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Silodosin vs Tamsulosin as MET

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05570084
Enrollment
80
Registered
2022-10-06
Start date
2022-05-31
Completion date
2023-12-31
Last updated
2022-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stone, Urinary

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.

Interventions

DRUGSilodosin

Cap silodosin for medical expulsion therapy

DRUGTamsulosin

Cap tamsulosin

Sponsors

Princess Margaret Hospital, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stone free rateFU at week 2Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU)

Secondary

MeasureTime frameDescription
Pain controlFU at week 2Use of analgesics and VAS pain scale (0-10)

Countries

Hong Kong

Contacts

Primary ContactYI CHIU, MBBS(HK)
cy225@ha.org.hk29901960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026