Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Overview

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.

Full Title of Study: “Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2020

Detailed Description

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.

Interventions

  • Drug: Tamsulosin Hydrochloride 0.4 milligrams
    • Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis
  • Drug: Placebo Oral Tablet
    • Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis

Arms, Groups and Cohorts

  • Experimental: tamsulosin hydrochloride
    • Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy
  • Placebo Comparator: Placebo oral tablet
    • Placebo oral tablets by mouth per day for 5 days before ureteroscopy

Clinical Trial Outcome Measures

Primary Measures

  • stone free rate
    • Time Frame: 30 days
    • stone free rate after ureteroscopic management of urolithiasis

Secondary Measures

  • failed ureteroscopy rate
    • Time Frame: 05 days
    • failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pontificia Universidad Catolica de Chile
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gaston Astroza, MD, Principal Investigator, Pontificia Universidad Catolica de Chile
  • Overall Contact(s)
    • Gaston Astroza, MD, +56223543468, gaeulufi@gmail.com

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