Combination Of Tamsulosin Research Articles

Detrusor Overactivity May Be a Prognostic Factor for Better Response to Combination Therapy Over Monotherapy in Male Patients With Benign Prostatic Enlargement and Storage Lower Urinary Tract Symptoms.

PurposeSeveral trials have shown that in men with overactive bladder (OAB) and benign prostate enlargement (BPE), the combination of an α-blocker with an anticholinergic is superior to α-blocker monotherapy. The purpose of this study is to explore whether urodynamic detrusor overactivity (DO) affects clinical outcomes in men with BPE and OAB.MethodsThis is a post hoc analysis of a prospective, randomized trial, designed to evaluate the changes of morphometric parameters of the prostate following monotherapy or combination therapy in men with BPE-OAB. The initial study recruited men aged ≥50 years, with BPE and predominantly storage lower urinary tract symptoms (LUTS). Patients were randomized to receive tamsulosin monotherapy or a combination of tamsulosin and solifenacin for 26 weeks. All participants completed a 3-day bladder diary and the International Prostate Symptom Score (IPSS), and then underwent pressure-flow and ultrasonographic studies. Data were stratified and analysed based on the urodynamic observation of DO at baseline (DO vs. non-DO). The primary endpoint was the mean change in urgency episodes from baseline. Secondary outcomes were the changes in nocturia, total IPSS, and urodynamic parameters.ResultsSixty-nine men were initially randomized, but only 60 men were included in this analysis. Urgency episodes significantly improved in men with DO who received combination therapy compared to the DO monotherapy subgroup (P=0.04) or to the non-DO combination treatment subgroup (P=0.038). Nocturia also improved in the DO combination treatment subgroup as compared to the non-DO combination subgroup (P=0.037). The 24-hour frequency and total IPSS significantly improved from baseline without significant differences among the subgroups.ConclusionsThe present study suggests that baseline DO could be a prognostic factor for a better response to combination therapy over monotherapy in men with BPE and storage LUTS.

The impact of medical therapy for benign prostatic obstruction on the health-related quality of life at tertiary hospital: A prospective study

Benign prostatic obstruction (BPO) is a common condition in older men that often result in lower urinary tract symptoms (LUTS). LUTS associated with Benign Prostate Enlargement (BPE) may have significant negative impact on patients’ health-related quality of life as can certain treatments for the condition. This study aimed to determine the impact of medical therapy on health-related quality of life among patients on treatment for BPO.This was a hospital based descriptive study carried out in urology public and private clinics from April to December 2017. All diagnostic and treatment options of patients were decided by attending clinicians of which Patients aged ≥40 years on medical treatment for BPO were included. Symptom and Health Related Quality Life (HRQL) were measured at baseline and at 3 months using the International Prostate Symptom Score (IPSS) and the Benign Prostatic Hyperplasia Impact Index score (BII) tools. A total 150 patients were included in the analysis with a mean age of 54), mean PSA of 4.45ng/ml and a mean prostate volume 54.62cc. Majority, 144(96.5%) had moderate and severe LUTS and 94(63%) men received a combination of tamsulosin and finasteride and 44(29%) men received tamsulosin alone: Medical therapy was associated with overall improvement of quality of life (p<0.001). A combination of tamsulosin and finasteride was associated with more adverse effects. Improvements in Quality of life (QoL) and symptoms were noted across the medical treatments most widely used in real-life practice at MNH to manage patients with BPO. Tamsulosin showed an equivalent efficacy to a combination of tamsulosin and finasteride at third month of therapy with fewer adverse effects.

Features of conservative therapy of benign prostatic hyperplasia in patients with metabolic syndrome: "treat to target"

Purpose of the study. To improve the results of treatment of benign prostatic hyperplasia with symptoms of the lower urinary tract in the presence of concomitant metabolic syndrome.Materials and methods. The investigation included 103 patients aged 42 to 75 years with a reliable diagnosis of BPH and signs of MS, according to the criteria of GFCF (2009). Patients were randomized into two comparable groups: Group 1 included 52 men who were prescribed tamsulosin in combination with targeted correction of metabolic disorders; Group 2 consisted of 51 men who were prescribed tamsulosin monotherapy. After 6 and 12 months of the study, the dynamics of metabolic parameters, prostate volume, residual urine volume, maximum urine flow rate, and total IPSS and QoL score were evaluated in each group of patients.Results. A direct correlation was established between the severity of metabolic disorders and the progression of BPH /LUTS in the main assessed indicators. The use of combination therapy with metformin, ACE inhibitors / ARA and statins in combination with tamsulosin showed efficacy after 6 and 12 months of the study compared with tamsulosin monotherapy. The treatment is based on the rinciple of T2T ("Treat to Target"): maintaining target levels of blood pressure, glucose, blood lipid parameters, and body weight correction.Conclusion. Overweight, arterial hypertension, the atherogenic profile of dyslipidemia and hyperglycemia are risk factors for more pronounced progression of BPH / LUTS and a deterioration in the quality of life of patients. The investigation IMSYPA showed the effectiveness of pathogenetically based complex therapy aimed at eliminating metabolic imbalance.

ROLE OF COMBINED KETOCONAZOLE AND TAMSULOSIN IN SUCCESSFUL TRIAL OF VOIDING WITHOUT CATHETER (TWOC) IN PATIENTS WITH ACUTE URINARY RETENTION DUE TO BENIGN PROSTATIC OBSTRUCTION

Objective: To compare the frequency of patients with successful Trial of voiding without catheter (TWOC) after acute urinary retention secondary to benign prostatic hyperplasia in patients taking ketoconazole and tamsulosin vs tamsulosin alone.
 Study Design: A randomized controlled trial. 
 Place and Duration: The current study was conducted at Urology Ward, Liaquat National Hospital, Pakistan for a period of six months.
 Methodology: A total of 162 patients presenting with acute urinary retention were divided into two groups. Group A received tamsulosin 0.4mg OD and ketoconazole 200mg while Group B received tamsulosin and placebo. Trial of voiding without a catheter was induced after one week of medication. SPSS version 20 was used for data compilation and analysis.
 Results: In Group-A, 85.2% of patients were able to void as compared to group B, where only 74.1% of patients were able to void (p<0.05). Successful trial of voiding without catheter was observed in 79.0% and 60.5% in patients of Group-A and Group-B respectively. The association of successful TWOC with the two study groups was found significant (p=0.010).
 Conclusion: TWOC in men catheterized for AUR due to BPH was significantly more successful if treated in a combination of ketoconazole and tamsulosin as compared to tamsulosin only.

PIH13 Consumption of Drugs for the Treatment of Benign Prostate Hyperplasia in Ukraine Compared to the Baltic Countries

Analyze the volume and structure of consumption of drugs for the treatment of Benign prostatic hyperplasia (BPH) in Ukraine for 2016-2018 and compare their consumption with data in Latvia and Estonia. Estimation of drug consumption was performed according to the ATC / DDD method. During the study, the international index DDD / 1000 inhabitants / day (DID) was calculated. The number of packages of drugs sold during the year in Ukraine was taken from the information system "Pharmexplorer” of the company "Morion” (November 2016-2018). DDD for drugs was obtained from the WHO website (http://www.whocc.no/atc_ddd_index/). The level of drug consumption in Latvia and Estonia was estimated using statistics from these countries. The highest consumption in all countries studied was found for tamsulosin. Its consumption levels in Ukraine amounted to 1.93-2.71 DID, in Estonia - 6.25-7.22 DID, and in Latvia - 4.08-5.14 DID. The second leader in consumption in the two comparison countries, apart from Ukraine, was the combination of tamsulosin and dutasteride. The level of consumption of this combination in Estonia (2.71-3.34 DID), on average, exceeded the level in Ukraine 49 times, and in Latvia - 12 times. The third leader in consumption in Ukraine and Estonia were herbal preparations of Sabalis serrulatae, which were absent in the Latvian. The third leader in consumption In Latvia was finasteride (0.97-1.00 DID). In terms of the total consumption of study drugs, the clear leader was Estonia, in second place - Latvia and Ukraine took the last place. The alpha-1-blocker tamsulosin was the leader in the level of consumption among drugs for the treatment of BPH in Ukraine, Estonia, and Latvia during 2016-2018. In terms of consumption of the studied drugs, the first place was taken by Estonia, the second - Latvia, and Ukraine - the last place.

The impact of adding solifenacin to tamsulosin therapy for treatment of storage lower urinary tract symptoms owing to benign prostatic hyperplasia

BackgroundBenign prostatic hyperplasia (BPH) is a common problem in aging males which has a potential impact on patients’ health-related quality of life. In the present prospective study, we evaluated the effect of adding solifenacin to tamsulosin, compared to tamsulosin alone on overactive bladder symptoms scores (OABSS) and patients’ quality of life (QoL) in patients with filling lower urinary tract symptoms due to BPH.MethodsPatients included in our study were randomly assigned into 2 groups: group 1 included patients with BPH who received tamsulosin alone and group 2 included patients with BPH who received a combination of tamsulosin and sofinacin. Treatment period was 12 weeks in both groups. Quality of life and overactive bladder symptoms score questionnaires were obtained and compared in both groups before and after treatment.ResultsNo significant differences were found between both groups before treatment. At the end of treatment period, The QoL score for Group 1 patients was significantly greater than the other group (mean rank was 138.98 in tamsulosin group versus 62.02 in the combination group, P-value < 0.01). Similarly, OABSS for tamsulosin only group was significantly higher than combined treatment patients (mean rank was 145.03 in tamsulin group versus 55.98 in the combination group, P-value < 0.01).ConclusionAdding solifenacin to tamsulosin was associated with an improvement of QoL and OABSS in patients with irritative urinary symptoms due to BPH when compared with tamsulosin monotherapy.

To Compare the Efficacy of Tamsulosin, Solifenacin and Combination of Both in the Treatment of Double-J Stent Related Irritative Lower Urinary Tract Symptoms and Low Back Pain

Background: Stent-associated symptoms can have a significant impact on patient quality of life. Hematuria, urgency, frequency, dysuria, and both bladder and flank pain are the most prevalent symptoms related to indwelling ureteral stents. Among them irritative lower urinary tract symptoms and low back pain are more frequent. Despite the stent related symptoms, because of its importance stent is being kept in situ with varieties of medication. Several alpha-adrenergic blocker and antimuscarinic drugs are used to relief these symptoms like Tamsulosin, Solifenacin, Alphazosin etc. Both Tamsulosin and Solifenacin are not costly as use daily single dose. So combination of Tamsulosin and Solifenacin may act as a reliever of stent related symptoms and also cost effective. Methods and materials: For this purpose, a total of 126 patients having unilateral double-J ureteral stent for 7 days with stent related irritative LUTS and low back pain were included in this study. This hospital based prospective randomized clinical trial was carried out in Urology department of Bangabandhu Sheikh Mujib Medical University, Dhaka, during January 2014 to June 2015, to compare the irritative IPSS, improvement of quality of life score component of IPSS ,the low back pain score for double-J ureteral stent using Tamsulosin, Solifenacin and combination of both (Tamsulosin and Solifenacin) Results: Regarding the irritative sub group of International Prostate Symptom Score (IPSS) was observed during 2nd and 4th weeks follow up IPSS was significantly (p&lt;0.05) higher in solifenacin and Tamsulosin group with compared to Tamsulosin+Solifenacin group. During 4th weeks follow up the mean quality of life (QOL) score was significantly (p&lt;0.05) higher in solifenacin group and Tamsulosin group with compared to Tamsulosin+Solifenacin group.During 2nd weeks and 4th weeks follow up visual Analogue Pain Scale (VAPS) was significantly (p&lt;0.05) higher in solifenacin group followed by Tamsulosin group and Tamsulosin+Solifenacin group. Conclusion: Combined use of Tamsulosin and Solifenacin is more effective than use of single drug (either Tamsulosin or Solifenacin) in the treatment of ureteral double-J stent related irritative LUTS and low back pain. Bangladesh Journal of Urology, Vol. 23, No. 1, January 2020 p.48-51

Efficacy and Safety of Combination Comprising Tamsulosin and PDE5-Is, Relative to Monotherapies, in Treating Lower Urinary Tract Symptoms and Erectile Dysfunction Associated With Benign Prostatic Hyperplasia: A Meta-Analysis.

We report safety and efficacy of a combination therapy, comprising tamsulosin and phosphodiesterase type 5 inhibitors (PDE5-Is), relative to monotherapy, to ascertain its potential in treating lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) secondary to benign prostatic hyperplasia (BPH) after 3 months’ treatment. We screened MEDLINE, EMBASE, and the Cochrane Controlled Trials Register databases, for randomized controlled trials, and obtained eight articles comprising 1144 participants. Results showed that the combination group had superior outcomes with regard to International Prostate Symptom Score (IPSS) and Qmax, compared to the other two groups. The combination group also had superior efficacy with regard to International Index of Erectile Function (IIEF) than the tamsulosin group, but not over the PDE5-Is group. Further, the combination group showed better efficacy in IPSS voiding and quality of life (QoL) compared to the PDE5-Is group. An analysis of safety outcomes revealed extremely high adverse events (AEs) and pain in the combination group. However, therapy discontinuation due to pain and AEs did not increase with increase in AEs. Overall, our findings indicate that a combination of tamsulosin and PDE5-Is is superior to individual tamsulosin and PDE5-Is monotherapy, with regard to improving LUTS and ED secondary to BPH.

Comparative Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil versus Tadalafil alone for BPH Patients with Lower Urinary Tract Symptoms and Erectile Dysfunction

Abstract Background benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the nonmalignant hyperplasia of prostatic cells. Most of patients with benign prostate hyperplasia present with lower urinary tract symptoms (LUTS). Aim of the Study to assess the efficacy and safety of fixed-dose combinations therapy of Tamsulosin &amp; Tadalafil versus Tadalafil alone in treatment for BPH patient with lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Patients and Methods this is a randomized controlled clinical study at Urology Department, Faculty of Medicine, Ain Shams University (El Demerdash Hospital) &amp; Damanhour National Institute Hospital from 1-1-2018 till 1-9-2018. It concluded men of 45 years old or older with a history of LUTS secondary to BPH of at least 6 months were eligible for this study. Patients agreed not to use BPH medications during the research other than the study medications. Results the study showed that the fixed-dose combinations of Tamsulosin and Tadalafil significantly improve IPSS score and Qmax more than with Tadalafil 5 mg/day alone. Furthermore, PVRU significantly decreased with the fixed-dose combinations of Tamsulosin and Tadalafil more than with Tadalafil alone. Fixed-dose combinations of Tamsulosin 0.4 mg plus Tadalafil 5 mg were determined to be safe, efficacious, and well tolerated in the subjects investigated, which suggests the new fixed-dose combinations therapy can offer clinically relevant benefits for patients with LUTS complaints and desiring amelioration for comorbid ED complaints. Conclusion the study shows that the fixed- dose combination of Tamsulosin 0.4 mg/day and Tadalafil 5 mg/day are significantly superior to Tadalafil 5 mg/day alone for the treatment of BPH patients with LUTS and non-inferiority in treatment of ED Without showing any clinically significant safety issues, supporting favorable benefit-risk balance of the fixed-dose combinations of therapy for the treatment of BPH patients with LUTS and ED because of its synergistic effects, well toleration and its safety.

Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double-blinded, randomised controlled trial.

To compare the efficacy and safety of tamsulosin vs the combination of tamsulosin and tadalafil in male lower urinary tract symptoms (LUTS). This was a double-blinded, parallel-arm randomised controlled trial. Men aged >45years with moderate LUTS and a maximum urinary flow rate (Qmax ) of 5-15mL/s were included. One arm received 0.4mg tamsulosin only (Group-A), while the second received 5mg tadalafil with tamsulosin (Group-B). The primary outcome was the International Prostate Symptom Score (IPSS). Secondary outcomes were IPSS quality of life (QoL) score, five-item version of the International Index of Erectile Function (IIEF-5) score, Qmax , and post-void residual urine (PVR). Block randomisation was used. Placebo was used for blinding and allocation concealment. Intention-to-treat analysis was used for outcome measures. Of the 183 men screened, 140 were randomised (71 in Group-A, 69 in Group-B); 116 (82.85%) (61 in Group-A, 55 in Group-B) completed the study. Baseline characteristics were comparable. The improvements in the IPSS, IPSS QoL score, IIEF score and Qmax were -1.69 (95% confidence interval [CI] -1.4 to -2.0), -0.70 (95% CI -0.60 to -0.80), 3.8 (95% CI 3.4-4.2) and 1.8mL/s (95% CI 1.1-2.4) respectively, in favour of the combination group. The difference in PVR was not significant. There were no serious adverse events (AEs). The dropout rate due to AEs was 2.85%. Myalgia (five patients) was the commonest AE in the combination group. The combination of tamsulosin and tadalafil produced significantly better improvements in LUTS, QoL, erectile function and Qmax compared to monotherapy with tamsulosin, without an increase in AEs.

Add-on treatment with mirabegron may improve quality of life in patients with benign prostatic hyperplasia complaining of persistent storage symptoms after tamsulosin monotherapy.

Background:The aim of this study was to evaluate the change in lower urinary tract symptoms and quality of life (QoL) after combination therapy of solifenacin and mirabegron in patients with benign prostatic hyperplasia presenting with persistent storage symptoms after treatment with tamsulosin.Material & Methods:We evaluated the International Prostatic Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), prostate-specific antigen, prostate volume, peak flow rate (Qmax), and post-voided residual volume (PVR) before and after treatment. Patients showing baseline OABSS ⩾3 were included and treated with tamsulosin 0.2 mg as an initial drug for 1 month. After 1 month, add-on treatment with solifenacin 5 mg or mirabegron 50 mg was provided to patients who did not show improvement in OABSS with tamsulosin 0.2 mg. After 2 months, we evaluated changes in OABSS, IPSS, Qmax, and PVR.Results:After combination therapy for 2 months, there were no significant differences between patients receiving add-on treatment with solifenacin and those receiving mirabegron. However, the IPSS QoL score improved in patients treated with mirabegron and tamsulosin more than in those treated with solifenacin and tamsulosin (p < 0.05).Conclusion:A combination of tamsulosin and mirabegron might improve the QoL of patients presenting with persistent storage symptoms after tamsulosin monotherapy. Better QoL due to mirabegron compared with solifenacin could be associated with fewer adverse effects, such as dry mouth and constipation.

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.

PurposeThe 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 MethodsThis 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.ResultsOverall, 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%).ConclusionsSide 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.

Prospects for the Use of Indole-3-carbinol in the Treatment of Benign Prostatic Hyperplasia

The objective: to establish the possibility of the effect of indole-3-carbinol on the inflammatory component in men with benign prostatic hyperplasia by assessing symptoms before and after treatment.Materials and methods. The Institute of Sexology and Andrology LLC observed 142 male patients with BPH I degree, which were divided into three clinical groups. Group I included patients (n=39) who received a combination of I3C extract (Invitol) and Тamsulosin 0,4 mg/day; the second – patients (n=71) who received standard therapy, with the inclusion of Тamsulosin 0,4 mg/day; in III – (n=32) persons who did not receive treatment at all. The control group consisted of 30 healthy men. Invitol was prescribed in a dose of 1 capsule twice a day. After eating for 12 weeks, Тamsulosin at a dose of 0,4 mg/day once in the morning after eating for 12 weeks. The age of patients ranged from 50,2 to 62,5 years, on average – 56,2±3,2 years. The duration of the disease is from 3,5 to 7 years (on average 5,5±0,8 years). Before and during the treatment, all patients underwent traditional examinations.Results. Based on the results of examinations in patients with BPH who received conservative therapy, it follows that: the concomitant inflammatory process in the tissues of the prostate gland requires the use of pathogenetic agents, which include natural catechin – indole-3-carbinol in combination with selective α-blocker; the combination of Invitol Invitol and tamsulosin prescribed to patients contributed to a significant decrease in leukocyturia levels by 5,1 times and bacteriuria by 7,1 times (p&lt;0,001) than traditional tamsulosin monotherapy.Conclusion. The combination of Invitol and tamsulosin creates the conditions for a faster recovery of IPSS and QoL in people with BPH than traditional tamsulisin monotherapy.

Persistence and adherence to dutasteride/tamsulosin fixed-dose versus free-combination alpha blocker/5ARI therapy in patients with benign prostate hyperplasia in Germany .

Objective: To evaluate real-world persistence and adherence in patients with benign prostate hyperplasia (BPH) receiving a fixed-dose combination of dutasteride plus tamsulosin (DUT-TAM FDC) versus α-blocker plus 5-α reductase inhibitor (AB/5ARI) free-combination therapy. Materials and methods: This retrospective, observational cohort study utilized the German IMS LRx (IQVIA) database. Patients ≥ 45 years old with BPH receiving DUT-TAM FDC or AB/5ARI free-combination therapy from July 1, 2011 to November 30, 2017 were included. Data were analyzed for 48 months from index date (date of first prescription). Persistence, measured as time to discontinuation (defined as a 90-day gap in therapy), was evaluated using Kaplan-Meier curves (log-rank tests). Adherence, measured as medication possession ratio (MPR), was based on a comparison of mean prescribing duration and expected treatment duration. Results: A total of 141,667 patients were included (DUT-TAM FDC, n = 86,057; free AB/5ARI: n = 55,610). Small differences in persistence were observed between treatment arms. At month 12, 41.8% of DUT-TAM FDC-treated and 41.0% of AB/5ARI free-combination therapy-treated patients were persistent; at month 24, 28.2% and 27.1% were persistent, respectively. A higher proportion of DUT-TAM FDC-treated patients had MPR ≥ 0.80, ≥ 0.75 and ≥ 0.70 compared with AB/5ARI free-combination therapy (p < 0.0001). Conclusion: Small differences observed in persistence between treatment arms may not translate to meaningful clinical relevance. Adherence was significantly better in the FDC arm, which may be clinically relevant as improved adherence is associated with better outcomes. Persistence and adherence to BPH therapy in Germany is low; further studies exploring the reasons behind this are required.

Meta-Analysis of Efficacy and Safety of Tadalafil Plus Tamsulosin Compared with Tadalafil Alone in Treating Men with Benign Prostatic Hyperplasia and Erectile Dysfunction.

This meta-analysis was performed to evaluate the efficacy and safety of tadalafil plus tamsulosin compared with tadalafil alone in treating men with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) after 12 weeks’ treatment. Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses. MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched to collect randomized controlled trials. The references of related articles were also searched. Four articles including 621 patients were involved in the analysis. The study identified that combination-therapy had significant improvements in total international prostate symptom score (IPSS), quality of life (QoL) and maximum urine flow rate (Qmax) compared with monotherapy, and there were no obvious significance in respects of post-void residual volume, international index of erectile function and IPSS storage. The difference of total IPSS was mainly reflected in the change of IPSS voiding. For safety, combination-therapy had a higher incidence rate of any adverse events (AEs) and discontinuation due to AEs than monotherapy with the exception of pain. In conclusion, the combination of tadalafil and tamsulosin provided a better improvement of IPSS voiding, QoL and Qmax compared with tadalafil alone in treating men with BPH and ED, and the former therapy appeared to show a higher incidence of AEs.

Meta-analysis of the efficacy and safety of combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia

BackgroundWe 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.MethodsRandomized 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.ResultsFive 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).ConclusionThe 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.

A 52-week multicenter randomized controlled study of the efficacy and safety of add-on dutasteride and imidafenacin to tamsulosin in patients with benign prostatic hyperplasia with remaining overactive bladder symptoms (DIrecT study).

ObjectiveThe aim of this study was to examine the long‐term efficacy of combination of tamsulosin 0.2 mg + dutasteride 0.5 mg + imidafenacin 0.2 mg (TDI) therapy compared with tamsulosin + dutasteride (TD) therapy for 52 weeks in benign prostatic hyperplasia (BPH) patients with a prostate volume (PV) ≥30 mL and remaining overactive bladder (OAB) symptoms after having received tamsulosin for ≥8 weeks. Previously, we reported that the improvement in OAB symptoms at 24 weeks was significantly greater in the TDI than TD group.MethodsBPH patients with OAB symptoms after ≥8 weeks tamsulosin were randomly assigned to the TDI or TD group in a ratio of 1:1 ratio, and followed‐up for 52 weeks. Changes in the OAB Symptom Score (OABSS), International Prostate Symptom Score (IPSS), and post‐void residual (PVR) were evaluated.ResultsIn all, 163 patients were randomized, and 125 patients (76.7%) completed 52 weeks of treatment. At Week 52, there were significant decreases in the OABSS and IPSS storage subscore compared with baseline in the TDI versus TD group, but the change in the total IPSS did not differ significantly between the two groups. There was no change in PVR from Week 24 to Week 52 in either group.ConclusionsFor BPH patients with PVR ≥30 mL and remaining storage symptoms despite tamsulosin monotherapy, TDI treatment showed better results in terms of improved OAB symptoms than TD treatment up to 52 weeks.

Role of medical expulsive therapy in lower ureteral calculus

Background: Urolithiasis is a chronic disease with a significant burden on the healthcare system. The aim of this study was to evaluate the role of medical expulsive therapy (tamsulosin alone or in combination with deflazacort) in the treatment of lower ureteric calculi.Methods: This was a prospective, randomized, controlled trial conducted at a tertiary care centre between November 2015 and October 2017. Patients aged more than 18 years solitary ureteral calculus 5-10 mm in size, located at distal ureter were randomized (1:1:1) to receive tamsulosin 0.4 mg once-daily (OD), deflazacort 6 mg twice-daily (BD) and analgesic OD (Group A); tamsulosin 0.4 mg and analgesic OD (Group B); or only analgesic OD (Group C, control Group) for 7 days. The treatment duration was extended to 28 days or until the expulsion of stone. Patients were followed-up weekly during the treatment period.Results: A total of 105 patients were enrolled in the study. Overall, 51.5% of patients in Group A, 48.5% of patients in Group B and 54.3% of patients in Group C had calculus size 7-10 mm. Patients allocated to Group A (80%) and Group B (74.3%) showed higher stone expulsion rate as compared to those in Group C (48.6%). The mean time taken for stone expulsion was around 12 days in Group A, whereas around 15 days in Group B and C.Conclusions: The combination of tamsulosin and deflazacort resulted in higher stone expulsion rate in patients with lower ureteral calculus.

Medical Expulsive Therapy for Symptomatic Distal Ureter Stones: Is the Combination of Bromelain and Tamsulosin More Effective than Tamsulosin Alone? Preliminary Results of a Single-Center Study

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.

Effect of tamsulosin on blood glucose levels in euglycemic and alloxan induced diabetic rats and its interaction with glibenclamide

Background: To evaluate the effect of tamsulosin on blood glucose levels in euglycaemic rats and to investigate the effect of glibenclamide, tamsulosin and their combination on alloxan induced diabetic rats.Methods: Albino male wistar rats were randomly assigned into 6 groups (2 euglycaemic and 4 alloxan induced diabetic rats groups). In Euglycaemic rats either normal saline (0.5ml P.O) or tamsulosin (0.072mg/kg P.O) were given and blood glucose levels was estimated at 0 hr, 30min, 1hr, 2hr, 4hr on day 1 and at 0hr and 1hr on day 3 and day 7. Four groups of diabetic rats were given normal saline (0.5ml P.O), glibenclamide (5mg/kg P.O), tamsulosin (0.072mg/kg P.O), combination of glibenclamide and tamsulosin respectively and blood glucose levels were estimated on day 1, 3 and 7. Repeated measures ANOVA or paired ‘t ‘test were used for within group comparison and one way ANOVA or unpaired ‘t’ test were used for between group comparison.Results: In euglycaemic rats tamsulosin caused significant rise in blood glucose levels at 1 hr on all days and in diabetic rats tamsulosin itself did not cause any significant alteration in blood glucose levels. However, its combination with glibenclamide delayed the onset of hypoglycemic effect of glibenclamide &amp; also reduced its hypoglycemic effect.Conclusions: Tamsulosin significantly increase blood glucose level in euglycaemic rats and it interact with Glibenclamide to reduce its hypoglycemic activity in diabetic rats.