Silodosin vs Tamsulosin as MET

NCT ID: NCT05570084

Last Updated: 2022-10-06

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Stone, Urinary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tamsulosin

0.4mg daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

Cap tamsulosin

Silodosin

8mg daily for 4 weeks

Group Type EXPERIMENTAL

Silodosin

Intervention Type DRUG

Cap silodosin for medical expulsion therapy

Interventions

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Silodosin

Cap silodosin for medical expulsion therapy

Intervention Type DRUG

Tamsulosin

Cap tamsulosin

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ellen Yu

Research manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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YI CHIU, MBBS(HK)

Role: CONTACT

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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