Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Service d'Urologie- Hôpital du Val de Grâce
Paris, France
Service d'Urologie - Hôpital de La Milétrie
Poitiers, France
Hôpital de Redon
Redon, France
Service d'Urologie- Hôpital Robert Debré
Reims, France
Time to stone elimination in days (censored criterion)
Time frame: between day 1 and 42
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
Time frame: days 1, 2, 3
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 frame: Within 42 days
Time to surgery in days in patients with surgical elimination
Time frame: between day 1 and day 42
Rate of pain recurrences
Time frame: within 42 days
Time to the first recurrence in days
Time frame: between day 1 and day 42
Rate of need for corticoids or morphine
Time frame: Within 42 days
Time to the first administration of corticoids or morphine in days
Time frame: between day 1 and day 42
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Service d'Urologie- Hôpital Pontchaillou
Rennes, France
Service d'Urologie - Hôpital Bretonneau
Tours, France
Rate of adverse events
Time frame: Within 42 days