outcomes in patients with LUTS/BPE. The primary endpoint was variation in bladder outlet obstruction index (BOOI). Secondary endpoints were the maximum urinary flow rate ( Q max ) and detrusor pressure at Q max ( P det Q max ). A meta-analysis of placebo-controlled randomized clinical trials (RCTs) was performed to compare ABs with placebo. Evidence acquisition A systematic review of PubMed/Medline, ISI Web of Knowledge, and Scopus databases was performed in May 2015. Seventeen studies were selected for inclusion. Evidence synthesis The overall pooled data showed a mean BOOI change of –14.19 ( p < 0.0001), a mean P det Q max change of –11. 39 cm H 2 O ( p < 0.0001), and a mean Q max improvement of 2.27 ml/s ( p < 0.0001). Subgroup analysis showed a mean BOOI change of –14.88 ( p = 0.01) for alfuzosin, –19.41 ( p = 0.01) for doxazosin, –16.47 ( p < 0.0001) for naftopidil, –30.45 ( p < 0.0001) for silodosin, –14.27 ( p = 0.002) for tamsulosin, and –6.69 ( p = 0.005) for terazosin. Subanalysis of RCTs containing a placebo arm showed a significant improvement in BOOI in patients undergoing ABs treatment. Meta-regression revealed a significant positive association between the percentage of patients with obstruction at baseline and the improvement in BOOI after treatment with ABs. Conclusion ABs improve BOOI in patients with LUTS/BPE mainly by reducing P det Q max , and this effect is higher in patients presenting with urodynamic obstruction at baseline. The free Q max variation underestimates the real effect of ABs on benign prostatic obstruction. Patient summary Results of this meta-analysis suggest that α1-blockers objectively improve urinary voiding function in patients with benign prostatic obstruction. [ABSTRACT FROM AUTHOR]

Context There is a potential risk that testosterone replacement therapy (TRT) may exacerbate lower urinary tract symptoms (LUTS) among aging men with late-onset hypogonadism (LOH) because of testosterone's growth-promoting effects on the prostate. Objective To compare the change in LUTS severity as assessed using the International Prostate Symptom Score (IPSS) between men receiving TRT versus placebo for the treatment of LOH. Evidence acquisition Systematic search of MEDLINE, Embase, ClinicalTrials.gov, and The Cochrane Library for randomized controlled trials of TRT for LOH published between January 1992 and September 2015. Studies were eligible for inclusion if they were a randomized control trial, used TRT, and assessed LUTS outcomes using the IPSS. Estimates were pooled using random effects meta-analysis. Differences by study-level characteristics were estimated using meta-regression. Evidence synthesis Data were extracted from 14 trials involving 2029 participants. The average age was 64.5 yr and the average follow-up was 34.4 mo. Seven studies used topical, five used injectable, and two used oral testosterone. There was no statistically significant difference in pooled changes in IPSS from baseline to follow up in men treated with TRT compared with those receiving placebo (–0.41 points [95% confidence interval: –0.89 to 0.07; I 2 = 0%, p = 0.28] vs. 0.12 points [95% confidence interval: –0.32 to 0.55; I 2 = 0%, p = 0.81], between-group difference p > 0.05). No between-group differences were noted in subanalyses that controlled for potential confounders such as type of testosterone, change in testosterone, aging male symptom scale, or prostate-specific antigen levels ( p > 0.05 for all comparisons). Conclusions In this meta-analysis of 14 clinical trials of TRT for LOH, the change in IPSS was similar among men receiving TRT versus placebo, suggesting that TRT treatment does not worsen LUTS among men with LOH. Patient summary In this analysis of 14 clinical trials, testosterone replacement therapy did not worsen lower urinary tract symptoms among men being treated for late-onset hypogonadism. [ABSTRACT FROM AUTHOR]

Background It has been shown that increased prostate size is a risk factor for lower urinary tract symptom (LUTS) progression in men who currently have LUTS presumed due to benign prostatic hyperplasia (BPH). Objective To determine if prostate size is a risk factor for incident LUTS in men with mild to no symptoms. Design, setting, and participants We conducted a post hoc analysis of the REDUCE study, which contained a substantial number of men ( n = 3090) with mild to no LUTS (International Prostate Symptom Score [IPSS] <8). Outcome measurements and statistical analysis Our primary outcome was determination of the effect of prostate size on incident LUTS presumed due to BPH defined as two consecutive IPSS values >14, or receiving any medical (α-blockers) or surgical treatment for BPH throughout the study course. To determine the risk of developing incident LUTS, we used univariable and multivariable Cox models, as well as Kaplan-Meier curves and the log-rank test. Results and limitations Among men treated with placebo during the REDUCE study, those with a prostate size of 40.1–80 ml had a 67% higher risk (hazard risk 1.67, 95% confidence interval 1.23-2.26, p = 0.001) of developing incident LUTS compared to men with a prostate size 40.0 ml or smaller. There was no association between prostate size and risk of incident LUTS in men treated with 0.5 mg of dutasteride. The post hoc nature of our study design is a potential limitation. Conclusions Men with mild to no LUTS but increased prostate size are at higher risk of incident LUTS presumed due to BPH. This association was negated by dutasteride treatment. Patient summary Benign prostatic hyperplasia (BPH) is a very common problem among older men, which often manifests as lower urinary tract symptoms (LUTS), and can lead to potentially serious side effects. In our study we determined that men with mild to no current LUTS but increased prostate size are much more likely to develop LUTS presumed due to BPH in the future. This association was not seen in men treated with dutasteride, a drug approved for treatment of BPH. Our study reveals that men with a prostate size of 40.1–80 ml are potential candidates for closer follow-up. [ABSTRACT FROM AUTHOR]

Background The GOLIATH study is a 2-yr trial comparing transurethral resection of prostate (TURP) to photoselective vaporization with the GreenLight XPS Laser System (GL-XPS) for the treatment of benign prostatic obstruction (BPO). Noninferiority of GL-XPS to TURP was demonstrated based on a 6-mo follow-up from the study. Objective To determine whether treatment effects observed at 6 mo between GL-XPS and TURP was maintained at the 2-yr follow-up. Design, setting, and participants Prospective randomized controlled trial at 29 centers in nine European countries involving 281 patients with BPO. Intervention Photoselective vaporization using the 180-W GreenLight GL-XPS or conventional (monopolar or bipolar) TURP. Outcome measurements and statistical analysis The primary outcome was the International Prostate Symptom Score for which a margin of three was used to evaluate the noninferiority of GL-XPS. Secondary outcomes included Q max , prostate volume, prostate specific antigen, Overactive Bladder Questionnaire Short Form, International Consultation on Incontinence Questionnaire Short Form, occurrence of surgical retreatment, and freedom from complications. Results and limitations One hundred and thirty-six patients were treated using GL-XPS and 133 using TURP. Noninferiority of GL-XPS on International Prostate Symptom Score, Q max , and freedom from complications was demonstrated at 6-mo and was sustained at 2-yr. The proportion of patients complication-free through 24-mo was 83.6% GL-XPS versus 78.9% TURP. Reductions in prostate volume and prostate specific antigen were similar in both arms and sustained over the course of the trial. Compared with the 1 st yr of the study, very few adverse events or retreatments were reported in either arm. Treatment differences in the Overactive Bladder Questionnaire Short Form observed at 12-mo were not statistically significant at 24-mo. A limitation was that patients and treating physicians were not blinded to the therapy. Conclusions Twenty-four-mo follow-up data demonstrated that GL-XPS provides a durable surgical option for the treatment of BPO that exhibits efficacy and safety outcomes similar to TURP. Patient summary The long-term effectiveness and safety of GLP-XLS was similar to conventional TURP for the treatment of prostate enlargement. [ABSTRACT FROM AUTHOR]

Background Robot-assisted simple prostatectomy (RASP) is a minimally invasive procedure for treatment of patients with lower urinary tract symptoms (LUTS) due to large benign prostatic enlargement (BPE). Objective To present the perioperative and short-term functional outcomes of RASP in a large series of patients with LUTS due to BPE treated in a high-volume referral center. Design, setting, and participants We retrospectively collected data for 67 consecutive patients who underwent RASP from October 2008 to August 2014. Surgical procedure RASP was performed using a Da Vinci S or Si system with a transvesical approach. Measurements Complications were graded according to the Clavien-Dindo system. Continuous variables are reported as median and interquartile range (IQR). Comparison of preoperative and postoperative outcomes was assessed by Wilcoxon test. A two-sided value of p < 0.05 was considered statistically significant. Results and limitations The median preoperative prostate volume was 129 ml (IQR 104–180). For the 45 patients who did not have an indwelling catheter, the median preoperative International Prostate Symptom Score (IPSS) was 25 (20.5–28), the median maximum flow rate ( Q max ) was 7 ml/s (IQR 5–11), and the median post-void residual volume (PVRV) was 73 ml (IQR 40–116). The median operative time was 97 min (IQR 80–127) and the median estimated blood loss was 200 ml (IQR 115–360). The postoperative complication rate was 30%, including three cases (4.5%) with grade 3b complications (major bleeding requiring cystoscopy and coagulation). The median catheterization time was 3 d (IQR 2–4) and the median length of stay was 4 d (IQR 3–5). The median follow-up was 6 mo (IQR 2–12). At follow-up, the median IPSS was 3 (IQR 0–8), the median Q max was 23 ml/s (IQR 16–35), and the median PVRV was 0 ml (IQR 0–36) (all p < 0.001 vs baseline values). The retrospective design is the major study limitation. Conclusions Our data indicate good perioperative outcomes, an acceptable risk profile, and excellent improvements in patient symptoms and flow scores at short-term follow-up following RASP. Patient summary We analyzed the perioperative and functional outcomes of robot-assisted simple prostatectomy in the treatment of male patients with lower urinary tract symptoms due to large prostatic adenoma. The procedure was associated with a relatively low risk of complications and excellent functional outcomes, including considerable improvements in symptoms and flow performance. We can conclude that the procedure is a valuable option in the treatment of such patients. However, comparative studies evaluating the efficacy of the procedure in comparison with endoscopic treatment of large prostatic adenomas are needed. [ABSTRACT FROM AUTHOR]

Background Little is known about drug adherence in men treated for lower urinary tract symptoms (LUTS). Benign prostatic hyperplasia (BPH) is one of the causes of LUTS. Objective To examine adherence to pharmacological therapy and its clinical value in men with LUTS. Design, setting, and participants Population-based cohort study using an administrative prescription database and hospital discharge codes for 1.5 million men aged ≥40 yr treated with alpha blockers (ABs) and 5-alpha reductase inhibitors (5ARIs) alone or in combination (CT). Interventions Therapy with ABs and/or 5ARIs. Outcome measurements and statistical analysis The 1-yr and long-term adherence; hospitalization rates for BPH and BPH surgery. Multivariate Cox proportional hazards regression model, propensity score matching, and sensitivity analyses. Results and limitations The 1-yr adherence was 29% in patients exposed to at least 6-mo therapy. Patients on CT had a higher discontinuation rate in the first 2 yr compared to those on monotherapy ( p < 0.0001). Overall hospitalization rates for BPH and BPH surgery were 9.04 and 12.6 per 1000 patient-years, respectively. A lower risk of hospitalization was observed for 5ARI compared to AB therapy (hazard ratio [HR] 0.46 and 0.23; p < 0.0001). CT was associated with a reduced risk of hospitalization for BPH surgery (HR 0.94; p < 0.0001) compared to AB. Discontinuation of drug treatment was an independent risk factor for hospitalization for BPH and BPH surgery (HR 1.65 and 2.80; p < 0.0001) regardless of therapeutic group. Limitations include the paucity of clinical measures and the absence of patient-reported outcomes. Conclusions Adherence to pharmacological therapy for BPH is low and could affect clinical outcomes. Long-term 5ARI and CT use was associated with an independent reduced risk of hospitalization for BPH surgery. Our findings suggest the need for new strategies to increase patient adherence to prescribed treatment and more appropriate prescribing by physicians. Patient summary Our research shows that adherence to prescribed pharmacological therapy is crucial in the management of patients suffering from lower urinary tract symptoms. Moreover, pharmacological therapy can prevent disease progression. [ABSTRACT FROM AUTHOR]

Background Epidemiological studies of lower urinary tract symptoms (LUTS) are few in China, and none has been conducted nationwide. Objective To estimate the prevalence and potential risk factors of LUTS and the bother they impose on adult women in China. Design, setting, and participants This is the second analysis of a population-based cross-sectional survey on urinary incontinence conducted between February and July 2006 in six regions of China. Cluster samples were randomly selected for interviews. Interventions No intervention was implemented. Outcome measurements and statistical analysis A modified Chinese Bristol Female Lower Urinary Tract Symptoms questionnaire was administered. The participants were asked about the presence of individual LUTS and rated their symptom bother. Descriptive statistics, χ 2 tests, receiver operating characteristic curves, and multivariate logistic regressions were used for data analysis. Results and limitations A total of 18 992 respondents (94.96%) were included. The prevalence of any LUTS, storage symptoms, or voiding symptoms was 55.5%, 53.9%, and 12.9%, respectively, and increased with age. Nocturia was the most common symptom (23.4%), followed by urgency (23.3%) and stress urinary incontinence (SUI; 18.9%). Nocturia was most frequently rated as bothersome (93.0%) but was generally minor (80.5%). Urgency and urgency urinary incontinence (UUI) were most frequently reported as severe (11.5% and 10.8%) or moderate (18.5% and 16.8%) bothers. Any LUTS were more prevalent in urban women (57.1% vs 53.9%). Multiple factors increased the odds of bother and individual LUTS, and older age and coexisting pelvic organ prolapse were strong predictors (p < 0.05). This survey was conducted 8 yr ago and did not assess all LUTS. Conclusions Half of adult women suffered with LUTS; nocturia, urgency, and SUI were more prevalent. Urgency and UUI were most frequently reported as severe or moderate bothers. Multiple factors influenced bother and individual LUTS. Patient summary The prevalence of lower urinary tract symptoms is high and increases with age in adult women in China. Urgency and urgency urinary incontinence were most frequently regarded as severe or moderate bothers and should be targeted for medical intervention. [ABSTRACT FROM AUTHOR]

Context Lower urinary tract symptoms (LUTS) represent one of the most common clinical complaints in adult men and have multifactorial aetiology. Objective To develop European Association of Urology (EAU) guidelines on the assessment of men with non-neurogenic LUTS. Evidence acquisition A structured literature search on the assessment of non-neurogenic male LUTS was conducted. Articles with the highest available level of evidence were selected. The Delphi technique consensus approach was used to develop the recommendations. Evidence synthesis As a routine part of the initial assessment of male LUTS, a medical history must be taken, a validated symptom score questionnaire with quality-of-life question(s) should be completed, a physical examination including digital rectal examination should be performed, urinalysis must be ordered, post-void residual urine (PVR) should be measured, and uroflowmetry may be performed. Micturition frequency-volume charts or bladder diaries should be used to assess male LUTS with a prominent storage component or nocturia. Prostate-specific antigen (PSA) should be measured only if a diagnosis of prostate cancer will change the management or if PSA can assist in decision-making for patients at risk of symptom progression and complications. Renal function must be assessed if renal impairment is suspected from the history and clinical examination, if the patient has hydronephrosis, or when considering surgical treatment for male LUTS. Uroflowmetry should be performed before any treatment. Imaging of the upper urinary tract in men with LUTS should be performed in patients with large PVR, haematuria, or a history of urolithiasis. Imaging of the prostate should be performed if this assists in choosing the appropriate drug and when considering surgical treatment. Urethrocystoscopy should only be performed in men with LUTS to exclude suspected bladder or urethral pathology and/or before minimally invasive/surgical therapies if the findings may change treatment. Pressure-flow studies should be performed only in individual patients for specific indications before surgery or when evaluation of the pathophysiology underlying LUTS is warranted. Conclusions These guidelines provide evidence-based practical guidance for assessment of non-neurogenic male LUTS. An extended version is available online ( www.uroweb.org/guidelines ). Patient summary This article presents a short version of European Association of Urology guidelines for non-neurogenic male lower urinary tract symptoms (LUTS). The recommended tests should be able to distinguish between uncomplicated male LUTS and possible differential diagnoses and to evaluate baseline parameters for treatment. The guidelines also define the clinical profile of patients to provide the best evidence-based care. An algorithm was developed to guide physicians in using appropriate diagnostic tests. [ABSTRACT FROM AUTHOR]

Context Treatment for lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH) is varied, and significant side effects, particularly concerning sexual function, affect uptake. The prostatic urethral lift (PUL) procedure is a recent addition to the armamentarium for BPH treatment, with independent reports suggesting improvement of symptoms, sexual function, and urinary flow. Objective We undertook a systematic review and meta-analysis of reported symptomatic, functional, and sexual outcomes following the PUL procedure. Evidence acquisition We performed a critical review of Medline, Embase, ScienceDirect, Cochrane Library, and Web of Science databases in May 2014 according to the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. Quality assessment was performed using a modification of the Methodological Index for Non-Randomized Studies tool. All retrospective, prospective, and controlled trials were included for analysis. Symptom scores, sexual health scores, and functional outcomes were pooled and meta-analysed using quality and random-effects models. Evidence synthesis Ten articles comprising six independent patient cohorts were included for analysis. Pooled estimates from between 452 and 680 patients suggested overall improvement following PUL, including symptoms (large gain; standardised mean gain range of 1.3–1.6, International Prostate Symptom Score difference of −7.2 to −8.7 points), maximum flow rate (3.8–4.0 ml/s), and quality of life (2.2–2.4 points). Sexual function was preserved with a small improvement estimated at 12 mo (standardised mean gain range of 0.3–0.4). Pooled estimates were mostly heterogeneous across study groups. Conclusions PUL is a well-tolerated, minimally invasive therapy for BPH that provides favourable symptom, sexual health, and functional outcomes during follow-up to 12 mo. Longer follow-up and larger randomised studies are required to further confirm these preliminary results. Patient summary We reviewed the early results of an innovative procedure directed towards the management of prostate enlargement. The results revealed a well-tolerated procedure that produces improvement in urinary symptoms and function while preserving sexual function. [ABSTRACT FROM AUTHOR]

Background Short-term trials have demonstrated the efficacy and safety of combination therapy using antimuscarinics and α-blockers in men with lower urinary tract symptoms (LUTS). The Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS (oral controlled absorption system) in Males with Lower Urinary Tract Symptoms (NEPTUNE) II is the first long-term study using solifenacin (Soli) and the oral controlled absorption system formulation of tamsulosin (TOCAS). Objective To evaluate long-term (up to 52 wk) safety and efficacy of flexible dosing of two fixed-dose combinations (FDC) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms. Design, setting, and participants Patients with both storage and voiding LUTS, maximum urinary flow rate of 4.0–12.0 ml/s, prostate size <75 ml, and postvoid residuals ≤150 ml, who completed the 12-wk, double-blind NEPTUNE study could continue in the 40-wk, open-label NEPTUNE II study. Intervention FDC of Soli 6 mg plus TOCAS 0.4 mg, or Soli 9 mg plus TOCAS 0.4 mg; patients could switch between doses in NEPTUNE II. Outcome measurements and statistical analysis Safety and efficacy data from NEPTUNE and NEPTUNE II were combined to cover a 52-wk period. Primary efficacy end points were total International Prostate Symptom Score (IPSS) and total urgency and frequency score (TUFS); secondary end points included IPSS storage and voiding subscores, micturition diary variables, and quality of life parameters. Results In all, 1066 men completed NEPTUNE and received one dose or more of study medication in NEPTUNE II. Treatment-emergent adverse events were reported in 499 (46.8%) patients who participated in NEPTUNE II; most were mild or moderate. Urinary retention occurred in 13 of 1208 (1.1%) patients receiving one or more FDCs in NEPTUNE and/or NEPTUNE II; 8 (0.7%) required catheterisation (acute urinary retention [AUR]). Reductions in total IPSS and TUFS during NEPTUNE were maintained for up to 52 wk of FDC treatment, with mean reductions of 9.0 (standard deviation [SD]: 5.7) and 10.1 (SD: 9.2), respectively, from baseline to end of treatment. Clinically relevant improvements were also observed for secondary efficacy end points. Conclusions Long-term treatment with FDC Soli plus TOCAS was well tolerated and efficacious in men with storage and voiding LUTS, with a low incidence of AUR. Patient summary Treatment with solifenacin plus tamsulosin in a fixed-dose combination tablet was well tolerated by men with lower urinary tract symptoms. Improvements in symptoms were achieved after 4 wk of treatment, with further improvements at week 16 maintained for up to 52 wk throughout the study. [ABSTRACT FROM AUTHOR]

Background The international prostate symptom score (IPSS) evaluates lower urinary tract symptoms (LUTS) in men with suspected benign prostatic hyperplasia (BPH); the total score does not differentiate between storage and voiding and is unevenly weighted (four questions [57%] on voiding, three questions [43%] on storage). Objective To evaluate the relative contributions of storage and voiding IPSS subscores to total IPSS at baseline and in response to treatment with tadalafil. Design, setting, and participants Integrated analysis of data from four placebo-controlled, 12-wk studies of tadalafil (5 mg once daily) in 1499 men with LUTS/BPH. Outcome measurements and statistical analysis Relationships between total IPSS and the storage and voiding subscores were assessed using graphical exploration and linear regression modelling. Linear modelling was performed for the baseline and endpoint and for changes in subscores. The optimal storage subscore to total IPSS (S:T) ratio for IPSS improvement was identified using nonparametric regression and gradient-descent optimisation. Results and limitations The contribution of storage and voiding subscores at baseline and endpoint was 38.8% and 61.2%, and 39.2% and 60.7%, respectively. This intuitive 40:60 storage-to-voiding ratio was similar at baseline and endpoint by treatment group and for changes in subscores, but spanned the entire range for individuals. Changes in total IPSS were greatest for a storage subscore percentage contribution to total IPSS of 42.7%. There was no statistical association between S:T ratio (≥40% vs <40%) at baseline and response to tadalafil. The main limitation was the use of unvalidated storage and voiding IPSS subscores. Conclusions A constant S:T ratio of 4:10 was observed at baseline and endpoint. The greatest effect on total IPSS was noted for an S:T percentage contribution of 42.7%. Tadalafil efficacy was unaffected by the level of storage dysfunction at baseline. Patient summary This analysis shows that for men with BPH, improvements during treatment with tadalafil apply to both storage and voiding symptoms at a constant ratio. The extent of storage dysfunction before treatment did not affect the response to treatment. [ABSTRACT FROM AUTHOR]

Context Although family studies have shown that male lower urinary tract symptoms (LUTS) are highly heritable, no systematic review exists of genetic polymorphisms tested for association with LUTS. Objective To systematically review and meta-analyze studies assessing candidate polymorphisms/genes tested for an association with LUTS, and to assess the strength, consistency, and potential for bias among pooled associations. Evidence acquisition A systematic search of the PubMed and HuGE databases as well as abstracts of major urologic meetings was performed through to January 2013. Case-control studies reporting genetic associations in men with LUTS were included. Reviewers independently and in duplicate screened titles, abstracts, and full texts to determine eligibility, abstracted data, and assessed the credibility of pooled associations according to the interim Venice criteria. Authors were contacted for clarifications if needed. Meta-analyses were performed for variants assessed in more than two studies. Evidence synthesis We identified 74 eligible studies containing data on 70 different genes. A total of 35 meta-analyses were performed with statistical significance in five ( ACE, ELAC2, GSTM1, TERT , and VDR ). The heterogeneity was high in three of these meta-analyses. The rs731236 variant of the vitamin D receptor had a protective effect for LUTS (odds ratio: 0.64; 95% confidence interval, 0.49–0.83) with moderate heterogeneity (I 2 = 27.2%). No evidence for publication bias was identified. Limitations include wide-ranging phenotype definitions for LUTS and limited power in most meta-analyses to detect smaller effect sizes. Conclusions Few putative genetic risk variants have been reliably replicated across populations. We found consistent evidence of a reduced risk of LUTS associated with the common rs731236 variant of the vitamin D receptor gene in our meta-analyses. Patient summary Combining the results from all previous studies of genetic variants that may cause urinary symptoms in men, we found significant variants in five genes. Only one, a variant of the vitamin D receptor, was consistently protective across different populations. [ABSTRACT FROM AUTHOR]

Abstract: Background: No study has compared the bothersomeness of all lower urinary tract symptoms (LUTS) using a population-based sample of adults. Despite this lack of evidence, investigators have often cited their LUTS of interest as the “most bothersome” or “one of the most bothersome.” Objective: To compare the population- and individual-level burden of LUTS in men and women. Design, setting, and participants: In this population-based cross-sectional study, questionnaires were mailed to 6000 individuals (18–79 yr of age) randomly identified from the Finnish Population Register. Outcome measurements and statistical analysis: The validated Danish Prostatic Symptom Score questionnaire was used for assessment of bother of 12 different LUTS. The age-standardized prevalence of at least moderate bother was calculated for each symptom (population-level burden). Among symptomatic individuals, the proportion of affected individuals with at least moderate bother was calculated for each symptom (individual-level bother). Results and limitations: A total of 3727 individuals (62.4%) participated (53.7% female). The LUTS with the greatest population-level burden were urgency (7.9% with at least moderate bother), stress urinary incontinence (SUI) (6.5%), nocturia (6.0%), postmicturition dribble (5.8%), and urgency urinary incontinence (UUI) (5.0%). Burden from incontinence symptoms was higher in women than men, and the opposite was true for voiding and postmicturition symptoms. At the individual level, UUI was the most bothersome for both genders. Although the response proportion was high, approximately a third did not participate. Conclusions: Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS. At the population level, the most prevalent bothersome symptoms are urgency, SUI, and nocturia. Patient summary: Urinary urgency was the most common troubling symptom in a large population-based study; however, for individuals, urgency incontinence was the most likely to be rated as bothersome. [Copyright &y& Elsevier]

Abstract: Background: Storage symptoms are particularly bothersome in men with lower urinary tract symptoms (LUTS) but may not be adequately treated by α-blocker monotherapy. Objective: To assess the efficacy and safety of a fixed-dose combination (FDC) of solifenacin and an oral controlled absorption system (OCAS) formulation of tamsulosin compared with placebo and compared with tamsulosin OCAS (TOCAS) monotherapy in men with moderate to severe storage symptoms and voiding symptoms. Design, setting, and participants: A double-blind 12-wk phase 3 study in 1334 men with storage and voiding LUTS: total International Prostate Symptom Score (IPSS) ≥13, maximum urinary flow rate (Qmax) 4.0–12.0ml/s, two or more urgency episodes per 24 h of Patient Perception of Intensity of Urgency Scale grade 3 or 4, and eight or more micturitions per 24h. Intervention: Patients were randomised to placebo, TOCAS 0.4mg, FDC solifenacin 6mg plus TOCAS 0.4mg, or FDC solifenacin 9mg plus TOCAS 0.4mg. Outcome measurements and statistical analysis: Primary efficacy end points were (1) total IPSS and (2) Total Urgency and Frequency Score (TUFS). An FDC met the success criteria if it demonstrated superiority compared with placebo and noninferiority compared with TOCAS for total IPSS, as well as superiority compared with TOCAS for TUFS. Results and limitations: Reductions in total IPSS and TUFS were observed with both solifenacin 6mg plus TOCAS (−7.0 and −8.1, respectively) and solifenacin 9mg plus TOCAS (−6.5 and −7.6, respectively) compared with TOCAS (−6.2 and −6.7, respectively) and placebo (−5.4 and −4.4, respectively). Solifenacin 6mg plus TOCAS met all prespecified success criteria for both primary end points, while solifenacin 9mg plus TOCAS met success criteria compared with placebo but not compared with TOCAS. Both FDCs improved quality of life (QoL) measures and were well tolerated, with low incidences of acute urinary retention. Conclusions: The FDC of solifenacin 6mg plus TOCAS significantly improved storage and voiding symptoms, as well as QoL parameters, compared with placebo. This FDC also improved storage symptoms and QoL compared with TOCAS alone in men with moderate to severe storage symptoms and voiding symptoms, and it was well tolerated. Trial registration: ClinicalTrials.gov Identifier: NCT01018511). [Copyright &y& Elsevier]