Silodosin vs Tamsulosin as MET

NCT05570084 — Phase 3, Unknown, 80 participants, Princess Margaret Hospital, Hong Kong

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

Registry	NCT05570084
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	80 (Estimated)
Sponsor	Princess Margaret Hospital, Hong Kong (Other gov)
Conditions	Stone, Urinary
Interventions	Silodosin, Tamsulosin (Drug)
Dates	start 2022-05-31, primary completion 2023-06-30 (estimated), completion 2023-12-31 (estimated), first posted 2022-10-06, last updated 2022-10-06
Locations	1 site in Hong Kong

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Tamsulosin	Active comparator	Drug: Tamsulosin	0.4mg daily for 4 weeks
Silodosin	Experimental	Drug: Silodosin	8mg daily for 4 weeks

Silodosin (Drug): Cap silodosin for medical expulsion therapy
Tamsulosin (Drug): Cap tamsulosin

+Outcome measures

Primary outcomes

Stone free rate [FU at week 2]: Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)
Stone free rate [FU at week 4]: Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)

Secondary outcomes

Pain control [FU at week 2]: Use of analgesics and VAS pain scale (0-10)
Pain control [FU at week 4]: Use of analgesics and VAS pain scale (0-10)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Hong Kong	Hong Kong	Hong Kong	Recruiting