An interventional study of Silodosin in Tamsulosin, Silodosin and Medical Expulsive Therapy, sponsored by Fatima Jinnah Medical University. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Fatima Jinnah Medical University · Not applicable, Interventional, and Treatment
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.
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.
Fatima Jinnah Medical University is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Tamsulosin is an alpha-1 adrenergic receptor blocker commonly used to treat benign prostatic hyperplasia (BPH) by relaxing the smooth muscles in the prostate and bladder neck. In the context of medical expulsive therapy (MET), it helps facilitate the passage of ureteric stones by relaxing the smooth muscles of the lower ureter, reducing ureteric spasm, and easing stone expulsion. It is widely used due to its effectiveness and relatively well-tolerated side effect profile.
Drug: Silodosin
Silodosin is used as a medical expulsive therapy (MET) to facilitate the passage of distal ureteral stones, particularly those sized between 4 to 10 mm. It works by selectively blocking alpha-1A adrenergic receptors in the ureter, relaxing the smooth muscle, which helps stones pass more easily and quickly.
Drug: Silodosin
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
Also known as: Sildat, Sildoso
STONE EXPULSION RATE
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: 6 MONTHS
TIME TO STONE EXPULSION
Number of days from treatment initiation to confirmed stone passage, measured by imaging and patient report.
Time frame: 6MONTHS
INCIDENCE OF ORTHOSTATIC HYPOTENSION
Percentage of patients experiencing orthostatic hypotension, measured by clinical blood pressure monitoring.
Time frame: 6 months
Incidence of Abnormal Ejaculation
Percentage of patients reporting abnormal ejaculation, assessed via patient questionnaires.
Time frame: 6 months
Incidence of Headache Percentage of patients reporting headaches, assessed via patient questionnaires.
Percentage of patients reporting headaches, assessed via patient questionnaires.
Time frame: 6 months
Analgesic Requirement:
Percentage of patients requiring analgesics during treatment, recorded from prescription or patient report.
Time frame: 6 months
Need for Auxiliary Procedures
Percentage of patients requiring interventions such as ureteroscopy or lithotripsy, documented from clinical records.
Time frame: 6 months
Stone Position and Laterality
: Distribution of stone location (proximal, mid, distal ureter) and side (right or left), determined by imaging.
Time frame: 6 months
Symptom Duration Prior to CT:
Categorized duration of symptoms before diagnosis, collected from patient history.
Time frame: 6 months
BMI
Measurement: Categorized as Normal or Obese based on standard BMI thresholds (weight in kilograms divided by height in meters squared).
Time frame: 6 MONTHS
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Plan to share: No
Ran from Oct 2023 to primary completion in Apr 2024, 6 months.
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Studies of the drug tested here: Silodosin
Fatima Jinnah Medical University