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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
Princess Margaret Hospital, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stone, Urinary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
September 28, 2022
Last Updated
October 3, 2022
Sponsor
Princess Margaret Hospital, Hong Kong
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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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