Evaluation of Tamsulosin in the Treatment of Ureteral Stones (TAMSULOSINE)

• Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion) [ Time Frame: between day 1 and 42 ] [ Designated as safety issue: No ]
• Pain using Visual Analogue Scale [ Time Frame: days 1, 2, 3 ] [ Designated as safety issue: No ]
• Spontaneous stone elimination rate [ Time Frame: days 1, 7, 14, 21, 28, 35, and 42 ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• Rate of need for surgery [ Time Frame: Within 42 days ] [ Designated as safety issue: No ]
• Time to surgery in days in patients with surgical elimination [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
• Rate of pain recurrences [ Time Frame: within 42 days ] [ Designated as safety issue: No ]
• Time to the first recurrence in days [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
• Rate of need for corticoids or morphine [ Time Frame: Within 42 days ] [ Designated as safety issue: No ]
• Time to the first administration of corticoids or morphine in days [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
• Rate of adverse events [ Time Frame: Within 42 days ] [ Designated as safety issue: Yes ]

• - Time to stone elimination in days between day 1 and day 42 in patients with spontaneous elimination (quantitative criterion)
• - Pain using Visual Analogue Scale
• - Spontaneous stone elimination rate at days 1, 7, 14, 21, 28, 35, and 42
• - Spontaneous stone elimination rate at days 1, 7, 14, 21, 28, 35, and 42 according to stone size (2-3 mm, 4-5 mm, 6-7 mm)
• - Rate of need for surgery
• - Time to surgery in days between day 1 and day 42 in patients with surgical elimination
• - Rate of pain recurrences
• - Time to the first recurrence in days between day 1 and day 42
• - Rate of need for corticoids or morphine
• - Time to the first administration of corticoids or morphine in days between day 1 and day 42
• - Rate of adverse events

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.

• Ureterolithiasis
• Ureteral Calculi

• Drug: Tamsulosin
  Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
• Drug: Placebo
  Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)

• Experimental: 1
  Tamsulosin
  Intervention: Drug: Tamsulosin
• Placebo Comparator: 2
  Placebo
  Intervention: Drug: Placebo

• Resim S, Ekerbicer H, Ciftci A. Effect of tamsulosin on the number and intensity of ureteral colic in patients with lower ureteral calculus. Int J Urol. 2005 Jul;12(7):615-20.
• Wilde MI, McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs. 1996 Dec;52(6):883-98. Review.
• Vincendeau S, Bellissant E, Houlgatte A, Doré B, Bruyère F, Renault A, Mouchel C, Bensalah K, Guillé F; Tamsulosin Study Group. Tamsulosin hydrochloride vs placebo for management of distal ureteral stones: a multicentric, randomized, double-blind trial. Arch Intern Med. 2010 Dec 13;170(22):2021-7.

Inclusion Criteria:

• Adult over 18 years
• Emergency admission for a ureteral colic
• Radio-opaque ureterolithiasis
• Stone of 2 to 7 mm diameter
• Informed written consent

Exclusion Criteria:

• Pregnancy or breast-feeding
• Treatment with alpha or beta-blocker
• Contraindication to tamsulosin (orthostatic hypertension, hepatic failure)
• Complication needing surgery
• Calculi spontaneous passage before randomization
• Patient not available for a 6 week follow-up

• Ministry of Health, France
• Yamanouchi