Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

January 29, 2020 updated by: Pontificia Universidad Catolica de Chile

Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Hospital Clínico Pontificia Universidad Católica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Gaston Astroza, MD, Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

January 26, 2020

Study Completion (Actual)

January 26, 2020

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 171229002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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