Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones
- Conditions
- TamsulosinSilodosinMedical Expulsive Therapy
- Interventions
- Registration Number
- NCT06999135
- Lead Sponsor
- Fatima Jinnah Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Patients between ages 18 years - 55 years.
- Solitary unilateral ureteral stone
- Stone sizes less than 10 mm measured on non-contrast computed tomography of kidney, ureter and bladder.
- Stones being treated primarily with medical expulsive therapy
- Radio opaque Stone
- Pregnancy
- Untreated UTI
- Bleeding disorders
- Obstruction distal to stone
- Serum Creatinine > 1.3 mg/dl in males and > 1.2 mg/dl in females.
- Congenital renal anomaly/ skeletal malformation
- Previous treatment for the same stone (PCNL/ URS / push back)
- Solitary Kidney
- Prior JJ stent insertion
- Bilateral ureteral stone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAMSULOSIN Silodosin 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. Silodosin 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.
- Primary Outcome Measures
Name Time Method STONE EXPULSION RATE 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 TO STONE EXPULSION 6MONTHS Number of days from treatment initiation to confirmed stone passage, measured by imaging and patient report.
- Secondary Outcome Measures
Name Time Method INCIDENCE OF ORTHOSTATIC HYPOTENSION 6 months Percentage of patients experiencing orthostatic hypotension, measured by clinical blood pressure monitoring.
Incidence of Abnormal Ejaculation 6 months Percentage of patients reporting abnormal ejaculation, assessed via patient questionnaires.
Incidence of Headache Percentage of patients reporting headaches, assessed via patient questionnaires. 6 months Percentage of patients reporting headaches, assessed via patient questionnaires.
Analgesic Requirement: 6 months Percentage of patients requiring analgesics during treatment, recorded from prescription or patient report.
Need for Auxiliary Procedures 6 months Percentage of patients requiring interventions such as ureteroscopy or lithotripsy, documented from clinical records.
Stone Position and Laterality 6 months : Distribution of stone location (proximal, mid, distal ureter) and side (right or left), determined by imaging.
Symptom Duration Prior to CT: 6 months Categorized duration of symptoms before diagnosis, collected from patient history.
Trial Locations
- Locations (1)
Fatima Jinnah Medical University
🇵🇰Lahore, Punjab, Pakistan