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Study aim
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To compare the effectiveness of Silodosin and extracorporeal shock wave lithotripsy (ESWL) in patients admitted for management of lower ureteric stone.
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Design
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Randomized Clinical Trial
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Settings and conduct
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The trial was double-blind and commenced at the Urology department of LUMHS, Jamshoro from August 2023 to July 2024. Blinding maintenance was ensured by using envelopes/slips that indicate only the group allocation without revealing the intervention details, keeping trial participants, data collectors, and outcome assessors blinded; additionally, interventions were designed to appear identical where feasible, such as in color, consistency, or packaging.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Patients between the ages of 15-70 years, both gender, and having stone sizes 5-10mm in the lower ureteric region were included.
Exclusion Criteria:Patients having a single functional kidney before treatment, previous ureteric surgery, ureteric stones bilaterally, stricture in the ureteric region, previous stone passage, using alpha-adrenergic receptor blockers, and pregnant women and patients who lost follow up were excluded.
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Intervention groups
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Group A 8 mg capsule of Silodosin was given for 28 days and once daily and advised for urine collection and discontinuation of the medication upon passage of stone, with the time and date of passage recorded. Group B underwent ESWL
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Main outcome variables
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Demographic and basekine data, including age, duration of symptoms, BMI, hypertensive status, and diabetes, were recorded. Baseline investigations, including a computed tomography (CT) scan of the kidneys, ureters, and bladder (KUB), were performed to measure the size of the stone. After 1 month of treatment, patients underwent computed tomography scans to detect any residual stones or fragments in the ureter. If stones were not found, the patient was classified as stone-free.