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

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

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

Study Overview

• Status: Completed
• Conditions: Ureteric Stent-related Morbidity
• Intervention / Treatment: Drug: Tamsulosin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qina, Egypt
    • Qena Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tamsulosin 0.4mg; About 100 patients will receive Tamsulosin (0.4mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults	Drug: Tamsulosin; to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity; Other Names: Mirabegron
Active Comparator: Mirabegron 50mg; About 100 patients will receive Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults	Drug: Tamsulosin; to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity; Other Names: Mirabegron
Active Comparator: combination of tamsulosin 0.4mg and Mirabegron 50mg; About 100 patients will receive A combination of tamsulosin (0.4mg) and Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults	Drug: Tamsulosin; to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity; Other Names: Mirabegron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of Ureteral Stent Pain	All patients will be evaluated before and after the treatment from the pain by the visual analog pain scale..	4 Weeks

Collaborators and Investigators

• Sponsor: Avraiem Talaat
• Investigators: Study Chair: Mohammad Sayed Abdel-kader, Professor, Urology Department,faculty of Medicine, South Valley university.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): October 5, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Tamsulosin; mirabegron
• Other Study ID Numbers: Mirabegron Vs Tamsulosin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No