Completed

Silodosin and Tamsulosin for Ureteral Stones Treatment

What is being tested

Silodosin

Drug

Who is being recruted

From 18 to 55 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: October 2023

See protocol details

Summary

Principal SponsorFatima Jinnah Medical University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2023

Actual date on which the first participant was enrolled.

This clinical trial aims to compare two medications, Silodosin and Tamsulosin, to help pass kidney stones located in the ureter, which is the tube connecting the kidney to the bladder. The study involves adults aged 18 to 60 who have a single stone between 5 to 10 mm in size. The research focuses on finding out which medication is more effective in helping stones pass naturally without surgical intervention. This is important because passing stones without surgery can reduce discomfort, medical costs, and recovery time for patients. Participants in the study are randomly assigned to receive either Tamsulosin or Silodosin daily, along with pain relief medication as needed. They are encouraged to stay well-hydrated and continue the treatment until the stone is expelled or for up to 28 days. The progress is monitored through weekly check-ups and imaging tests like ultrasounds or X-rays. The study also records any side effects such as dizziness or headache using questionnaires. The results are analyzed to determine which drug is more effective in helping people pass their stones safely and efficiently.

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

NCT06999135

Principal SponsorFatima Jinnah Medical University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

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

Show More Criteria

10 exclusion criteria prevent from participating

Serum Creatinine > 1.3 mg/dl in males and > 1.2 mg/dl in females.

Pregnancy

Untreated UTI

Bleeding disorders

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Active Comparator

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Fatima Jinnah Medical University

Lahore, PakistanOpen Fatima Jinnah Medical University in Google Maps

CompletedOne Study Center