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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamsulosin hydrochloride | Experimental | Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy |
|
| Placebo oral tablet | Placebo Comparator | Placebo oral tablets by mouth per day for 5 days before ureteroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin Hydrochloride 0.4 milligrams | Drug | Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| stone free rate | stone free rate after ureteroscopic management of urolithiasis | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| failed ureteroscopy rate | failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter | 05 days |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Gaston Astroza, MD | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Pontificia Universidad católica de Chile | Santiago | Santiago Metropolitan | Chile |
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| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D014514 | Ureteral Calculi |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo Oral Tablet | Drug | Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis |
|
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |