Fatima Jinnah Medical University
Lahore, Punjab Province, 54000, Pakistan
NCT Number: NCT06999135
This study compares the effectiveness and side effect profiles of Tamsulosin and Silodosin in medical expulsive therapy (MET) for ureteric stones. Conducted as a randomized control trial at Sir Ganga Ram Hospital, Lahore, 180 patients were analyzed-89 on Tamsulosin and 93 on Silodosin. Results showed that Silodosin had a higher stone expulsion rate, especially within 14 days, and fewer side effects compared to Tamsulosin. Common side effects included orthostatic hypotension, abnormal ejaculation, and headaches, with Silodosin showing a better overall safety profile.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
This study was designed as a prospective, randomized, open-label, controlled trial conducted at the Urology Department of Sir Ganga Ram Hospital, Lahore, over a period of 12 months. Ethical approval was obtained from the institutional review board, and written informed consent was secured from all participants.
Participants included adults aged 18 to 60 years with a single, unilateral ureteric stone measuring 5 to 10 mm, confirmed by non-contrast CT scan. Patients with a history of ureteral surgery, congenital anomalies, severe renal impairment (serum creatinine above 1.5 mg/dL), pregnancy, lactation, urinary tract infection, or those using calcium channel blockers or other alpha-blockers were excluded. A total of 180 eligible patients were randomized into two groups: 89 patients received Tamsulosin 0.4 mg daily, while 93 patients received Silodosin 8 mg daily.
Both groups received standard analgesia with diclofenac sodium 50 mg as needed and were advised to maintain adequate hydration. Treatment continued until stone expulsion or for a maximum of 28 days. Patients were monitored weekly through clinical evaluation and imaging (ultrasound or X-ray), and adverse events such as dizziness, ejaculatory dysfunction, and headaches were recorded using standardized questionnaires.
Data analysis was performed using SPSS version 25.0. Continuous variables were compared using Student's t-test, while categorical variables were assessed with Chi-square or Fisher's exact test. A p-value of less than 0.05 was considered statistically significant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Silodosin is an oral medication primarily used to treat benign prostatic hyperplasia (BPH) by relaxing the muscles in the prostate and bladder neck to improve urine flow. It belongs to a class of drugs called alpha-1 adrenergic antagonists, which block receptors responsible for muscle contraction in these areas. This action helps relieve symptoms such as difficulty urinating, urgency, and weak urine stream. Silodosin is taken once daily with food and is known for its high selectivity for alpha-1A receptors, contributing to its effectiveness and safety profile
Other names: Sildat, Sildoso
Time frame: 6 MONTHS
This measure evaluates the proportion of patients who pass ureteral stones within specific time frames (0-14 days, 15-21 days, and 22-28 days) when treated with Silodosin versus Tamsulosin.
Time frame: 6MONTHS
Number of days from treatment initiation to confirmed stone passage, measured by imaging and patient report.
Time frame: 6 months
Percentage of patients experiencing orthostatic hypotension, measured by clinical blood pressure monitoring.
Time frame: 6 months
Percentage of patients reporting abnormal ejaculation, assessed via patient questionnaires.
Time frame: 6 months
Percentage of patients reporting headaches, assessed via patient questionnaires.
Time frame: 6 months
Percentage of patients requiring analgesics during treatment, recorded from prescription or patient report.
Time frame: 6 months
Percentage of patients requiring interventions such as ureteroscopy or lithotripsy, documented from clinical records.
Time frame: 6 months
: Distribution of stone location (proximal, mid, distal ureter) and side (right or left), determined by imaging.
Time frame: 6 months
Categorized duration of symptoms before diagnosis, collected from patient history.
Time frame: 6 MONTHS
Measurement: Categorized as Normal or Obese based on standard BMI thresholds (weight in kilograms divided by height in meters squared).
Fatima Jinnah Medical University
Other
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