Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

NCT03614052 | Terminated Phase 4

• 1 other identifier: 171229002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureterolithiasis; Ureteral Calculi; Urolithiasis

Outcome Measures

Primary Outcomes (1)

• stone free rate

  stone free rate after ureteroscopic management of urolithiasis

  30 days

Secondary Outcomes (1)

• failed ureteroscopy rate

  05 days

Study Arms (2)

tamsulosin hydrochloride

EXPERIMENTAL

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

Drug: Tamsulosin Hydrochloride 0.4 milligrams

Placebo oral tablet

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Tamsulosin Hydrochloride 0.4 milligrams DRUG

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

Also known as: tamsulosin0,4mg

tamsulosin hydrochloride

Placebo Oral Tablet DRUG

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

Also known as: placebo

Placebo oral tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with urolithiasis undergoing to endoscopic ureterolithotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico Pontificia Universidad católica de Chile

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Ureterolithiasis; Ureteral Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaston Astroza, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: June 1, 2018
• Primary Completion: January 26, 2020
• Study Completion: January 26, 2020
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

CL (1)