Silodosin vs Tamsulosin as MET

Study Overview
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Brief Summary
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The spontaneous passage rate for ureteral stone less than 1cm causing acute ureteral obstruction is about 50%. Previous Cochrane review has concluded that alpha blocker is likely to increase stone passage rate, reduce time to stone passage, analgesic use and hospitalisations. The European Association of Urology Guideline also recommends giving alpha blockers as Medical Expulsive Therapy to patients with distal ureteric stones >5mm. However there is heterogeneity in different alpha blockers. Silodosin is a recently introduced selective alpha blocker which has a much higher selectivity for the alpha-1-A receptor (17-fold compared with tamsulosin). From previous animal studies, ureteral contraction is mainly mediated by the alpha-1-A receptor, hence silodosin maybe more effective in increasing stone passage compared with tamsulosin. Previous studies and meta-analysis has shown superiority of silodosin over tamsulosin on earlier stone passage and less pain. However, there is no data on Chinese population. The investigators would like to compare the efficacy and side effect profile of Silodosin versus tamsulosin on improving stone passage rate and hence reduce rate of further intervention for stone clearance.

Official Title
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Randomised Controlled Trial on Silodosin Versus Tamsulosin for Medical Expulsive Treatment of Ureteral Stones Size 5-10mm in Chinese

Conditions
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Stone, Urinary

Intervention / Treatment
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* Drug: Silodosin
* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Presented with radio-opaque ureteric stone of size 5mm to 10mm on KUB Patients who can understand the study protocol and comply with the followup schedule Exclusion criteria: Radiolucent stone Paper thin cortex Non-functioning kidney Renal insufficiency (serum creatinine greater than 1.8 mg/dl or 160umol/dL) Concurrent urosepsis Current [alpha]-blocker usage, Ca channel blocker, steroid Pregnancy Age < 18 History of ureteral stricture History of ureteric stone treatment within 2 years Allergic reaction to the study medication Unable to Consent Patient on JJ stent or PCN drainage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tamsulosin<br>0.4mg daily for 4 weeks | Drug: Tamsulosin<br>* Cap tamsulosin<br>|
| Experimental: Silodosin<br>8mg daily for 4 weeks | Drug: Silodosin<br>* Cap silodosin for medical expulsion therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU) | FU at week 2 | 
| Stone free rate | Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU) | FU at week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control | Use of analgesics and VAS pain scale (0-10) | FU at week 2 | 
| Pain control | Use of analgesics and VAS pain scale (0-10) | FU at week 4 |