A comparison of nifedipine and tamsulosin as medical expulsive therapy for the management of lower ureteral stones without ESWL.
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SUBMITTER: Cao D
PROVIDER: S-EPMC4052729 | biostudies-other | 2014
REPOSITORIES: biostudies-other
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Project description:This research aims to evaluate the role of tamsulosin in the medical expulsion therapy for distal ureteral stones, including her effects in stone expulsion time, expulsion rates, stone size, pain episodes and analgesic dosage usage.The 104 patients with distal ureteral calculi were examined, with the size of the stones 4-10 mm. They were randomly divided into two groups: study group (n=52), received tamsulosin 0.4 mg in morning, for 28 days, analgesic (diclofenac 75 mg), high fluid intake and Control group (n=52) received analgesic (diclofenac 75 mg), high fluid intake.There is no significant difference between groups, based on sex (P=0.835) and age (P=0.987). Average size of the stones was 6.5 mm (SD ± 1.6 mm), with no significant difference (P=0.996). Stone expulsion rate is 90.4% in the study group and 71.2% from the control group, with statistical significance (P=0.023). The average time of the expulsion of stones in the study group was 9.6 days (SD ± 7.1 days), control group 13.7 days (SD ± 7.3 days), with statistical significance, (P=0.034). Average dose of analgesics in the study group was 63.7 mg (SD ± 45.2 mg), control group is 109.2 (SD ± 53.3), with statistical significance (P=0.019).Our study reveals that tamsulosin is efficient for the treatment of distal ureteral stones. Tamsulosin decrease the number of ureteral colic episodes, by acting as a spasmolytic, increase and hasten stone expulsion rates, reduce days of stone expulsion, decrease analgesic dose usage.
| S-EPMC5511523 | biostudies-other
Project description:Silodosin, a recently introduced selective ?-blocker, has a much higher selectivity for the ?-1A receptor. The efficacy and safety of silodosin compared to tamsulosin in medical expulsive therapy (MET) are controversial. The objective of this study was to assess the efficacy and safety of silodosin compared to tamsulosin for treating ureteral stones <10 mm in diameter. We systematically searched the PubMed, EMBASE, Cochrane library, and Scopus databases from their inception to May 2018. We included randomized controlled studies (RCTs) and observational studies, which investigated stone expulsion rates using silodosin compared to tamsulosin. Data were synthesized using a random-effects model. Sixteen studies with 1824 patients were eligible for inclusion. Silodosin achieved significantly higher expulsion rates than tamsulosin (pooled risk difference (RD): 0.13, 95% confidence interval (CI): 0.09 to 0.18, GRADE: high). A subgroup analyses showed that silodosin has a significantly higher expulsion rate on stone sizes of 5-10 mm than tamsulosin (pooled RD: 0.14, 95% CI: 0.06 to 0.22, I2 = 0%). The superior effect was not observed on stone sizes <5 mm. A multivariate regression showed that the RD was negatively associated with the control expulsion rate after adjusting for age and gender (coefficient -0.658, p = 0.01). A sensitivity analysis showed that our findings were robust. Patients receiving silodosin also probably had a significantly shorter expulsion time (pooled mean difference (MD): -2.55 days, 95% CI: -4.06 to -1.04, I2 = 85%, GRADE: moderate) and may have fewer pain episodes (pooled MD: -0.3, 95% CI: -0.51 to -0.09, GRADE: low) but a higher incidence of retrograde ejaculation by 5% compared to those receiving tamsulosin. In conclusion, compared to tamsulosin, silodosin provided significantly better stone passage for patients with ureteral stones (particularly for sizes of 5~10 mm), shorter expulsion times, and fewer pain episodes but caused a higher incidence of retrograde ejaculation.
| S-EPMC6112672 | biostudies-literature
Project description:ImportanceUrinary 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.ObjectiveTo determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients.Design, setting, and participantsWe 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.InterventionsParticipants were randomized to treatment with either tamsulosin, 0.4 mg, or matching placebo daily for 28 days.Main outcomes and measuresThe 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.ResultsThe 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 relevanceTamsulosin 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 registrationClinicalTrials.gov Identifier: NCT00382265.
| S-EPMC6082698 | biostudies-literature
Project description:ObjectiveTo systematically review and quantitively evaluate the efficacy and safety of mirabegron as a medical expulsive therapy for ureteral stones.MethodsWe performed an extensive search of the EMBASE and PubMed databases for studies examining the use of mirabegron as a medical expulsive therapy for ureteral stones. The primary outcome measure assessed was the stone expulsion rate (SER), while the secondary outcomes evaluated were the stone expulsion interval (SEI) and the occurrence of pain episodes during follow-up. Risk ratios (RRs) and mean differences (MDs) with their respective 95% CIs were calculated.ResultsWe included a total of seven studies involving 728 participants. Our analysis revealed a significant increase in the stone expulsion rate (SER) with mirabegron (RR = 1.40; 95% CI = 1.17-1.67; p < 0.001) and a reduction in the frequency of pain episodes (MD = -0.80; 95% CI = -0.39 to -0.21; p = 0.008) compared to the control group. No significant difference was found in SEI between the two groups (MD = -3.04; 95% CI = -6.33 to 0.25; p = 0.07). Subgroup analysis revealed that the increased SER was significant for distal ureteral stones, but not for proximal and middle ureter stones. Compared to tamsulosin or silodosin, mirabegron showed no significant difference in SER, SEI, or pain episode frequency. The adverse effects of mirabegron were relatively rare and mild.ConclusionMirabegron appears to be a promising candidate for the MET of distal ureteral stones rather than proximal and middle ureteral stones, as it significantly increases SER and reduces pain episode frequency. Further well-designed randomised controlled trials are needed to validate and affirm these findings.Systematic review registrationPROSPERO (CRD42022341603).
| S-EPMC10797003 | biostudies-literature
Project description:This study aims to evaluate the efficacy of tamsulosin and alfuzosin for the distal ureteral stone. This study assessed the spontaneous passage and expulsion of the stone.The study was conducted in the Department of Surgery at Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala, from May 2013 to May 2014. A total number of 136 patients diagnosed as distal ureteric stone (US) of size <10 mm were included in this study. It was divided into two groups (I and II) out of which 36 cases were excluded. Group I received tablet tamsulosin 0.4 mg/day, and Group II received alfuzosin 10 mg/day. The efficacy of tamsulosin and alfuzosin as an adjunctive medical therapy was determined.Both the drugs can be safely used for the distal USs. The stone expulsion rate was seen in 36 patients (72.0%) in Group I, and in 34 patients (68.0%) in Group II (P = 0.545). The passage of stones noticed by 32 patients in each Groups I and II (P = 1.000). The mean number of pain attacks was 2.91 ± 1.01 for Group I, and 1.8 ± 0.83 for Group II (P < 0.001 and P < 0.001). Thus, we propagate the use of alfuzosin significantly lower number of pain attacks. The drug-related side-effects were postural hypertension (four in Group I and one in Group II) and retrograde ejaculation (eight in Group I, and one in Group II). Thus, the difference was statistically significant in terms of retrograde ejaculation but insignificant for postural hypotension.There is no difference between both medications in term of efficacy (passing stones) for the management of distal ureteral stones. Both medications are safe and effective. In addition, alfuzosin was better tolerated than tamsulosin as it has fewer side effects.
| S-EPMC5525465 | biostudies-other
Project description:BackgroundAlfuzosin has been widely used to treat benign prostatic hyperplasia and prostatitis, and is claimed to be a selective agent for the lower urinary tract with low incidence of adverse side-effects and hypotensive changes. Recently, several randomized controlled trials have reported using Alfuzosin as an expulsive therapy of ureteral stones. Tamsulosin, another alpha blocker, has also been used as an agent for the expulsive therapy for ureteral stones. It is unclear whether alfuzosin has similar efficacy as Tamsulosin in the management of ureteral stones.ObjectiveTo perform a systematic review and analysis of literatures comparing Alfuzosin with Tamsulosin or standard conservative therapy for the treatment of ureteral stones less than 10 mm in diameter.MethodsA systematic literature review was performed in December 2014 using Pubmed, Embase, and the Cochrane library databases to identify relevant studies. All randomized and controlled trials were included. A subgroup analysis was performed comparing Alfuzosin with control therapy on the management of distal ureteral stones.ResultsAlfuzosin provided a significantly higher stone-free rate than the control treatments (RR: 1.85; 95% confidence interval [CI], 1.35-2.55; p<0.001), and a shorter stone expulsion time (Weighted mean difference [WMD]: -4.20 d, 95%CI, -6.19 to -2.21; p<0.001), but it has a higher complication rate (RR: 2.02; 95% CI, 1.30-3.15; p<0.01). When Alfuzosin was compared to Tamsulosin, there was no significant difference in terms of stone-free rate (RR: 0.90; 95% CI, 0.79-1.02; p = 0.09) as well as the stone expulsion time (WMD: 0.52 d, 95%CI, -1.61 to 2.64; p = 0.63). The adverse effects of Alfuzosin were similar to those of Tamsulosin (RR: 0.88; 95% CI, 0.61-1.26; p = 0.47).ConclusionsAlfuzosin is a safe and effective agent for the expulsive therapy of ureteral stones smaller than 10 mm in size. It is more effective than therapeutic regiment without alpha blocker. It is equivalent to Tamsulosin in its effectiveness and safety profile. Adverse effects should always be kept in mind when use this class of drugs.
| S-EPMC4526635 | biostudies-literature
Project description:BackgroundAlthough some trials assessed the efficacy and safety of the α-blocker in facilitating renal and ureteral stones expulsion after extracorporeal shock wave lithotripsy (ESWL), the role of the α-blocker in facilitating upper urinary calculi expulsion after ESWL remain controversial.AimsTo determine the efficacy and safety of the α-blocker in facilitating renal and ureteral stones expulsion after ESWL.MethodsA literature search was carried out using the PubMed database, EMBASE and the Cochrane Library database to identify relevant studies. Two reviewers independently extracted data and assessed methodological quality. Pooled effect estimates were obtained using a fixed- and random-effects meta-analysis.ResultsThe meta-analysis included 23 RCTs, α-blocker significantly enhanced expulsion rate of upper urinary tract calculi after ESWL (P<0.00001; RR 1.21; 95% CI 1.12-1.31), significantly promoted steinstrasse expulsion (P=0.03; RR 1.25; 95% CI 1.03-1.53), significantly shortened the discharge time of upper urinary tract calculi (P=0.0001; MD -2.12; 95% CI -3.20--1.04), significantly reduced the patient's pain VAS score (P=0.001; RR -1.0; 95% CI -1.61--0.39). Compared with the control group, dizziness (P=0.002; RR 5.48; 95% CI 1.91-15.77), anejaculation (P=0.02; RR 12.17; 95% CI 1.61-91.99) and headache (P=0.04; RR 4.03; 95% CI 1.04-15.72) in the α-blocker group was associated with a higher incidence.ConclusionsTreatment with α-blocker after ESWL appears to be effective in enhancing expulsion rate of upper urinary tract calculi, shortening the discharge time of upper urinary tract calculi, reducing the patient's pain. The side effects of α-blocker were light and few.
| S-EPMC4393103 | biostudies-literature
Project description:BACKGROUND:Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications.Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective ?-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation.This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones. METHODS/DESIGN:The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo.Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The primary economic outcome is a reduction in the incremental cost per quality-adjusted life years, determined at 12 weeks. The analysis will be based on all participants as randomized (intention to treat). The trial has 90% power with a type I error rate of 5% to detect a 10% increase in primary outcome between the tamsulosin and nifedipine treatment groups. TRIAL REGISTRATION:ISRCTN69423238; EudraCT number: 2010-019469-26.
| S-EPMC4090633 | biostudies-literature
Project description:This study aimed to investigate the clinical outcomes of causative microorganisms in obstructive pyelonephritis associated with ureteral stones (OPU) and their antibiotic susceptibilities. This retrospective cohort study included female patients diagnosed with community-acquired acute pyelonephritis (APN) at a tertiary-care hospital between 2008 and 2017. A comparison of APN cases associated with the obstruction of the upper urinary tract by ureteral stones and APN cases without complications was performed. Propensity score (PS) matching was used to adjust the heterogeneity within each group. Of the 588 female patients with community-acquired APN, 107 were diagnosed with OPU and 481 with uncomplicated APN. After PS matching, Enterobacteriaceae strains isolated from OPU cases were more resistant to fluoroquinolones (51.9% vs 16.0%, P < .001). Extended-spectrum β-lactamase was detected in 22.2% and 21.0% of the Enterobacteriaceae strains isolated from OPU and uncomplicated APN cases, respectively (P = 1.000). The treatment failure rate was similar in OPU and uncomplicated APN groups (16.0% vs 21.0%, P = .545). Patients with OPU may be empirically treated with antibiotics in accordance with the treatment protocol for general pyelonephritis. Clinicians should exercise caution in prescribing fluoroquinolones for treating OPU.
| S-EPMC9410613 | biostudies-literature
Project description:Ureteric colic, the term used to describe the pain felt when a stone passes down the ureter from the kidney to the bladder, is a frequent reason for people to seek emergency health care. Treatment with the muscle-relaxant drugs tamsulosin hydrochloride (Petyme, TEVA UK Ltd) and nifedipine (Coracten(®), UCB Pharma Ltd) as medical expulsive therapy (MET) is increasingly being used to improve the likelihood of spontaneous stone passage and lessen the need for interventional procedures. However, there remains considerable uncertainty around the effectiveness of these drugs for routine use.To determine whether or not treatment with either tamsulosin 400 µg or nifedipine 30 mg for up to 4 weeks increases the rate of spontaneous stone passage for people with ureteric colic compared with placebo, and whether or not it is cost-effective for the UK NHS.A pragmatic, randomised controlled trial comparing two active drugs, tamsulosin and nifedipine, against placebo. Participants, clinicians and trial staff were blinded to treatment allocation. A cost-utility analysis was performed using data gathered during trial participation.Urology departments in 24 UK NHS hospitals.Adults aged between 18 and 65 years admitted as an emergency with a single ureteric stone measuring ≤ 10 mm, localised by computerised tomography, who were able to take trial medications and complete trial procedures.Eligible participants were randomised 1 : 1 : 1 to take tamsulosin 400 µg, nifedipine 30 mg or placebo once daily for up to 4 weeks to make the following comparisons: tamsulosin or nifedipine (MET) versus placebo and tamsulosin versus nifedipine.The primary effectiveness outcome was the proportion of participants who spontaneously passed their stone. This was defined as the lack of need for active intervention for ureteric stones at up to 4 weeks after randomisation. This was determined from 4- and 12-week case-report forms completed by research staff, and from the 4-week participant self-reported questionnaire. The primary economic outcome was the incremental cost per quality-adjusted life-year (QALY) gained over 12 weeks. We estimated costs from NHS sources and calculated QALYs from participant completion of the European Quality of Life-5 Dimensions health status questionnaire 3-level response (EQ-5D-3L™) at baseline, 4 weeks and 12 weeks.Primary outcome analysis included 97% of the 1167 participants randomised (378/391 tamsulosin, 379/387 nifedipine and 379/399 placebo participants). The proportion of participants who spontaneously passed their stone did not differ between MET and placebo [odds ratio (OR) 1.04, 95% confidence interval (CI) 0.77 to 1.43; absolute difference 0.8%, 95% CI -4.1% to 5.7%] or between tamsulosin and nifedipine [OR 1.06, 95% CI 0.74 to 1.53; absolute difference 1%, 95% CI -4.6% to 6.6%]. There was no evidence of a difference in QALYs gained or in cost between the trial groups, which means that the use of MET would be very unlikely to be considered cost-effective. These findings were unchanged by extensive sensitivity analyses around predictors of stone passage, including sex, stone size and stone location.Tamsulosin and nifedipine did not increase the likelihood of stone passage over 4 weeks for people with ureteric colic, and use of these drugs is very unlikely to be cost-effective for the NHS. Further work is required to investigate the phenomenon of large, high-quality trials showing smaller effect size than meta-analysis of several small, lower-quality studies.Current Controlled Trials ISRCTN69423238. European Clinical Trials Database (EudraCT) number 2010-019469-26.This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 63. See the NIHR Journals Library website for further project information.
| S-EPMC4781616 | biostudies-other