Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Urolithiasis Clinical Trial

Official title:

Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03614052
• Other study ID #: 171229002
• Status: Terminated
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: January 26, 2020

Study information

• Verified date: January 2020
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 26, 2020
• Est. primary completion date: January 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Ureteral Calculi
• Ureterolithiasis
• Urolithiasis

Intervention

Drug:
• Tamsulosin Hydrochloride 0.4 milligrams
Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis
• Placebo Oral Tablet
Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis

Locations

Country	Name	City	State
Chile	Hospital Clinico Pontificia Universidad católica de Chile	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone free rate	stone free rate after ureteroscopic management of urolithiasis	30 days
Secondary	failed ureteroscopy rate	failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter	05 days