Completed

NCT Number: NCT07307261

Evaluation of Mirabegron Versus Tamsulosin or Their Combination in Treatment of Lower Urinary Tract Symptoms

Stent related symptoms (SRSs) comprise of complaints such as irritative symptoms, sense of incomplete emptying, flank and suprapubic pain, and incontinence. Mechanical irritation of trigone, urinary reflux, and stent movement are plausible causes for SRSs.

Alpha-blockers are the primary medications for ureteral stent-related symptoms. These medications are suggested to patients by the American Urological Association (AUA)/Endourological Society guideline to reduce stent-related symptoms with moderate recommendation. Nevertheless, there are many side effects associated with alpha-blockers such as dizziness, headache, and orthostatic hypotension

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Key information

Conditions

Ureteric Stent-related Morbidity

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qena Hospital

Qina, Egypt

About this study

Ureteral stents have become an important part of urologic practice since first described the double-J stent . most often urolithiasis. Their use may be associated with significant bothersome symptoms and discomfort. Ureteral stent-related symptoms (SRSs) may occur in up to 88% of patients in mild or more severe degree.

Mirabegron is the first and only selective β3-adrenergic receptor agonist agent currently available and it is one of the treatment options for overactive bladder (OAB). Hence, many urologists have been introducing mirabegron therapy for OAB in recent years and because the SRS are similar to OAB symptoms, it may be another treatment option for reducing bladder irritability in patients indwelling DJ stent.

It is currently unclear whether mirabegron has a place in the treatment of SRSs. Our study aims to systematically evaluate the efficacy and safety of mirabegron in treating SRSs in comparison to Tamsulosin and their combination in adult patients

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

First time to use Ureteric stent .

Exclusion criteria

Urinary tract infection.
Previous ureteral surgery.
Congenital malformation of the ureter.
Distal ureteric stricture.
Hypersensitivity to the drugs.
Pregnancy or lactation.
Hepatic insufficiency
Non-compliant patients.
Age < 18 years old .

Treatment and study plan

Tamsulosin

Drug

to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity

Other names: Mirabegron

Primary outcomes

Treatment of Ureteral Stent Pain

Time frame: 4 Weeks

All patients will be evaluated before and after the treatment from the pain by the visual analog pain scale..

Sponsors and collaborators

Lead sponsor

Avraiem Talaat

Other

Registry information

Official study title

Evaluation of Mirabegron Versus Tamsulosin or Their Combination in Treatment of Lower Urinary Tract Symptoms Related to Double j Stent in Adults: A Prospective Randomized Study

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 29, 2025
Registry last updated: Dec 29, 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.