Primary Outcome Measures:
- Time to stone elimination in days (censored criterion) [ Time Frame: between day 1 and 42 ]
Secondary Outcome Measures:
- Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion) [ Time Frame: between day 1 and 42 ]
- Pain using Visual Analogue Scale
- Spontaneous stone elimination rate [ Time Frame: days 1, 7, 14, 21, 28, 35, and 42 ]
- Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm) [ Time Frame: days 1, 7, 14, 21, 28, 35, and 42 ]
- Rate of need for surgery
- Time to surgery in days in patients with surgical elimination [ Time Frame: between day 1 and day 42 ]
- Rate of pain recurrences
- Time to the first recurrence in days [ Time Frame: between day 1 and day 42 ]
- Rate of need for corticoids or morphine
- Time to the first administration of corticoids or morphine in days [ Time Frame: between day 1 and day 42 ]
- Rate of adverse events
Ureteral colic, mainly due to ureterolithiasis, represents 1 to 2% of hospital emergency admissions. When a surgical intervention is not required, usual treatment combines hydration and anti-inflammatory drugs.
Alpha1-blockers, firstly developed as anti-hypertensive drugs, are now also used in the management of benign prostatic hyperplasia, due to their relaxing properties on the urinary tract. The aim of the study is to investigate whether tamsulosin could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis. Patients are randomized to receive either tamsulosin or a placebo in addition to usual treatment until stone elimination. Efficacy is assessed by evaluating the time to spontaneous passage of the stone between day 1 and day 42, the need for surgery and pain recurrences.
Purpose
