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CompletedNCT06707181Updated Nov 27, 2024

Comparative Study for Medical Therapy for Lower Ureteral Stones

A Phase 3 interventional study of • 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 in Lower Ureteral Stones, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Beni-Suef University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Lower Ureteral Stones
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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:

  • 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) .
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • 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.

05

What researchers measure

Primary outcomes

  1. Expulsion rate

    Time frame: 28 days

06

Study locations

1 site
  • Faculty of Medicine, Fayoum University
    Fayoum, Egypt
07

Registry details

Key details

Study ID
NCT06707181
Lead sponsor
Beni-Suef University
Responsible party
Hasnaa Osama (Lecturer at Clinical Pharmacy Department, Beni-Suef University) — Principal investigator
First posted
Nov 27, 2024
Start date
Nov 1, 2023
Primary completion
May 20, 2024
Completion
Aug 18, 2024
Last update
Nov 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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