Medical Expulsive Therapy, Silodosin, Tamsulosin
Conditions
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.
Interventions
DRUGSilodosin
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
Sponsors
Fatima Jinnah Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TIME TO STONE EXPULSION | 6MONTHS | Number of days from treatment initiation to confirmed stone passage, measured by imaging and patient report. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Need for Auxiliary Procedures | 6 months | Percentage of patients requiring interventions such as ureteroscopy or lithotripsy, documented from clinical records. |
| INCIDENCE OF ORTHOSTATIC HYPOTENSION | 6 months | Percentage of patients experiencing orthostatic hypotension, measured by clinical blood pressure monitoring. |
Other
| Measure | Time frame | Description |
|---|---|---|
| BMI | 6 MONTHS | Measurement: Categorized as Normal or Obese based on standard BMI thresholds (weight in kilograms divided by height in meters squared). |
Countries
Pakistan
Outcome results
None listed