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Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Terminated
CT.gov ID
NCT03614052
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
19.8
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tamsulosin Hydrochloride 0.4 milligrams
  • Drug: Placebo Oral Tablet
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Jan 26, 2020
Actual Study Completion Date :
Jan 26, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. stone free rate [30 days]

      stone free rate after ureteroscopic management of urolithiasis

    Secondary Outcome Measures

    1. failed ureteroscopy rate [05 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clinico Pontificia Universidad católica de Chile Santiago Metropolitana Chile

    Sponsors and Collaborators

    • Pontificia Universidad Catolica de Chile

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pontificia Universidad Catolica de Chile
    ClinicalTrials.gov Identifier:
    NCT03614052
    Other Study ID Numbers:
    • 171229002
    First Posted:
    Aug 3, 2018
    Last Update Posted:
    Jan 31, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urolithiasis
    Ureteral Calculi
    Ureterolithiasis
    Calculi
    Tamsulosin

    Study Results

    No Results Posted as of Jan 31, 2020