Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones

Fatima Jinnah Medical University

Status: Completed

Conditions: Silodosin; Medical Expulsive Therapy; Tamsulosin

Treatments: Drug: Silodosin

Study type: Interventional

Funder types: Other

Identifiers

NCT06999135

No.31-Synopsis-FCPS-Pharma/FJ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

TAMSULOSIN

Active Comparator group

Description:

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.

Treatment:

Drug: Silodosin

Silodosin

Experimental group

Description:

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.

Treatment:

Drug: Silodosin