Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy

February 10, 2023 updated by: Dr. SamiUllah, Services Hospital, Lahore
Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and bladder neck. Its role as part of medical expulsion therapy for the treatment of patients with kidney and ureteric stones has proved to be of considerable success. However, its role in clearing upper ureteric stones as an adjunct to ESWL is controversial. Therefore, this study will be conducted to evaluate its role in stone clearance along with extracorporeal shock wave lithotripsy in patients with upper ureteric stones

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Services Institute of Medical Sciences

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • single upper ureteric stone
  • size ranging from 6-15 mm
  • stones history less than 6 months

Exclusion Criteria:

  • Patients with urinary tract infection
  • multiple ureteric stones,
  • presence of a ureteric stricture distal to the stone,
  • previous unsuccessful ESWL,
  • concomitant use of calcium channel blockers or alpha-adrenergic antagonists
  • patients with abnormal coagulation profile

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ESWL alone
Extracorporeal shock wave lithotripsy will be given to the patient
Procedure: Extracorporeal shock wave lithotripsy
Extracorporeal shock wave lithotripsy will given to the patients
ACTIVE_COMPARATOR: ESWL combined with tamsulosin therapy
Extracorporeal shock wave lithotripsy combined with tamsulosin therapy will be given to the patient
Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.
Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy will be given to the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone clearance
Time Frame: 4 weeks
Number of patients cleared from ureteric stones
4 weeks

Collaborators and Investigators

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

Sponsor

Services Hospital, Lahore

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)

February 1, 2018

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (ACTUAL)

February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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