Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2022-05-31
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tamsulosin
0.4mg daily for 4 weeks
Tamsulosin
Cap tamsulosin
Silodosin
8mg daily for 4 weeks
Silodosin
Cap silodosin for medical expulsion therapy
Interventions
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Silodosin
Cap silodosin for medical expulsion therapy
Tamsulosin
Cap tamsulosin
Eligibility Criteria
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Inclusion Criteria
* Patients who can understand the study protocol and comply with the followup schedule
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Princess Margaret Hospital, Hong Kong
OTHER_GOV
Responsible Party
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Ellen Yu
Research manager
Locations
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Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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YI CHIU, MBBS (HK)
Role: primary
Other Identifiers
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KW/FR-19-075-(139-02)
Identifier Type: -
Identifier Source: org_study_id
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