A Phase 3 interventional study of Silodosin and Tamsulosin in Stone, Urinary, sponsored by Princess Margaret Hospital, Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-06.
Sponsored by Princess Margaret Hospital, Hong Kong · Phase 3, Interventional, and Treatment
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.
160 studies on the registry are indexed under Urinary Calculi; 29 are open to participants now.
This study's planned enrollment of 80 is below the median of 110 across 111 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Princess Margaret Hospital, Hong Kong is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion criteria:
0.4mg daily for 4 weeks
Drug: Tamsulosin
8mg daily for 4 weeks
Drug: Silodosin
Cap silodosin for medical expulsion therapy
Cap tamsulosin
Stone free rate
Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)
Time frame: FU at week 2
Stone free rate
Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)
Time frame: FU at week 4
Pain control
Use of analgesics and VAS pain scale (0-10)
Time frame: FU at week 2
Pain control
Use of analgesics and VAS pain scale (0-10)
Time frame: FU at week 4
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Silodosin
Princess Margaret Hospital, Hong Kong