Silodosin in Management of Lower Ureteral Stones

April 19, 2024 updated by: Diaa Haj Ali, Syrian Private University

The Use of Selective Alpha Blockers (Silodosin) in Management of Lower Ureteral Stones Larger Than 6 mm in Diameter

This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • 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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients attending the urology Clinic with a distal unilateral ureteral stone larger than 6 mm in diameter.

Exclusion Criteria:

  • Patients under 18 years of age
  • Pregnant women
  • Patients with whom we were unable to contact
  • Patients treated with silodosin for another reason
  • Single kidney patients
  • Patients with bilateral ureter stones
  • Patients with deteriorating kidney function
  • Patients with grades 3rd and 4th of hydronephrosis

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: case group
patients who had given silodosin
Drug: Silodosin
Selective Alpha Blocker drug
No Intervention: Control group
patients who had not given silodosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone expulsion (yes)
Time Frame: 1 year
patients who were able to expel the stone
1 year
Stone expulsion (no)
Time Frame: 1 year
patients who were not able to expel the stone
1 year

Collaborators and Investigators

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

Sponsor

Syrian Private University

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)

October 20, 2022

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

October 25, 2023

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No 475

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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