Evaluation of Tamsulosin in the Treatment of Ureteral Stones
NCT ID: NCT00151567
Last Updated: 2012-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
129 participants
INTERVENTIONAL
2002-02-28
2006-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Tamsulosin
Tamsulosin
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
2
Placebo
Placebo
Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Interventions
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Tamsulosin
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Placebo
Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Eligibility Criteria
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Inclusion Criteria
* Emergency admission for a ureteral colic
* Radio-opaque ureterolithiasis
* Stone of 2 to 7 mm diameter
* Informed written consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Yamanouchi
UNKNOWN
Rennes University Hospital
OTHER
Responsible Party
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Rennes University Hospital
Principal Investigators
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Francois Guillé, MD
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Eric Bellissant, MD, PhD
Role: STUDY_CHAIR
Rennes University Hospital
Locations
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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
Service d'Urologie- Hôpital Pontchaillou
Rennes, , France
Service d'Urologie - Hôpital Bretonneau
Tours, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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PHRC/00-01
Identifier Type: OTHER
Identifier Source: secondary_id
CIC0203/004
Identifier Type: -
Identifier Source: secondary_id
AFSSAPS 010751
Identifier Type: -
Identifier Source: org_study_id