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Completed

NCT Number: NCT06999135

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

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatima Jinnah Medical University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silodosin

Drug

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

Primary outcomes

  1. STONE EXPULSION RATE

    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.

  2. TIME TO STONE EXPULSION

    Time frame: 6MONTHS

    Number of days from treatment initiation to confirmed stone passage, measured by imaging and patient report.

Secondary outcomes

  1. INCIDENCE OF ORTHOSTATIC HYPOTENSION

    Time frame: 6 months

    Percentage of patients experiencing orthostatic hypotension, measured by clinical blood pressure monitoring.

  2. Incidence of Abnormal Ejaculation

    Time frame: 6 months

    Percentage of patients reporting abnormal ejaculation, assessed via patient questionnaires.

  3. Incidence of Headache Percentage of patients reporting headaches, assessed via patient questionnaires.

    Time frame: 6 months

    Percentage of patients reporting headaches, assessed via patient questionnaires.

  4. Analgesic Requirement:

    Time frame: 6 months

    Percentage of patients requiring analgesics during treatment, recorded from prescription or patient report.

  5. Need for Auxiliary Procedures

    Time frame: 6 months

    Percentage of patients requiring interventions such as ureteroscopy or lithotripsy, documented from clinical records.

  6. Stone Position and Laterality

    Time frame: 6 months

    : Distribution of stone location (proximal, mid, distal ureter) and side (right or left), determined by imaging.

  7. Symptom Duration Prior to CT:

    Time frame: 6 months

    Categorized duration of symptoms before diagnosis, collected from patient history.

Other outcomes

  1. BMI

    Time frame: 6 MONTHS

    Measurement: Categorized as Normal or Obese based on standard BMI thresholds (weight in kilograms divided by height in meters squared).

Sponsors and collaborators

Lead sponsor

Fatima Jinnah Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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