Clinical trial NCT00151567: Evaluation of Tamsulosin in the Treatment of Ureteral Stones
Official title: Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ureterolithiasis
Ureteral Calculi
Keywords: Ureterolithiasis
Alpha1-blocker
Lower ureteral stone
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Yamanouchi
First posted: 2005-09-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to stone elimination in days (censored criterion)
timeFrame: between day 1 and 42
Secondary outcomes:
measure: Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)
timeFrame: between day 1 and 42
measure: Pain using Visual Analogue Scale
timeFrame: days 1, 2, 3
measure: Spontaneous stone elimination rate
timeFrame: days 1, 7, 14, 21, 28, 35, and 42
measure: Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)
timeFrame: days 1, 7, 14, 21, 28, 35, and 42
measure: Rate of need for surgery
timeFrame: Within 42 days
measure: Time to surgery in days in patients with surgical elimination
timeFrame: between day 1 and day 42
measure: Rate of pain recurrences
timeFrame: within 42 days
measure: Time to the first recurrence in days
timeFrame: between day 1 and day 42
measure: Rate of need for corticoids or morphine
timeFrame: Within 42 days
measure: Time to the first administration of corticoids or morphine in days
timeFrame: between day 1 and day 42
measure: Rate of adverse events
timeFrame: Within 42 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'Urologie- Hôpital du Val de Grâce
city: Poitiers
country: France
facility: Service d'Urologie - Hôpital de La Milétrie
city: Redon
country: France
facility: Hôpital de Redon
city: Reims
country: France
facility: Service d'Urologie- Hôpital Robert Debré
city: Rennes
country: France
facility: Service d'Urologie- Hôpital Pontchaillou
city: Tours
country: France
facility: Service d'Urologie - Hôpital Bretonneau
Study officials:
affiliation: Rennes University Hospital
name: Francois Guillé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Eric Bellissant, MD, PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1111/j.1442-2042.2005.01116.x.
citation: 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. doi: 10.2165/00003495-199652060-00012.
citation: Vincendeau S, Bellissant E, Houlgatte A, Dore B, Bruyere F, Renault A, Mouchel C, Bensalah K, Guille 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. doi: 10.1001/archinternmed.2010.447.