NCT05570084

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

September 28, 2022

Last Update Submit

October 3, 2022

Conditions

Stone, Urinary

Outcome Measures

Primary Outcomes (2)

  • Stone free rate

    Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)

    FU at week 2

  • Stone free rate

    Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)

    FU at week 4

Secondary Outcomes (2)

  • Pain control

    FU at week 2

  • Pain control

    FU at week 4

Study Arms (2)

Tamsulosin

ACTIVE COMPARATOR

0.4mg daily for 4 weeks

Drug: Tamsulosin

Silodosin

EXPERIMENTAL

8mg daily for 4 weeks

Drug: Silodosin

Interventions

SilodosinDRUG

Cap silodosin for medical expulsion therapy

Silodosin
TamsulosinDRUG

Cap tamsulosin

Tamsulosin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Urinary Calculi

Interventions

silodosinTamsulosin

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Central Study Contacts

YI CHIU, MBBS(HK)

CONTACT

29901960cy225@ha.org.hk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research manager

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 6, 2022

Study Start

May 31, 2022

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)