NCT05570084

Silodosin vs Tamsulosin as MET

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Princess Margaret Hospital, Hong Kong · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stone, Urinary

Interventions

Type	Name	Description
DRUG	Silodosin	Cap silodosin for medical expulsion therapy
DRUG	Tamsulosin	Cap tamsulosin

Timeline

• Start date: 2022-05-31
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2022-10-06
• Last updated: 2022-10-06

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study