Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Phase 4

Terminated

• Conditions: Ureterolithiasis; Ureteral Calculi; Urolithiasis
• Interventions: Drug: Placebo Oral Tablet; Drug: Tamsulosin Hydrochloride 0.4 milligrams

• Registration Number: NCT03614052
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Status Verified: 2020-01
• Primary Completion: 2020-01-26
• Study Completion: 2020-01-26
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo oral tablet	Placebo Oral Tablet	Placebo oral tablets by mouth per day for 5 days before ureteroscopy
tamsulosin hydrochloride	Tamsulosin Hydrochloride 0.4 milligrams	Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy

Primary Outcome Measures

Name	Time	Method
stone free rate	30 days	stone free rate after ureteroscopic management of urolithiasis

Secondary Outcome Measures

Name	Time	Method
failed ureteroscopy rate	05 days	failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter

Trial Locations

Locations (1)

Hospital Clinico Pontificia Universidad católica de Chile; 🇨🇱 Santiago, Metropolitana, Chile