Evaluation of Tamsulosin 0.4 mg versus 0.8 mg in management of lower urinary tract symptoms due to benign prostatic enlargement.

PURPOSE: To compare the efficacy and the safety of Tamsulosin 0.4 mg/day and 0.8 mg/day in patients suffering from lower urinary tract symptoms due to benign prostatic obstruction. PATIENTS AND METHODS: A prospective interventional, double-blinded, controlled study was carried out on 93 patients who met the criteria and divided randomly into two groups: group A for Tamsulosin 0.4 mg/day and group B for Tamsulosin 0.8 mg/day. International prostate symptom score, post void residual urine volume, and maximum flow rate of urine were assessed before and after 4 weeks of treatment. RESULTS: Both study groups showed a significant reduction in storage sub-score but only frequency was significantly reduced in group B (P < 0.001). On the other hand, Tamsulosin 0.8 mg was superior to Tamsulosin 0.4 mg regarding voiding sub-score except for straining (P = 0.325). Accordingly, the total international prostate symptom score was significantly improved in group B versus group A (P < 0.001). Furthermore, maximum flow rate and post-void residual urine volume were notably improved in Group B as compared to Group A (P < 0.001). Of all adverse events only dizziness was noted to be statistically significant in Group B versus Group A (P < 0.001). CONCLUSION: Tamsulosin 0.8 mg has shown better outcomes in treating patients who suffer from lower urinary tract symptoms due to benign prostatic enlargement than Tamsulosin 0.4 mg, and besides that, it is well tolerated. TRIAL REGISTRATION NUMBER: M S 292/2020, SID: 373, date: 22/4/2020.

Tamsulosin and risk of priapism: A causality assessment using Austin Bradford Hill Criteria.

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 (IC025  = 4.1; PRR025  = 19.9; ROR025  = 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.

Tamsulosin facilitates depressive-like behaviors in mice: Involvement of endogenous glucocorticoids.

The benign prostatic hyperplasia (BPH) is the main source of lower urinary tract symptoms. The BPH is a common age-dependent disease and tamsulosin is an α1-adrenoceptor blocker widely prescribed for BPH. Beyond the common adverse effects of tamsulosin, increased diagnosis of dementia after prescription was observed. Importantly, a clinical study suggested that tamsulosin may exert antidepressant effects in BPH patients. Considering the expression of α1-adrenoceptors in the brain, this study aimed to investigate the effects of tamsulosin in the forced swimming and open field tests in mice. For this, tamsulosin (0.001-1 mg/kg) was orally administered subacutely (1, 5 and 23 hr) and acutely (60 min) before tests. Mifepristone (10 mg/kg), a glucocorticoid receptor antagonist, and aminoglutethimide (10 mg/kg), a streoidogenesis inhibitor, were intraperitoneally injected before tamsulosin to investigate the role of the hypothalamic-pituitary-adrenal axis in the mediation of tamsulosin-induced effects. Subacute and acute administrations of tamsulosin increased the immobility time in the first exposition to an inescapable stressful situation. In the re-exposition to the swim task, controls displayed a natural increase in the immobility time, and the treatment with tamsulosin further increased this behavioral parameter. Tamsuslosin did not affect spontaneous locomotion neither in naïve nor in stressed mice. Our findings also showed that mifepristone and aminoglutethimide prevented the tamsulosin-induced increase in the immobility time in the first and second swimming sessions, respectively. In conclusion, tamsulosin may contribute to increased susceptibility to depressive-like behaviors, by facilitating the acquisition of a passive stress-copying strategy. These effects seem to be dependent on endogenous glucocorticoids.

Free combination of dutasteride plus tamsulosin for the treatment of benign prostatic hyperplasia in South Korea: analysis of drug utilization and adverse events using the National Health Insurance Review and Assessment Service database.

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.

Physiologically based pharmacokinetic (PBPK) modelling of tamsulosin related to CYP2D6*10 allele.

Tamsulosin, a selective [Formula: see text]-adrenoceptor blocker, is commonly used for alleviation of lower urinary tract symptoms related to benign prostatic hyperplasia. Tamsulosin is predominantly metabolized by CYP3A4 and CYP2D6 enzymes, and several studies reported the effects of CYP2D6 genetic polymorphism on the pharmacokinetics of tamsulosin. This study aims to develop and validate the physiologically based pharmacokinetic (PBPK) model of tamsulosin in CYP2D6*wt/*wt, CYP2D6*wt/*10, and CYP2D6*10/*10 genotypes, using Simcyp® simulator. Physicochemical, and formulation properties and data for absorption, distribution, metabolism and excretion were collected from previous publications, predicted in the simulator, or optimized in different CYP2D6 genotypes. The tamsulosin PBPK model in CYP2D6*wt/*wt and CYP2D6*wt/*10 genotypes were developed based on the clinical pharmacokinetic study where a single oral dose of 0.2 mg tamsulosin was administered to 25 healthy Korean male volunteers with CYP2D6*wt/*wt and CYP2D6*wt/*10 genotypes. A previous pharmacokinetic study was used to develop the model in CYP2D6*10/*10 genotype. The developed model was validated using other clinical pharmacokinetic studies not used in development. The predicted exposures via the PBPK model in CYP2D6*wt/*10 and CYP2D6*10/*10 genotype was 1.23- and 1.76-fold higher than CYP2D6*wt/*wt genotype, respectively. The simulation profiles were visually similar to the observed profiles, and fold errors of all development and validation datasets were included within the criteria. Therefore, the tamsulosin PBPK model in different CYP2D6 genotypes with regards to CYP2D6*10 alleles was appropriately established. Our model can contribute to the implementation of personalized pharmacotherapy of patients, appropriately predicting the pharmacokinetics of tamsulosin reflecting their demographic and CYP2D6 genotype characteristics without unnecessary drug exposure.

Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients.

In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.

Association of Glycolysis-Enhancing α-1 Blockers With Risk of Developing Parkinson Disease.

Importance: Parkinson disease (PD) is a common neurodegenerative disease. A treatment that prevents or delays development of PD is a critical unmet need. Terazosin and closely related drugs were recently discovered to enhance glycolysis and reduce PD progression in animal models and human clinical databases. Objective: To determine whether use of terazosin, doxazosin, and alfuzosin is associated with a decreased risk of developing PD. Design, Setting, and Participants: This cohort study used active comparator control and propensity score-matched data from Danish nationwide health registries, including the Danish National Prescription Registry, the Danish National Patient Registry, and the Danish Civil Registration System, from January 1996 to December 2017 and data from the Truven Health Analytics MarketScan database from January 2001 to December 2017. Men without PD who newly initiated terazosin/doxazosin/alfuzosin therapy or tamsulosin therapy, which is used for a similar indication (benign prostatic hyperplasia or unspecified urinary problems) but does not enhance glycolysis, and had at least 1 year of follow-up after medication start were included. In Denmark, the database included all residents, while the Truven database is a compilation of insurance claims across the US. Data were analyzed from February 2019 to July 2020. Exposures: Patients who used terazosin/doxazosin/alfuzosin vs tamsulosin. Additional dose-response analyses were carried out. Main Outcomes and Measures: Differences in the hazard of developing PD identified by diagnoses or use of PD-specific medications between patients who ever used terazosin/doxazosin/alfuzosin or tamsulosin. Results: A cohort of 52 365 propensity score-matched pairs of terazosin/doxazosin/alfuzosin and tamsulosin users were identified in the Danish registries, of which all were male and the mean (SD) age was 67.9 (10.4) years, and 94 883 propensity score-matched pairs were identified in the Truven database, of which all were male and the mean (SD) age was 63.8 (11.1) years. Patients in the Danish cohort who used terazosin/doxazosin/alfuzosin had a hazard ratio (HR) for developing PD of 0.88 (95% CI, 0.81-0.98), and patients in the Truven cohort had an HR of 0.63 (95% CI, 0.58-0.69). There was a dose-response association with short-duration, medium-duration, and long-duration use of terazosin/doxazosin/alfuzosin users having a decreasing HR in both the Danish cohort (short: HR, 0.95; 95% CI, 0.84-1.07; medium: HR, 0.88; 95% CI, 0.77-1.01; long: HR, 0.79; 95% CI, 0.66-0.95) and Truven cohort (short: HR, 0.70; 95% CI, 0.64-0.76; medium: HR, 0.58; 95% CI, 0.52-0.64; long: HR, 0.46; 95% CI, 0.36-0.57). Conclusions and Relevance: These data suggest that users of terazosin/doxazosin/alfuzosin are at lower hazard of developing PD compared with users of tamsulosin. Future work is needed to further assess this association.

CT-related parameters and Framingham score as predictors of spontaneous passage of ureteral stones ≤ 10 mm: results from a prospective, observational, multicenter study.

To investigate the reliability of newly defined CT-related parameters and cardiovascular risk factors in groups adjusted for stone size and location to predict spontaneous stone passage (SP) of uncomplicated ureteral stones ≤ 10 mm. The data of 280 adult patients with solitary unilateral ureteral stones ≤ 10 mm in diameter in non-contrast computed tomography were prospectively recorded. All patients undergoing a four-week observation protocol with medical expulsive therapy using tamsulosin were divided into two groups according to SP or no SP. Demographic, clinical and radiological findings of these groups were recorded. Spontaneous stone passage was observed in 176 (62.9%) of the patients, whereas the SP rate was 57.6% for 118 upper ureteral stones and 66.7% for 162 lower ureteral stones. The SP rate was 13.3 times greater with ureteral wall thickness < 1.88 mm, 4.4 times greater with a ratio of ureter to stone diameter of < 1.24, 3.4 times greater with Framingham score of < 11.5%, 2 times greater with neutrophil lymphocyte ratio < 1.96, 1.9 times greater with ureteral diameter < 6.33 mm and 1.5 times greater with stone volume < 38.54 mm3. Lower levels of ureteral wall thickness, ratio of ureter to stone diameter, Framingham score, neutrophil lymphocyte ratio, ureteral diameter, stone volume and absence of hydronephrosis were found to be more successful predictors. We consider that the success rate can be increased by selection of the proper option (observation or active treatment) according to these predictors.

Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.

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.

Periprostatic fat thickness measured on MRI correlates with lower urinary tract symptoms, erectile function, and benign prostatic hyperplasia progression.

This study investigated the correlation between periprostatic fat thickness (PPFT) measured on magnetic resonance imaging and lower urinary tract symptoms, erectile function, and benign prostatic hyperplasia (BPH) progression. A total of 286 treatment-naive men diagnosed with BPH in our department between March 2017 and February 2019 were included. Patients were divided into two groups according to the median value of PPFT: high (PPFT >4.35 mm) PPFT group and low (PPFT <4.35 mm) PPFT group. After the initial evaluation, all patients received a combination drug treatment of tamsulosin and finasteride for 12 months. Of the 286 enrolled patients, 244 completed the drug treatment course. Patients with high PPFT had larger prostate volume (PV; P = 0.013), higher International Prostate Symptom Score (IPSS; P = 0.008), and lower five-item version of the International Index of Erectile Function (IIEF-5) score (P = 0.002) than those with low PPFT. Both high and low PPFT groups showed significant improvements in PV, maximum flow rate, IPSS, and quality of life score and a decrease of IIEF-5 score after the combination drug treatment. The decrease of IIEF-5 score was more obvious in the high PPFT group than that in the low PPFT group. In addition, more patients in the high PPFT group underwent prostate surgery than those in the low PPFT group. Moreover, Pearson's correlation coefficient analysis indicated that PPFT was positively correlated with age, PV, and IPSS and negatively correlated with IIEF-5 score; however, body mass index was only negatively correlated with IIEF-5 score.

Impact of early vs. delayed initiation of dutasteride/tamsulosin combination therapy on the risk of acute urinary retention or BPH-related surgery in LUTS/BPH patients with moderate-to-severe symptoms at risk of disease progression.

PURPOSE: To evaluate the effect of delayed start of combination therapy (CT) with dutasteride 0.5 mg and tamsulosin 0.4 mg on the risk of acute urinary retention or benign prostatic hyperplasia (BPH)-related surgery (AUR/S) in patients with moderate-to-severe lower urinary tract symptoms (LUTS) at risk of disease progression. METHODS: Using a time-to-event model based on pooled data from 10,238 patients from Phase III/IV dutasteride trials, clinical trial simulations (CTS) were performed to assess the risk of AUR/S up to 48 months in moderate-to-severe LUTS/BPH patients following immediate and delayed start of CT for those not responding to tamsulosin monotherapy. Simulation scenarios (1300 subjects/arm) were investigated, including immediate start (reference) and alternative delayed start (six scenarios 1-24 months). AUR/S incidence was described by Kaplan-Meier survival curves and analysed using log-rank test. The cumulative incidence of events as well as the relative and attributable risks were summarised stratified by treatment. RESULTS: Survival curves for patients starting CT at month 1 and 3 did not differ from those who initiated CT immediately. By contrast, significant differences (p < 0.001) were observed when switch to CT occurs ≥ 6 months from the initial treatment. At month 48, AUR/S incidence was 4.6% vs 9.5%, 11.0% and 11.3% in patients receiving immediate CT vs. switchers after 6, 12 and 24 months, respectively. CONCLUSIONS: Start of CT before month 6 appears to significantly reduce the risk of AUR/S compared with delayed start by ≥ 6 months. This has implications for the treatment algorithm for men with LUTS/BPH at risk of disease progression.

Comparison of Serenoa repens With Tamsulosin in the Treatment of Benign Prostatic Hyperplasia: A Systematic Review and Meta-Analysis.

Studies reported that Serenoa repens was effective in relieving lower urinary tract symptoms (LUTS). This article carried out a systematic review and meta-analysis to compare Serenoa repens with tamsulosin in the treatment of benign prostatic hyperplasia (BPH) after at least 6-month treatment cycle. Four studies involving 1,080 patients (543 in the Serenoa repens group and 537 in the tamsulosin group) were included in the meta-analysis. The results were as follows: compared with tamsulosin, Serenoa repens had a same effect in treating BPH in terms of International Prostate Symptom Score (IPSS) (mean difference [MD] 0.63, 95% confidence interval [CI] [-0.33, 1.59], p = 0.20), quality of life (QoL) (MD 1.51, 95% CI [-1.51, 4.52], p = 0.33), maximum flow rate (Qmax) (MD 0.27, 95% CI [-0.15, 0.68], p = 0.21), postvoid residual volume (PVR) (MD -4.23, 95% CI [-22.97, 14.44], p = 0.65), prostate-specific antigen (PSA) (MD 0.46, 95% CI [-0.06, 0.97], p = 0.08) with the exception of prostate volume (PV) (MD -0.29, 95% CI [-0.41, -0.17], p < 0.00001). For side effects, Serenoa repens was well tolerated compared with tamsulosin especially in ejaculation disorders (odds ratio [OR] = 12.56, 95% CI [3.83, 41.18], p < 0.0001) and decreased libido (OR = 5.40; 95% CI [1.17, 24.87]; p = 0.03). This study indicated that Serenoa repens had the same effect in treating BPH compared with tamsulosin in terms of IPSS, QoL, and PVR after at least 6-month treatment cycle, however, the latter had a greater improvement in PV compared with the former. And Serenoa repens did not increase the risk of adverse events especially with respect to ejaculation disorders and libido decrease.

Rate of urinary retention after ileostomy takedown in men and role of routine placement of urinary catheter.

Ileostomy takedown has been proposed as one of the procedures where the placement of the catheters can be avoided, however, the rate of UR after ileostomy takedown is unknown. The aim of this study is to investigate the rate of UR after ileostomy takedown and the potential benefit of perioperative Tamsulosin. Retrospective cohort study of men undergoing ileostomy takedown after pelvic colorectal surgery between January 2009 and December 2016. A total of 100 patients were identified. The rate of UR after ileostomy takedown was high at 26%. There were no instances of urinary tract infection, however, most instances of UR were in patients who did not have catheter in surgery (96% vs. 4%, p = 0.044). Perioperative use of tamsulosin did not result in significant decrease in urinary retention. Rates of urinary retention after ileostomy takedown are high. Although not placing the catheter may be protective against urinary tract infections, patients should be counseled about the possibility of UR after ileostomy takedown.

Acupuncture combined with tamsulosin hydrochloride sustained-release capsule in the treatment of chronic prostatitis/chronic pelvic pain syndrome: A study protocol for a randomized controlled trial.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common urinary system disease in men. As part of traditional Traditional Chinese medicine, acupuncture has been widely used in clinical practice. In order to evaluate the exact effect of acupuncture on the clinical efficacy of CP/CPPS, this experiment uses randomized controlled experiments. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 166 patients who are diagnosed with CP/CPPS. Simple randomization to conventional drug treatment with a 1:1 allocation ratio will be used. Ten 30-minute acupuncture sessions will be provided to patients assigned to the Intervention group. All participants will continue to receive conventional drug treatment. The selection of outcomes will be evaluated by Health's Symptom Score Index (NIH-CPSI) score at week 4. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with CP/CPPS. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR1900021132, Registered on 29 January 2019.

Role of Sexual Intercourse after Shockwave Lithotripsy for Distal Ureteral Stones: A Randomized Controlled Trial.

PURPOSE: To explore whether sexual intercourse is beneficial to the clinical outcome of SWL for ureteral calculi of 7-15 mm in the distal ureter. MATERIALS AND METHODS: Between March 2016 and January 2017, 225 patents with a stone (7-15 mm) in distal ureter were randomly divided into three groups after SWL: Group 1 was asked to have sexual intercourse at least three times a week, Group 2 was administered tamsulosin 0.4 mg/d and Group 3 was received standard therapy alone and served as the controls. Stone free rate, time to stone expulsion, pain score at admission, number of hospital visits for pain and steinstrasse were recorded in 2 weeks. RESULTS: 70 patients in Group 1, 71 patients in Group 2 and 68 patients in Group 3 were enrolled to the study. At the end of the first week and the second week, the stone free rates for Group 1 (68.6%, 80.0%) and Group 2 (69.0%, 81.7%) were approximately the same, but were significantly higher than Group 3 (50.0%, 63.2%) (P = .031, P = .022). The VAS scores of Groups 1 and 2 were slightly higher than those of Group 3 (P = .233). The number of patients in Group 3 who visited the emergency room for pain was significantly higher than in the other two groups (P = .015). At the end of the second week, the incidence of steinstrasse in Groups 1 and 2 was significantly lower (2.9%, 2.8% vs 11.8%) (P = .034). CONCLUSION: At least three sexual intercourses per week after SWL can effectively improve the stone free rate, reduce the formation of steinstrasse and relieve renal colic. It provides a choice for urologists in the SWL treatment of lower ureteral calculi.

To evaluate the efficacy and safety of different kinds of PDE5-Is with tamsulosin as a medical therapy for LUTS secondary to benign prostatic hyperplasia: A protocol for systematic review and meta analysis.

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.

Treatment persistence with a fixed-dose combination of tadalafil (5 mg) and tamsulosin (0.4 mg) and reasons for early discontinuation in patients with benign prostatic hyperplasia and erectile dysfunction.

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.

The effect of alpha blocker treatment prior to prostate biopsy on voiding functions, pain scores and health-related quality-of-life outcomes: A prospective randomized trial.

PURPOSE: To evaluate the effect of alpha-blocker treatment prior to transrectal ultrasound-guided prostate biopsy (TRUS-Bx) on voiding functions, pain scores and health-related quality-of-life outcomes. MATERIALS AND METHODS: From January 2018 to April 2019, a total of 112 patients underwent TRUS-Bx due to elevated prostate-specific antigen (PSA) or abnormal digital rectal examination findings. Patients were divided into 2 groups depending on whether they received pharmacological treatment before biopsy. Group 1 consisted of patients with no alpha-blocker treatment prior to biopsy and Group 2 consisted of patients who received Tamsulosin for one week before biopsy continuing for one week after biopsy. Voiding function was evaluated three times using the validated International Prostate Symptom Score (IPSS) and uroflowmetry (maximal flow rate (Qmax) and residual volume (PVR)). The Turkish version of the Medical Outcomes Study Short Form 36-item Questionnaire (SF-36) was used to assess health-related quality of life. Pain scores were rated according to the Visual Analogue Scale (VAS) just after the biopsy procedure. RESULTS: Mean IPSS and Qmax on the post-biopsy 7 day were significantly in favor of Group 2 (P<0.001, P=0.004). Although post-biopsy day 7 PVR was similar between the groups, Δ1 PVR was significantly in favor of Group 2 (P=0.004). Mean VAS score was 2.7±2.3 for the Tamsulosin group and 4.2±2.2 for the control group (P=0.001). There was no significant difference between two groups according to baseline and postoperative 1st month SF-36 scores. CONCLUSION: Alpha-blocker therapy prior to TRUS-Bx is effective in preventing voiding dysfunction and biopsy-related pain in patients undergoing TRUS-Bx. LEVEL OF EVIDENCE: 2.

A first case of fixed drug eruption due to Tamsulosin.

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.

Tamsulosin to Prevent Postoperative Urinary Retention After Female Pelvic Reconstructive Surgery.

OBJECTIVE: This study aimed to determine the effect of tamsulosin on postoperative urinary retention in female patients after pelvic reconstructive surgery. METHODS: Data were obtained from a retrospective, matched cohort of female patients who were admitted after pelvic reconstructive surgery at a single academic institution. Patients who received tamsulosin were compared with those who did not at a 1:4 ratio, matched by surgical procedure. Patients were excluded if they were discharged on the day of surgery or if an intraoperative complication necessitated prolonged postoperative bladder drainage. Information on demographics, preoperative diagnoses, prolapse stage, preoperative voiding dysfunction, urodynamic findings, intraoperative details, postoperative complications, and voiding outcomes up to 6 weeks after surgery was gathered. The primary outcome was postoperative urinary retention, defined by failure of an active voiding trial. RESULTS: Patients underwent surgery between January 2016 and March 2018. We identified 35 patients who received tamsulosin and matched to 140 controls. Patients in the tamsulosin group were younger; groups were otherwise similar. Patients who received tamsulosin after surgery were less likely to develop postoperative urinary retention (2.9% vs 24.3%, P = 0.004). After controlling for confounders, multivariable logistic regression identified tamsulosin use as the only independent predictor of postoperative urinary retention with a significant protective effect (odds ratio, 0.09; 95% confidence interval, 0.01-0.67; P = 0.03). CONCLUSIONS: Prophylactic tamsulosin use may be effective in preventing postoperative urinary retention in female patients undergoing pelvic reconstructive surgery.