Evaluation of Tamsulosin in the Treatment of Ureteral Stones
Information source: Rennes University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ureterolithiasis; Ureteral Calculi
Intervention: Tamsulosin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Rennes University Hospital Official(s) and/or principal investigator(s):
Francois Guillé, MD, Principal Investigator, Affiliation: Rennes University Hospital
Eric Bellissant, MD, PhD, Study Chair, Affiliation: Rennes University Hospital
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.
Clinical Details
Official title: Interest of a Treatment With the alpha1-Blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Time to stone elimination in days (censored criterion)
Secondary outcome: Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)Pain using Visual Analogue Scale Spontaneous stone elimination rate Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm) Rate of need for surgery Time to surgery in days in patients with surgical elimination Rate of pain recurrences Time to the first recurrence in days Rate of need for corticoids or morphine Time to the first administration of corticoids or morphine in days Rate of adverse events
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Service d'Urologie- Hôpital Pontchaillou, Rennes 35033, France
Service d'Urologie- Hôpital du Val de Grâce, Paris 75005, France
Service d'Urologie - Hôpital de La Milétrie, Poitiers 86021, France
Service d'Urologie- Hôpital Robert Debré, Reims 51092, France
Hôpital de Redon, Redon 35600, France
Service d'Urologie - Hôpital Bretonneau, Tours 37044, France
Additional Information
Related publications: 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.
Starting date: February 2002
Ending date: December 2006
Last updated: May 7, 2007
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