NCT04819828

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

6.7 years

First QC Date

March 25, 2021

Last Update Submit

March 26, 2021

Conditions

Renal Stone

Keywords

Extracorporeal shock wave lithotripsyTamsulosinUrolithiasis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Complications rate associated with residual stone fragments

    2, 4, and 8 weeks

Study Arms (2)

Tamsulosin

EXPERIMENTAL

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.

Procedure: Extracorporeal shock wave lithotripsyDrug: DiclofenacDrug: Tamsulosin

Control

ACTIVE COMPARATOR

At the end of the ESWL session, the patients received standard treatment for analgesia consisting of oral diclofenac (75 mg/12 h) as needed

Procedure: Extracorporeal shock wave lithotripsyDrug: Diclofenac

Interventions

Extracorporeal shock wave lithotripsyPROCEDURE

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.

ControlTamsulosin
DiclofenacDRUG

Standard treatment for analgesia: oral diclofenac (75 mg/12 h) as needed.

ControlTamsulosin
TamsulosinDRUG

Oral tamsulosin (0.4 mg/day) for eight weeks.

Tamsulosin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A single radiopaque kidney stone (5-20 mm) in diameter visible on CT scan of the abdomen.

You may not qualify if:

  • A lower calyx stone.
  • A history of spontaneous stone passage.
  • A previous failed ESWL.
  • Treatment with alpha adrenergic antagonists, calcium channel inhibitors or steroids.
  • Severe obesity (BMI≥40).
  • Pregnancy.
  • Serum creatinine ≥2 mg/dl.
  • Renal artery aneurysm and/or abdominal aorta aneurysm.
  • The presence of a ureteral stent.
  • Anatomical abnormalities or previous surgery on the upper urinary tract.
  • Bone deformities.
  • Presence of a urinary tract infection.
  • Coagulation disorders.
  • Poorly controlled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35685573DERIVED

MeSH Terms

Conditions

NephrolithiasisUrolithiasis

Interventions

LithotripsyDiclofenacTamsulosin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, OperativePhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Rafael E Maldonado-Valadez, MD, MSc

    Hospital Regional de Alta Especialidad del Bajio

    PRINCIPAL INVESTIGATOR

  • Edel R Rodea-Montero, MPH

    Hospital Regional de Alta Especialidad del Bajio

    STUDY CHAIR

  • Jose A Alvarez-Canales, MD, Phd

    Hospital Regional de Alta Especialidad del Bajio

    STUDY CHAIR

  • Angel D Valdez-Vargas, MD

    Hospital Regional de Alta Especialidad del Bajio

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 29, 2021

Study Start

January 1, 2010

Primary Completion

August 31, 2016

Study Completion

December 31, 2016

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share