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Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Primary Purpose

Ureterolithiasis, Ureteral Calculi, Urolithiasis

Status
Terminated
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Tamsulosin Hydrochloride 0.4 milligrams
Placebo Oral Tablet
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureterolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinico Pontificia Universidad católica de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tamsulosin hydrochloride

Placebo oral tablet

Arm Description

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

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

Outcomes

Primary Outcome Measures

stone free rate
stone free rate after ureteroscopic management of urolithiasis

Secondary Outcome Measures

failed ureteroscopy rate
failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter

Full Information

First Posted
July 30, 2018
Last Updated
January 29, 2020
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT03614052
Brief Title
Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy
Official Title
Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Problems with the number of participants
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
January 26, 2020 (Actual)
Study Completion Date
January 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureterolithiasis, Ureteral Calculi, Urolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tamsulosin hydrochloride
Arm Type
Experimental
Arm Description
Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy
Arm Title
Placebo oral tablet
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablets by mouth per day for 5 days before ureteroscopy
Intervention Type
Drug
Intervention Name(s)
Tamsulosin Hydrochloride 0.4 milligrams
Other Intervention Name(s)
tamsulosin0,4mg
Intervention Description
Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
placebo
Intervention Description
Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis
Primary Outcome Measure Information:
Title
stone free rate
Description
stone free rate after ureteroscopic management of urolithiasis
Time Frame
30 days
Secondary Outcome Measure Information:
Title
failed ureteroscopy rate
Description
failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter
Time Frame
05 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaston Astroza, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico Pontificia Universidad católica de Chile
City
Santiago
State/Province
Metropolitana
Country
Chile

12. IPD Sharing Statement

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Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

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