Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-01-26

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.

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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.

Conditions

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Ureterolithiasis Ureteral Calculi Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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tamsulosin hydrochloride

Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy

Group Type EXPERIMENTAL

Tamsulosin Hydrochloride 0.4 milligrams

Intervention Type DRUG

Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis

Placebo oral tablet

Placebo oral tablets by mouth per day for 5 days before ureteroscopy

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis

Interventions

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Tamsulosin Hydrochloride 0.4 milligrams

Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis

Intervention Type DRUG

Placebo Oral Tablet

Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis

Intervention Type DRUG

Other Intervention Names

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tamsulosin0,4mg placebo

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No