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Sildenafil citrate as a medical expulsive therapy for distal ureteric stones: A randomised double-blind placebo-controlled study.

ABSTRACT: OBJECTIVE:To study the effect of sildenafil citrate on spontaneous passage of distal ureteric stones (DUS). PATIENTS AND METHODS:This was a randomised double-blinded placebo-controlled study of 100 patients with DUS. Inclusion criteria were: male, age 18-65 years, normal renal function, and a single radiopaque unilateral DUS of 5-10 mm. Patients were randomly allocated into two equal groups, one that received placebo and the other that received 50 mg sildenafil citrate once daily. Both investigators and patients were masked to the type of treatment. Patients self-administered the medication until spontaneous passage of the DUS. In patients where there was uncontrolled pain, fever, an increase in serum creatinine of >1.8 mg/dL, progressive hydronephrosis or no further progress after 4 weeks, a decision was taken for further treatment. RESULTS:In all, 47 and 49 patients were available for analysis in both the placebo and sildenafil citrate groups; respectively. Both groups were comparable for age and stone characteristics. Spontaneous expulsion occurred in 19 of 47 patients (40.4%) in the placebo group and in 33 of 49 (67.3%) in the sildenafil citrate group (P = 0.014). The mean time to stone expulsion was significantly shorter in the sildenafil citrate group (P < 0.001). A multivariable Cox proportional hazards model showed that receiving sildenafil citrate was the only independent factor that had a significant impact on stone passage with a hazard ratio of 2.7 (95% confidence interval 1.5-4.8; P < 0.001). CONCLUSION:Sildenafil citrate enhances spontaneous passage of 5-10 mm DUS.

SUBMITTER: Shokeir AA

PROVIDER: S-EPMC4767793 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Sildenafil citrate as a medical expulsive therapy for distal ureteric stones: A randomised double-blind placebo-controlled study.

Shokeir Ahmed A AA Tharwat Mohamed A MA Abolazm Ahmed Elhussein AE Harraz Ahmed A

Arab journal of urology 20160121 1

<h4>Objective</h4>To study the effect of sildenafil citrate on spontaneous passage of distal ureteric stones (DUS).<h4>Patients and methods</h4>This was a randomised double-blinded placebo-controlled study of 100 patients with DUS. Inclusion criteria were: male, age 18-65 years, normal renal function, and a single radiopaque unilateral DUS of 5-10 mm. Patients were randomly allocated into two equal groups, one that received placebo and the other that received 50 mg sildenafil citrate once daily. ...[more]

PMID: 26966585

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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.

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.

Dataset Information

Sildenafil citrate as a medical expulsive therapy for distal ureteric stones: A randomised double-blind placebo-controlled study.

Publications

Sildenafil citrate as a medical expulsive therapy for distal ureteric stones: A randomised double-blind placebo-controlled study.

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