NCT00151567

Evaluation of Tamsulosin in the Treatment of Ureteral Stones

Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ureterolithiasis
• Ureteral Calculi

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2002-02-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-09
• Last updated: 2012-12-04

Locations

6 sites across 1 country: France