The Study of Tamsulosin for Urolithiasis in the Emergency Department (STONE)
Number of Subjects in Study Archive: 512
Study Design: Interventional
Conditions: Kidney Diseases
# Recruitment Centers: 6
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
The Study of Tamsulosin for Urolithiasis in the Emergency Department (STONE) was initiated at a single site with 109 participants who were randomized from 2008 to 2009. This first phase allowed an assessment of the feasibility of recruitment and provided the opportunity to determine the rate of stone passage in the placebo group. The primary outcome was not analyzed at the end of phase 1. The second phase of the study was conducted from 2013 to 2016 at 6 emergency department recruiting sites, including the original site in phase 1. The data from participants enrolled in both phases were analyzed together.
Eligible patients were randomized to either tamsulosin at a dose of 0.4 mg daily or a matching placebo in a 1:1 allocation. Both treatments consisted of identically encapsulated pills with identical packaging (1 bottle with 30 capsules per patient). Neither the participant nor the study staff knew to which group the participant was randomized. The randomization sequence was generated using the simple urn method, stratified by site. Study participants were contacted by telephone to collect data at 2, 7, 15, 20, 29, and 90 days after randomization. Study participants enrolled in the second phase were also asked to undergo a follow-up CT scan after the 28-day treatment period to determine whether their stone had passed based on this imaging modality.
To determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients.
The primary outcome was stone passage based on visualization or capture by the study participant by day 28. Secondary outcomes included crossover to open-label tamsulosin, time to stone passage, return to work, use of analgesic medication, hospitalization, surgical intervention, and repeated emergency department visit for urinary stones.
1. Age ≥ 18 years
2. Evidence of ureterolithiasis (i.e. stone is located in ureter, not in bladder) as demonstrated on radiographic studies, specifically non-contrast spiral CT
1. Patient desiring or requiring immediate surgical intervention making then not a candidate for outpatient kidney stone management
2. See the Clinical Trials URL page (above) for a complete list of exclusion criteria
Tamsulosin did not significantly increase the stone passage rate compared with placebo. The findings did not support the use of tamsulosin for symptomatic urinary stones smaller than 9 mm.