Effectiveness of nifedipine and deflazacort in the management of distal ureter stones

doi:10.1016/S0090-4295(00)00732-9

Urology

Volume 56, Issue 4, October 2000, Pages 579-582

https://doi.org/10.1016/S0090-4295(00)00732-9 Get rights and content

Abstract

Objectives. To evaluate the effectiveness of medical therapy during watchful waiting in patients with distal ureter stones.

Methods. Ninety-six patients with radiopaque stones located in the distal tract of the ureter and with stone sizes of 1 cm or smaller were involved in the study. The patients were randomly divided into two groups. Group A (n = 48) received oral treatment with 30 mg of deflazacort daily (maximum 10 days) plus 30 mg of slow-release nifedipine daily (maximum 4 weeks). Group B (n = 48) underwent a wait-and-watch approach. Both groups of patients were allowed to use diclofenac on demand. Statistical analyses were carried out using Student’s t test, the chi-square test, and Fisher’s exact test.

Results. The average stone size was 5.8 ± 1.8 mm for group A and 5.5 ± 1.4 mm for group B. No statistically significant difference was found in stone size. Stone expulsion was observed in 38 (79%) of 48 patients in group A and in 17 (35%) of 48 patients in group B. The average expulsion time was 7 days (range 2 to 10) for group A and 20 days (range 10 to 28) for group B. A statistically significant difference was observed in both the expulsion rate and the expulsion time (P <0.05). The mean amount of sodium diclofenac used was 15 mg per patient for group A and 105 mg per patient for group B (P <0.05).

Conclusions. The medical treatment proved to be effective and safe, as demonstrated by the increased stone expulsion rate, decreased expulsion time, and reduced need for analgesic therapy.

Section snippets

Material and methods

The population of this study consisted of patients with radiopaque stones 1 cm or smaller located in the distal tract of the ureter. Subjects with infections of the urinary tract, high-grade hydronephrosis, diabetes, ulcer disease, or a history of hypersensitivity to nifedipine or corticosteroids and pregnant women were excluded. Patients with a history of spontaneous stone expulsion, hypotension, or those who were found to have systolic blood pressure less than 110 mm Hg during their first

Results

Ninety-two of the 96 enrolled patients completed the study. Two patients in group A (4%) stopped the medical therapy and therefore dropped out of this study. Two patients (4%) in group B also dropped out, one because of the development of a urinary tract infection and the other because of repeated urinary colic.

Group A consisted of 26 men and 22 women (average age 44 years, range 21 to 65) and group B consisted of 24 men and 24 women (average age 49 years, range 18 to 70). No statistically

Comment

The availability of mini-invasive treatments and the high percentage of success of ESWL and ureteroscopic extractions have greatly changed the stone treatment scenario.7, 13 Some investigators believe that the good results that can be obtained with these techniques when applied to distal stones justify intervention even for small ureteral stones, even though spontaneous stone passage is probable.14 Morse and Resnick13 report that a stone measuring 6 mm, located in the distal tract of the

Conclusions

The results of our study indicate that stones up to 1 cm in size in the distal tract of the ureter can be treated with an expulsive medical therapy (nifedipine plus deflazacort) in any patient in whom a watchful waiting approach can be chosen and in whom no contraindications to drug use are present. In our study, the medical treatment proved to be effective and safe, as determined by the increased stone expulsion rate, decreased expulsion time, and reduced need for analgesic therapy.

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Cited by (173)

Silodosin in the treatment of distal ureteric stones in children: A prospective, randomised, placebo-controlled study
2017, Arab Journal of Urology
To evaluate the possible role of silodosin (a highly selective α_1A-adrenoceptor antagonist) in facilitating the passage of distal ureteric stones (DUS) in children, as the role of α-blockers as medical expulsive therapy is well known in adults.
In all, 40 paediatric patients (27 boys and 13 girls) diagnosed with unilateral, single, radiopaque DUS of <10 mm were included in the study. Their mean (SD, range) age was 8.1 (2.7, 5–17) years. The patients were randomly divided into two groups: Group A, received silodosin 4 mg as a single bedtime dose; and Group B, received placebo as a single bedtime dose. Ibuprofen was prescribed to both groups on-demand for pain episode relief. Patients were followed up biweekly for 4 weeks. The stone expulsion time and rate, pain episodes, analgesic use, and any adverse effects were recorded.
The mean (SD) stone size in Group A was 6.6 (1.7) mm and in Group B was 6.7 (1.4) mm (P = 0.4). Two patients were lost to follow-up (one from each group), and one patient in Group A refused to complete the study. The stone-free rate at end of the 4-week treatment period was 88.8% in Group A vs 73.6% in Group B (P = 0.4). The mean (SD) stone expulsion time was 7.0 (4.3) vs 10.4 (4.7) days in groups A and B, respectively (P = 0.02). The mean (SD) number of pain episodes requiring ibuprofen was 2.3 (1.4) vs 4.7 (2.6) episodes in groups A and B, respectively (P < 0.001). Adverse effects (headache and dizziness) were recorded in three patients (16.7%) in Group A, which were mild and none of them discontinued treatment, whilst no adverse effects were recorded in Group B.
The data in the present study show that silodosin can be safely used in the treatment of DUS in children for decreasing time to stone expulsion, pain episodes, and analgesic requirement.
Medical Expulsive Therapy in Urolithiasis: A Review of the Quality of the Current Evidence
2017, European Urology Focus
Medical expulsive therapy (MET) is widely used to promote spontaneous passage of urinary stones. However, there is conflicting evidence on the actual role of MET.
To evaluate the conformance of published randomized controlled trials (RCTs) on MET with the Consolidated Standards for Reporting Trials (CONSORT) criteria, and to clarify the current role of MET in management of urinary stones on the basis of our findings.
We carried out an electronic search of the Cochrane Library, PubMed, and Embase databases for RCTs on MET. For each RCT included, we created a checklist table documenting the minimum essential items that should be included in reports of RCTs according to the CONSORT 2010 statement.
Clinical heterogeneity between pooled studies in terms of the MET given, inclusion criteria, sample size, pre- and post-treatment imaging, and differential follow-up was profound. The overall methodological rigor of the pooled studies was low, as indicated by the moderate to poor conformance of the studies with the CONSORT criteria. The aforementioned reasons may explain the discrepancies found between the supporting results of several meta-analyses and those of well-designed placebo-controlled double-blind studies revealing no benefit from MET. Recent well-designed RCTs have shown no benefit from α-blockers versus placebo. However, on the basis of sensitivity analyses in a recently published meta-analysis, α-blockers may still promote spontaneous expulsion of large stones.
Conflicting data on MET may be explained by clinical heterogeneity and methodological flaws. Urologists must decide whether to follow single, large, well-conducted RCTs or pooled data from meta-analyses. The latter still support selective use of MET for larger urinary stones.
In this review we tested the accuracy of the studies published on various medications given to promote spontaneous passage of stones from the ureter. Although the majority of the studies were not designed properly, there is still some evidence to support medical expulsive therapy.
Silodosin vs tamsulosin in the management of distal ureteric stones: A prospective randomised study
2016, Arab Journal of Urology
To compare the efficacy of silodosin (8 mg) vs tamsulosin (0.4 mg), as a medical expulsive therapy, in the management of distal ureteric stones (DUS) in terms of stone clearance rate and stone expulsion time.
A prospective randomised study was conducted on 115 patients, aged 21–55 years, who had unilateral DUS of ⩽10 mm. Patients were divided into two groups. Group 1 received silodosin (8 mg) and Group 2 received tamsulosin (0.4 mg) daily for 1 month. The patients were followed-up by ultrasonography, plain abdominal radiograph of the kidneys, ureters and bladder, and computed tomography (in some cases).
There was a significantly higher stone clearance rate of 83% in Group 1 vs 57% in Group 2 (P = 0.007). Group 1 also showed a significant advantage for stone expulsion time and analgesic use. Four patients, two in each group, discontinued the treatment in first few days due to side-effects (orthostatic hypotension). No severe complications were recorded during the treatment period. Retrograde ejaculation was recorded in nine and three patients in Groups 1 and 2, respectively.
Our data show that silodosin is more effective than tamsulosin in the management of DUS for stone clearance rates and stone expulsion times. A multicentre study on larger scale is needed to confirm the efficacy and safety of silodosin.
EAU Guidelines on Diagnosis and Conservative Management of Urolithiasis
2016, European Urology
Low-dose computed tomography (CT) has become the first choice for detection of ureteral calculi. Conservative observational management of renal stones is possible, although the availability of minimally invasive treatment often leads to active treatment. Acute renal colic due to ureteral stone obstruction is an emergency that requires immediate pain management. Medical expulsive therapy (MET) for ureteral stones can support spontaneous passage in the absence of complicating factors. These guidelines summarise current recommendations for imaging, pain management, conservative treatment, and MET for renal and ureteral stones. Oral chemolysis is an option for uric acid stones.
To evaluate the optimal measures for diagnosis and conservative and medical treatment of urolithiasis.
Several databases were searched for studies on imaging, pain management, observation, and MET for urolithiasis, with particular attention to the level of evidence.
Most patients with urolithiasis present with typical colic symptoms, but stones in the renal calices remain asymptomatic. Routine evaluation includes ultrasound imaging as the first-line modality. In acute disease, low-dose CT is the method of choice. Ureteral stones <6 mm can pass spontaneously in well-controlled patients. Sufficient pain management is mandatory in acute renal colic. MET, usually with α-receptor antagonists, facilitates stone passage and reduces the need for analgesia. Contrast imaging is advised for accurate determination of the renal anatomy. Asymptomatic calyceal stones may be observed via active surveillance.
Diagnosis, observational management, and medical treatment of urinary calculi are routine measures. Diagnosis is rapid using low-dose CT. However, radiation exposure is a limitation. Active treatment might not be necessary, especially for stones in the lower pole. MET is recommended to support spontaneous stone expulsion.
For stones in the lower pole of the kidney, treatment may be postponed if there are no complaints. Pharmacological treatment may promote spontaneous stone passage.
Predictive factors for spontaneous stone passage and the potential role of serum C-reactive protein in patients with 4 to 10 mm distal ureteral stones: A prospective clinical study
2015, Journal of Urology
We investigated possible predictive factors for spontaneous stone passage and the potential role of serum C-reactive protein and white blood count in patients with 4 to 10 mm distal ureteral stones.
A total of 251 patients who presented with renal colic secondary to distal ureteral stone were included in study. Patients were grouped according to spontaneous stone passage. Serum C-reactive protein, white blood count and other possible factors were investigated for their potential predictive value for spontaneous stone passage at a followup of 5 weeks. Potential predictive factors for spontaneous stone passage were evaluated with univariate and multivariate analyses. ROC curve analysis was performed to find an optimal cutoff value for serum C-reactive protein according to spontaneous stone passage. Statistical significance was considered at p <0.05.
Spontaneous stone passage was observed in 135 patients (53.8%) in group 1 while 116 (46.2%) in group 2 did not expel the stone spontaneously. Median stone size was 5.7 mm. Stone size, serum C-reactive protein and white blood count were significantly higher in group 2 than in group 1. The number of patients with hydronephrosis and the number with spontaneous stone passage history were significantly lower in group 2 compared to group 1. The cutoff value of serum C-reactive protein provided by ROC analysis was 0.506 mg/l. Time to spontaneous stone passage was significantly higher in patients with serum C-reactive protein above the threshold and in patients with ureteral stones greater than 6 mm.
Stone size, previous spontaneous passage, hydronephrosis, serum C-reactive protein and white blood count can be used to predict spontaneous stone passage in patients with 4 to 10 mm distal ureteral stones. A serum C-reactive protein level of 0.506 mg/l can serve as a cutoff value to predict spontaneous stone passage.
Spectroscopic Characterization and Assignments of Nifedipine Via Computational Modeling and Experiment (Ftir, Raman, and Solid-State Nmr)
2024, SSRN

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Adult urologyEffectiveness of nifedipine and deflazacort in the management of distal ureter stones

Abstract

Section snippets

Material and methods

Results

Comment

Conclusions

Lancet

J Urol

J Urol

Urology

J Urol

J Urol

J Urol

The frequency of urolithiasis in hospital discharge diagnoses in the United States

Invest Urol

Frequency of urolithiasis in a prepaid medical care program

Am J Epidemiol

Stones in ureter

Acta Chir Scand

Natural history and current concepts for the treatment of small ureteral calculi

Eur Urol

Adult urology
Effectiveness of nifedipine and deflazacort in the management of distal ureter stones