Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03614052

Enrollment

Registered

2018-08-03

Start date

2018-06-01

Completion date

2020-01-26

Last updated

2020-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Calculi, Ureterolithiasis, Urolithiasis

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.

Interventions

DRUGTamsulosin Hydrochloride 0.4 milligrams

Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis

DRUGPlacebo Oral Tablet

Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
stone free rate	30 days	stone free rate after ureteroscopic management of urolithiasis

Secondary

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

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026