A Comparison of Boron Supplement and Tamsulosin as Medical Expulsive Therapy for Urinary Stones After Extracorporeal Shock Wave Lithotripsy: a Randomized Controlled Clinical Trial.

Treatment with alpha-blockers has been used in many studies to facilitate stone clearance after extra-corporeal shock wave lithotripsy (ESWL), based on mediating ureteral wall relaxation. Ureteral wall edema is another barrier against the stone passage. We aimed to compare the effectiveness of boron supplement (due to its anti-inflammatory effect) and tamsulosin in the passage of stone fragments after ESWL. Eligible patients after ESWL were randomly assigned to two groups and were treated with boron supplement (10 mg/BD) or tamsulosin (0.4 mg per night) for 2 weeks. The primary outcome was the stone expulsion rate according to the remained fragmented stone burden. The secondary outcomes were the time of stone clearance, pain intensity, drug side effects, and the need for auxiliary procedures. In this randomized control trial, 200 eligible patients were treated with boron supplement or tamsulosin. Finally, 89 and 81 patients in the two groups completed the study, respectively. The expulsion rate was 46.6% in the boron and 38.7% in the tamsulosin group, which there was no statistically significant difference between the two groups (p = 0.003), as well as the time of stone clearance (7.47 ± 22.4 vs 6.52 ± 18.45, days, p = 0.648, respectively), after 2-week follow-up. Moreover, pain intensity was the same in both groups. No Significant side effects were reported in the two groups. Boron supplement could be effective as adjuvant medical expulsive therapy after ESWL with no significant side effects in short-term follow-up. Iranian Clinical Trial Registration number and date of registration: IRCT20191026045244N3, 07/29/2020.

Gilaburu extract (Viburnum opulus Linnaeus) is as effective as Tamsulosin in medical expulsive therapy of distal ureteral calculi.

BACKGROUND: To compare the extract of Gilaburu (Viburnum opulus Linnaeus) and Tamsulosin as a medical expulsive therapy (MET) in patients with distal ureteral calculi of 10 mm or less. METHODS: Data of 86 patients were prospectively collected. The patients were divided into two groups. In the first group, Viburnum opulus 1000 mg peroral 3 × 2 and diclofenac 50 mg peroral on-demand (n = 43), in the second group Tamsulosin 0.4 mg peroral 1 × 1 and diclofenac 50 mg peroral on-demand (n = 43) was given for MET in patients with distal ureteral calculi. Stone expulsion rates, time until expulsion, additional analgesic requirement, need for emergency admission, need for additional treatment were evaluated. In addition, subgroup analyses of ≤5 and 5-10 mm were also performed. RESULTS: There was no difference between the groups in terms of stone expulsion rates and time until the expulsion in all stones. Additional analgesic requirement and need for emergency admission were found to be lower in the Viburnum opulus group (37.2% vs 65.1%, P = .017 and 11.6% vs 34.8%, P = .02, respectively). In subgroup analyses, while stone expulsion rates were similar in subgroups, it was found shorter in the time until expulsion, lower additional analgesic requirement and need for emergency admission in V. opulus group than Tamsulosin group in 5-10 mm stone size subgroup (7.1 ± 4.2 vs 11.8 ± 5.2, P = .005, 32.2% vs 77.7%, P = .001 and 12.9% vs 40.7%, respectively). CONCLUSION: V. opulus can be used effectively and safely for the treatment of MET in distal ureteral calculi.

Comparison of the efficacy of silodosin and a terpene combination in the medical expulsive therapy of distal ureteral stones.

OBJECTIVE: We aimed to compare the efficacy of silodosin and a terpene combination in the treatment of distal ureteral stones. METHODOLOGY: The data of the patients admitted to the urology policlinic with renal colic, diagnosed with distal ureteral stones, and followed up with medical expulsive therapy between December 2017 and June 2018 were retrospectively reviewed. The patients were divided into two groups: Group 1 comprised 72 patients that received 8 mg/day silodosin and Group 2 consisted of 51 patients that were given three capsules of a terpene combination daily. The groups were compared in terms of the patients' demographic characteristics, medical history, localisation of the present stone, renal collecting system status, daily fluid intake, number of emergency service visits, number of additional analgesic applications needed, number of pain attacks, number of days off work, stone expulsion rate and time to stone expulsion. RESULTS: Of the total 123 patients, 98 (79.7%) were stone-free. The stone-free rate was 75.0% in Group 1 and 86.3% in Group 2, with no statistical difference between the two groups. However, the number of visits to the emergency service because of pain, number of additional analgesic applications required, number of days off work, and time to stone expulsion were statistically significantly lower in Group 2 than in Group 1. CONCLUSIONS: The treatment of distal ureteral stones with silodosin is as effective as the terpene combination. However, the terpene combination is more effective than silodosin in managing pain and accelerating stone expulsion.

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.

Comparative efficacy of tamsulosin versus nifedipine for distal ureteral calculi: a meta-analysis.

OBJECTIVE: The aim of this study was to systematically compare the therapeutic effect and safety of tamsulosin with nifedipine in medical expulsive therapy for distal ureteral calculi. METHODS: Databases, including PubMed, EMBASE, the Cochrane Library, and Clinical Trial Register Centers, were comprehensively searched. Relevant randomized controlled trials (RCTs) were selected, and quality assessment was performed according to the Cochrane Handbook. RevMan software was used to analyze the outcome measures, which consisted of expulsion rate, expulsion time, and complications. RESULTS: Twelve RCTs consisting of 4,961 patients were included (tamsulosin group, 2,489 cases; nifedipine group, 2,472 cases). Compared with nifedipine, tamsulosin significantly increased the expulsion rate (risk ratio =1.29, 95% CI [1.25, 1.33], P<0.0001) and reduced the expulsion time (standard mean difference =-0.39, 95% CI [-0.72, -0.05], P=0.02). Regarding safety, tamsulosin was associated with fewer complications than nifedipine (risk ratio =0.45, 95% CI [0.28, 0.72], P=0.0008), and further subgroup analysis showed that tamsulosin was associated with a lower risk of both mild and moderate-to-severe complications. CONCLUSION: On the bias of current evidence, tamsulosin showed an overall superiority to nifedipine for distal ureteral calculi <10 mm in aspects of expulsion rate, expulsion time, and safety. Tamsulosin was supposed to be the first drug to be recommended to patients willing to receive medical expulsive therapy.

The importance of citrates in treatment and prophylaxis of calcium oxalate urinary stones.

About 10% of the people is the subject of an episode of kidney stones during their lifetime, about 70% of these people undergoes relapses. About 80% of the urinary stones contains calcium, of wich 80% is formed of calcium oxalate, in pure form or associated with calcium phosphate. Therefore we can saythat in most cases (about 65%) the urinary stones are composedof calcium oxalate. Use of supplements of potassium citrate and magnesium citrate can help in the prevention of kidney stones of calcium oxalate, but mostly they can be used in the days before a shockwaves lithotripsy treatment to make the stones more fragile to the effect of the shock waves. A case of successful treatment with magnesium potassium citrate of a SWL resistant ureteral stone is presented.

Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial.

BACKGROUND: Meta-analyses of previous randomised controlled trials concluded that the smooth muscle relaxant drugs tamsulosin and nifedipine assisted stone passage for people managed expectantly for ureteric colic, but emphasised the need for high-quality trials with wide inclusion criteria. We aimed to fulfil this need by testing effectiveness of these drugs in a standard clinical care setting. METHODS: For this multicentre, randomised, placebo-controlled trial, we recruited adults (aged 18-65 years) undergoing expectant management for a single ureteric stone identified by CT at 24 UK hospitals. Participants were randomly assigned by a remote randomisation system to tamsulosin 400 µg, nifedipine 30 mg, or placebo taken daily for up to 4 weeks, using an algorithm with centre, stone size (≤5 mm or >5 mm), and stone location (upper, mid, or lower ureter) as minimisation covariates. Participants, clinicians, and trial personnel were masked to treatment assignment. The primary outcome was the proportion of participants who did not need further intervention for stone clearance within 4 weeks of randomisation, analysed in a modified intention-to-treat population defined as all eligible patients for whom we had primary outcome data. This trial is registered with the European Clinical Trials Database, EudraCT number 2010-019469-26, and as an International Standard Randomised Controlled Trial, number 69423238. FINDINGS: Between Jan 11, 2011, and Dec 20, 2013, we randomly assigned 1167 participants, 1136 (97%) of whom were included in the primary analysis (17 were excluded because of ineligibility and 14 participants were lost to follow-up). 303 (80%) of 379 participants in the placebo group did not need further intervention by 4 weeks, compared with 307 (81%) of 378 in the tamsulosin group (adjusted risk difference 1·3% [95% CI -5·7 to 8·3]; p=0·73) and 304 (80%) of 379 in the nifedipine group (0·5% [-5·6 to 6·5]; p=0·88). No difference was noted between active treatment and placebo (p=0·78), or between tamsulosin and nifedipine (p=0·77). Serious adverse events were reported in three participants in the nifedipine group (one had right loin pain, diarrhoea, and vomiting; one had malaise, headache, and chest pain; and one had severe chest pain, difficulty breathing, and left arm pain) and in one participant in the placebo group (headache, dizziness, lightheadedness, and chronic abdominal pain). INTERPRETATION: Tamsulosin 400 µg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Tamsulosin versus nifedipin in medical expulsive therapy for distal ureteral stones and the predictive value of Hounsfield unit in stone expulsion.

We evaluated the efficacy of tamsulosin and nifedipine in medical expulsive therapy (MET) in patients with distal ureteral stone. In addition, we tried to determine the predictive value of Hounsfield Unit (HU) of the stone in the success of MET. A total of 75 patients with a distal ureteral stone of 5-10 mm diameter were randomly divided into three groups. Group 1 (n = 25) received tamsulosin 0.4 mg/d; group 2 (n = 25) received nifedipine 10 mg/day p.o and group 3 (n = 25) received diclofenac sodium 50 mg p.o. when required. At the beginning of each treatment, the HU of the stone was also measured using a non-contrast computerized tomography in all the patients. The results were evaluated at week four. The mean age of the patients was 36.8 (range, 16-68) years. Stone expulsion was observed in 19 (76%) patients in group 1, 16 (64%) patients in group 2 and 9 (36%) patients in group 3 (pgroup1-3 = 0.004, pgroup2-3 = 0.048 and pgroup1-2 = 0.355). The mean expulsion time was 9, 9.1 and 10.3 d, respectively (pgroup1-3 < 0.001, pgroup2-3 < 0.001 and pgroup1-2 = 0.619). The mean diclofenac sodium dose per patient was 544, 602 and 1408 mg in groups 1, 2 and 3, respectively (pgroup1-3 < 0.001, pgroup2-3 < 0.001 and pgroup1-2 = 0.977). The mean HU of the stone in patients with and without a successful MET was 363 and 389, respectively (p = 0.462). Our results showed that MET with both nifedipine and tamsulosin provided a similar increase in the expulsion rate for distal ureteral stones. HU does not seem to be a predictive parameter for stone expulsion.

Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial.

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 α-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.

Terpene compound drug as medical expulsive therapy for ureterolithiasis: a meta-analysis.

The aim of this study is to investigate the efficacy of terpene compound drug (pinene, camphene, borneol, anethole, fenchone and cineol in olive oil) in facilitating spontaneous passage of ureteral calculi through meta-analysis of randomized controlled trials (RCT). Systematic literature search on MEDLINE, EMBASE, OVID, Science Direct, Proquest, Google scholar, Cochrane Library databases and reference list of related literatures were done without language restriction. RCTs on ureterolithiasis medical expulsive therapy (MET) that compare terpene compound drug versus placebo/control group or alpha-blockers were identified. Articles retrieved were critically appraised by two independent reviewers according to Cochrane Collaboration recommendations. Data from included studies were extracted for calculation of risk ratio (RR) and 95 % confidence interval (CI). Effect estimates were pooled using Mantel-Haenszel method with random effect model. Inter-study heterogeneity and publication bias were assessed. The PRISMA guidelines for meta-analysis reporting were followed. Five RCTs (total of 344 subjects) of adequate methodological quality were included. Pooled effect estimates from homogenous studies showed that compared to placebo/control group, patients treated with terpene compound drug had significantly better ureteral calculi spontaneous expulsion rate (pooled RR: 1.34; 95 % CI 1.12, 1.61). Subgroup analysis of studies that compare terpene compound drug with alpha-blockers showed no significant difference (pooled RR: 0.79; 95 % CI 0.59, 1.06), while significant inter-study heterogeneity was noted. Only minor gastrointestinal adverse effect was reported on terpene compound drug use. The results suggest that terpene compound drug as MET is effective in augmenting spontaneous passage of ureterolithiasis. High quality large-scale RCTs comparing alpha-blockers and terpene compound drug are warranted to make a more definitive conclusion.

Evaluation of the efficiency of tamsulosin and Rowatinex in patients with distal ureteral stones: a prospective, randomized, controlled study.

PURPOSE: To compare the efficiency and spontaneous expulsion rates of tamsulosin and Rowatinex in patients with distal ureteral stones. METHODS: Between March and July 2009, 90 patients with distal ureteral stones <10 mm in size were included in the study. Patients were randomized in 3 groups: Group 1 (n = 31, those received 0.4 mg tamsulosin once daily), Group 2 (n = 30, those received 100 mg Rowatinex capsules 3 times a day), and Group 3 (n = 29, those received diclofenac 100 mg once daily). All patients were followed up for 10 days. RESULTS AND CONCLUSIONS: Mean age of the patients was 42.4 ± 16.1 (range, 22-75), 46.5 ± 16.5 (range, 22-76), and 43.5 ± 16.6 (range, 18-71) years in Groups 1-3, respectively. On admission, 37.8% had hematuria and 78.9% had lower urinary tract symptoms (LUTS). No statistically significant differences were detected between the three groups regarding patient age, gender, mean stone size, stone location, stone site, additional analgesic requirement, number of ureteral colics during the treatment, and upper urinary tract dilation. The mean stone expulsion time was 3.5 days in Group 1, 6 days in Group 2, and 7 days in Group 3 (P = 0.02). Stone expulsion rate was significantly high in Group 1 compared to Group 2 (P = 0.002). Similarly, stone expulsion rate was significantly high in Group 1 compared to Group 3 (P = 0.001). Medical treatment with tamsulosin seems to be effective in patients with distal ureteral stones <10 mm in size. However, use of Rowatinex does not seem to have any significant effect on clearance rate of distal ureteral calculi.

A multicentre, prospective, randomized trial: comparative efficacy of tamsulosin and nifedipine in medical expulsive therapy for distal ureteric stones with renal colic.

OBJECTIVE: • To determine the comparative efficacy of tamsulosin and nifedipine in medical expulsive therapy (MET) for distal ureteric stones with renal colic. PATIENTS AND METHODS: • We evaluated the comparative efficacy of tamsulosin and nifedipine in MET in a prospective randomized trial of 3189 outpatients from 10 centres in China. • Eligible patients randomly received tamsulosin or nifedipine. Efficacies of the two agents in MET were compared at 4 weeks. • The primary endpoint was overall stone-expulsion rate. • Secondary endpoints were stone-expulsion time, rate of pain relief therapy, mean analgesic consumption for renal colic recurrence, and side-effects incidence. RESULTS: • Stone-expulsion rates in the tamsulosin group (group 1) were greater than those in the nifedipine group (group 2; P < 0.01). • There was a significant variation in stone-expulsion rates and times between groups 1 and 2 (P < 0.01); with improvements in stone-expulsion rate and time significantly better in group 1 than in group 2. • There was a significant variation in the rate of pain relief therapy for renal colic recurrence between groups 1 and 2 (P < 0.01); patients in group 1 required significantly less analgesics than those in group 2 (P < 0.01). • There were no statistically significant differences in side-effects incidence between the groups. CONCLUSIONS: • Administration of tamsulosin and nifedipine in MET was determined to be safe and effective for distal ureteric stones with renal colic. • Tamsulosin was significantly better than nifedipine in relieving renal colic and facilitating ureteric stone expulsion.

Facilitation of expulsion of ureteral stones by addition of α1-blockers to conservative therapy.

OBJECTIVE: An antispasmodic agent and a medicine that facilitates stone expulsion are given commonly as conservative therapy for ureteral stones in Japan. The goal of this study was to compare the efficacy of the addition of various α(1)-blockers to the conservative therapy for spontaneous passage of ureteral stones. MATERIAL AND METHODS: The subjects were 132 patients with stones from the upper to the lower ureter who were randomly placed into one of four groups and followed for 1 month to assess spontaneous passage of stones. The control group received daily doses of 240 mg flopropione as an antispasmodic agent and 1350 mg extract of Quercus salicina Blume/Quercus stenophylla Makino as a medicine that facilitates stone expulsion. The other three groups received this therapy and daily doses of 30 mg urapidil, 0.2 mg tamsulosin or 50 mg naftopidil, respectively. The characteristics of the stones and stone expulsion were evaluated by urinalysis, a kidney, ureter and bladder (KUB) X-ray, ultrasound and computed tomography. RESULTS: All patients completed the study and there were no major side-effects. There was no difference in age, stone position or stone size among the groups. Multivariate analysis using a Cox proportional hazards model indicated that the probability of stone expulsion for 1 month was increased 2.38 times (95% confidence interval 1.23-4.61) by naftopidil compared with control therapy alone (p = 0.01). CONCLUSION: Naftopidil in combination with an antispasmodic agent and a medicine that facilitates stone expulsion produces a significantly increased rate of ureteral stone expulsion.

[Phytotherapy in the treatment of ureteral calculi].

Phytotherapy with prolit was given to 95 patients with ureteroliths (size of the concrrements 0.4-0.6 cm). A 40-day treatment resulted in elimination of the concrements from the ureter in 89 (93.7%) patients. Prolit had a positive action on metabolism in urolithiasis patients: lowered hypercalciuria, uric acid in the blood, oxalates and uric acid in urine. This is important for prevention of recurrent lithogenesis which for 3 years after the treatment occurred only in 4 (4.2%) patients.