Tadalafil Alone or in Combination with Tamsulosin for the Management for LUTS/BPH and ED.

PURPOSE OF REVIEW: Aim of our systematic review is to evaluate and summarize the efficacy and safety of tadalafil alone or in combination with tamsulosin for the management of lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). RECENT FINDINGS: Daily tadalafil, in particular 5 mg, according to retrieved studies, appears to be both safe and effective in treating LUTS/BPH and ED, compared with placebo or tamsulosin. The combination of daily tadalafil 5 mg and tamsulosin 0.4 mg allows a better improvement of LUTS compared with both the monotherapies, even if with an increased, but acceptable and tolerated, adverse events rate. After discontinuation of tamsulosin or tadalafil in patients previously treated with their combination, the improvement of LUTS retains significance compared with baseline. Tadalafil 5 mg should be considered a primary treatment option for patients with LUTS/BPH and ED. Evidence highlight an excellent tolerability, safety, and effectiveness profile, both alone or in combination with tamsulosin 0.4 mg. A better efficacy on LUTS relief has been observed for combination therapy, preserving also sexual function. The further switch to monotherapy allows to preserve LUTS relief, but tadalafil only is able to retain ED improvement. Our results support the evidence for a more and more tailored and modular LUTS treatment.

Effectiveness of splinting for pain and function in people with thumb carpometacarpal osteoarthritis: a systematic review with meta-analysis.

OBJECTIVE: To examine the effectiveness of splinting for reducing pain and improving function and health-related quality of life (HR-QoL) in people with thumb carpometacarpal osteoarthritis (CMC OA). DESIGN: The Cochrane Library, MEDLINE, Embase, CINAHL, ISI Web of Science, Scopus and Google Scholar, 3 trial registries and 4 conference proceedings were systematically searched for randomised and non-randomised controlled trials up to March 17th, 2018. Two reviewers independently applied the inclusion criteria to select potential studies and assess risk of methodologic bias using the Cochrane Collaboration's Risk of Bias Tool. Studies were pooled using the inverse variance method to calculate standardised mean difference (SMD). Sensitivity analyses were conducted and the quality of evidence for each outcome was judged following the Grades of Recommendation Assessment, Development and Evaluation (GRADE) approach. RESULTS: Twelve studies were retrieved (n = 1353), 4 comparing a splint to control and 8 to another splint. In the medium-term (3-12 months), low quality evidence showed that splints cause a moderate to large reduction in pain (SMD 0.7 [95% confidence interval (CI) 1.04, 0.35], P < 0.0001) and small to moderate improvement in function (SMD 0.42 [95% CI 0.77, 0.08], P = 0.02). No significant effect was found at short-term or for different types of splints. No studies reported HR-QoL. CONCLUSIONS: Splinting demonstrated a moderate to large effect for pain and small to moderate effect for function in the medium-term but not in the short term. Quality of the evidence is low. Major challenges are the lack of diagnostic criteria and of a gold-standard outcome measure for thumb CMC OA.

Incremental clinical effectiveness and cost effectiveness of providing supervised physiotherapy in addition to usual medical care in patients with osteoarthritis of the hip or knee: 2-year results of the MOA randomised controlled trial.

OBJECTIVE: To investigate the clinical- and cost-effectiveness at 2-year follow-up of providing individual, supervised exercise physiotherapy and/or manual physiotherapy in addition to usual medical care. METHOD: People with hip or knee osteoarthritis meeting the American College of Rheumatology clinical diagnostic criteria were randomised (1:1, concealed, assessor-blinded) to four groups: usual medical care; supervised exercise physiotherapy; manual physiotherapy; or combined exercise and manual physiotherapy. Physiotherapy group participants were provided 10 50-min treatment sessions including booster sessions at 4 and 13 months, in addition to usual care. The primary outcome at 2-year follow-up was incremental cost-utility ratio (ICUR) of each physiotherapy intervention in addition to usual care, compared with usual care alone, from the health system and societal perspectives. To allow interpretation of negative ICURs, we report incremental net benefit (INB). The primary clinical outcome was the Western Ontario and McMaster Osteoarthritis Index (WOMAC). RESULTS: Of 206 patients, 186 (90·3%) were retained at 2-year follow-up. Exercise physiotherapy and manual physiotherapy dominated usual care, demonstrating cost savings; combined therapy did not. Exercise therapy had the highest incremental net benefits (INBs), statistically significant at all willingness-to-pay (base-case: societal New Zealand (NZ)$6,312, 95%CI 334 to 12,279; health system NZ$8,065, 95%CI 136 to 15,994). Clinical improvements were superior to usual care only in the exercise physiotherapy group (-28.2 WOMAC points, 95%CI -49.2 to -7.1). No serious adverse events were recorded. CONCLUSION: Individually supervised exercise therapy is cost-effective and clinically effective in addition to usual medical care at 2-year follow-up, and leads to cost savings for the health system and society. TRIAL REGISTRATION: Prospectively registered with the Australian NZ Clinical Trials Registry, reference ACTRN12608000130369.

Patient radiation doses in paediatric interventional cardiology procedures: a review.

A large number of investigations into the radiation doses from x-ray guided interventional cardiology procedures in children have been carried out in recent years. A review was conducted of these studies, gathering data on kerma area product (P KA), fluoroscopic screening time (FT), air kerma, and estimates of effective dose and organ doses. The majority of studies focus on P KA and FT with no estimation of dose to the patient. A greater than ten-fold variation in average P KA was found between different studies, even where data were stratified by patient age or weight. Typical values of P KA were 0.6-10 Gy · cm2 (<1 year/10 kg), 1.5-30 Gy · cm2 (1-5 years), 2-40 Gy · cm2 (5-10 years), 5-100 Gy · cm2 (10-16 years) and 10-200 Gy · cm2 (>16 years). P KA was lowest for heart biopsy (0.3-10 Gy · cm2 for all ages combined) and atrial septostomy (0.4-4.0 Gy · cm2), and highest for pulmonary artery angioplasty (1.5-35 Gy · cm2) and right ventricular outflow tract dilatation (139 Gy · cm2). Most estimates of patient dose were in the form of effective dose (typically 3-15 mSv) which is of limited usefulness in individualised risk assessment. Few studies estimated organ doses. Despite advances in radiation protection, recent publications have reported surprisingly large doses, as represented by P KA and air kerma. There is little indication of a fall in these dose indicators over the last 15 years. Nor is there much suggestion of a fall in doses associated with the use of flat panel detectors, as opposed to image intensifiers. An assessment of the impact of radiation dose in the context of overall patient outcome is required.

The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials.

PURPOSE: To understand how improvements in the symptoms of overactive bladder (OAB) seen with the ß3-adrenoceptor agonist mirabegron 50 mg, correlate with patient experience as measured by validated and standard patient-reported outcomes (PROs), and to identify whether there is overall directional consistency in the responsiveness of PROs to treatment effect. METHODS: In a post hoc analysis of pooled data from three randomized, double-blind, placebo-controlled, 12-week Phase III trials of mirabegron 50 mg once daily, responder rates for incontinence frequency (≥50 % reduction in incontinence episodes/24 h from baseline to final visit), micturition frequency (≤8 micturitions/24 h at final visit), and PROs [minimally important differences in patient perception of bladder condition (PPBC) and subsets of the overactive bladder questionnaire (OAB-q) measuring total health-related quality of life (HRQoL), and symptom bother] were evaluated individually and in combination. RESULTS: Mirabegron 50 mg demonstrated greater improvement from baseline to final visit than placebo for each of the responder analyses, whether for individual objective and subjective outcomes or combinations thereof. These improvements versus placebo were statistically significant for all double and triple responder analyses and for all single responder analyses except PPBC. PRO measurements showed directional consistency and significant correlations, and there were also significant correlations between objective and subjective measures of efficacy. CONCLUSIONS: The improvements in objective measures seen with mirabegron 50 mg translate into a meaningful clinical benefit as evident by the directional consistency seen in HRQoL measures of benefit.

Nocturia: risk factors and associated comorbidities; findings from the EpiLUTS study.

OBJECTIVE: To evaluate the risk factors and comorbidities associated with nocturia in men and women aged ≥ 40 years. MATERIAL AND METHODS: The EpiLUTS study was an Internet-based cross-sectional, population-representative survey involving 30,000 men and women from the USA, UK and Sweden evaluating lower urinary tract symptoms (LUTS) using the LUTS Tool. A secondary analysis of the EpiLUTS data using participants with nocturia was performed. Descriptive statistics were used to examine the data. Logistic regressions were used to analyse associations of comorbid conditions and risk factors in men and women with nocturia ≥ 2. RESULTS: With a 59% response rate, nocturia ≥ 1 was quite common at 69% in men and 76% in women; 28% men and 34% women had nocturia ≥ 2. Age, body mass index (in women), Hispanic and Black responders, diabetes, high blood pressure, anxiety and depression and a history of bed-wetting were significantly associated with nocturia ≥ 2. Arthritis, asthma, diabetes, heart disease, inflammatory bowel disease, bladder infection, uterine prolapse, hysterectomy and menopausal status were all significantly associated with nocturia ≥ 2 in women. Prostatitis and prostate cancer were significant in men with nocturia ≥ 2. British and Swedish participants had a lesser risk of nocturia ≥ 2. CONCLUSION: Nocturia is a highly prevalent condition associated with various risk factors and comorbidities. Treatment of nocturia should be aimed at these causes in a multidisciplinary fashion. Further studies are needed to look specifically at these conditions in the pathophysiology of nocturia.

Is there a link between overactive bladder and the metabolic syndrome in women? A systematic review of observational studies.

OBJECTIVES: To conduct a systematic review to determine whether there is an association between metabolic syndrome (MetS) and lower urinary tract symptoms (LUTS) or overactive bladder (OAB) in women. METHODS: We systematically reviewed English language observational studies on the effect of MetS (or component factors) on the presence of OAB or LUTS in women. We searched PubMed, Web of Science and The Cochrane Library with no date restrictions, checked reference lists and undertook citation searches in PubMed and Google Scholar. Studies were assessed for risk of bias. Because of heterogeneity, results were not pooled, but are reported narratively. RESULTS: Of 27 included studies, only three looked at the link between MetS and OAB. The rest looked at links between OAB and components of MetS such as obesity or insulin resistance (n = 10), between MetS and urinary symptoms (n = 3) and between urinary symptoms and components of MetS, such as obesity (n = 14). Evidence is currently limited, but it does suggest that there may be important links between MetS and OAB and components of MetS such as obesity. CONCLUSIONS: The literature on MetS and OAB or LUTS in women is limited, and poor quality. However, the evidence available on obesity appears to support MetS as a contributor and predictor of LUTS in women. Many of the women with LUTS will be overweight and will have features of the MetS, if looked for. This provides not only an opportunity to encourage weight loss as an adjunct to therapy for the OAB symptoms but also a window of opportunity to address cardiovascular risk factors and prevent future cardiovascular morbidity and mortality.

Nutritional characteristics of camelina meal for 3-week-old broiler chickens.

Limited information on nutritional characteristics on camelina meal for broiler chickens limits its use in diets of broiler chickens. The objectives of this study were to determine the ileal digestible energy (IDE), ME, and MEn contents of 2 different camelina meal (CM1 and CM2) samples for 3-wk-old broiler chickens using the regression method and to determine glucosinolate compounds in the camelina meal samples. The CM1 and CM2 were incorporated into a corn-soybean meal-based reference diet at 3 levels (0, 100, or 200 g/kg) by replacing the energy-yielding ingredients. These 5 diets (reference diet, and 100 and 200 g/kg camelina meal from each of CM1 and CM2) were fed to 320 male Ross 708 broilers from d 21 to 28 post hatching with 8 birds per cage and 8 replicates per treatment in a randomized complete block design. Excreta were collected twice daily from d 25 to 28, and jejunal digesta and ileal digesta from the Meckel's diverticulum to approximately 2 cm proximal to the ileocecal junction were collected on d 28. The total glucosinolate content for CM1 and CM2 were 24.2 and 22.7 nmol/mg, respectively. Jejunal digesta viscosity was linearly increased (P<0.001) from 2.2 to 4.1 cP with increasing dietary camelina meal levels. There were linear effects (P<0.001) of CM1 and CM2 substitution on final weight, weight gain, feed intake, and G:F. The inclusion of CM1 and CM2 linearly decreased (P<0.001) ileal digestibility of DM, energy, and IDE. The supplementation of CM1 and CM2 linearly decreased (P<0.001) the retention of DM, nitrogen, and energy; ME, and MEn. By regressing the CM1 and CM2-associated IDE intake in kilocalories against kilograms of CM1 and CM2 intake, the IDE regression equation was Y=-10+1,429×CM1+2,125×CM2, r2=0.55, which indicates that IDE values were 1,429 kcal/kg of DM for CM1 and 2,125 kcal/kg of DM for CM2. The ME regression was Y=5+882×CM1+925×CM2, r2=0.54, which implies ME values of 882 kcal/kg of DM for CM1 and 925 kcal/kg of DM for CM2. MEn regression was Y=2+795×CM1+844×CM2, r2=0.52, which implies MEn values of 795 kcal/kg of DM for CM1 and 844 kcal/kg of DM for CM2. Based on these results, utilization of energy and nitrogen in camelina meal by broiler chickens is low and the high viscosity observed in jejunal digesta as well as the total glucosinolate in camelina meal may have contributed to the poor energy and nitrogen utilization.

Durable improvements in urinary incontinence and positive treatment response in patients with idiopathic overactive bladder syndrome following long-term onabotulinumtoxinA treatment: Final results of 3.5-year study.

OBJECTIVES: Here we present the final results from an extension study assessing long-term onabotulinumtoxinA treatment (3.5 years) in patients with idiopathic overactive bladder. METHODS: Patients who completed either of 2 Phase III trials were eligible to enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100 U) treatments. Data were analyzed for the overall population of patients who received 100 U in any treatment cycle (n=829) and within discrete subgroups of patients who received exactly 1 (n=105), 2 (n=118), 3 (n=117), 4 (n=83), 5 (n=46), or 6 (n=33) treatments of the 100 U dose throughout the study (n=502). RESULTS: Of the 829 patients enrolled, 51.7 % completed the study. Discontinuations due to AEs/lack of efficacy were low (5.1/5.7 %); other reasons were not treatment-related. Mean reductions from baseline in urinary incontinence (UI) episodes/day (week 12; co-primary endpoint) were consistent among discrete subgroups who received 1 (-3.1), 2 (-2.9, -3.2), 3 (-4.1 to -4.5), 4 (-3.4 to -3.8), 5 (-3.0 to -3.6), or 6 (-3.1 to -4.1) treatments. A consistently high proportion of patients reported improvement/great improvement on the Treatment Benefit Scale (week 12; co-primary endpoint) in the discrete subgroups across all treatments (70.0-93.5 %). Median time to request retreatment was ≤6 months for 34.2 %, >6-≤12 months for 37.2 %, and >12 months for 28.5 % of patients. Most common AE was UTI, with no changes in safety profile over time. CONCLUSION: Long-term onabotulinumtoxinA treatment resulted in consistent reductions in UI and high proportions of patients reporting improvement after each treatment, with no new safety findings.

[AN EVIDENCE BASED UPDATE ON THE INVESTIGATION AND MANAGEMENT OF MALE LOWER URINARY TRACT SYMPTOMS].

In this review, we aim to summarise the evidence regarding the diagnosis and management of male Lower urinary tract symptoms (LUTS). It is inevitable that with an ageing population the prevalence of male LUTS is likely to increase. Thus symptom prevention and preservation of quality oflife (QoL) feature as high priorities for clinicians and patients alike. There are now a number of different pharmacological options available to men with LUTS which lead to significant improvements in symptom scores, flow rate and QoL. Meta-analyses have shown the benefits for 5-α reductase inhibitors, antimuscarinics, alpha blockers and more recently the phosphodiesterase-5 inhibitors. High level evidence also exists for combinations of all of the above agents with alpha blockers except phosphodiesterase-5 inhibitors and so men with concomitant storage symptoms, prostate volume >30ml/ PSA>1.4 or erectile dysfunction may be considered for combination treatment. The last few years have seen an increase in the data regarding less invasive methods of cystometry. Although these do not provide the same information as cystometry, they may have a role in answering specific questions and counselling men with BPH/LUTS. The key to incorporating these newer techniques in the assessment of men will lie with standardisation and use for specific indications. In an era of personalised medicine, appropriate patient selection is likely to provide the key to the most effective clinical investigative and management strategy.

Phase II study on the efficacy and safety of the EP1 receptor antagonist ONO-8539 for nonneurogenic overactive bladder syndrome.

PURPOSE: We evaluated the efficacy, safety and tolerability of the EP1 receptor antagonist ONO-8539 in patients with overactive bladder syndrome. MATERIALS AND METHODS: This was a 12-week, randomized, double-blind, placebo controlled, parallel group, multicenter study with a 2-week single blind placebo run-in phase. The 435 patients were randomized to receive twice daily ONO-8539 (30, 100 or 300 mg), placebo or once daily tolterodine (4 mg). RESULTS: At the end of the 12-week treatment no statistically significant difference was found between ONO-8539 and placebo in the change from baseline in the number of micturitions per 24 hours. The primary end points for 30, 100 and 300 mg ONO-8539, and placebo were -1.02, -1.53, -1.31 and -1.40, respectively. There was no statistically significant difference between any ONO-8539 group and placebo in the change from baseline in the number of urgency or urinary urgency incontinence episodes per 24 hours, or the mean volume voided per micturition, which were secondary end points. Statistically significant differences for tolterodine vs placebo were observed in the change from baseline in the number of micturitions (p = 0.045), urgency episodes (p = 0.04) and mean volume voided per micturition (p <0.001). The incidence of adverse events was 54.1% in the placebo group, 43.0% to 54.0% in the ONO-8539 groups and 46.6% in the tolterodine group. The intensity of adverse events was similar among the treatment groups. Similar to other treatments, the most frequently reported adverse events after ONO-8539 were nasopharyngitis and diarrhea. CONCLUSIONS: The results of this study, which to our knowledge represents the first evaluation of ONO-8539 in patients with overactive bladder, suggest a minimal role for EP1 receptor antagonism in the management of overactive bladder syndrome.

Contemporary issues with pharmacotherapy for lower urinary tract symptoms.

Two articles appeared in the November 2012 edition of the journal evaluating aspects relating to the use of two important pharmacotherapeutic classes for lower urinary tract symptoms (LUTS) in real life clinical practice. LUTS is a non-specific term that encompasses urine storage, voiding and postmicturition symptoms. LUTS is a common bothersome problem affecting both men and women with a comparable prevalence in age-matched patients of both sexes that increases with ageing.

OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder.

INTRODUCTION: A prespecified pooled analysis of two placebo-controlled, phase 3 trials evaluated whether the number of prior anticholinergics used or reason for their discontinuation affected the treatment response to onabotulinumtoxinA 100U in overactive bladder (OAB) patients with urinary incontinence (UI). METHODS: Patients with symptoms of OAB received intradetrusor injections of onabotulinumtoxinA 100U or placebo, sparing the trigone. Change from baseline at week 12 in UI episodes/day, proportion of patients reporting a positive response ('greatly improved' or 'improved') on the treatment benefit scale (TBS), micturition and urgency were evaluated by number of prior anticholinergics (1, 2 or ≥ 3) and reason for their discontinuation (insufficient efficacy or side effects). Adverse events (AE) were assessed. RESULTS: Patients had taken an average of 2.4 anticholinergics before study enrolment. OnabotulinumtoxinA reduced UI episodes/day from baseline vs. placebo, regardless of the number of prior anticholinergics (-2.82 vs. -1.52 for one prior anticholinergic; -2.58 vs. -0.58 for two prior anticholinergics; and -2.92 vs. -0.73 for three or more prior anticholinergics; all p < 0.001). The proportion of TBS responders was higher with onabotulinumtoxinA vs. placebo (69.0% vs. 37.2% for one prior anticholinergic; 58.8% vs. 24.8% for two prior anticholinergics and 56.4% vs. 22.5% for three or more prior anticholinergics; all p < 0.001). Similar results were observed regardless of the reason for discontinuation. OnabotulinumtoxinA reduced the episodes of urgency and frequency of micturition vs. placebo in all groups. AEs were well tolerated, with a comparable incidence in all groups. CONCLUSION: In patients with symptoms of OAB who were inadequately managed by one or more anticholinergics, onabotulinumtoxinA 100U provided significant and similar treatment benefit and safety profile regardless of the number of prior anticholinergics used or reason for inadequate management of OAB. ClinicalTrials.gov: NCT00910845, NCT00910520.

Safety and tolerability of the ß3 -adrenoceptor agonist mirabegron, for the treatment of overactive bladder: results of a prospective pooled analysis of three 12-week randomised Phase III trials and of a 1-year randomised Phase III trial.

AIMS: To evaluate the safety and tolerability of the ß3 -adrenoceptor agonist, mirabegron, in patients with overactive bladder (OAB). METHODS: Tolerability and safety data from three 12-week, randomised, placebo-controlled, double-blind, Phase III trials (Studies 046, 047 and 074) were pooled by treatment group. The three studies were of a similar design, although the assessed doses of mirabegron [25, 50 or 100 mg once daily (qd)] varied, and tolterodine extended release (ER) 4 mg was included as an active-control arm in Study 046 only. Tolerability and safety data from a 1-year, randomised, double-blind, Phase III trial (Study 049) are also presented. Safety variables included the incidence and severity of treatment-emergent adverse events (TEAEs), vital signs and electrocardiogram data. RESULTS: Mirabegron (25, 50 or 100 mg qd) was safe and well-tolerated in patients with OAB over 12-week (n = 2736) and 1-year (n = 1632) periods. The incidence of TEAEs and treatment discontinuations as a result of TEAEs was low; the majority were mild in severity and few were serious. Hypertension, nasopharyngitis and urinary tract infection were the most common TEAEs with mirabegron. The mirabegron tolerability profile was similar to that seen with placebo and tolterodine ER 4 mg, except for dry mouth, which occurred, on average, five times less frequently with mirabegron than tolterodine ER 4 mg. In the pooled 12-week analysis, mirabegron 50 mg was associated with placebo-adjusted mean increases of 0.4-0.6 mmHg in blood pressure and approximately one beat per minute in pulse rate, both reversible upon treatment discontinuation. The incidence of Major Adverse Cardiovascular Events as adjudicated by an independent cardiovascular committee was low and similar across treatment groups. CONCLUSION: The favourable tolerability profile of mirabegron in patients with OAB may allow improved treatment compliance compared with antimuscarinics, with important implications for patient outcomes.

Urgency and pain in patients with overactive bladder and bladder pain syndrome. What are the differences?

BACKGROUND: The Overactive Bladder Syndrome (OAB) and the Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) are different urological conditions sharing 'urgency' as a common symptom. The aim of this review is to address our existing knowledge and establish how these symptoms are interrelated and to determine whether or not there is a common link between both symptoms complexes that help to distinguish one from the other. METHODS: Pubmed was used to obtain references for this non-systematic review aiming to discuss differences between OAB and BPS/IC. Guidelines of several professional associations and discussions based on expert opinion from the authors were implemented. RESULTS: Whilst in BPS the hallmark symptom is pain on bladder filling, urgency is the defining symptom of OAB. Whilst it is likely that the pain in BPS/IC arises from local inflammation in the bladder wall, the nature of urgency as a symptom, its origin, and the relationship between urgency and pain, as well as the different afferent mechanisms associated with the genesis of these sensory symptoms, remains unknown. Although the aetiology of both OAB and PBS/IC is unclear, the influence of environmental factors has been suggested. Both are chronic conditions with very variable symptom resolution and response to therapy. The relationship with voiding dysfunction, gynaecological causes of chronic pelvic pain or the possible alteration of the hypothalamic-pituitary-adrenal axis and psychological disorders has not been established. Inflammation has been suggested as the common link between OAB and BPS/IC. CONCLUSIONS: OAB and BPS/IC are different symptoms complexes that share urgency as a common symptom. None of them have a specific symptom although pain on bladder filling is the hallmark symptom in BPS/IC. Bladder pain with urgency should be a trigger for referral to the provider with appropriate knowledge and expertise in this disease state, whereas the management of OAB should be part of normal routine care in the community.

Evaluation and treatment of lower urinary tract symptoms in older men.

PURPOSE: The 6th International Consultation on New Developments in Prostate Cancer and Prostate Diseases met from June 24-28, 2005 in Paris, France to review new developments in benign prostatic disease. MATERIALS AND METHODS: A series of committees were asked to produce recommendations on the evaluation and treatment of lower urinary tract symptoms in older men. Each committee was asked to base recommendations on a thorough assessment of the available literature according to the International Consultation on Incontinence level of evidence and grading system adapted from the Oxford system. RESULTS: The Consultation endorsed the appropriate use of the current terminology lower urinary tract symptoms/benign prostatic hyperplasia/benign prostate enlargement and benign prostatic obstruction, and recommended that terms such as "clinical benign prostatic hyperplasia" or "the benign prostatic hyperplasia patient" be abandoned, and asked the authorities to endorse the new nomenclature. The diagnostic evaluation describes recommended and optional tests, and in general places the focus on the impact (bother) of lower urinary tract symptoms on the individual patient when determining investigation and treatment. The importance of symptom assessment, impact on quality of life, physical examination and urinalysis is emphasized. The frequency volume chart is recommended when nocturia is a bothersome symptom to exclude nocturnal polyuria. The recommendations are summarized in 2 algorithms, 1 for basic management and 1 for specialized management of persistent bothersome lower urinary tract symptoms. CONCLUSIONS: The use of urodynamics and transrectal ultrasound should be limited to situations in which the results are likely to benefit the patient such as in selection for surgery. It is emphasized that imaging and endoscopy of the urinary tract have specific indications such as dipstick hematuria. Treatment should be holistic, and may include conservative measures, lifestyle interventions and behavioral modifications as well as medication and surgery. Only treatments with a strong evidence base for their clinical effectiveness should be used.

Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness.

OBJECTIVE: To evaluate the clinical effectiveness of manual physiotherapy and/or exercise physiotherapy in addition to usual care for patients with osteoarthritis (OA) of the hip or knee. DESIGN: In this 2 × 2 factorial randomized controlled trial, 206 adults (mean age 66 years) who met the American College of Rheumatology criteria for hip or knee OA were randomly allocated to receive manual physiotherapy (n = 54), multi-modal exercise physiotherapy (n = 51), combined exercise and manual physiotherapy (n = 50), or no trial physiotherapy (n = 51). The primary outcome was change in the Western Ontario and McMaster osteoarthritis index (WOMAC) after 1 year. Secondary outcomes included physical performance tests. Outcome assessors were blinded to group allocation. RESULTS: Of 206 participants recruited, 193 (93.2%) were retained at follow-up. Mean (SD) baseline WOMAC score was 100.8 (53.8) on a scale of 0-240. Intention to treat analysis showed adjusted reductions in WOMAC scores at 1 year compared with the usual care group of 28.5 (95% confidence interval (CI) 9.2-47.8) for usual care plus manual therapy, 16.4 (-3.2 to 35.9) for usual care plus exercise therapy, and 14.5 (-5.2 to 34.1) for usual care plus combined exercise therapy and manual therapy. There was an antagonistic interaction between exercise therapy and manual therapy (P = 0.027). Physical performance test outcomes favoured the exercise therapy group. CONCLUSIONS: Manual physiotherapy provided benefits over usual care, that were sustained to 1 year. Exercise physiotherapy also provided physical performance benefits over usual care. There was no added benefit from a combination of the two therapies. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry ACTRN12608000130369.

Erectile dysfunction and lower urinary tract symptoms: a consensus on the importance of co-diagnosis.

Despite differences in design, many large epidemiological studies using well-powered multivariate analyses consistently provide overwhelming evidence of a link between erectile dysfunction (ED) and lower urinary tract symptoms (LUTS). Preclinical evidence suggests that several common pathophysiological mechanisms are involved in the development of both ED and LUTS. We recommend that patients seeking consultation for one condition should always be screened for the other condition. We propose that co-diagnosis would ensure that patient management accounts for all possible co-morbid and associated conditions. Medical, socio-demographic and lifestyle risk factors can help to inform diagnoses and should be taken into consideration during the initial consultation. Awareness of risk factors may alert physicians to patients at risk of ED or LUTS and so allow them to manage patients accordingly; early diagnosis of ED in patients with LUTS, for example, could help reduce the risk of subsequent cardiovascular disease. Prescribing physicians should be aware of the sexual adverse effects of many treatments currently recommended for LUTS; sexual function should be evaluated prior to commencement of treatment, and monitored throughout treatment to ensure that the choice of drug is appropriate.

The Semon Lectures and the foundation of modern ENT.

BACKGROUND: Sir Felix Semon established the Semon Lecture series in 1913 to advance the specialty of laryngology. The annual lectures continue to the present day (there have been 95 to date). OBJECTIVE: This review illustrates how instrumental these lectures have been in shaping otolaryngology. METHOD: The period 1913-1970 preceded subspecialisation, and so forms the background of laryngology (as well as rhinology and otology) as we know it today. This era forms the focus of the article. RESULTS: Changes came about by a standardisation of practices and research, and in the treatment of conditions. The initial period was crucial. CONCLUSION: Many lectures highlight the specialty's growth. Now, another vital resource, a dedicated website (semonlectures.org), has made this information more accessible to the wider public.