Silodosin

Eur Urol. 2015 May;67(5):959-64.

Silodosin to facilitate passage of ureteral stones: a multi-institutional, randomized, double-blinded, placebo-controlled trial.[Pubmed: 25465978]

Using a selective α-blocker for medical expulsive therapy (MET) is a cost-effective treatment approach widely used for ureteral stones. To evaluate the efficacy of Silodosin, a selective α-1a receptor antagonist, in this setting.
METHODS AND RESULTS:
This was a multicenter, phase 2 study conducted in adult patients with a unilateral ureteral calculus of 4-10mm. Of 239 patients in the safety population, six discontinued due to adverse events. Patients were randomized 1:1 to receive Silodosin 8 mg or placebo for up to 4 wk. The primary outcome was spontaneous stone passage, analyzed using logistic regression. Secondary outcomes included time to stone passage, emergency room (ER) visits, hospital admissions, analgesic use, and incidence and severity of pain. No significant differences between the Silodosin and placebo groups were observed for passage rate of all stones (52% vs 44%, respectively; p=0.2). However, Silodosin achieved a significantly greater rate of distal ureter stone passage than placebo (p=0.01). Significant differences were not observed for ER visits, hospital admission, or use of analgesics. The number of patients in the intent-to-treat population was slightly below the calculated sample size (232 vs 240) and sample sizes were not calculated for subgroup analyses.
CONCLUSIONS:
This is among the first prospective, randomized, multi-institutional trials to examine the efficacy of a selective α-1a antagonist as MET in patients with ureteral calculi and did not demonstrate a benefit to the entire ureter. However, Silodosin was found to be well tolerated and beneficial in facilitating the passage of distal ureteral stones, warranting additional future studies on distal stone elimination. In this report, we looked at the efficacy of Silodosin for the treatment of ureteral stones. We found that Silodosin increased passage of distal ureteral stones.

Int J Urol. 2012 Mar;19(3):268-72.

Silodosin and its potential for treating premature ejaculation: a preliminary report.[Pubmed: 22188258]

However, compared with other α1-adrenoceptor antagonists, Silodosin appeared to suppress ejaculation in a relatively higher percent of trial participants. This suppression of ejaculation by Silodosin suggested its potential for treating premature ejaculation. Consequently, we evaluated the feasibility of off-label Silodosin as a new treatment option for premature ejaculation.
METHODS AND RESULTS:
Eight patients suffering premature ejaculation were treated with Silodosin. Silodosin (4 mg) was given 2 h before sexual intercourse. Intravaginal ejaculatory latency time, premature ejaculation profile item, clinical global impression change in premature ejaculation and systemic adverse events were recorded. Intravaginal ejaculatory latency time was significantly prolonged (from 3.4 min to 10.1 min, P = 0.003). All patients answered better (much better) or slightly better for their own premature ejaculation problem compared with pretreatment condition in the clinical global impression change. Premature ejaculation profile also significantly improved. Two (25%), three (37.5%) and seven patients (87.5%) experienced anejaculation, reduced semen volume and discomfort during orgasm, respectively. However, these problems were not of major concern for the participants. No systemic adverse effects were reported.
CONCLUSIONS:
The current results support the possible use of Silodosin as a new treatment option for premature ejaculation, and suggest that a placebo controlled study assessing its clinical usefulness would be worthwhile.

Arch Ital Urol Androl. 2014 Jun 30;86(2):103-7.

Medical expulsive therapy for distal ureteric stones: tamsulosin versus silodosin.[Pubmed: 25017589]

To compare the efficacy and safety of tamsulosin and Silodosin in the context of medical expulsive therapy (MET) of distal ureteric stones.
METHODS AND RESULTS:
Observational data were collected retrospectively from patients who received Silodosin (N = 50) or tamsulosin (N = 50) as MET from January 2012 to January 2013. Inclusion criteria were: patients aged ≥ 18 years with a single, unilateral, symptomatic, radiopaque ureteric stone of 10 mm or smaller in the largest dimension located between the lower border of the sacroiliac joint and the vesico-ureteric junction. Stone expulsion rate, stone expulsion time, number of pain episodes, need for analgesics use, incidence of side effects were compared. Stone-expulsion rate in the Silodosin and in the tamsulosin groups were 88% and 82%, respectively (p not significant). Mean expulsion times were 6.7 and 6.5 days in the Silodosin and tamsulosin group, respectively (p not significant). Mean number of pain episodes were 1.6 and 1.7 in the Silodosin and tamsulosin group, respectively (p not significant). The mean number of analgesic requirement was 0.84 and 0.9 for the Silodosin and tamsulosin group, respectively (p not significant). Overall, incidence of side effects was similar in both groups. Patients taking Silodosin experienced an higher incidence of retrograde ejaculation but a lower incidence of side effects related to peripheral vasodilation when compared to patients taking tamsulosin. Subgroup analysis demonstrated significantly lower mean expulsion times and pain episodes in patients with stones ≤ 5 mm in both groups.
CONCLUSIONS:
Tamsulosin and Silodosin are equally effective as MET for distal ureteric stones sized 10 mm or smaller. MET with Silodosin is associatd with a lower incidence of side effects related to peripheral vasodilation but an higher incidence of retrograde ejaculation when compared to tamsulosin.

Drugs. 2015 Feb;75(2):207-17.

Silodosin: a review of its use in the treatment of the signs and symptoms of benign prostatic hyperplasia.[Pubmed: 25575983]

Silodosin is a highly selective α1A-adrenoceptor antagonist indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
METHODS AND RESULTS:
Oral Silodosin had a rapid onset of effect in men with lower urinary tract symptoms (LUTS) associated with BPH, with improvements seen in voiding and storage symptoms, maximum urinary flow rate and health-related quality of life in well-designed, 12-week trials. Silodosin was noninferior to tamsulosin in terms of improving LUTS associated with BPH. The efficacy of Silodosin was maintained in 9-month extension studies and was also seen in a phase IV study conducted in a real-world setting. Silodosin was generally well tolerated and was associated with a low risk of orthostatic hypotension. Abnormal ejaculation was the most commonly reported adverse event, although few patients discontinued treatment with Silodosin because of this adverse event.
CONCLUSIONS:
In conclusion, Silodosin is a useful option for the treatment of LUTS associated with BPH.