Tamsulosin 0.8 mg daily dose in management of BPH patients with failed tamsulosin 0.4 mg monotherapy and unfit for surgical intervention.

AIM: This study aims to evaluate the effectiveness and safety of administering double-dose tamsulosin (0.8 mg) for treating patients with benign prostatic hyperplasia (BPH) who have not responded to the standard single dose of tamsulosin (0.4 mg) and are deemed unsuitable for transurethral resection (TUR) intervention. MATERIALS AND METHODS: Between November 2022 and July 2023, we prospectively analyzed 111 patients who were experiencing severe BPH symptoms. These patients received a double dose of tamsulosin for one month. We collected baseline characteristics such as age, body mass index, and underlying medical conditions. Various parameters including the International Prostate Symptom Score (IPSS), prostate-specific antigen (PSA) levels, prostate volume, peak urinary flow rate (Qmax), voided volume, and post-void residual volume were evaluated before and after treatment. RESULTS: All 111 patients completed the study. The mean age, PSA level, and prostate volume were 63.12 ± 4.83 years, 3.42 ± 0.93 ng/ml, and 50.37 ± 19.23 ml, respectively. Of these patients, 93 showed improvement in Qmax, post-void residual volume, and IPSS score (p-value = 0.001). The total IPSS score and total Qmax improved from 24.03 ± 2.49 and 7.72 ± 1.64 ml/sec to 16.41 ± 3.84 and 12.08 ± 2.37 ml/sec, respectively. CONCLUSION: Double-dose 0.8mg tamsulosin as an alpha-blocker therapy appears to be a viable temporary management option for BPH patients who have not responded to the standard single dose 0.4mg tamsulosin and are not suitable candidates for TUR intervention.

Risk of Parkinson's disease among users of alpha-adrenergic receptor antagonists: a systematic review and meta-analysis.

Background: Recent studies have tried to establish an association between the use of alpha-1-adrenergic receptor antagonists (A1ARAs) used in benign prostatic hyperplasia (BPH) and the risk of PD. The objective of the study is to compare the risk of Parkinson's disease (PD) between terazosin/alfuzosin/doxazosin (TZ/AZ/DZ) users and tamsulosin users. Methods: PubMed, Google Scholar, and Embase were systematically searched from inception to April 2023. Observational studies comparing the risk of PD among patients using different types of A1ARAs were included in the meta-analysis. The primary outcome was the hazard ratio (HR) with a 95% CI for the risk of occurrence of PD among A1ARAs users of two different classes. Results: This study was based on a total of 678 433 BPH patients, out of which 287 080 patients belonged to the TZ/AZ/DZ cohort and 391 353 patients belonged to the tamsulosin cohort. The pooled incidence of PD was higher in tamsulosin users (1.28%, 95% CI: 1.04-1.55%) than in TZ/AZ/DZ drug users (1.11%, 95% CI: 0.83-1.42%). The risk of occurrence of PD was significantly lower in patients taking TZ/AZ/DZ than tamsulosin (n= 610,363, HR = 0.82, 95% CI = 0.71-0.94, P = 0.01; I2 = 87.4%). Conclusion: This meta-analysis demonstrated that patients with BPH who take TZ/AZ/DZ have a lower risk for developing PD than those who take tamsulosin.

Pooled-analysis of tadalafil and tamsulosin for ureteral calculi.

Objective: Urolithiasis is a common urological diseases and affects the daily life of patients. Medical expulsive therapy has become acceptable for many parents. We conducted a meta-analysis to determine the efficacy and safety of tadalafil compared with tamsulosin for treating distal ureteral stones less than 10 mm in length. Methods: Related studies were identified via searches of the PubMed, Embase, and Cochrane Library databases. All the articles that described the use of tadalafil and tamsulosin for treating distal ureteral stones were collected. Results: A total of 14 studies were included in our meta-analysis. Our results revealed that tadalafil enhanced expulsion rate [odds ratio (OR) = 0.68, 95% confidence interval (CI): 0.47 to 0.98, p = 0.04]; reduced expulsion time [mean difference (MD) = 1.22, 95% CI (0.13, 2.30), p = 0.03]; lowered analgesia use [MD = 38.66, 95% CI (7.56, 69.77), p = 0.01] and hospital visits [MD = 0.14, 95% CI (0.06, 0.22), p = 0.0006]. According to our subgroup analysis, either tadalafil 5 mg or 10 mg did not promote expulsion rate and accelerate expulsion time compared with tamsulosin. But patients receiving 5 mg tadalafil decreased analgesia usage [MD = 101.04, 95% CI (67.56, 134.01), p < 0.00001]. Conclusion: Compared with tamsulosin, tadalafil demonstrates a higher expulsion rate and less expulsion time for patients with distal ureteral stones less than 10 mm with a favorable safety profile.

Assessing safety and tolerability of super selective alpha-1 adrenergic blockers in infants under 3 years: Insights from a single-center study on lower urinary tract obstruction (LUTO).

BACKGROUND: Little is known about alpha blocker use in young children, particularly in those with lower urinary tract obstruction (LUTO). Therefore, we aimed to assess the safety and tolerability of selective alpha-blockers in children under 3 years of age with LUTO. METHODS: A prospectively-collected database captured 93 patients born between 12/2005 and 01/2023. Assessed data included baseline characteristics, ultrasound features, blood pressure (BP), side effects and creatinine values. Primary outcome was side effects or discontinuation of alpha-blockers. Secondary outcomes were BP parameters, growth, and kidney function. Data are shown as median with interquartile range (IQR), Odds Ratio (OR) with 95% CI and mean value with standard deviation (SD). RESULTS: A total of 33 patients less than 3 years of age were started on alpha-blockers at 16.8 ± 11.8 months and followed for 48.9 ± 40.5 months. At last follow-up, no significant effect on systolic/diastolic BP percentiles (p > 0.9 and p > 0.9), creatinine levels (p > 0.9). Weight percentiles increased to the last follow-up (37.8 ± 33.2 vs. 53.6 ± 32.9, p = 0.0133) while height percentiles increased from 28 to 100 days to last follow-up (12.9 ± 18.3 vs. 39.6 ± 35.2, p=0.001). Four patients discontinued alpha-blockers; however, no side-effects were reported during the study period. CONCLUSIONS: No severe clinical or systemic side effects were observed, demonstrating safety and tolerability in young children with LUTO. Although alpha-blockers did not significantly improve kidney function in short term follow-up, and failure to thrive was not observed in these children. Additional studies with more patients are required to assess the optimal dosing and timing leading to maximal benefits for these infants.

Preoperative α1-Blockers Impact on Outcomes of Patients Undergoing Ureteroscopy with Ureteral Access Sheaths: A Systematic Review and Meta-Analysis.

Introduction: The use of a ureteral access sheath (UAS) during ureteroscopy (URS) has been associated with the risk for ureteral injuries. Preoperative administration of α1-blockers presents a potential mitigator of such lesions by inducing ureteral relaxation, which may also contribute to improving other surgical outcomes. Methods: A comprehensive literature search was conducted across MEDLINE, Embase, and Cochrane databases for studies comparing preoperative α1-blockers administration vs its non-use in adult patients without pre-stenting undergoing URS. Binary outcomes were evaluated using risk ratios (RRs) and odds ratios (ORs) with 95% confidence intervals (CIs). Heterogeneity was measured with the Cochran's Q test, I2 statistics, and prediction intervals (PIs). A DerSimonian and Laird random-effects model was utilized for all outcomes. Results: Eleven studies encompassing 1074 patients undergoing URS were included, of whom 522 (48.60%) received α1-blockers before the procedure. Preoperative α1-blockers were associated with a reduction in significant ureteral injuries (RR 0.30; 95% CI 0.17-0.53; I2 = 6%; PI 0.10-0.88) and an increase in mean successful UAS insertion (OR 2.14; 95% CI 1.08-4.23; I2 = 23%; PI 0.51-8.93). In patients undergoing exclusively ureteroscopy lithotripsy (URSL), the medications also reduced total complications (RR 0.62; 95% CI 0.46-0.84; I2 = 0%) and complications graded Clavien-Dindo III or higher (RR 0.16; 95% CI 0.04-0.69; I2 = 0%), but no significant difference between groups was found in the stone-free rate (RR 1.10; 95% CI 0.86-1.40; I2 = 91%; PI 0.47-2.59). Conclusion: Preoperative α1-blockers were linked to a decrease in significant ureteral injuries with UAS use and fewer complications during URSL procedures. However, their impact on the successful insertion of a UAS remains uncertain. Consideration of administering preoperative α1-blockers in non-stented adult patients undergoing URS with UAS is advisable.

Efficacy of combination therapy tadalafil plus tamsulosin in ureteral stents-related symptoms relief.

Introduction: Ureteral stents-related symptoms (USRs) are the common complications of ureteral stenting. Tamsulosin a selective alpha-1 blocker and Tadalafil a PDE-5 inhibitor are one of drugs have been used for USRs relief. In this study we aimed to evaluate the effectiveness and safety of combination therapy Tamsulosin+Tadalafil for treating USRs comparing it with the efficacy of either Tamsulosin or Tadalafil monotherapies. Material and methods: 279 patients with indwelled unilateral ureteral stents were randomized to Tamsulosin 0.4 mg + Tadalafil 5 mg once a day (Group 1, n = 67), Tamsulosin 0.4 mg once a day (Group 2, n = 71), Tadalafil 5 mg once a day (Group 3, n = 69) and Placebo once a day (Group 4, n = 72). USRs severity was registered and calculated by using the Ureteral Symptoms Score Questionnaire (USSQ) at the 14th day of treatment. Side-effects and total analgesic use were recorded and compared. Results: At the endpoint in patients with unilateral ureteral stents the combination therapy Tamsulosin + Tadalafil led to statistically lower intensity of urinary symptoms comparing with Tamsulosin (15.2 ±4.3 vs 21.8±3.6, p = 0.0003) or Tadalafil (15.2 ±4.3 vs 20.6 ±2.8, p = 0.0004) monotherapy. All groups of treatment demonstrated significant relief of USRs comparing with Placebo mostly beneficial in the combined therapy group. Body pain and analgesic need in Group 1 was lower than in Groups 2, 3 or 4. Side-effects were registered rarely without statistical differences in frequency between groups. Conclusions: Combination therapy with Tamsulosin + Tadalafil is an effective and safe option that achieves the statistically more significant relief of USRs comparing with Tadalafil or Tamsulosin monotherapies.

Optimal duration of medical expulsive therapy for lower ureteral stones: a critical evaluation.

To evaluate the optimal duration of Medical Expulsive Therapy (MET) application for distal ureteric stones on a time period based manner. 89 patients with 5-10 mm distal ureter stones received tamsulosin (0.4 mg) for MET and diclofenac sodium (75 mg) for analgesia. Patients were evaluated once a week for 4 weeks. Radiologic stone passage was evaluated by kidney ureter bladder (KUB) and ultasonography where non-contrast computed tomography (NCCT) was also performed if needed. While 23 cases (28.4%) were SF after first week, 23 were SF (28.4%) after 2 weeks, 9 cases (11.1%) after 3 and lastly 7 cases (8.6%) became SF after four weeks. Nineteen (23.5%) cases were not SF after 4 weeks. A positive relationship was found between the time period elapsed for stone passage and ureteral wall thickness (UWT) along with the degree of hydronephrosis. In addition, mean number of renal colics and emergency department (ED) visits were found to be higher in patients passing stones in the 4th week along with the ones who could not despite MET. SFR for distal ureteric stones sizing 5-10 mm was higher within the first 3 weeks under MET application. Thus, waiting for a longer period of time may result in increased analgesic and unnecessary MET treatment with increased risk of emergency department visits and additional costs as well. We believe that other options could be considered in such cases who are not SF at the end of the first 3 weeks.

Effect of different alpha-receptor antagonists on metabolic parameters: a head-to-head comparison.

PURPOSE: Although it is known that alpha-adrenergic receptor antagonists have positive effects on metabolic parameters such as glucose metabolism, lipid profile, and insulin sensitivity, it is unclear whether this is a class effect. Tamsulosin is reported to have adverse effects on glucose metabolism and insulin resistance, and this may be because of its lack of glycolysis-enhancing effect compared with other alpha-adrenergic receptor antagonists with glycolysis-enhancing effects such as doxazosin, terazosin, and alfuzosin. The aim of this study was to compare the effect of tamsulosin on metabolic parameters with another alpha-1 adrenergic receptor antagonist, doxazosin. METHODS: In this prospective, observational, controlled, 12-week clinical study, a total of 60 male patients aged ≥ 40 years who were first started on tamsulosin (n = 30; 0.4 mg/day, oral; mean age, 59.20 ± 8.97 years) or doxazosin (n = 30; 4 or 8 mg/day, oral; mean age, 58.50 ± 8.93 years) for benign prostatic hyperplasia (BPH) or lower urinary tract symptoms (LUTS) were enrolled. The groups were compared according to the changes in anthropometric and biochemical parameters (glycemia, lipid profile, and insulin sensitivity) at the end of treatment. RESULTS: In intragroup analyses, systolic blood pressure, diastolic blood pressure, total cholesterol, and HbA1c levels decreased significantly in the doxazosin group compared with baseline (p < 0.05 for all), while no significant change was observed in the tamsulosin group. In comparisons between groups, systolic blood pressure, total cholesterol, and low-density lipoprotein cholesterol levels showed a significant decrease in the doxazosin group compared with the tamsulosin group (percent change: - 6.68 ± 13.08 vs. 0.53 ± 11.02, p = 0.025; - 3.63 ± 9.56 vs. 4.02 ± 10.86, p = 0.005; and - 5.62 ± 18.18 vs. 5.24 ± 15.42, p = 0.015, respectively). CONCLUSION: Although these results do not support previous findings that tamsulosin has adverse effects on metabolic parameters, they suggest that doxazosin treatment may be a reason for preference in patients with BPH or LUTS accompanied by metabolic disorder.

Effect of tamsulosin on urethral tone in healthy male cats.

OBJECTIVES: Alpha-adrenergic antagonists are commonly used to prevent recurrent urethral obstruction in cats with mixed reports of efficacy. No published data on tamsulosin use in cats are available. The objective of this study was to measure changes in urodynamic parameters and blood pressure in five healthy male cats before and after administration of tamsulosin orally for 4 and 10 days. METHODS: Five young healthy adult male cats from a research colony were administered tamsulosin at 0.1 mg/cat PO q24h for 10 days. Urethral pressure profile and blood pressure measurements were performed before treatment and approximately 6 h after treatment on days 4 and 10. Maximum urethral closure pressure (MUCP) for the prostatic and penile urethra, functional urethral length (FPL), functional area (FA) and systolic blood pressures were recorded and compared between the time points. RESULTS: Significant changes in blood pressure on day 4 (121.1 mmHg ± 20.2 mmHg) and on day 10 (112.6 mmHg ± 14.9 mmHg) compared with day 0 (141.1 mmHg± 33.4 mmHg) were not detected (P = 0.18) in anesthetized cats. No significant difference in MUCP, FA or FPL measurements were detected among baseline, day 4 and day 10 of treatment. Hematuria and transient pollakiuria were induced in two cats with 3.5 Fr urethral catheters. CONCLUSIONS AND RELEVANCE: Tamsulosin at 0.1 mg/cat PO q24h did not induce hypotension in healthy cats. Urodynamic testing performed 6 h after the tamsulosin pill was administered did not detect consistent decreases in urodynamic functions induced by tamsulosin. Repeated catheterization of tom cats with 3.5 Fr catheters may induce significant urethral trauma.

Efficacy of medication for overactive bladder symptoms in 70 patients with Parkinson's disease.

Background: Managing overactive bladder (OAB) symptoms in Parkinson's disease (PD) is challenging. This study aimed to investigate the medical management of OAB symptoms in patients with PD. Methods: Patients with OAB symptoms who were newly treated with tolterodine and/or tamsulosin were screened from a database of 187 PD patients. Before treatment, the Hoehn-Yahr scale, International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), and urodynamic evaluation were evaluated. On day 21 of treatment, the IPSS and OABSS were re-evaluated. The changes of these scores and urinary symptoms were analyzed. Results: Seventy patients with a mean age of 62.2±7.9 years and median Hoehn-Yahr stage of 2 (IQR 2-3) were enrolled. Tolterodine, tamsulosin, and tolterodine + tamsulosin were used in 43, 20, and 7 patients, respectively. The IPSS storage symptoms (9.4±3 vs. 3.5±2.3) and OABSS (9±2.8 vs. 4.8±3.3) improved significantly after treatment (both P<0.01). However, 28 (40%) patients displayed moderate urinary symptoms, and nocturia and urgency still affected more than half of the patients after treatment. Conclusions: Tolterodine and/or tamsulosin can significantly improve OAB symptoms in PD patients. Nocturia and urgency remain common after treatment.

Response Surface Methodology (RSM) approach to formulate and optimize the bilayer combination tablet of Tamsulosin and Finasteride.

An orally administered bilayer tablet with Tamsulosin (TAM) as the sustained release (SR) and Finasteride (FIN) as immediate release (IR) was manufactured. A response surface methodology was employed to formulate bilayer tablets with individual release layers, i.e., sustained and immediate release (SR and IR). Independent variables selected in both cases comprise hydroxypropyl methylcellulose (HPMC) as SR polymer, and avicel PH102 in the inner layer while Triacetin and talc in the outer layer, respectively. Tablets were prepared by direct compression, a total of 11 formulations were prepared for inner layer TAM, and 9 formulations for outer layer FIN were designed; these formulations were evaluated for hardness, friability, thickness, %drug content, and %drug release. A central composite design was employed in response surface methodology to design and optimize the formulation. The percentage of drug released was evaluated by in-vitro USP dissolution method of optimized formulation for 0.5, 2, and 6 hrs, and results were 24.63, 52.96, and 97.68 %, respectively. Drug release data was plotted in various kinetic models using a D.D solver, where drug release was first order that is concentration dependent and was best explained by Korsmeyer-Peppa kinetics, as the highest linearity was observed (R2 = 0.9693). However, a very close relationship was also noted with Higuchi kinetics (R2 = 0.9358). The mechanism of drug release was determined through the Korsmeyer model, and exponent "n" was found to be 0.4, indicative of an anomalous diffusion mechanism or diffusion coupled with erosion.

Alpha-blockers: the magic pill for endourology-The great delusion.

PURPOSE: The present paper takes a different and more critical look at the role of alpha-blockers, sometimes nicknamed as "magical pills", in particular for stone disease and medical expulsive therapy (MET). METHODS: A non-systematic narrative review was performed, synthesizing pertinent information from selected articles, and critically evaluating their conclusions. Sometimes different views on alpha-blockers were laid bare, including curiosities or other entertaining nuances suitable to the present topic, but always maintaining sharp objectivity and the foremost scientific rigor. RESULTS AND CONCLUSIONS: Alpha-blockers seem to be a panacea, being used to treat a wide variety of non-urological diseases and conditions. Urological applications include erectile dysfunction to benign prostatic hyperplasia, from incontinence to urinary retention, or even to facilitate urinary stone passage along the urinary tract. Due to its versatility, alpha-blockers appear to be the Swiss army knife of urological medications. However, the efficacy of alpha-blockers for MET, pain management, or facilitating upper tract access is very disappointing, bringing no, or in some instances, only marginal benefits. Their treatment results are far from being significant or impressive let alone magical. Regular sexual intercourse is an effective alternative to alpha-blockers, providing faster ureteral stone expulsion rates and reducing the need for pain medication. Most of the research supporting alpha-blockers has been based on single-center, underpowered, low-quality studies. These low-quality studies biased several subsequent meta-analyses, contaminating them with their low-quality data, enhancing and prolonging this delusion. These results emphasize the need for large, multi-centric, unbiased, randomized, double-blinded, placebo-controlled trials to prevent future year-long delusions that may afflict any medical field.

Semirigid ureteroscopy and tamsulosin therapy as dilatation methods before flexible ureteroscopy: evaluation and benefits.

OBJECTIVE: To evaluate the effect of semirigid ureteroscopy and tamsulosin therapy as dilatation methods before flexible ureteroscopy advancement to the renal collecting system. PATIENTS AND METHODS: This prospective study included patients with renal stones less than 2 cm who underwent retrograde flexible ureteroscopy and laser lithotripsy. The patients were randomized into two groups: group A patients were given a placebo for 1 week before flexible ureteroscopy, and group B patients were administered 0.4 mg of tamsulosin once daily for 1 week before surgery and underwent active dilatation using semirigid ureteroscopy before flexible ureteroscopy. The ability of the flexible ureteroscope to reach the collecting system in both groups during the same operative session was assessed. Operative outcomes and complications were collected and analyzed in both groups. RESULTS: A total of 170 patients were included in our study, with each group comprising 85 patients. In group B, the flexible ureteroscope successfully accessed the kidney in 61 patients, while in group A, the flexible ureteroscope was successful only in 28 cases (71.4% versus 32.9%). In group A, 33 (38.8%) patients had lower urinary tract symptoms compared to 17 (20.2%) patients in group B (P = 0.013). CONCLUSION: Using tamsulosin therapy and semirigid ureteroscopy as dilatation methods before flexible ureteroscopy increased the success of primary flexible ureteroscopy advancement to renal collecting system.

Tadalafil versus tamsulosin as combination therapy with 5-alpha reductase inhibitors in benign prostatic hyperplasia, urinary and sexual outcomes.

PURPOSE: To compare the urological and sexual outcomes of using either tamsulosin/finateride or tadalafil/finasteride as combination therapies in patients with large prostate. PATIENTS AND METHODS: Selection criteria included prostate volume > 40 ml and IPSS > 7. Patients with severe erectile dysfunction (IIEF-erectile functions ≤ 10) were excluded. Patients were randomized into group I (tamsulosin/finasteride) and group II (tadalafil/finasteride). The primary endpoint was to define urinary and sexual function changes (IPSS, IPSS-quality of life, urinary flow rates and IIEF domains) within each group. The secondary endpoint was to compare the treatment induced changes between both groups. RESULTS: At 4th and 12th weeks, 131 and 127 patients were available in both groups, respectively. Both groups showed significant LUTS improvement (IPSS changes: - 4.9 ± 2.7 and - 4.3 ± 2.9 at 4th week and - 6.1 ± 3 and - 5.4 ± 2.8 points by the 12th week in both groups, respectively). Group I had better average flow rates at both follow-up visits. Meanwhile, maximum flow rates were comparable in both groups at 12th week (13.5 ± 3.9vs. 12.6 ± 3.7, p > 0.05). In group I, all IIEF domains were significantly lowered at both visits (p < 0.05). Group II showed significant increase in IIEF-erectile function scores (1.3 ± 1.1 and 1.8 ± 1.2 at the 4th and 12th weeks) with a transient significant reduction of IIEF-orgasm and sexual desire noted only by the 4th week (- 0.8 ± 0.4 and - 0.6 ± 0.4, respectively). CONCLUSION: Within three months, both combinations are comparably effective in improving BPH related LUTS. Tamsulosin/finasteride provided significantly better Qmax only at 4th week. Tadalafil/finasteride had the advantage of improving sexual performance over the other combination.

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.

Comparison between combination of tamsulosin and Pentoxifylline versus tamsulosin alone in the treatment of lower urinary tract symptoms due to benign prostate hyperplasia: A preliminary study.

BACKGROUND: In older adults, bladder outlet obstruction (BOO) is prevalent, primarily due to benign prostatic hyperplasia (BPH). These patients' lower urinary tract symptoms can be treated surgically and with medical therapy. Compared to standard treatment with tamsulosin, Pentoxifylline, a phosphodiesterase inhibitor, could benefit patients with BOO due to its properties on microcirculatory blood flow and oxygenation of ischemic tissues. Hence, this trial intended to study the efficacy of Pentoxifylline combined with tamsulosin in treating BOO patients. MATERIALS AND METHODS: This randomized, double-blind clinical trial recruited 60 patients with BPH from a single center in 2022. Upon consent of patients meeting the eligibility criteria, they were randomly allocated to intervention (Pentoxifylline + tamsulosin) and control (placebo + tamsulosin) groups. The patients were evaluated for international prostate symptom score (IPSS), quality of life (QoL), maximum urinary flow rate (Qmax ) by uroflowmetry, and post-void residual volume (PVR) by abdominal sonography at the onset of the study and after the 12th week. RESULTS: Patients who used the combination therapy had significantly better results of prostate symptoms and quality of life improvement (IPSS: -36.6%, QoL: -45.3%) compared to patients who received tamsulosin alone (IPSS: -21.2%, QoL: -27.7%) (p < .001). Also, this study shows that the improvement in maximum urinary flow rate and residual volume by combination therapy is significantly higher (Qmax : +42.5%, PVR: -42.6%) compared to monotherapy (Qmax : +25.1%, PVR: -26.1%) (p < .001). CONCLUSION: When combined with tamsulosin, Pentoxifylline could significantly improve the lower urinary symptoms of BPH patients. It is well tolerated, and the treatment outcomes are better in patients who receive the combination of Pentoxifylline and tamsulosin than those who only receive tamsulosin.

Mirabegron Add-On Tamsulosin for Men with Overactive Bladder Symptoms: A Pooled Analysis of Four Randomized Controlled Trials.

INTRODUCTION: Overactive bladder symptoms (OABSs) affect patients' quality of life (QOL) worldwide. This pooled analysis compared the efficacy and safety of mirabegron add-on tamsulosin with those of tamsulosin add-on placebo in OABS treatment. METHODS: PubMed, Embase, MEDLINE, and the Cochrane Controlled Trial Register databases were searched for randomized controlled trials (RCTs) examining the efficacy of mirabegron add-on therapy to tamsulosin in the treatment of OABS. Moreover, references from the selected studies were screened. Review Manager 5.4 was used to analyze data. RESULTS: Four RCTs involving 1,397 patients with OABS were selected. Of the total, 697 patients receiving mirabegron add-on tamsulosin constituted the experimental group, and 700 patients receiving tamsulosin add-on placebo constituted the control group. The efficacy endpoints were as follows: mean number of micturition per day (mean difference [MD] = -0.26, 95% confidence interval [CI] = -0.41 to -0.10, p = 0.0001), urgency episodes per day (MD = -0.67, 95% CI = -1.02 to -0.32, p = 0.0002), urgency urinary incontinence (UUI) episodes per day (MD = -0.42, 95% CI = -0.66 to -0.19, p = 0.0005), mean volume voided/micturition (MD = 10.84, 95% CI = 4.97-16.71, p = 0.0003), total International Prostate Symptom Score (IPSS) (MD = -2.01, 95% CI = -4.02 to -0.01, p = 0.05), and IPSS QOL index (MD = -0.65, 95% CI = -0.94 to -0.35, p < 0.0001). Mirabegron therapy, an add-on therapy to tamsulosin, was effective in treating patients with OABS. Moreover, mirabegron might reduce the total IPSS (MD = -2.01, 95% CI = -4.02 to -0.01, p = 0.05). The safety endpoint, treatment-emergent adverse events (odds ratio = 0.94, 95% CI = 0.78-1.13, p = 0.49), suggested that although mirabegron was well-tolerated, it possibly increased the post-void residual urine volume (MD = 10.28, 95% CI = 1.82-18.75, p = 0.02). CONCLUSION: Combination therapy using mirabegron and tamsulosin may be effective in treating patients with non-neurogenic OABS in terms of UUI episodes, total IPSS, and IPSS QOL index. However, its effectiveness must be verified by analyzing additional factors for OABS through further RCTs.

Investigating how tamsulosin combined with levofloxacin impacts wound healing in patients with chronic prostatitis who may also have perineal or urethral wounds.

Chronic prostatitis, which frequently manifests with perineal or urethral ulcers, can have substantial impact on the quality of life experienced by affected individuals. Present treatment approaches primarily target the alleviation of symptoms and control of complications. In patients with chronic prostatitis, this investigation examined the potential synergistic effects of tamsulosin and levofloxacin on urinary function and urethral and perineal wounds healing. This cross-sectional observational study was carried out at Chongqing Western Hospital, China, from February to November 2023. The participants comprised 88 males aged 40-75 years who had been clinically diagnosed with chronic prostatitis and complications that accompany the wound healing process. The participants were equally distributed into two groups: one assigned to the treatment group, which received a daily combination of levofloxacin (500 mg) and tamsulosin (0.4 mg) and other to receive conventional care. The wound healing rate and improvement in urinary function were the primary outcomes evaluated monthly for 9 months. Patient satisfaction and symptom amelioration were secondary outcomes, in addition to the surveillance of adverse effects. In comparison to the control, treatment group exhibited significantly higher rate of wound closure (78.08% at 1 month and 79.38% at 9 months) and urinary function improvement (66.69% at 1 month and 67.95% at 9 months). In addition, the treatment group exhibited a greater degree of symptom amelioration; however, a rise in adverse effects was observed. In every domain, patient satisfaction scores were significantly higher in the treatment group. Thus the combination of tamsulosin and levofloxacin improved urinary function and wound repair in patients with chronic prostatitis, while also exhibiting tolerable profile of adverse effects.

Comparison of Monotherapies and Combination Therapy of Tamsulosin and Tadalafil for Treating Lower Urinary Tract Symptoms Caused by Benign Prostatic Hyperplasia with or without Erectile Dysfunction: A Meta-Analysis.

BACKGROUND: There is limited research into the efficacy and safety of tadalafil combined with tamsulosin for the treatment of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH), with or without erectile dysfunction (ED). Therefore, we aimed to investigate the efficacy and safety of combination therapy compared to that of monotherapy. METHODS: We searched PubMed, Embase, Cochrane Library, Web of Science, SinoMed, CNKI, WanFang Data Service Platform, and ClinicalTrials.gov to identify eligible studies. A total of 639 articles were retrieved, of which 12 were randomized controlled trials (RCTs) published as of February 2023 and included in this meta-analysis. RESULTS: After screening 639 articles, 12 RCTs including 1,531 subjects were considered eligible for the meta-analysis. The results showed that the total International Prostate System Score (total IPSS), maximum flow rate (Qmax), and quality of life (QoL) in tadalafil combined with tamsulosin were significantly better than those in monotherapy. Compared with tadalafil monotherapy, combination therapy mainly improved IPSS voiding. As for postvoid residual urine (PVR), the combination therapy did not improve PVR compared to the tadalafil group, but significantly improved PVR compared to the tamsulosin group. For the International Index of Erectile Function (IIEF), the curative effect of the combined group was better than that of the tamsulosin group but not better than that of the tadalafil group. In terms of safety, the adverse reactions (AEs) in the combined treatment group were significantly higher than those in the monotherapy group. None of the 12 RCTs reported serious adverse events. CONCLUSIONS: Tadalafil combined with tamsulosin was more effective in the treatment of male LUTS/BPH, with or without ED, on the improvement of total IPSS, QoL, and Qmax. However, the benefits of combination therapy for ED remain unclear. However, combination therapy seemed to have a higher incidence of adverse reactions.

[Study of allelic variants of the CYP2D6 and CYP3A genes on the effectiveness and safety of tamsulosin therapy in patients with BPH: results of a pilot study].

INTRODUCTION: Tamsulosin is a member of the group of selective 1-adrenoblockers. Tamsulosin monotherapy is the most common first-line option in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and can be used regardless on severity of LUTS. The CYP2D6, CYP3A4, and CYP3A5 enzymes are involved in the metabolism of tamsulosin. Carriage of different allelic variants of CYP2D6, CYP3A4 and CYP3A5, involved in its metabolism, may potentially affect the variability of efficacy and safety of the drug. AIM: To evaluate the effect of carriage of allelic variants of cytochrome P450 superfamily enzyme genes (CYP2D6*3, CYP2D6*4, CYP2D6*9, CYP2D6*10, CYP2D6*41, CYP3A4*3, CYP3A4*22 and CYP3A5*3) on the efficiency and safety of tamsulosin in patients with LUTS associated with BPH. MATERIALS AND METHODS: All phases of the study were completed by 106 patients with LUTS/BPH (N40 according to ICD 10). All patients received monotherapy with tamsulosin 0.4 mg/day for a minimum of 8 weeks. Based on the severity of symptoms, they were divided into two groups using the International Prostate Symptom Score (IPSS). In Group 1, there were patients with moderate symptoms (IPSS score of 8-19) (n=57), while Group 2 consisted of those with severe symptoms (IPSS score >20) (n=49). Treatment outcomes were assessed using the IPSS score with determination of quality of life (QoL), transrectal ultrasound with evaluation of prostate volume and residual urine, and uroflowmetry. Follow-up visits were at 2, 4, and 8 weeks after the start of therapy. Genotyping of all patients was performed using polymerase chain reaction to determine the CYP2D6 (*3, *4, *9, *10, and *41), CYP3A4 (*3, *22), and CYP3A5*3 markers. RESULTS: In the group of patients with moderate symptoms, carriers of the CYP2D6*10 and CYP2D6*41 polymorphisms showed a significantly greater reduction in symptoms according to the overall IPSS score at 8 weeks (p=0.046) and in the micturition symptom subscale starting from 4 weeks of treatment (p<0.05). Carriers of the CYP2D6*10 polymorphism in both groups were associated with a decrease in residual urine volume at 8 weeks (p<0.05). The presence of the CYP3A5*3 variant in those with severe symptoms significantly improved quality of life during therapy. Allelic variants of the CYP2D6 and CYP3A genes did not affect the frequency of adverse events. CONCLUSION: The results obtained by calculating the prognostic significance of individual polymorphic markers pointed to the contribution of CYP2D6*10 and CYP2D6*41. Tamsulosin therapy is more effective in patients with LUTS who are carriers of these allele variants. The safety parameters of tamsulosin were not influenced by the studied polymorphic variants. It was found that CYP3A5*3 was associated with an increase in the subjective assessment of the patient's quality of life, but it is too early to draw final conclusions. The issue of the contribution of genetic factors to the efficiency and safety of treatment of LUTS in BPH requires further study with a larger sample size and analyzed parameters.