Tamsulosin as Adjunctive Therapy After Extracorporeal Shock Wave Lithotripsy for Renal Stones

March 26, 2021 updated by: Rafael Maldonado-Valadez, Hospital Regional de Alta Especialidad del Bajio
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Urolithiasis is a common health problem worldwide affecting ∼10% of the population at some stage in their lives. It affects approximately 5% of women and 12% of men in the United States, and it has been suggested that the incidence is increasing. Because of its efficacy and low morbidity, extracorporeal shock wave lithotripsy (ESWL) is an effective treatment for kidney stones smaller than 20 mm in diameter. The objective of this therapy is to achieve an adequate fragmentation of the calculus that allows a spontaneous expulsion of the fragments, and finally, a stone-free state, which is not always possible.

The presence of adrenergic receptors in the ureter has suggested the involvement of the sympathetic nervous system in its peristaltic activity. It has also been shown that alpha 1 adrenergic antagonist medications such as tamsulosin are capable of inhibiting the basal tone and the ureteral peristalsis, causing dilation and facilitating the migration of stones. Some authors have reported the efficacy of this type of medication for spontaneous calculus expulsion, but there is no conclusive evidence of the adjuvant effectiveness of tamsulosin after ESWL for stone clearance and even less among a Mexican population.

This is a single center, randomized, non-placebo-controlled study with a sample of adults (men and women ≥18 years old) with a single radiopaque kidney stone (5-20 mm) in diameter. Post-ESWL session, the patients will be randomly divided into two groups (the control group and the tamsulosin group). After discharge, all patients will be instructed to drink a minimum of 2 L water daily. The control group will receive standard treatment for analgesia consisting of oral diclofenac (75 mg/12 h) as needed. The tamsulosin group will receive standard treatment for analgesia plus oral tamsulosin (0.4 mg/day) for eight weeks.

Patients will attend follow-up visits every two weeks during the first month of treatment and a final visit at the end of the second month. During each visit, vital signs will be taken, a physical examination will be conducted, and possible adverse effects will be monitored; additionally, a plain X-ray of the kidney, ureter, and bladder (KUB) will be taken at two and four weeks for evaluating possible complications associated with residual fragments, as well as an abdominal CT scan at eight weeks after the ESWL in order to determine stone-free status.

Data will be analyzed using R Statistical Software. Descriptive statistics will be determined for the patients' clinical characteristics, grouped by the treatment assigned (control group and tamsulosin group) and will be compared using the Mann-Whitney U test or the chi-square test depending on the variable type. The strength of the association between the ESWL treatment with adjuvant tamsulosin and the stone-free rate will be evaluated by calculating the relative risk (RR) and the number needed to treat (NNT). In all cases, an alpha=0.05 was considered significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tamsulosin
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 lithotripsy
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.
Drug: Diclofenac
Standard treatment for analgesia: oral diclofenac (75 mg/12 h) as needed.
Drug: Tamsulosin
Oral tamsulosin (0.4 mg/day) for eight weeks.
Active Comparator: Control
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 lithotripsy
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.
Drug: Diclofenac
Standard treatment for analgesia: oral diclofenac (75 mg/12 h) as needed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stone-free rate
Time Frame: 8 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications rate associated with residual stone fragments
Time Frame: 2, 4, and 8 weeks
Percentage of patients with the presence of complications associated with residual stone fragments.
2, 4, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Regional de Alta Especialidad del Bajio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rafael E Maldonado-Valadez, MD, MSc, Hospital Regional de Alta Especialidad del Bajio
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CI-HRAEB-2008-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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