Silodosin vs Tamsulosin as MET
Primary Purpose
Stone, Urinary
Status
Recruiting
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Silodosin
Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Stone, Urinary
Eligibility Criteria
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
Sites / Locations
- Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tamsulosin
Silodosin
Arm Description
0.4mg daily for 4 weeks
8mg daily for 4 weeks
Outcomes
Primary Outcome Measures
Stone free rate
Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU)
Stone free rate
Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU)
Secondary Outcome Measures
Pain control
Use of analgesics and VAS pain scale (0-10)
Pain control
Use of analgesics and VAS pain scale (0-10)
Full Information
NCT ID
NCT05570084
First Posted
September 28, 2022
Last Updated
October 3, 2022
Sponsor
Princess Margaret Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05570084
Brief Title
Silodosin vs Tamsulosin as MET
Official Title
Randomised Controlled Trial on Silodosin Versus Tamsulosin for Medical Expulsive Treatment of Ureteral Stones Size 5-10mm in Chinese
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Margaret Hospital, Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone, Urinary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin
Arm Type
Active Comparator
Arm Description
0.4mg daily for 4 weeks
Arm Title
Silodosin
Arm Type
Experimental
Arm Description
8mg daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Silodosin
Intervention Description
Cap silodosin for medical expulsion therapy
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
Cap tamsulosin
Primary Outcome Measure Information:
Title
Stone free rate
Description
Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU)
Time Frame
FU at week 2
Title
Stone free rate
Description
Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU)
Time Frame
FU at week 4
Secondary Outcome Measure Information:
Title
Pain control
Description
Use of analgesics and VAS pain scale (0-10)
Time Frame
FU at week 2
Title
Pain control
Description
Use of analgesics and VAS pain scale (0-10)
Time Frame
FU at week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YI CHIU, MBBS(HK)
Phone
29901960
Email
cy225@ha.org.hk
Facility Information:
Facility Name
Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YI CHIU, MBBS (HK)
12. IPD Sharing Statement
Plan to Share IPD
No
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Silodosin vs Tamsulosin as MET
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