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Current Urology Reports Oct 2020Aim of our systematic review is to evaluate and summarize the efficacy and safety of tadalafil alone or in combination with tamsulosin for the management of lower... (Review)
Review
PURPOSE OF REVIEW
Aim of our systematic review is to evaluate and summarize the efficacy and safety of tadalafil alone or in combination with tamsulosin for the management of lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and erectile dysfunction (ED).
RECENT FINDINGS
Daily tadalafil, in particular 5 mg, according to retrieved studies, appears to be both safe and effective in treating LUTS/BPH and ED, compared with placebo or tamsulosin. The combination of daily tadalafil 5 mg and tamsulosin 0.4 mg allows a better improvement of LUTS compared with both the monotherapies, even if with an increased, but acceptable and tolerated, adverse events rate. After discontinuation of tamsulosin or tadalafil in patients previously treated with their combination, the improvement of LUTS retains significance compared with baseline. Tadalafil 5 mg should be considered a primary treatment option for patients with LUTS/BPH and ED. Evidence highlight an excellent tolerability, safety, and effectiveness profile, both alone or in combination with tamsulosin 0.4 mg. A better efficacy on LUTS relief has been observed for combination therapy, preserving also sexual function. The further switch to monotherapy allows to preserve LUTS relief, but tadalafil only is able to retain ED improvement. Our results support the evidence for a more and more tailored and modular LUTS treatment.
Topics: Combined Modality Therapy; Erectile Dysfunction; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Randomized Controlled Trials as Topic; Tadalafil; Tamsulosin; Treatment Outcome; Urological Agents
PubMed: 33108544
DOI: 10.1007/s11934-020-01009-7 -
JAMA Internal Medicine Aug 2018Urinary stone disease is a common presentation in the emergency department, and α-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Urinary stone disease is a common presentation in the emergency department, and α-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate stone passage.
OBJECTIVE
To determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients.
DESIGN, SETTING, AND PARTICIPANTS
We conducted a double-blind, placebo-controlled clinical trial from 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase). Participants were followed for 90 days. The first phase was conducted at a single US emergency department; the second phase was conducted at 6 US emergency departments. Adult patients were eligible to participate if they presented with a symptomatic urinary stone in the ureter less than 9 mm in diameter, as demonstrated on computed tomography.
INTERVENTIONS
Participants were randomized to treatment with either tamsulosin, 0.4 mg, or matching placebo daily for 28 days.
MAIN OUTCOMES AND MEASURES
The primary outcome was stone passage based on visualization or capture by the study participant by day 28. Secondary outcomes included crossover to open-label tamsulosin, time to stone passage, return to work, use of analgesic medication, hospitalization, surgical intervention, and repeated emergency department visit for urinary stones.
RESULTS
The mean age of 512 participants randomized to tamsulosin or placebo was 40.6 years (range, 18-74 years), 139 (27.1%) were female, and 110 (22.8%) were nonwhite. The mean (SD) diameter of the urinary stones was 3.8 (1.4) mm. Four hundred ninety-seven patients were evaluated for the primary outcome. Stone passage rates were 50% in the tamsulosin group and 47% in the placebo group (relative risk, 1.05; 95.8% CI, 0.87-1.27; P = .60), a nonsignificant difference. None of the secondary outcomes were significantly different. All analyses were performed according to the intention-to-treat principle, although patients lost to follow-up before stone passage were excluded from the analysis of final outcome.
CONCLUSIONS AND RELEVANCE
Tamsulosin did not significantly increase the stone passage rate compared with placebo. Our findings do not support the use of tamsulosin for symptomatic urinary stones smaller than 9 mm. Guidelines for medical expulsive therapy for urinary stones may need to be revised.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00382265.
Topics: Adolescent; Adrenergic alpha-1 Receptor Antagonists; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Emergency Service, Hospital; Female; Follow-Up Studies; Humans; Male; Middle Aged; Retrospective Studies; Tamsulosin; Tomography, X-Ray Computed; Treatment Outcome; Ureteral Calculi; Urination; Young Adult
PubMed: 29913020
DOI: 10.1001/jamainternmed.2018.2259 -
Indian Journal of Pharmacology 2016Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting elderly males, often associated with lower urinary tract symptoms (LUTS). α1-blockers... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting elderly males, often associated with lower urinary tract symptoms (LUTS). α1-blockers are the mainstay in symptomatic therapy of BPH. Because of their greater uroselectivity and minimal hemodynamic effects, alfuzosin, tamsulosin, and silodosin are generally preferred. The aim of this study was to compare the efficacy and tolerability of alfuzosin, tamsulosin, and silodosin in patients with BPH and LUTS.
METHODS
Ninety subjects with BPH and LUTS were randomized into three groups of thirty in each, to receive alfuzosin sustained release (SR) 10 mg, tamsulosin 0.4 mg, or silodosin 8 mg for 12 weeks. The primary outcome measure was a change in the International Prostate Symptom Score (IPSS), and the secondary outcome measures were changes in individual subjective symptom scores, quality of life score (QLS), and peak flow rate (Qmax) from baseline. The treatment response was monitored at 2, 4, 8, and 12 weeks.
RESULTS
IPSS improved by 88.18%, 72.12%, and 82.23% in alfuzosin SR, tamsulosin and silodosin groups (P < 0.001) at 12 weeks. Improvement in QLS was >75% in all the three groups (P < 0.001). A significant improvement in Qmax was seen with alfuzosin and tamsulosin (P = 0.025 and P < 0.001) but not with silodosin (P = 0.153). However, the intergroup differences in IPSS, QLS, and Qmax were not significant. Ejaculatory dysfunction was more common with silodosin and corrected QT (QTc) prolongation occurred only with alfuzosin (two subjects) and tamsulosin (three subjects).
CONCLUSION
Alfuzosin, tamsulosin, and silodosin showed similar efficacy in improvement of LUTS secondary to BPH, with good tolerability, acceptability, and minimum hemodynamic adverse effects. Alfuzosin, tamsulosin, and silodosin are comparable in efficacy in symptomatic management of BPH. The occurrence of QTc prolongation in three subjects with tamsulosin in the present study is an unexpected adverse event as there are no reports of QTc prolongation with tamsulosin in any of the previous studies.
Topics: Adrenergic alpha-1 Receptor Antagonists; Aged; Humans; Indoles; Male; Middle Aged; Prostatic Hyperplasia; Quinazolines; Sulfonamides; Tamsulosin; Treatment Outcome; Urological Agents
PubMed: 27127315
DOI: 10.4103/0253-7613.178825 -
Veterinary Sciences Oct 2022The incidence of diseases associated with feline ureteral obstruction is increasing; however, non-surgical treatment options are limited. This study evaluated the...
The incidence of diseases associated with feline ureteral obstruction is increasing; however, non-surgical treatment options are limited. This study evaluated the outcome of medical treatment in cats with obstructive ureteral stones treated with tamsulosin and identified potential factors predicting spontaneous stone passage. We retrospectively reviewed 70 client-owned cats treated at the Western Referral Animal Medical Center, Seoul, Korea, from 2018 to 2022. All the cats had obstructive ureterolithiasis and were treated using tamsulosin. The baseline characteristics of the cats, stone diameter and location, and stone passage outcomes were analyzed. Stone passage occurred in 22 cats; the remaining 48 cats showed no change in stone locations. Sex, creatinine, and diameter and location of stones were potential risk factors associated with successful stone passage, but age, weight, and side of the stone were not. No serious adverse events related to tamsulosin treatment were observed. This is the first study to identify the risk factors predictive of the spontaneous stone passage of cats with obstructive ureterolithiasis after tamsulosin treatment. Tamsulosin could be an alternative treatment for ureteral obstruction in male cats with smaller distal ureteral stones and low baseline serum creatinine levels. These findings could help develop guidelines for treating feline ureterolithiasis.
PubMed: 36288181
DOI: 10.3390/vetsci9100568 -
BMC Urology Dec 2021To assess the use and safety of free combination therapy (dutasteride and tamsulosin), dutasteride monotherapy, or tamsulosin monotherapy in patients with benign...
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.
Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adult; Aged; Databases, Factual; Drug Therapy, Combination; Dutasteride; Humans; Male; Middle Aged; Prostatic Hyperplasia; Republic of Korea; Retrospective Studies; Tamsulosin
PubMed: 34933674
DOI: 10.1186/s12894-021-00941-1 -
Archivio Italiano Di Urologia,... Feb 2023To compare the efficacy of Tamsulosin, Silodosin and Tadalafil as a medical expulsive therapy for treatment of distal ureteral calculi. (Comparative Study)
Comparative Study Randomized Controlled Trial
OBJECTIVE
To compare the efficacy of Tamsulosin, Silodosin and Tadalafil as a medical expulsive therapy for treatment of distal ureteral calculi.
PATIENTS AND METHODS
Over a period of 6 months (January 2022 to June 2022) this prospective randomized study was conducted on 170 patients with distal ureteric stone ≤ 10 mm. Patients were randomly divided into three groups. Patients in group A received Tamsulosin 0.4mg, in group B received Silodosin, and in group C receive Tadalafil 5 mg. Therapy was given for a maximum of 4 weeks. The rate and time of stone expulsion, the analgesic use, attacks of colic and hospital visits for pain, and adverse effects of drugs were recorded.
RESULTS
Among 170 patients who were enrolled in study, 20 were lost to follow-up (7, 8, 5 in group A, B, And C respective-ly). There was a significant higher stone passage rate in group C than group A and B (90% vs. 70% and 76% respectively; p-value = 0.043) and shorter expulsion time in group C (8.7 ± 3.3 days) vs. group A (12.5 ± 5.2 days) and group B (11.3 ± 4.2 days) with (p-value = 0.001)(highly statistically significant with p-value < 0.001) and increased amount of analgesics required in group A (225 ± 115.7 mg) and group B (163 ± 77.5 mg) when compared with group C (120 ± 55.3 mg).
CONCLUSION
Tadalafil is more effective than Tamsulosin and Silodosin in treatment of patients with distal ureteric stones ≤ 10 mm as regard stone expulsion rate, expulsion time with decreased number of colicky episodes and side effects.
Topics: Humans; Male; Female; Adult; Middle Aged; Prospective Studies; Tamsulosin; Ureteral Calculi; Tadalafil; Urological Agents; Indoles; Treatment Outcome
PubMed: 36924384
DOI: 10.4081/aiua.2023.10849 -
American Journal of Men's Health 2023Lower urinary tract symptoms (LUTS) secondary to benign prostrate hyperplasia (BPH) are common geriatric diseases, and its incidence rises with age. The treatment of BPH... (Meta-Analysis)
Meta-Analysis
A Systematic Review and Meta-Analysis of the Efficacy and Safety of Tamsulosin Plus Tadalafil Compared With Tamsulosin Alone in Treating Males With Lower Urinary Tract Symptoms Secondary to Benign Prostrate Hyperplasia.
Lower urinary tract symptoms (LUTS) secondary to benign prostrate hyperplasia (BPH) are common geriatric diseases, and its incidence rises with age. The treatment of BPH and LUTS is becoming a burden for health care. The meta-analysis was performed to evaluate the efficacy and safety of combination therapy (tamsulosin plus tadalafil) compared with tamsulosin alone in treatment of males with LUTS/BPH. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were utilized to conduct this study. There were several databases available for literature retrieval, including Medline, Embase, PubMed, Scopus, Web of Science databases, and Cochrane Controlled Trials Register. To improve the comprehensiveness of the search, related references were also searched. Finally, six randomized controlled trials including 441 patients were included. The combination therapy had significant improvements in total International Prostate Symptom Score ( < .0001), quality of life score ( = .003), maximum urine flow rate ( < .00001), and International Index of Erectile Function ( < .00001) compared with the tamsulosin monotherapy, but there was no obvious difference in postvoid residual volume ( = .06). In terms of safety, the combination group had comparable rates of discontinuation due to adverse events ( = .19) than the monotherapy group except for pain symptoms ( < .0001). The combination of tamsulosin and tadalafil provided a preferable therapeutic effect compared with the tamsulosin alone in treating males with BPH/LUTS, and both therapy regimens were well tolerated by the patients.
Topics: Male; Humans; Aged; Tamsulosin; Tadalafil; Prostatic Hyperplasia; Hyperplasia; Quality of Life; Erectile Dysfunction; Drug Therapy, Combination; Treatment Outcome; Lower Urinary Tract Symptoms; Randomized Controlled Trials as Topic
PubMed: 36842963
DOI: 10.1177/15579883231155096 -
Medicina (Kaunas, Lithuania) Dec 2022Background and Objectives: This systematic review and meta-analysis of randomized controlled trials was performed to compare the therapeutic effects and safety profiles... (Review)
Review
Background and Objectives: This systematic review and meta-analysis of randomized controlled trials was performed to compare the therapeutic effects and safety profiles of silodosin and tamsulosin for medical expulsive therapy (MET) of ureteral stones. Materials and Methods: We searched PubMed, EMBASE, the Cochrane Library, and Web of Science to identify articles published before July 2022 that described randomized controlled trials comparing silodosin and tamsulosin for MET of ureteral stones. Endpoints were stone expulsion rate, stone expulsion time, and total complication rate. Results: In total, 14 studies were included in our analysis. The size of ureteral stones was <1 cm. Compared with tamsulosin, silodosin resulted in a significantly higher stone expulsion rate (p < 0.01, odds ratio (OR) = 2.42, 95% confidence interval (CI) = 1.91 to 3.06, I2 = 0%) and significantly shorter stone expulsion time (p < 0.01, mean difference = −3.04, 95% CI = −4.46 to −1.63, I2 = 89%). The total complication rate did not significantly differ between silodosin and tamsulosin (p = 0.33, OR = 1.15, 95% CI = 0.87 to 1.52, I2 = 7%). Conclusions: Compared with tamsulosin, silodosin resulted in significantly better expulsion of ureteral stones <1 cm. The total complication rate did not significantly differ between silodosin and tamsulosin. Thus, silodosin may be superior to tamsulosin for MET of ureter stones <1 cm.
Topics: Humans; Tamsulosin; Ureteral Calculi; Adrenergic alpha-1 Receptor Antagonists; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 36556996
DOI: 10.3390/medicina58121794