Silodosin vs Tamsulosin as MET

Phase 3

Recruiting

• Conditions: Stone, Urinary
• Interventions: Drug: Tamsulosin; Drug: Silodosin

• Registration Number: NCT05570084
• Lead Sponsor: Princess Margaret Hospital, Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-31
• Study First Submitted: 2022-09-28
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-03
• Last Update Submitted: 2022-10-03
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin	Tamsulosin	0.4mg daily for 4 weeks
Silodosin	Silodosin	8mg daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Stone free rate	FU at week 4	Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)

Secondary Outcome Measures

Name	Time	Method
Pain control	FU at week 4	Use of analgesics and VAS pain scale (0-10)

Trial Locations

Locations (1)

Hong Kong; 🇭🇰 Hong Kong, Hong Kong