Search

Purpose: To study the effects of benign prostatic hyperplasia treatments, namely: alpha-adrenergic receptor blockers, 5-alpha-reductase inhibitors and phosphodiesterase-5 inhibitors on the risk of Parkinson's disease, Alzheimer's disease and mortality., Materials and Methods: All male Medicare enrollees aged 65 or above who were diagnosed with benign prostatic hyperplasia and received one of the study drugs between 2007-2020 were followed-up for the three outcomes. We used Cox regression analysis to assess the relative risk of each of the outcomes for each study drug compared to the most prescribed drug, tamsulosin, while controlling for demographic, socioeconomic and comorbidity factors., Results and Conclusions: The study analyzed 1.1 million patients for a mean follow-up period of 3.1 years from being prescribed one of the study drugs. For all outcomes, patients on tamsulosin were used as the reference for comparison. For mortality, alfuzosin was associated with 27% risk reduction (HR 0.73, 95%CI 0.68-0.78), and doxazosin with 6% risk reduction (HR 0.94, 95%CI 0.91-0.97). For Parkinson's disease, terazosin was associated with 26% risk reduction (HR 0.74, 95%CI 0.66-0.83), and doxazosin with 21% risk reduction (HR 0.79, 95%CI 0.72-0.88). For Alzheimer's disease, terazosin was associated with 27% risk reduction (HR 0.73, 95%CI 0.65-0.82), and doxazosin with 16% risk reduction (HR 0.84, 95%CI 0.76-0.92). Tadalafil was associated with risk reduction (27-40%) in all 3 outcomes. More research is needed to elucidate the underlying mechanisms of these observations. Given the availability of safer alternatives for treating benign prostatic hyperplasia, caution should be exercised when using tamsulosin in elderly patients, especially those with an increased risk of developing neurodegenerative diseases., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Recent studies suggest that 5α-reductase inhibitors (5ARIs) for benign prostate hyperplasia (BPH) result in abnormal retinal anatomical alteration., Objective: To compare age-related macular degeneration (AMD) incidence in BPH patients receiving 5ARIs or tamsulosin., Design: Retrospective, population-based cohort study using new-user and active-comparator design., Setting: General population., Subjects: Males with BPH, newly receiving 5ARIs or tamsulosin from 2010 to 2018., Methods: Data were extracted from Taiwan's National Health Insurance Research Database. We used Cox proportional hazards model with 1:4 propensity score (PS) matching, based on intention-to-treat analysis to determine the risk of incident AMD. Sensitivity analyses included an as-treated approach and weighting-based PS methods. We also separately reported the risks of incident AMD in patients receiving finasteride and dutasteride to determine risk differences among different 5ARIs., Results: We included 13 586 5ARIs users (mean age: 69 years) and 54 344 tamsulosin users (mean age: 68.37 years). After a mean follow-up of 3.7 years, no differences were observed in the risk of incident AMD between 5ARIs and tamsulosin users [hazard ratio (HR): 1.06; 95% confidence intervals (95% CI): 0.98-1.15], with similar results from sensitivity analyses. However, increased risk of incident age-related macular degeneration was observed in patients receiving dutasteride [HR: 1.13; 95% CI: 1.02-1.25], but not in those receiving finasteride [HR: 0.99; 95% CI: 0.87-1.12], in the subgroup analyses., Conclusions: We found no difference between 5ARIs and tamsulosin regarding the incidence of AMD in BPH patients. However, the risk profiles for AMD differed slightly between dutasteride and finasteride, suggesting that the potency of androgen inhibition is a factor related to AMD incidence., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: An association between adrenergic alpha-1 receptor antagonists and delirium has been suggested, but the details are unclear., Aim: This study investigated the association between adrenergic alpha-1 receptor antagonists and delirium in patients with benign prostatic hyperplasia using the Japanese Adverse Drug Event Report database., Method: First, disproportionality analysis compared the frequency of delirium in the adrenergic alpha-1 receptor antagonists silodosin, tamsulosin, and naftopidil. Next, multivariate logistic analysis was performed to examine the association between delirium and adrenergic alpha-1 receptor antagonists where disproportionality was detected., Results: A disproportionality in delirium was observed in patients receiving tamsulosin (reporting odds ratio [ROR] 1.85, 95% confidence interval [CI] 1.38-2.44, P < 0.01) compared with those who did not, and also in patients receiving naftopidil (ROR 2.23, 95% CI 1.45-3.28, P < 0.01) compared with those who did not. Multivariate logistic analysis revealed that in addition to previously reported risk factors for delirium, delirium in patients receiving tamsulosin was significantly increased with concomitant use of anticholinergics (odds ratio 2.73, 95% CI 1.41-5.29, P < 0.01) and delirium in patients receiving naftopidil was significantly increased with concomitant use of beta3-adrenergic receptor agonists (odds ratio 4.19, 95% CI 1.66-10.6, P < 0.01)., Conclusion: Anticholinergics or beta3-adrenergic receptor agonists to treat overactive bladder in patients receiving tamsulosin and naftopidil was strongly associated with delirium. Confirming the medical history and concomitant medications of patients receiving tamsulosin or naftopidil may contribute to preventing delirium in patients with benign prostatic hyperplasia and to improving their outcomes., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Benign prostatic hyperplasia is one of the most common diseases in men, with a prevalence rate of 50% in their 50s to 80% in their 80s, and is mostly treated with chronic drug therapy. The aim of this study was to analyze adverse drug reactions (ADR) to drugs used in benign prostate hyperplasia (BPH) treatment reported to HALMED from 2008 to 2021. Data on ADR reports in Croatia were obtained from the VigiFlow national database and on the use of drugs for BPH in Croatia from Drug Utilization Reports from HALMED. In the observed period, the number of reports on each BPH drug, total number of reports, seriousness of reported ADR, patient age and sex, type of reporter, and most reported ADRs were analyzed. Results showed that 438 ADR reports were received, of which 45.95% on tamsulosin as the most frequently used drug for BPH. Of all reports, 84% were non-serious, 96% were reported in men and 82% in patients older than 45 years. The most frequently reported ADRs were consistent with the known safety profile of BPH drugs. Pharmacists were the most common (47%) reporters of ADRs for BPH drugs, while 33% were reported by physicians. Analysis of the reported ADRs showed that most frequently reported ones were in line with the known safety profile of BPH drugs. However, given the prevalence of the disease and the extent of the use of BPH drugs, it could be argued that the number of reports could be higher (i.e., 34 reports/year). Reporting on ADRs is necessary to better understand the safety profile of drugs in the post-authorization period, and more information on the safe use of medicines could be collected by raising awareness of healthcare professionals., (Sestre Milosrdnice University Hospital.)

Tamsulosin and dutasteride are drugs widely used to treat benign prostatic hypertrophy. having a good safety profile. There are few reports of liver injury associated with the use of tamsulosin; however, there are no reports of hepatic toxicity from the use of dutasteride and the combined use of tamsulosin/dutasteride. We present the case of a 64-year-old man who developed liver injury after the combined use of tamsulosin/dutasteride, developing a pattern of hepatocellular damage and acute hepatitis symptoms. Viral, autoimmune, and metabolic storage diseases of the liver were ruled out, as well as biliary pathology by means of abdominal ultrasound and resonance cholangiography. In the causality evaluation, CIOMS-RUCAM presented: 6 points (probable) and Naranjo: 4 points (possible). The patient presented a clinical and laboratory response after discontinuing the drug.

Purpose: Tamsulosin has been associated with dementia, but the results have been inconsistent. Concerns have been raised about using exposure assessment time too close to the outcome. We investigated the association between use of α1-adrenoceptor antagonists indicated for benign prostate hyperplasia and risk of Alzheimer's disease (AD) using different exposure windows., Methods: The study (24 602 cases and 98 397 matched controls) included men from the Finnish nationwide nested case-control study on Medication and Alzheimer's disease (MEDALZ). Cases received clinically verified AD diagnosis during 2005-2011 and were community-dwelling at the time of diagnosis. Use of tamsulosin and alfuzosin in 1995-2011 was identified from the Prescription Register and categorized based on whether it had occurred within 3 years before AD diagnosis (lag time) or before that. Dose-response analysis using defined daily doses of drug (DDDs) was conducted. Associations were investigated with conditional logistic regression, adjusted for confounders and mediators., Results: The use of α1-adrenoceptor antagonists before lag time associated with an increased risk of AD (OR 1.24 [1.20-1.27]). After adjustment for comorbidities and concomitant drug use throughout the assessment time (confounders) and healthcare contacts within the lag period (mediators), the association weakened (aOR 1.10 [1.06-1.14]). We found no evidence of dose-response-relationship when comparing the users of higher than median DDDs to the users of lower than median DDDs., Conclusion: Our findings, especially the lack of dose-response-relationship and attenuation after mediator adjustment, do not provide strong support for the previous hypothesis on α1-adrenoceptor antagonists as a risk factor for dementia., (© 2022 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)

Objective To evaluate the literature related to the use of alpha1-blockers and the risk of intraoperative floppy iris syndrome (IFIS), particularly in cataract surgery. IFIS is characterized by floppiness or billowing of the iris, iris prolapse, and progressive miosis, possibly leading to severe complications. It is thought to be associated with adrenergic alpha-1 receptor antagonists commonly used to treat lower urinary tract symptoms in patients with benign prostatic hyperplasia. Data Sources A literature search was conducted in Pubmed, EMBASE, and Web of Science through May 2021 with MeSH terms and keywords 'intraoperative floppy iris syndrome,' ' adrenergic alpha-1 receptor antagonists,' and 'cataract surgery.' Study Selection and Data Extraction Relevant articles were reviewed and included. In addition, reference lists from identified publications were reviewed to identify additional reports and studies of interest. Data Synthesis Numerous reports have linked IFIS to multiple risk factors including age, gender, hypertension, and the use of adrenergic alpha-1 receptor antagonists, most notably tamsulosin. Tamsulosin selectively blocks the adrenergic alpha-1 receptor in the iris dilator muscle, preventing mydriasis during cataract surgery. Other adrenergic alpha-1 receptor antagonists, including terazosin, doxazosin, alfuzosin, and sildosin, have also been linked to IFIS; however, their relationship to IFIS is not as well defined. Conclusion Patients should be educated regarding potential adverse effects and discuss this with their health care providers prior to cataract surgery. In addition, health care providers should be aware of the adverse effect and take steps to reduce the risk of surgical complications.

Background: Tamsulosin is one of the most commonly prescribed alpha-1A antagonists for the treatment of benign prostatic syndrome (BPS). Patients treated with tamsulosin often develop intraoperative floppy iris syndrome (IFIS) during cataract surgery. This leads to increasing miosis and an undulating iris, which increases the risk of complications significantly and can cause permanent damage., Aim of the Work: The aim is to raise awareness for the effects of tamsulosin intake before cataract surgery., Material and Methods: We conducted a critical review of publications on the association of IFIS in cataract surgery with alpha-receptor blockers., Results and Discussion: Tamsulosin has a risk of complications of up to 80 %, whereas doxazosin and alfuzosin only have a 15-20 % chance of complications. Tamsulosin therefore represents a significant risk factor for permanent secondary damage after cataract surgery. Even after discontinuing tamsulosin, IFIS was still observed after up to 3 years. Nevertheless, pausing of tamsulosin intake is recommended. An alternative preparation should therefore be preferred in patients who have not yet had cataract surgery. If patients are already pseudophakic, tamsulosin can be given without concern., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Tamsulosin hydrochloride, a selective alpha-adrenergic blocking agent has been previously associated with priapism. Priapism is a medically serious condition that, if not intervened, can cause permanent erectile dysfunction. This study was conducted to investigate whether the association of tamsulosin and priapism is causal. All currently available evidence such as experimental, biological, toxicological, published studies, and safety data mined from the WHO global pharmacovigilance database was systematically organized into the Austin Bradford Hill causality assessment framework. In the international pharmacovigilance database, a strong association between tamsulosin and priapism (IC 025  = 4.1; PRR 025  = 19.9; ROR 025  = 20) was observed. There were 122 cases of priapism associated with tamsulosin submitted to the database from 23 countries. In 87.7% of the cases, tamsulosin was reported as a 'sole suspect,' and in 50.8%, it was the only drug administered. In several patients, priapism resolved following discontinuation of tamsulosin and recurred after its reintroduction. Both in the published and unpublished data, for majority of the cases, the time to onset of priapism was within few days following the first intake of tamsulosin. Cases of priapism, particularly those published, were consistent in their clinical features with patients experiencing prolonged painful erection that required aspiration of cavernosal blood, irrigation of the corpora cavernosa, and treatment with vasopressors. Other alpha-adrenergic blocking agents that are structurally analogous with tamsulosin have also been associated with priapism. In several cases, tamsulosin was used off-label, for the treatment of ureteral calculi expulsion. Eight patients experienced priapism that ended up with serious complications such as ejaculation disorders and erectile dysfunction. The currently available totality of evidence suggests that the association of tamsulosin and priapism is causal. Healthcare professionals are therefore recommended to cautiously prescribe tamsulosin and ensure that consumers are aware of the potential risk of priapism., (© 2022 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.)

Objective: To assess the use and safety of free combination therapy (dutasteride and tamsulosin), dutasteride monotherapy, or tamsulosin monotherapy in patients with benign prostatic hyperplasia (BPH)., Methods: This non-interventional retrospective cohort study used claims data from the Korea Health Insurance Review and Assessment-National Patient Sample database. Patients with BPH ≥ 40 years of age receiving combination therapy (dutasteride 0.5 mg and tamsulosin 0.4 mg daily) or dutasteride 0.5 mg, or tamsulosin 0.4 mg daily dose between 2012 and 2017 were included. The frequency, duration of treatment and risk of any adverse event (AE) or serious AE (SAE) was compared for combination therapy versus each monotherapy using non-inferiority testing., Results: Of 14,755 eligible patients, 1529 (10.4%) received combination therapy, 6660 (45.1%) dutasteride monotherapy, and 6566 (44.5%) tamsulosin monotherapy. The proportion of patients treated with combination therapy exceeded the pre-specified 3% threshold for 'frequent' use. Safety results indicated a similar risk of any AE and SAE irrespective of treatment group. The adjusted relative risk for any AE over the treatment observation period comparing combination therapy with dutasteride monotherapy was 1.07 (95% confidence interval [CI] 1.03, 1.12), and with tamsulosin monotherapy was 0.98 (95% CI 0.95, 1.02) demonstrating non-inferiority. The adjusted relative risk for any SAE was 1.07 (95% CI 0.66, 1.74) and 0.90 (95% CI 0.56, 1.45), compared with dutasteride and tamsulosin monotherapy, respectively. Although the SAE results did not statistically demonstrate non-inferiority of combination therapy based on pre-specified margins, the 95% CI for the risk ratio estimates included the null with a lower limit below the non-inferiority margins, indicating no meaningful differences in SAE risk between groups. Absolute SAE risks were low., Conclusion: Combination therapy with dutasteride and tamsulosin is frequently used in real-world practice in South Korea for treatment of BPH and demonstrates a safety profile similar to either monotherapy., (© 2021. The Author(s).)

Background: Benign prostatic hyperplasia (BPH) is very common in aging men. We aimed to compare the effects of tamsulosin and pumpkin (Cucurbita pepo) seed oil on BPH symptoms., Methods: This single-blind randomized clinical trial included patients with BPH aged ≥ 50 years referred to the Urology Clinic of Shahid Beheshti Hospital, Hamadan, Iran, from August 23, 2019 to February 19, 2020. Patients were randomized into two groups. One group received 0.4 mg tamsulosin every night at bedtime and the other received 360 mg pumpkin seed oil twice a day. Patients' age, weight, height, and body mass index (BMI) were recorded. The International Prostate Symptom Score (IPSS) was filled out by the patients at baseline and then 1 month and 3 months after the initiation of treatment. The BPH-associated quality of life (QoL), serum prostate-specific antigen, prostate and postvoid residual volume, and maximum urine flow were also assessed at baseline and 3 months later. Drug side effects were also noted., Results: Of the 73 patients included in this study with a mean age of 63.59 ± 7.04 years, 34 were in the tamsulosin group and 39 in the pupkin seed oil group. Patients were comparable with respect to age, weight, height, BMI, and baseline principal variables in both groups. Also, there was no significant difference between groups in terms of principal variables at any time point. However, there was a significant decrease in IPSS and a significant improvement in QoL in both groups. Although the decrease in IPSS from baseline to 1 month and 3 months was significantly higher in the tamsulosin group compared to the pumpkin group (P = 0.048 and P = 0.020, respectively), the decrease in IPSS from 1 to 3 months was similar (P = 0.728). None of the patients in the pumpkin group experienced drug side effects, while dizziness (5.9%), headache (2.9%), retrograde ejaculation (2.9%), and erythema with pruritus occurred in the tamsulosin group., Conclusions: Pumpkin (Cucurbita pepo) seed oil relieved BPH symptoms with no side effects, but was not as effective as tamsulosin. Further studies are required to confirm the role of pumpkin seed oil as an option for the treatment of BPH symptoms. Trial registration Iranian Registry of Clinical Trials, IRCT20120215009014N340. Registered 19.02.2020. Retrospectively registered, https://en.irct.ir/trial/45335 ., (© 2021. The Author(s).)

Background: Alpha1-adrenoceptor antagonists (α1-blockers) are first-line drugs for the treatment of lower urinary tract symptoms associated with benign prostate hyperplasia (BPH). Doxazosin gastrointestinal therapeutic system (GITS) and tamsulosin belong to the 2 most frequently prescribed α1-blockers. This systematic review and meta-analysis was performed to compare the efficacy and tolerability of these 2 α1-blockers., Methods: A systematic review of published randomized controlled trials in English or Chinese language was performed using the PubMed, EMBASE, Cochrane Library, CNKI, Wanfang, and Vip databases. After data extraction and quality assessment, the meta-analysis was performed to compare clinical parameters (International Prostate Symptom Score [IPSS] total [IPSS-T], storage [IPSS-S], voiding [IPSS-V], maximum urine flow [Qmax], and postvoid residual) and adverse events (AEs) that changed after first drug intake., Results: After the screening, 8 eligible randomized controlled trials with 1316 patients were identified. Doxazosin-GITS showed a significantly higher efficacy compared with tamsulosin (IPSS-T P < .001, IPSS-S P < .001, and IPSS-V P < .001). There were no significant differences between the 2 drugs for changes in Qmax (P = .477) or postvoid residual (P = .739). The overall AEs were significantly lower in the doxazosin-GITS group (risk ratio: 0.77; 95% CI: 0.54-1.08; P = .036). However, dizziness (P = .387), headache (P = .745), asthenia (P = .693), postural hypotension (P = .114), and retrograde ejaculation (P = .187) were similar between the 2 groups., Conclusions: This meta-analysis indicates that doxazosin-GITS has significantly higher efficacy and lower AEs than tamsulosin in patients with lower urinary tract symptoms/benign prostate hyperplasia., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: The purpose of this study was to evaluate the efficacy of tamsulosin, administered preoperatively, for the prevention of postoperative urinary retention (POUR). POUR is a common complication of abdominal surgery, leading to the use of urinary catheters, which are a risk factor for urinary tract infection. Tamsulosin is a uroselective alpha-1a blocker used for the treatment of lower urinary tract symptoms., Materials and Methods: A randomized, double-blind, placebo-controlled trial was undertaken from August 2015 to May 2018. Adults undergoing elective inpatient abdominal surgery were randomized to receive either tamsulosin 0.4 mg or placebo daily for 7 d before surgery and continuing for up to 7 d postoperatively. The primary outcome was need for at least a single intermittent catheterization postoperatively. Secondary outcomes included first postvoid residual volume, number of catheterizations, need for replacement of an indwelling catheter, hospital length of stay, and urinary tract infection within 30 d of surgery., Results: A total of 158 participants were enrolled, with a final analytic cohort of 141 participants. The two groups had similar baseline characteristics, operative characteristics, and timing of catheter removal. There was no difference in the incidence of POUR between the two groups (26% in tamsulosin versus 31% in placebo, P = 0.49). There was also no difference in any of the secondary outcomes between the two groups. Epidural usage, open surgery, and age <50 were identified as risk factors for POUR., Conclusions: Perioperative prophylaxis with tamsulosin is not effective in reducing the incidence of POUR in patients undergoing elective abdominal surgery., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Tamsulosin is an antagonist of a subtype-specific alpha-1A- and alpha-1D-adrenoceptor (AR) that is expressed in the prostate gland, urethra, and bladder. Several reports have shown a possible relationship between ophthalmologic adverse effects and the use of alpha-1-receptor medicines, including tamsulosin. This descriptive review evaluates the intraoperative floppy iris syndrome (IFIS) associated with tamsulosin. A search of the Medline and PubMed databases was conducted to identify control trials, case reports, and observational examinations published in English. The publication dates were restricted (January 1, 2000, to January 1, 2020). Keywords (tamsulosin, alpha-blocker, ocular, eye, adverse reaction, and IFIS) were used in the searches. The searches identified 66 studies including in vitro or in vivo studies, trials, and observational studies. Twenty-two (33.33%) studies were articles citing tamsulosin and IFIS as having confirmed potential risk to ocular safety. The results of this review, including a comprehensive summary of published research on tamsulosin use in different populations, have identified several articles showing associations between tamsulosin and IFIS that merit further investigation. Suspending of potential causative pharmacological treatment of IFIS before ocular surgery including tamsulosin, proper identification of at-risk patients, preoperative prophylaxis treatments, and surgical technique modifications clearly can mitigate the anticipated risk of IFIS induced by tamsulosin., Competing Interests: There are no conflicts of interest., (Copyright: © 2021 Middle East African Journal of Ophthalmology.)

Aim: To verify if the efficacy of the triple therapy with tamsulosin, dutasteride, and imidafenacin (TDI) is influenced by any background characteristics in patients with overactive bladder (OAB)., Methods: A subanalysis of data from the DIrecT study was conducted. Superiority of TDI over tamsulosin and dutasteride in terms of efficacy based on the Overactive Bladder Symptom Score (OABSS), total International Prostate Symptom Score (IPSS), IPSS quality of life index, and postvoid residual (PVR) was evaluated in binary subgroups., Results: In the treatment groups, there was a significant interaction of total OABSS with testosterone level (≥4.8 vs. <4.8 ng/mL, p = 0.043) and PVR (≥20 vs. <20 mL, p = 0.018). For the total IPSS, no significant interaction was found except for the IPSS QOL index. For the IPSS QOL index, a significant interaction was found with testosterone level (≥4.8 vs. <4.8 ng/mL, p < 0.0001) as well as with total IPSS and total OABSS. For the PVR, no significant interaction was found except with total OABSS., Conclusions: Triple therapy with TDI is suggested to be a therapeutic option for benign prostatic hyperplasia in patients with residual OAB symptoms refractory to tamsulosin and in patients with various background characteristics regardless of severity of OAB symptoms. Trial Registry No. UMIN 000011980., (© 2021 S. Karger AG, Basel.)

Objectives: To investigate the cardiovascular safety of mirabegron add-on treatment to tamsulosin in male patients with residual overactive bladder symptoms., Methods: This was a post hoc analysis of MATCH, the first double-blind, placebo-controlled study comparing mirabegron and placebo as add-on therapy to tamsulosin for treatment of overactive bladder in men with lower urinary tract symptoms. The analysis focused on treatment-emergent adverse events relating to the cardiovascular system or blood pressure, and changes in vital signs during 12 weeks of follow-up., Results: Cardiovascular-related treatment-emergent adverse events were reported by 6/566 patients, although only one serious treatment-emergent adverse event was related to treatment (unstable angina in the tamsulosin + placebo group). Hypertension (two patients) and increased blood pressure (one patient) were reported in the tamsulosin + placebo group, but there were no blood pressure-related treatment-emergent adverse events among tamsulosin + mirabegron patients. There were no clinically meaningful changes from baseline in blood pressure, and changes in pulse rate were small (+1.2 bpm in the tamsulosin + mirabegron group). Increased pulse rate was more frequent with tamsulosin + mirabegron than with tamsulosin + placebo in older patients, although within the normal range., Conclusions: Cardiovascular-related adverse events were uncommon in both treatment groups. Mirabegron is a well-tolerated add-on therapy to tamsulosin in Japanese and Korean males with residual overactive bladder symptoms., (© 2020 Astellas Pharma Inc. LUTS: Lower Urinary Tract Symptoms published by John Wiley & Sons Australia, Ltd.)

Purpose: Use of medical expulsive therapy (MET) is common practice in urology for the treatment of symptomatic urolithiasis, despite this its efficacy is debated. Its use in pregnancy is controversial. Our objective was to evaluate the safety and efficacy of Tamsulosin as a MET in pregnant women., Material and Methods: We retrospectively identified pregnant patients who presented with renal colic at the CHU de Québec from 2000 to 2015. We compared patients who received Tamsulosin as MET to a control group without MET. We evaluated efficacy as passage rate of lithiasis and necessity of intervention. We evaluated safety of the treatment according to fetal outcomes (birth weight, APGAR, gestational age)., Results: We evaluated 207 pregnant patients presenting renal colic, 69 patients in the MET group were compared to 138 patients in the control group. Of these, 48 (70%) in the Tamsulosin therapy group and 76 (56%) in the control group had proven urolithiasis. No significant difference was found for mean gestational age at birth, birth weight and APGAR. No sudden infant death syndrome was encountered in Tamsulosin group. There was no significant difference for length of hospital stay and need for surgical intervention. The spontaneous passage rate was 58% (25/48) in the MET group compared to 43% (29/76), but this difference was not statistically significant (p = 0.18)., Conclusions: Short-term utilisation of Tamsulosin as MET in second and third trimester of pregnancy is not associated with adverse maternal or infant outcomes. Moreover, there was no significant adjunct for the rate of stone passage.

Studies suggest that the use of alpha-blockers increases the risk of dementia in patients with benign prostate hyperplasia (BPH). Due to study limitations, the relationship between the use of alpha-blockers, such as tamsulosin, and the risk of dementia is still unclear. However, alpha1-adrenoreceptors are also present in the brain, so there is potential for adverse effects on cognitive function. Therefore, we investigated possible associations between the use of alpha-blockers and aggravation of cognitive decline in dementia patients using a clinical data analytic solution called the Smart Clinical Data Warehouse (CDW).We retrospectively investigated clinical data using the Smart CDW of Hallym University Medical Center from 2009 to 2019. We enrolled patients with probable Alzheimer disease (AD) who had completed the Mini-Mental State Examination (MMSE) at least twice during follow-up, and who had BPH. We compared the difference in MMSE scores between patients who took tamsulosin for >1000 days and those who did not take any alpha-blocker. We tested the effect of tamsulosin on cognitive decline in patients with AD, using propensity score-matched logistic regression analysis.Eligible cases were included in the tamsulosin (n = 68) or no-medication (n = 153) groups. After propensity score matching, clinical characteristics such as educational attainment and vascular risk factors were similar in the tamsulosin and no-medication groups. The MMSE scores did not differ significantly between the tamsulosin and no-medication groups (P = .470).The results suggest that tamsulosin for BPH is not associated with worsening of the cognitive decline in patients with AD.

Background: Fixed Drug Eruption (FDE) is a drug reaction involving the skin and less commonly the mucosal membranes. Tamsulosin is an alpha-1 adrenergic receptor blocker used to treat benign prostatic hyperplasia. Dizziness and headache are among its most common side effects (Singapore Med J, 2018;59:336). Although cutaneous drug eruption has been reported with other alpha-1 adrenergic receptor blockers., Aims: Drug rash due to Tamsulosin is relatively uncommon (Singapore Med J, 2018;59:336). In this case we report an incidence of fixed drug eruption due to Tamsulosin., Patients: A 54 year old male, with benign prostatic hyperplasia was referred to our office for evaluation of certain eruptions, having developed his hyper-pigmented patches after 2 weeks of using oral 0.4 mg Tamsulosin per day. Based on the clinical course and the skin biopsy we diagnosed the condition as Tamsulosin associated fixed drug eruption. The most important therapeutic measure was discontinuing Tamsulosin medication. Following this, his eruptions improved remarkably in a few days without complications., Results: According to previous findings, there has been no case report on fixed drug eruption caused by Tamsulosin., Conclusion: Our case is a relatively mild form of fixed drug eruption. Therefore it should be kept in mind that a severe cutaneous drug eruption might occur after Tamsulosin administration., (© 2019 Wiley Periodicals, Inc.)

Aim: To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia., Methods: This was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed-dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT-TAM FDC), or placebo. End-points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs., Results: The intent-to-treat population comprised 489 patients (DUT-TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT-TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT-TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT-TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6-10 points in the total MSHQ score were more likely to report SexAEs., Conclusion: Findings support the clinical utility of the MSHQ tool in assessing the impact of DUT-TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance., (© 2020 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.)

Drugs are serious but underestimated causative agents of interstitial lung disease (ILD). Both cytotoxic and immune mechanisms may be involved in drug-induced ILD (DI-ILD). We aimed to investigate whether polymorphisms of relevant CYP enzymes involved in the metabolization of tamsulosin might explain the pathologic mechanism of the DI-ILD in the cases with suspected tamsulosin DI-ILD. We collected 22 tamsulosin-associated DI-ILD cases at two ILD Expertise Centers in the Netherlands between 2009 and 2020. CYP2D6, CYP2C9, CYP2C19, CYP3A4, and CYP3A5 single nucleotide polymorphisms were genotyped and compared with a control group of 78 healthy Caucasian male volunteers. Nine cases were phenotyped as CYP2D6 poor metabolizers and 13 as CYP2D6 intermediate metabolizers. The phenotypes of the cases differed significantly from those of the healthy controls, with more poor metabolizers. After withdrawal of tamsulosin, the pulmonary condition of three cases had improved, six patients had stabilized, and one patient stabilized after reducing the tamsulosin dose. The described 22 cases suggest that an association between the presence of CYP2D6 allelic variants and tamsulosin-associated ILD is highly likely. These cases highlight the importance of both clinical and genetic risk stratification aimed to achieve a more accurate prevention of DI-ILD in the future and enhance the quality of life of patients.

Background: Drug therapy for lower urinary tract symptoms (LUTS) secondary to benign prostate hyperplasia (BPH) is a major and popular method. However, the therapeutic strategy is still not clear enough up to now. The purpose of this study was to compare the relative safety and efficacy of different types of phosphodiesterase type 5 inhibitors (PDE5-Is) with tamsulosin for the treatment of LUTS secondary to BPH., Methods: Databases including PubMed, OpenGrey, Embase, Cochrane Library, and Web of Science will be searched to identify qualified studies. We will use the Stata version 13.0 to conduct the network meta-analysis (NMA) with a random or fixed effects model of Bayesian framework. International prostate symptom score (IPSS), maximum urinary flow fate (Qmax) and their credible intervals (CI) will be used to compare every medical intervention with the efficacy and safety, including sildenafil plus tamsulosin, tadalafil plus tamsulosin, vardenafil plus tamsulosin. And the ranking of probability of different interventions will be estimated by comparing the surface under the cumulative ranking curve (SUCRA)., Results: A high quality-synthesis of the current evidence for comparing with different doses or types of PDE5-Is combined with tamsulosin to the treatment of LUTS secondary to BPH will be provided., Conclusions: This NMA and systematic review will generate evidence to help choose the best combination for treatment of LUTS secondary to BPH.PROSPERO registration number: PROSPERO CRD 42019139062.

Purpose: The primary aim of this study was to assess treatment persistence with a fixed-dose combination (FDC) of tadalafil (5 mg) and tamsulosin (0.4 mg). This study also evaluated the reasons for early treatment discontinuation., Materials and Methods: This retrospective observational study included patients with benign prostatic hyperplasia and erectile dysfunction who started an FDC treatment of tadalafil (5 mg) and tamsulosin (0.4 mg) between July 2017 and February 2018. Treatment persistence and reasons for early discontinuation were evaluated during the first 6 months. The cumulative discontinuation rate and differences in various parameters were assessed using Kaplan-Meier analysis and the log-rank test, respectively. Factors related to persistence were analyzed using a Cox proportional hazard model., Results: Overall, 97 patients were included in the study. The cumulative persistence rate at 30, 90, and 180 days was 88.7%, 66.0%, and 54.6%, respectively. The cumulative persistence over 6 months differed significantly according to the administration of FDC therapy (log-rank p=0.005) and age (log-rank p=0.024). Younger patients (odds ratio, 2.049; p=0.021) and treatment-naive patients (odds ratio, 2.461; p=0.006) were more likely to discontinue therapy within 6 months. The common reasons for discontinuing therapy were side effects (63.6%) and perceived poor efficacy (22.7%)., Conclusions: Side effects were reported to be the main reason for treatment discontinuation. Thus, to improve compliance for a once-daily FDC of tadalafil (5 mg) and tamsulosin (0.4 mg), it is recommended to select patients who show adaptation to a combination of α-blockers and phosphodiesterase type 5 inhibitors prior to FDC treatment., Competing Interests: CONFLICTS OF INTEREST: The authors have nothing to disclose., (© The Korean Urological Association, 2020.)

Numerous medications have been associated to the development of priapism as an adverse reaction, the most common are intracavernosal vasoactive agents, antipsychotics and antidepressants. Alpha blockers, in particular tamsulosin which is widely used in different urological conditions, has been associated to priapism in only few case reports. We present the case of a healthy 45-year-old man who medicated himself with two doses of 0.4 mg of tamsulosin due to a renal colic with spontaneous passage of a 3 mm stone. Eight hours after the second tamsulosin dose the patient developed a persistent painful erection not associated to sexual stimulation that lasted for 6 hours. He was admitted to the emergency room, and after history taking and physical evaluation the diagnosis of ischemic priapism was made. The patient denied consumption of any other medication or drug during the last month, blood tests in particular hemogram were normal and no recent history of pelvic trauma was reported. To achieve detumescence, five boluses of 200 mcg of phenylephrine were injected directly in the corpora cavernosa, no further procedures were needed. In the follow-up the patient had no new priapism episodes and he reported no problems with erections in sexual intercourse. Tamsulosin is one of most indicated medications in urological general practice; though priapism has been rarely associated to its consumption the risk of this side effect exists, suggesting that patients should be counselled about it.

Introduction : Muscarinic receptor antagonists, 5α-reductase inhibitors and α 1 -adrenoceptor antagonists are frequently used drug classes for the treatment of lower urinary tract symptoms including those of overactive bladder syndrome and benign prostatic enlargement/benign prostatic obstruction. Areas covered : The authors review the evidence for adverse effects of these drug classes on cognitive function, mood and other functions of the central nervous system and discuss such effects against the evidence for mechanistic plausibility. Expert opinion : Muscarinic antagonists carry a risk for impaired cognition and other brain functions that differs quantitatively between compounds, being highest with oral formulations of oxybutynin. 5□-Reductase inhibitors can cause depressive symptoms even at low doses and starting several months after discontinuation of treatment. The evidence for α 1 -adrenoceptor antagonists and specifically tamsulosin to cause dementia is controversial and lacks mechanistic plausibility. We recommend that physicians treating patients with lower urinary tract symptoms carefully monitor mental status prior to prescribing and periodically thereafter.

Purpose: A recent study demonstrated that tamsulosin increased the risk of dementia in patients with benign prostatic hyperplasia. However, this study had a number of limitations. We evaluated the association between α-blockers and dementia in patients with benign prostatic hyperplasia., Materials and Methods: From the National Health Insurance Service database we collected and analyzed data on α-blockers and dementia in the entire Korean adult population with benign prostatic hyperplasia between January 2011 and December 2011. These patients were followed until September 2017. We tested the effect of α-blockers on the risk of dementia using propensity score matched Cox proportional hazard regression models and Kaplan-Meier survival analysis., Results: During a mean ± SD followup of 1,580 ± 674.3 days all study inclusion and exclusion criteria were met by 59,263 patients with benign prostatic hyperplasia. In the unadjusted cohort the incidence of dementia in the tamsulosin, doxazosin, terazosin, alfuzosin and no medication cohorts were 17.97%, 18.55%, 20.64%, 17.62% and 22.60%, respectively. After propensity score matching the risk of dementia did not significantly differ in the tamsulosin cohort vs the doxazosin and alfuzosin cohorts (HR 1.038, 95% CI 0.960-1.121 and HR 1.008, 95% CI 0.925-1.098), respectively. Compared to the tamsulosin cohort the terazosin cohort had a higher risk of dementia (HR 1.112, 95% CI 1.052-1.196). However, the risk of dementia was significantly lower in the terazosin cohort than in the no medication cohort., Conclusions: The study findings indicate that benign prostatic hyperplasia medication is not associated with a risk of dementia by duration of use or by type.

Purpose: Tamsulosin, a medical expulsive therapy (MET), was always recommended for patients with distal ure-teral calculi less than 10 mm. The aim of the systematic review was to assess the efficacy and safety of tamsulosin in MET compared with placebo., Materials and Methods: A comprehensive search was conducted in the databases PubMed, EMBASE and Web of Science for relevant articles, covering all the literatures published until April 2018. All placebo controlled trails were identified in which patients were randomized to receive either tamsulosin or placebo for distal ureteral calculi., Results: A total of seven placebo controlled studies including 4135 patients met the inclusion criteria and were involved in the review. We found that tamsulosin was associated with a significantly higher expulsion rate (ESR) [odds ratio (OR) = 1.10, 95% confidence interval (CI) = 1.00-1.21] than placebo in patients with distal ureteral stones less than 7 mm. The ESR ranged from 67.0%-90.7%. But the significant difference was better seen in pa-tients with distal ureteral stones less than 10 mm (OR = 1.11, 95% CI = 1.01-1.21). Even though tamsulosin has a higher incidence of retrograde ejaculation than placebo, no significant difference was observed in the incidence of other adverse events., Conclusion: The results of the current meta-analysis indicated that tamsulosin was superior to placebo in its effi-cacy for distal ureteral stones though retrograde ejaculation was worse with tamsulosin use. It should be a safe and effective medical expulsive therapy choice for distal ureteral stones when stone sizes are less than 10 mm.

Objective: To evaluate efficiency and safety of adjunct tamsulosin and mirabegron therapy before semi-rigid ureteroscopy for ureteral stones., Materials and Methods: In this prospective, randomized, single-blind and multicentric study, participants were randomized into three groups. Group 1 was the control, participants in Group 2 used tamsulosin, and those in Group 3 used mirabegron. Operations were performed 7 days after drug administration. In all clinics, a 6/7.5-Fr ureteroscope with a laser power source for lithotripsy was used., Results: After excluding participants whose stones spontaneously passed, who discontinued medication due to adverse events and who were lost to follow-up, 186 participants were included in the final analysis. Mean age, gender, laterality, stone distribution and mean stone surface area were similar between groups. The number of participants requiring balloon dilatation was higher in the control group (23.8%) than in the tamsulosin (8.2%) and mirabegron (6.5%) groups (p = 0.006). Successful access rate was lower in the control group (81%) than in the tamsulosin (96.7%) and mirabegron (95.2%) groups (p = 0.003). Stone-free rate was lower in the control group (77.8%) than in the tamsulosin (90.2%) and mirabegron (95.2%) groups (p = 0.01). Complication rates were similar among groups., Conclusions: Tamsulosin or mirabegron use for 1 week before semi-rigid ureteroscope increases stone access and the stone-free rate. Tamsulosin or mirabegron can be used with safety and efficacy before ureteroscopy for ureteral stones.

Purpose: To evaluate modified anterior elongated corneal incisions as a simple technique to reduce the incidence and severity of intraoperative floppy iris syndrome (IFIS), in patients taking tamsulosin (a selective α 1a -adrenergic receptor antagonist)., Methods: This prospective case series was conducted at Meir Medical Center, a tertiary care facility in Israel. Included were 45 eyes of 39 male patients taking tamsulosin, and thus prone to IFIS. Patients underwent phacoemulsification cataract surgery with anterior elongated corneal incisions. The primary outcomes were the incidence and severity of IFIS, the complication rate and the need for additional IFIS management techniques. The secondary outcome was to quantify the surgically induced astigmatism, using Alpin's vector analysis. The tamsulosin treatment period and pupil diameter during five stages of the surgery were also noted., Results: The overall rate of IFIS was 33.33% (n = 15). The IFIS severity was rated as mild in 22.22% and moderate in 11.11% of the study eyes. No IFIS was noted in 66.67% of the eyes. There were no cases of severe IFIS, and no need for other IFIS management strategies. The complications rate was 2.22% (n = 1). Patients who developed IFIS had a significantly smaller pupil at the beginning of surgery (p < 0.05). There was no significant difference in tamsulosin treatment period between patients with and without IFIS (p = 0.19). The centroid - the mean SIA vector was 0.51 D @ 18° ±1.5 D (SD)., Conclusions: In tamsulosin treated patients, using modified corneal incisions may be feasible in order to reduce the incidence and severity of IFIS during cataract surgery. Future randomized studies are warranted.

Background: We performed a meta-analysis to confirm the efficacy and safety of the combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia (BPH) during a treatment cycle of at least 1 year., Methods: Randomized controlled trials were searched by using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses. The data was evaluated and statistically analyzed by using RevMan version 5.3.0., Results: Five studies including 4348 patients were studied. The analysis found that the combination group was significantly greater effect in international prostate symptom score (mean difference [MD], - 1.43; 95% confidence interval [CI], - 2.20 to - 0.66; P = 0.0003), prostate volume (MD, - 10.13; 95% CI, - 12.38 to - 7.88; P < 0.00001), transitional zone volume (MD, - 3.18; 95% CI, - 3.57 to - 2.79; P<0.0001), maximum urine flow rate (MD, 1.05; 95% CI, 0.82 to 1.29; P < 0.00001), prostate specific antigen (MD, - 0.54; 95% CI, - 0.80 to - 0.29; P < 0.0001) and post-void residual volume (MD, - 3.85; 95% CI, - 4.95 to - 2.76; P < 0.00001) compared with the tamsulosin group. In terms of safety, including adverse events (odds ratio [OR], 2.06; 95% CI, 1.34 to 3.17; P = 0.001), erectile dysfunction (OR, 2.24; 95% CI, 1.73 to 2.92; P < 0.00001), ejaculation disorder (OR, 3.37; 95% CI, 1.97 to 5.79; P < 0.0001), retrograde ejaculation (OR, 2.30; 95% CI, 1.08 to 4.93; P = 0.03), decreased libido (OR, 2.25; 95% CI, 1.53 to 3.31; P < 0.0001) and loss of libido (OR, 3.38; 95% CI, 1.94 to 5.88; P<0.0001), the combination group showed poor tolerance than the tamsulosin group with the exception of dizziness (OR, 1.16; 95% CI, 0.75 to 1.80; P = 0.50). The combination group significantly reduced the risk of clinical progression than the tamsulosin group especially in incidence of BPH-related symptom progression (OR, 0.56; 95% CI, 0.46 to 0.67; P < 0.00001) and acute urinary retention (OR, 0.61; 95% CI, 0.38 to 0.98; P = 0.04)., Conclusion: The combination of tamsulosin plus dutasteride provides a preferable therapeutic effect for BPH with a higher incidence of sexual side effects, but combination-therapy can markedly reduce risk of BPH-related symptom progression and acute urinary retention relative to tamsulosin monotherapy.

Purpose: To evaluate the incidence of and factors associated with intraoperative floppy iris syndrome (IFIS) in patients undergoing cataract phacoemulsification., Methods: In total, 319 eyes of 319 patients who underwent phacoemulsification with implantation of an intraocular lens (IOL) into the posterior chamber were included in this study. Direct injection of epinephrine into the anterior chamber was performed in all cases. The following patient information was collected: gender, age, axial length of the eye, presence of pseudoexfoliation syndrome, glaucoma, diabetes mellitus, hypertension, current use of medications including alpha1 adrenergic receptor antagonists (alpha1-ARAs), finasteride, and benzodiazepines, duration of intake of alpha1-ARAs and finasteride, and duration of the surgery. Patients were classified as IFIS or non-IFIS after the surgery. Univariate and multivariate logistic regression analyses were performed., Results: The overall incidence of IFIS was 9.09% (29/319 eyes). The multivariate analysis revealed that tamsulosin use (P = 0.004), finasteride use (P = 0.014), and increasing age (P = 0.006) were significantly associated with IFIS. Male gender and benzodiazepine use were significantly associated with IFIS in the univariate analysis, but not in the multivariate analysis. The non-selective alpha1-ARA doxazosin was not found to be associated with IFIS., Conclusions: The findings suggest that finasteride use and aging are risk factors for IFIS and confirm the association of tamsulosin use with IFIS. Further, doxazosin appears to be a relatively safe drug with respect to the occurrence of IFIS.

Background: Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life., Aims: The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and potential safety risks were evaluated in an open-label, uncontrolled, exploratory, 8-week OTC-simulated study., Methods: Men (≥ 18 years) were recruited via mass advertising about bothersome LUTS. In a working retail environment, respondents reviewed the product and decided whether it was appropriate for them to use (self-selection phase). After purchasing the product, participants' ability to use it as directed by the proposed drug facts label (DFL) was assessed (home-use phase)., Results: Of 1446 eligible men, 679 completed the self-selection phase, and 73.9% (502/679) self-selected to use tamsulosin correctly according to the DFL. Of 369 participants who purchased tamsulosin and entered the home-use phase, 321 took one or more doses of tamsulosin and participated in at least one telephone interview. In total, 85.4% (274/321) of participants adhered to the 'Stop Use' and 'Directions' instructions in the DFL. Overall, 139 (39.6%) participants experienced one or more adverse events (AEs); 65 (18.5%) were deemed drug-related, including dizziness (11 [3.1%]), ejaculation disorder (6 [1.7%]), and semen volume decrease (6 [1.7%]). No unexpected AEs were reported., Conclusions: Of the men interested in self-managing their LUTS, a majority had moderate-to-severe LUTS of long duration. Most men were able to appropriately self-select and use tamsulosin in concordance with DFL instructions and directions. No unexpected AEs were reported during self-directed use. With further label refinement, an over-the-counter tamsulosin option might be feasible., Trial Registration: ClinicalTrials.gov NCT01726270.

Objectives: To assess the safety and efficacy of bromelain plus tamsulosin versus tamsulosin alone as medical expulsive therapy (MET) for promoting spontaneous stone passage (SSP) of symptomatic distal ureter stones., Patients and Methods: One-hundred-fourteen patients with a 4-10 mm distal ureteral stone were enrolled (Group A). Patients self-administered daily bromelain with tamsulosin for 30 days or until SSP or intervention was mandatory. Patients were compared to those from a control group taking tamsulosin as MET (Group B) and matched for the following factors: sex, age ±10%, stone diameter. A logistic regression model evaluated bromelain and the ureteral stone diameter as explanatory variables., Results: SSP rates were 87.7 vs. 75.4% for group A vs. group B respectively (p = 0.016); with no difference observed for the time to self-reported stone expulsion (11.68 vs. 11.57 days; p = 0.91). Considering larger stones (> 5 mm), the SSP rate was 83.3% in group A and 61% in group B (p < 0.01). With each millimeter increment of stone diameter, the probability of SSP decreased by 59.1% (p < 0.0001), while it increased of 3.3 when bromelain was present. Only 3 cases of tamsulosin-related adverse events were recorded., Conclusion: The association of bromelain and tamsulosin as MET increases the probability of SSP of symptomatic distal ureteral stones, with no bromelain-related side effects recorded., (© 2018 S. Karger AG, Basel.)

Introduction: Alpha-adrenergic blockers are now the cornerstone medication in management of lower urinary tract symptom (LUTS); however, the associated treatment-related abnormal ejaculation could be a bothersome event. This is a comparative study among different methods of tamsulosin administration in terms of efficacy, recoverability of ejaculatory function, and quality of life (QoL) in men with tamsulosin-related abnormal ejaculation., Patients and Methods: Sexually active men receiving tamsulosin for LUTS who were bothered by treatment-related abnormal ejaculation following initiation of tamsulosin were randomized into 3 groups; group A received intermittent-full-standard-dose, group B received low-dose-tamsulosin, and group C received full-standard-dose tamsulosin The status of ejaculatory function, IPSS, QoL score, and Q-Max were measured at baseline and 3 months later., Results: A total of 93 men with mean age of 53.1 years were included in the study, 3-months after randomization, statistically significant improvements in IPSS, QoL index, and Q-Max in comparison to pre-treatment levels were noted. Restoration of normal ejaculation was reported by 74.1 and 90.3% of patients in group A and B, respectively, versus none in group C. The QoL score was significant when comparing group A to the other groups; finally, the Q-Max was significant when comparing group C to the other groups., Conclusion: For patients bothered by tamsulosin-related abnormal ejaculation, a significant improvement in the QoL, without deviation from the therapeutic purpose of treatment, can be achieved by administration of 0.4 mg tamsulosin every other day., (© 2019 S. Karger AG, Basel.)

A recent study of the relationship between tamsulosin and dementia found that, in propensity score-matched analyses that adjusted for measured risk factors for dementia, the use of tamsulosin to treat benign prostatic hyperplasia (BPH) was associated with a small but significant increase in the risk of incident dementia relative to untreated BPH, BPH treated with the 5α-reductase inhibitors dutasteride and finasteride, and BPH treated with the α adrenoceptor blockers doxazosin, terazosin, and alfuzosin. The choice of control groups addressed confounding by indication, confounding by disease severity, and confounding by pharmacologic drug class. The authors of the study provided a wealth of detail in their main paper and in supplementary materials, allowing an almost forensic examination of the findings. This article discusses the study from the perspective of whether the hypothesis relating tamsulosin to dementia was set a priori or emerged after an exploratory exercise; whether tamsulosin crosses the blood-brain barrier for dementia as the event of interest to be attributable to treatment; whether the action of tamsulosin is plausibly related to dementia as a possible outcome; whether confounding was adequately addressed in the analyses; whether the duration of follow-up was sufficient for the event of interest to be attributable to tamsulosin; whether the absolute increase in the rate of incident dementia was clinically significant; and what the curiosities in the dose-dependence and subgroup analysis findings could imply. These matters provide considerable food for thought. Thus, this article is intended to serve as an example of how to read a paper critically and how to think about what the findings might suggest., (© Copyright 2018 Physicians Postgraduate Press, Inc.)

Objectives: To assess the effectiveness and safety of dutasteride 0.5 mg + tamsulosin 0.2 mg combination compared with tamsulosin 0.2 mg in Asian men with moderate-to-severe benign prostatic hyperplasia., Methods: A 4-week, single-blind, placebo, run-in was followed by a 2-year double-blind randomized controlled trial in men age ≥50 years with symptomatic benign prostatic hyperplasia, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate-specific antigen ≥1.5 and ≤10 ng/mL, peak urinary flow >5 and ≤15 mL/s, and voided volume of ≥125 mL. Participants were randomized to oral daily dutasteride 0.5 mg + tamsulosin 0.2 mg combination or tamsulosin 0.2 mg. The primary efficacy end-point was change in International Prostate Symptom Score at year 2., Results: Data from 607 participants showed a significant reduction in International Prostate Symptom Score (P < 0.05) at month 24, along with greater improvements (P ≤ 0.006) in peak urinary flow at every assessment and significant prostate volume reduction at months 12 and 24 (P < 0.001) in the combination group. Combination therapy was associated with a significant reduction in the risk of acute urinary retention or benign prostatic hyperplasia-related surgery (P = 0.012), primarily due to a significant reduction in the risk of acute urinary retention (P = 0.005). The safety and tolerability profile of combination therapy was consistent with the known profiles for the individual monotherapies., Conclusions: Dutasteride 0.5 mg + tamsulosin 0.2 mg combination therapy showed better clinical outcomes than tamsulosin 0.2 mg monotherapy, making it an effective and safe treatment option for Asian men with moderate-to-severe benign prostatic hyperplasia., (© 2018 The Japanese Urological Association.)

Background: Benign prostatic hyperplasia (BPH) is a common condition in ageing men that may cause lower urinary tract symptoms (LUTS). Treatment aims are to relieve symptoms and prevent disease-related complications. Naftopidil is an alpha-blocker (AB) that has a high affinity for the A1d receptor that may have advantages in treating LUTS in this setting. This is an update of a Cochrane Review first published in 2009. Since that time, several large randomised controlled trials (RCTs) have been reported, making this update relevant., Objectives: To evaluate the effects of naftopidil for the treatment of LUTS associated with BPH., Search Methods: We performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, LILAC, and Web of Science), trials registries, other sources of grey literature, and conference proceedings with no restrictions on the language of publication or publication status up to 31 May 2018 SELECTION CRITERIA: We included all parallel RCTs. We also included cross-over design trials., Data Collection and Analysis: Two review authors independently classified and abstracted data from the included studies. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. Primary outcomes were urological symptom scores, quality of life (QoL) and treatment withdrawals for any reason; secondary outcomes were treatment withdrawals due to adverse events, acute urinary retention, surgical intervention for BPH, and cardiovascular and sexual adverse events. We considered outcomes measured up to 12 months after randomisation as short term, and later than 12 months as long term. We rated the certainty of the evidence according to the GRADE approach., Main Results: We included 22 RCTs with 2223 randomised participants across four comparisons for short-term follow-up. This abstract focuses on only two of four comparisons for which we found data since two comparators (i.e. propiverine and Eviprostat (phytotherapy)) are rarely used. One study comparing naftopidil to placebo did not report any relevant outcomes and was therefore excluded. There were no trials that compared to combination therapy with naftopidil or any 5-alpha reductase inhibitors (5-ARIs) to combination therapy with other ABs and any 5-ARIs.All included studies were conducted in Asian countries. Study duration ranged from four to 12 weeks. Mean age was 67.8 years, prostate volume was 35.4 mL, and International Prostate Symptom Score was 18.3. We were unable to perform any of the preplanned subgroup analyses based on age and baseline symptom score.Naftopidil versus tamsulosinBased on 12 studies with 965 randomised participants, naftopidil may have resulted in little or no difference in urological symptom score (mean difference (MD) 0.47, 95% confidence interval (CI) -0.09 to 1.04 measured on a scale from 0 to 35 with higher score representing increased symptoms), QoL (MD 0.11, 95% CI -0.09 to 0.30; measured on a scale from 0 to 6 with higher scores representing worse QoL), and treatment withdrawals for any reason (risk ratio (RR) 0.92, 95% CI 0.64 to 1.34; corresponding to 7 fewer per 1000 participants, 95% CI 32 fewer to 31 more). Naftopidil may have resulted in little to no difference in sexual adverse events (RR 0.54, 95% CI 0.24 to 1.22); this would result in 26 fewer sexual adverse events per 1000 participants (95% CI 43 fewer to 13 more). We rated the certainty of evidence as moderate for urological symptom score and low for the other outcomes.Naftopidil versus silodosinBased on five studies with 652 randomised participants, naftopidil may have resulted in little or no difference in the urological symptom scores (MD 1.04, 95% CI -0.78 to 2.85), QoL (MD 0.21, 95% CI -0.23 to 0.66), and treatment withdrawals for any reason (RR 0.80, 95% CI 0.52 to 1.23; corresponding to 26 fewer per 1000 participants, 95% CI 62 fewer to 32 more). We rated the certainty of evidence as low for all these outcomes. Naftopidil likely reduced sexual adverse events (RR 0.15, 95% CI 0.06 to 0.42; corresponding to 126 fewer sexual adverse events per 1000 participants, 95% CI 139 fewer to 86 fewer). We rated the certainty of evidence as moderate for sexual adverse events., Authors' Conclusions: Naftopidil appears to have similar effects in the urological symptom scores and QoL compared to tamsulosin and silodosin. Naftopidil has similar sexual adverse events compared to tamsulosin but has fewer compared to silodosin.

Objective: To verify the efficacy and safety of tamsulosin 0.4 mg and tamsulosin 0.2 mg compared with those of placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)., Methods: A total of 494 patients from multiple centers participated in this double-blind, randomized, phase 3 trial. Eligible patients were randomly assigned to the tamsulosin 0.4 mg group, tamsulosin 0.2 mg group or placebo group. The International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), post-void residual (PVR) urine volume, blood pressure, heart rate and adverse events were compared among the three groups at 4, 8 and 12 weeks., Results: A total of 494 BPH patients were analyzed. There were no differences in the baseline characteristics among the three groups. After 12 weeks of treatment, total IPSS was improved in the 0.2 mg and 0.4 mg tamsulosin groups; however, the extent of improvement was greater in the 0.4 mg group than in the 0.2 mg group (0.4 mg: -9.59 vs. 0.2 mg: -5.61; least-squares mean difference [95% confidence interval]: -3.95 [-5.01, -2.89], p < .0001). In addition, in the patients with severe symptoms (IPSS ≥20), total IPSS was improved the most in the 0.4 mg group (-11.27 ± 5.00, p < .0001). Qmax and PVR were improved in the 0.4 mg and 0.2 mg groups; however, the differences were not statistically significant between treatment groups. No patients experienced any serious adverse effects in any of the three groups., Conclusions: Tamsulosin 0.4 mg and 0.2 mg appear to be superior to placebo treatment, and tamsulosin 0.4 mg is more effective than 0.2 mg in terms of total IPSS improvement. Tamsulosin 0.4 mg has favorable efficacy and tolerability in Asian men with symptomatic BPH. ClinicalTrials.gov Identifier: NCT02390882.

Purpose: To determine the effect of phenylephrine 1.0%-ketorolac 0.3% injection (Omidria) on different components of intraoperative floppy-iris syndrome (IFIS)., Setting: Silverstein Eye Centers, Kansas City, Missouri, USA., Design: Prospective case series., Methods: Men treated with tamsulosin having standard cataract extraction surgery were placed in a treatment group that received phenylephrine 1.0%-ketorolac 0.3% injection in the irrigation solution and a control group) that received basic saline solution. Every procedure was video recorded using an endocyclophotocoagulation (ECP) probe and microscopic view. Pupil dilation, iris billowing, and iris prolapse were measured using a micrometer, ECP recording grading scale, and microscopic recordings, respectively., Results: Each group (treatment and control) comprised 25 eyes of 25 patients. Although both groups had a decrease in pupil diameter before and after cataract extraction and before cataract extraction and after intraocular lens implantation, the changes were statistically significantly greater in the treatment group. Iris prolapse occurred in 3 patients (12.0%) in the treatment group and 14 patients (56.0%) in the control group (P < .001). Stage 3 (severe) pupil billowing occurred in 1 eye (4.0%) in the treatment group and 10 eyes (40.0%) in the control group (P < .001)., Conclusions: The use of the phenylephrine 1.0%-ketorolac 0.3% injection combination added to the irrigating solution during cataract surgery in patients at risk for IFIS led to significantly better prevention of miosis, less pupil billowing, and a reduced incidence of iris prolapse. A new grading scale for intraoperative iris abnormalities might be used for future evaluation., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the add-on efficacy of a cyclooxygenase (COX)-2 inhibitor on the chronological changes in urinary function in patients who underwent low-dose-rate prostate brachytherapy., Methods and Materials: A total of 310 patients with prostate cancer who underwent low-dose-rate-brachytherapy were enrolled. Patients were randomized and allocated to the monotherapy group (tamsulosin alone: 0.2 mg/d) and the combination group (tamsulosin 0.2 mg/d plus celecoxib: 200 mg/d). We compared the chronological change in the international prostate symptom score (IPSS), the overactive bladder symptom score (OABSS), uroflowmetric parameters, and the frequency volume chart., Results: There was not a significant difference between the two groups in the chronological changes in IPSS and OABSS for 12 months after implantation. Regarding the frequency volume chart assessment, the mean daytime urinary frequency in the combination group at 3 and 6 months after implantation was significantly lower than that in the monotherapy group. Regarding IPSS recovery at 3 months after implantation, higher baseline IPSS and nonuse of external beam radiation therapy were independent factors, while smaller prostate volume and higher baseline IPSS were independent factors of IPSS recovery at 12 months after implantation based on multivariate analyses., Conclusions: There was not an additional effect of a COX-2 inhibitor to the action of an alpha-1 adrenoceptor antagonist on concerning the chronological changes in IPSS and OABSS. The use of a COX-2 inhibitor reduced the daytime urinary frequency and postvoid residual after seed implantation., (Copyright © 2017 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: In this study, we compared the effects of three agents frequently used in daily life for medical expulsive therapy., Materials and Methods: A total of 143 patients meeting the criteria were included in the study. Patients were divided into three homogeneous drug groups which were tamsulosin group (n:48), alfuzosin group (n:47) and silodosin group (n:48). The time of stone expulsion, analgesic needs, side effects of the medicine and endoscopic intervention needs of the patients were recorded., Results: The rate of stone expulsion was 70.8% (n:34) in tamsulosin group, 70.2% (n:33) in alfuzosin group, and 75% (n:36) in silodosin group. No significant difference was observed among the rates of stone expulsion in three groups, and the rates of stone expulsion were similar (p = 0.778). The duration of stone expulsion was significantly different in the groups (p = 0.012): the time of stone expulsion for tamsulosin was 2.33 ± 0.78 days longer than for Silodosin, indicating a significant difference. There was no significant difference between tamsulosin-alfuzosin and silodosin-alfuzosin (respectively p = 0.147, p = 0.925)., Conclusions: The results of this study showed that medical expulsive therapy by using alpha blocker agents is safe and efficacious. This option must be kept in mind for patients who do not ask for surgery as the first-step treatment for eligible patients.

Purpose: Clinicians use tamsulosin, an α1-adrenoceptor antagonist, to manage symptomatic benign prostatic hyperplasia (BPH). Because α1-adrenoceptors are also present in the brain, the potential exists for adverse effects on cognitive functions. We explored the association between tamsulosin use and dementia risk., Methods: We used Medicare data (2006-2012) to conduct a cohort study among patients aged ≥65 years and diagnosed with BPH. Men taking tamsulosin (n = 253 136) were matched at a 1:1 ratio using propensity-scores to each of 6 comparison cohorts: patients who used no BPH-medication (n = 180 926), and patients who used the following alternative-BPH-medications: doxazosin (n = 28 581), terazosin (n = 23 858), alfuzosin (n = 17 934), dutasteride (n = 34 027), and finasteride (n = 38 767). Assessment began following the first fill of BPH-medication to identify incident dementia by ICD-9 diagnosis codes. We estimated hazard ratios (HR) and 95% confidence intervals (CI) for dementia using Cox proportional hazard regression for each of the 6 propensity-score-matched cohort-pairs., Results: The median follow-up period for all cohorts was 19.8 months. After propensity-score matching, the tamsulosin cohort had an incidence of dementia of 31.3/1000 person-years compared with only 25.9/1000 person-years in the no-BPH-medication cohort. The risk of dementia was significantly higher in the tamsulosin cohort, when compared with the no-BPH-medication cohort (HR [95% CI]: 1.17 [1.14, 1.21]) and each of the alternative-BPH-medication cohorts: doxazosin (1.20 [1.12, 1.28]), terazosin (1.11 [1.04, 1.19]), alfuzosin (1.12 [1.03, 1.22]), dutasteride (1.26 [1.19, 1.34]), and finasteride (1.13 [1.07, 1.19]). The significance of these findings persisted in sensitivity analyses., Conclusion: Tamsulosin may increase the risk of dementia in older men with BPH., (Copyright © 2018 John Wiley & Sons, Ltd.)

Objective: To investigate the therapeutic effects of commonly used selective α-adrenergic receptor antagonists (α-ARA) on benign prostatic hyperplasia (BPH)., Methods: PubMed, Embase and CNKI databases were searched for the literature about selective α-ARAs for the treatment of BPH and the information was extracted on the common adverse reactions in the course of treatment. Multivariate meta-analysis was conducted to investigate the therapeutic effects of different α-ARAs., Results: The total rates of adverse effects of silodosin and tamsulosin were the highest, 51.9% and 34.0% respectively, with the highest incidences of headache (38.3%), weakness (23.6%) and dizziness (17.5%). Besides, tamsulosin ranked the first in inducing sexual dysfunction of the male patients with BPH (70.4%)., Conclusions: Doxazosin is preferable as the first-choice treatment of BPH for its therapeutic effect and improvement of the patient's quality of life. Silodosin and tamsulosin, however, can be selectively used according to the patient's specific tolerance to different adverse effects.

Objective: To compare the efficacy and safety of silodosin against tamsulosin as medical expulsion therapeutic agent in stone lower 1/3rd ureter., Patients and Methods: One hundred fifty patients divided equally into 2 groups I and II received silodosin 8 mg and tamsulosin 0.4 mg respectively. Patients aged 18 years or older having single unilateral stone 10 mm or less were included in the study. Patients with bilateral or multiple stones, marked hydronephrosis, previous open or endoscopic surgery and having urinary infection were excluded. Patients were followed weekly for 4 weeks by ultrasonography, plain radiography of the urinary tract and CT of the urinary tract when indicated., Results: Silodosin showed better results against tamsulosin as stone expulsion rate in silodosin and tamsulosin groups was 82.4 and 61.5% respectively with significant difference (p = 0.007). Also, the stone expulsion time was significantly lower in silodosin against tamsulosin groups as it was 9.4 ± 3.8 vs. 12.7 ± 5.1 days in group I and II respectively (p = 0.001). The adverse effects were comparable with non-significant more retrograde ejaculation in the silodosin group., Conclusion: Silodosin showed better efficacy in the stone expulsion rate and time with comparable safety of both drugs, with nonsignificant more retrograde ejaculation in silodosin., (© 2018 S. Karger AG, Basel.)

Objectives: To evaluate the efficacy and safety of a combination therapy with dutasteride and imidafenacin in patients with benign prostatic hyperplasia and persistent overactive bladder symptoms., Methods: A total of 163 patients presenting an enlarged prostate (volume >30 mL) and persistent overactive bladder symptoms despite at least 8 weeks of tamsulosin were randomized to receive tamsulosin and dutasteride, or tamsulosin, dutasteride and imidafenacin at a 1:1 ratio. The primary end-point was the mean change from baseline to week 24 in total overactive bladder symptom score., Results: The mean change in total overactive bladder symptom score from baseline at week 24 was -1.99 (95% confidence interval -2.57 to -1.41) in the tamsulosin and dutasteride group, and -3.12 (95% confidence interval -3.72 to -2.52) in the tamsulosin, dutasteride and imidafenacin group. The tamsulosin, dutasteride and imidafenacin group significantly improved total overactive bladder symptom score at week 24 as compared with the tamsulosin and dutasteride group; the mean difference was -1.18 (-2.02 to -0.34). The between-group difference was statistically significant as early as week 4. The total International Prostate Symptom Score, storage subscore, quality of life index, and benign prostatic hyperplasia impact index also significantly improved in the tamsulosin, dutasteride and imidafenacin group., Conclusions: Tamsulosin, dutasteride and imidafenacin combination therapy improves overactive bladder symptoms and quality of life without causing serious adverse drug reactions in patients with enlarged prostate not responding to tamsulosin. This combination therapy seems to represent a promising therapeutic option in these patients., (© 2017 The Japanese Urological Association.)