Evaluation of Tamsulosin in the Treatment of Ureteral Stones

Phase 3

Completed

• Conditions: Ureterolithiasis; Ureteral Calculi
• Interventions: Drug: Tamsulosin; Drug: Placebo

• Registration Number: NCT00151567
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-09
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tamsulosin	Tamsulosin
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Time to stone elimination in days (censored criterion)	between day 1 and 42

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Hôpital de Redon; 🇫🇷 Redon, France

Service d'Urologie- Hôpital du Val de Grâce; 🇫🇷 Paris, France

Service d'Urologie- Hôpital Robert Debré; 🇫🇷 Reims, France

Service d'Urologie - Hôpital de La Milétrie; 🇫🇷 Poitiers, France

Service d'Urologie- Hôpital Pontchaillou; 🇫🇷 Rennes, France

Service d'Urologie - Hôpital Bretonneau; 🇫🇷 Tours, France