Comparative Study Between Silodosin , Tamsulosin , Silodosin Plus Tadalafil and Tamsulosin Plus Tadalafil As a Medical Expulsive Therapy for Lower Ureteral Stones
| Registry | NCT06707181 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 180 (Actual) |
| Sponsor | Beni-Suef University (Other) |
| Conditions | Lower Ureteral Stones |
| Interventions | • 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 (Drug) |
| Dates | start 2023-11-01, primary completion 2024-05-20, completion 2024-08-18, first posted 2024-11-27, last updated 2024-11-27 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Lower Ureteral Stones All trials 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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A | Active comparator | 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 | Group A treated by silodosin 8mg. |
| Group B | Active comparator | 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 | Group B treated by a tamsulosin 0.4 mg . |
| Group C | Active comparator | 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 | Group C was treated with a combination of silodosin 8 mg and tadalafil 5 mg . |
| Group D | Active comparator | 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 | Group D treated by a combination of tamsulosin 0.4 mg and tadalafil 5 mg. |
Sex: All, ages: 18 Years to any
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) .
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of Medicine, Fayoum University | Al Fayyum | Egypt |