Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Study Overview
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Brief Summary
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This a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. The main outcome is the rate of stone free patients.

Detailed Description
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Endoscopic treatment of urolithiasis has increased during the last several years. Adrenergic receptors have been described mainly in the distal ureter. Blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. In this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis. Only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. Patients are randomized between placebo arm or tamsulosin 0.4 mg/day. Demographic characteristics, stones characteristics and information related to surgery are recorded. Main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 Fr. All patients are follow-up for 30 days after surgery.

Official Title
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Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica

Conditions
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Urolithiasis, Ureterolithiasis, Ureteral Calculi

Intervention / Treatment
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* Drug: Tamsulosin Hydrochloride 0.4 milligrams
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with urolithiasis undergoing to endoscopic ureterolithotomy Exclusion Criteria: Patients with previous ureteral catheter Patients with allergy to tamsulosin Patients currently in treatment with tamsulosin for other disease different than ureterolithiasis Multiple ureterolithiasis Patients with impairment of their mental status Patients with open surgeries in the affected ureter or urinary diversion Pregnancy

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tamsulosin hydrochloride<br>Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy | Drug: Tamsulosin Hydrochloride 0.4 milligrams<br>* Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis<br>* Other names: tamsulosin0,4mg;|
| Placebo Comparator: Placebo oral tablet<br>Placebo oral tablets by mouth per day for 5 days before ureteroscopy | Drug: Placebo Oral Tablet<br>* Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | stone free rate after ureteroscopic management of urolithiasis | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failed ureteroscopy rate | failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter | 05 days |