COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI

March 17, 2023 updated by: AJ Arif, Armed Forces Institute of Urology, Rawalpindi
to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 1

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
      • Rawalpindi, Punjab, Pakistan, 46000
        • AFIU Rawalpindi

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of <10 mm in size (on plain CT KUB)

Exclusion Criteria:

  • solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silodosin Group
The patients used Silodosin for ureteric calculi
Drug: Silodosin
The patients used Silodosin for Medical expulsive therapy of ureteric calculi
Experimental: Tamsulosin Group
The patients used Tamsulosin for ureteric calculi
Drug: Tamsulosin
The patients used Tamsulosin for Medical expulsive therapy of ureteric calculi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone clearance rate
Time Frame: upto 4 weeks
Stone clearance rate
upto 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone expulsion time
Time Frame: upto 4 weeks
Stone expulsion time
upto 4 weeks

Collaborators and Investigators

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

Sponsor

Armed Forces Institute of Urology, Rawalpindi

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)

September 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFIU-2022-02

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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