Comparative Study for Medical Therapy for Lower Ureteral Stones

November 24, 2024 updated by: Hasnaa Osama, Beni-Suef University

Comparative Study Between Silodosin , Tamsulosin , Silodosin Plus Tadalafil and Tamsulosin Plus Tadalafil As a Medical Expulsive Therapy for Lower Ureteral Stones

The goal of this clinical trial is to compare the efficacy and adverse effects of different drugs as a medical expulsive therapy for lower ureteral stones. The main questions it aims to answer are:

  • Which of the following are more effective silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil as a therapy for lower ureteral stones?
  • What medical problems do participants have when taking these drugs?

Researchers will compare silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil to see which drug works better to treat lower ureteral stones Participants will:

  • Take silodosin, tamsulosin, silodosin plus tadalafil or tamsulosin plus tadalafil every day for 28 days
  • Visit the clinic once every 2 weeks for checkups and tests
  • Keep a diary of their symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

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

  • Egypt
      • Fayoum, Egypt
        • Faculty of medicine, Fayoum university

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:

  • Inclusion criteria were adult patients aged 18 years and older with lower ureteral stones measuring 5-10 mm in diameter, diagnosed through imaging techniques such as kidney-ureter-bladder (KUB) x-rays or computed tomography (CT) scans.

Exclusion Criteria:

  • Exclusion criteria included pregnant and lactating women, renal insufficiency, congenital urinary tract abnormalities, associated kidney stones or contralateral ureteric stones, solitary kidneys, associated infected stones, uncontrolled pain, severe hydronephrosis, history of allergy to the study medications and recent treatment for ureteral stones within the past 3 months (e.g., lithotripsy or surgery) .

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
Active Comparator: Group A
Group A treated by silodosin 8mg.
Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf
• The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafil 5 mg (Group C) and tamsulosin 0.4 mg plus tadalafil 5 mg (Group D). Drugs are given for a maximal duration of 28 days.
Active Comparator: Group B
Group B treated by a tamsulosin 0.4 mg .
Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf
• The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafil 5 mg (Group C) and tamsulosin 0.4 mg plus tadalafil 5 mg (Group D). Drugs are given for a maximal duration of 28 days.
Active Comparator: Group C
Group C was treated with a combination of silodosin 8 mg and tadalafil 5 mg .
Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf
• The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafil 5 mg (Group C) and tamsulosin 0.4 mg plus tadalafil 5 mg (Group D). Drugs are given for a maximal duration of 28 days.
Active Comparator: Group D
Group D treated by a combination of tamsulosin 0.4 mg and tadalafil 5 mg.
Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf
• The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafil 5 mg (Group C) and tamsulosin 0.4 mg plus tadalafil 5 mg (Group D). Drugs are given for a maximal duration of 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Expulsion rate
Time Frame: 28 days
28 days

Collaborators and Investigators

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

Sponsor

Beni-Suef 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)

November 1, 2023

Primary Completion (Actual)

May 20, 2024

Study Completion (Actual)

August 18, 2024

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M713

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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