Evaluation of Tamsulosin in the Treatment of Ureteral Stones

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ureterolithiasis, Ureteral Calculi

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tamsulosin | Drug: Tamsulosin<br>* Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to stone elimination in days (censored criterion) |  | between day 1 and 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion) |  | between day 1 and 42 | 
| Pain using Visual Analogue Scale |  | days 1, 2, 3 | 
| 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 | 
| 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 | 
| Rate of adverse events |  | Within 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureterolithiasis, Alpha1-blocker, Lower ureteral stone