NCT04819828|CompletedPhase 4
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Sponsor study identifier
interventional
60
0 countries
N/A
Study Start
January 1, 2010
Actual (reported)Primary Completion
August 31, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)Urolithiasis is a common health problem worldwide affecting approximately 10% of the population at some stage in their lives. The aim of this study is to evaluate the efficacy of adjuvant treatment with tamsulosin for improving the stone-free rate after a single session of extracorporeal shock wave lithotripsy (ESWL) in the treatment of radiopaque kidney stones.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2010
Actual (reported)August 31, 2016
Actual (reported)December 31, 2016
Actual (reported)March 25, 2021
Actual (reported)March 29, 2021
Actual (reported)Stone-free rate
Percentage of patients with the absence of residual stones (≥ 5 mm in diameter), with the presence of asymptomatic nonsignificant residual stone fragments (≤4 mm in diameter) determined via abdominal computed tomography scan, and with the absence of additional procedures to resolve an event of acute symptomatic urinary obstruction.
8 weeks
Complications rate associated with residual stone fragments
2, 4, and 8 weeks
At the end of the ESWL session, the patients received standard treatment for analgesia consisting of oral diclofenac (75 mg/12 h) as needed plus oral tamsulosin (0.4 mg/day) for eight weeks.
At the end of the ESWL session, the patients received standard treatment for analgesia consisting of oral diclofenac (75 mg/12 h) as needed
A single session of extracorporeal shock wave lithotripsy: the session will be finished upon reaching a maximum of 4,000 shocks or if a complete fragmentation of the kidney stone is observed.
Standard treatment for analgesia: oral diclofenac (75 mg/12 h) as needed.
Maldonado-Valadez RE, Valdez-Vargas AD, Alvarez JA, Rodea-Montero ER. Efficacy of Adjuvant Tamsulosin for Improving the Stone-Free Rate after Extracorporeal Shock Wave Lithotripsy in Renal Stones: A Randomized Controlled Trial. Int J Clin Pract. 2022 Jan 31;2022:3757588. doi: 10.1155/2022/3757588. eCollection 2022.
Rafael E Maldonado-Valadez, MD, MSc
Hospital Regional de Alta Especialidad del Bajio
Edel R Rodea-Montero, MPH
Hospital Regional de Alta Especialidad del Bajio
Jose A Alvarez-Canales, MD, Phd
Hospital Regional de Alta Especialidad del Bajio
Angel D Valdez-Vargas, MD
Hospital Regional de Alta Especialidad del Bajio
60 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2021
First Posted
March 29, 2021
Study Start
January 1, 2010
Actual (reported)Oral tamsulosin (0.4 mg/day) for eight weeks.
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Primary Completion
August 31, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)Last Updated
April 1, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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