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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • 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

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
Intervention / Treatment
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

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

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

Hospital Regional de Alta Especialidad del Bajio

Investigators

  • 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)

January 1, 2010

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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