Silodosin vs Tamsulosin as MET

Sponsor

Princess Margaret Hospital, Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05570084

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stone, Urinary	Drug: Silodosin Drug: Tamsulosin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 31, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tamsulosin 0.4mg daily for 4 weeks	Drug: Tamsulosin Cap tamsulosin
Experimental: Silodosin 8mg daily for 4 weeks	Drug: Silodosin Cap silodosin for medical expulsion therapy

Arm

Intervention/Treatment

Active Comparator: Tamsulosin

0.4mg daily for 4 weeks

Drug: Tamsulosin

Cap tamsulosin

Experimental: Silodosin

8mg daily for 4 weeks

Drug: Silodosin

Cap silodosin for medical expulsion therapy

Outcome Measures

Primary Outcome Measures

Stone free rate [FU at week 2]
Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU)
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

Pain control [FU at week 2]
Use of analgesics and VAS pain scale (0-10)
Pain control [FU at week 4]
Use of analgesics and VAS pain scale (0-10)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

Princess Margaret Hospital, Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ellen Yu, Research manager, Princess Margaret Hospital, Hong Kong

ClinicalTrials.gov Identifier:

NCT05570084

Other Study ID Numbers:

KW/FR-19-075-(139-02)

First Posted:

Oct 6, 2022

Last Update Posted:

Oct 6, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Urinary Calculi

Tamsulosin

Silodosin

Study Results

No Results Posted as of Oct 6, 2022