Comparative Study for Medical Therapy for Lower Ureteral Stones
NCT ID: NCT06707181
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
2023-11-01
2024-08-18
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Group A treated by silodosin 8mg.
• 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.
Group B
Group B treated by a tamsulosin 0.4 mg .
• 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.
Group C
Group C was treated with a combination of silodosin 8 mg and tadalafil 5 mg .
• 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.
Group D
Group D treated by a combination of tamsulosin 0.4 mg and tadalafil 5 mg.
• 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.
Interventions
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• 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.
Eligibility Criteria
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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) .
18 Years
ALL
No
Sponsors
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Beni-Suef University
OTHER
Responsible Party
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Hasnaa Osama
Lecturer at Clinical Pharmacy Department
Locations
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Faculty of Medicine, Fayoum University
Al Fayyum, , Egypt
Countries
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Other Identifiers
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M713
Identifier Type: -
Identifier Source: org_study_id