Stone, UrinaryPhase 3NCT05570084
Silodosin vs Tamsulosin as MET
A Phase 3 study testing Silodosin and Tamsulosin in people with Stone, Urinary, run by Princess Margaret Hospital, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone, Urinary
- What is being tested?
- Silodosin and Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 May 2022to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong
Hong Kong
YI CHIU, MBBS (HK)
About this study
Official title: Randomised Controlled Trial on Silodosin Versus Tamsulosin for Medical Expulsive Treatment of Ureteral Stones Size 5-10mm in Chinese
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.
Read more
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.
- Conditions
- Stone, Urinary
- Being tested
- Silodosin, Tamsulosin
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Cap silodosin for medical expulsion therapy
TamsulosinDrug
Cap tamsulosin
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Active comparator | 0.4mg daily for 4 weeks Receives: Drug: Tamsulosin |
| Silodosin | Experimental | 8mg daily for 4 weeks Receives: Drug: Silodosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)
Measured: FU at week 2
Stone free rate
Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)
Measured: FU at week 4
Secondary outcomes (2)
Pain control
Use of analgesics and VAS pain scale (0-10)
Measured: FU at week 2
Pain control
Use of analgesics and VAS pain scale (0-10)
Measured: FU at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start31 May 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone, UrinaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Margaret Hospital, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ellen Yu, Princess Margaret Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570084
- Sponsor's protocol ID
- KW/FR-19-075-(139-02)
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on Silodosin Versus Tamsulosin for Medical Expulsive Treatment of Ureteral Stones Size 5-10mm in Chinese
- ClinicalTrials.gov ID
- NCT05570084
- Acronym / sponsor ID
- KW/FR-19-075-(139-02)
- Conditions
- Stone, Urinary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Princess Margaret Hospital, Hong KongOther government
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Active comparator | Drug: Tamsulosin0.4mg daily for 4 weeks |
| Silodosin | Experimental | Drug: Silodosin8mg daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- Radiolucent stone
- Paper thin cortex
- Non-functioning kidney
- Renal insufficiency (serum creatinine greater than 1.8 mg/dl or 160umol/dL)
- Concurrent urosepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilodosinCap silodosin for medical expulsion therapy | Drug | Silodosin |
| TamsulosinCap tamsulosin | Drug | Tamsulosin |
Primary outcome
Stone free rate
Time frame: FU at week 2
Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)
Stone free rate
Time frame: FU at week 4
Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)
2 secondary outcomes
Pain control
Time frame: FU at week 2
Pain control
Time frame: FU at week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silodosin and Tamsulosin in people with Stone, Urinary, run by Princess Margaret Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YI CHIU, MBBS(HK) (29901960, cy225@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: FU at week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.