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

NCT07307261 | Completed DMC

• 1 other identifier: Mirabegron Vs Tamsulosin
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ureteric Stent-related Morbidity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Tamsulosin 0.4mg

ACTIVE COMPARATOR

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

Mirabegron 50mg

ACTIVE COMPARATOR

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

combination of tamsulosin 0.4mg and Mirabegron 50mg

ACTIVE COMPARATOR

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

Interventions

Tamsulosin DRUG

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

Also known as: Mirabegron

Mirabegron 50mg; Tamsulosin 0.4mg; combination of tamsulosin 0.4mg and Mirabegron 50mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First time to use Ureteric stent .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Avraiem Talaat: lead

Study Sites (1)

Qena Hospital

Qina, Egypt

Location

MeSH Terms

Interventions

Tamsulosin; mirabegron

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Mohammad Sayed Abdel-kader, Professor

  Urology Department,faculty of Medicine, South Valley university.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident at Urology Department

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: December 29, 2025
• Study Start: October 10, 2024
• Primary Completion: October 5, 2025
• Study Completion: October 10, 2025
• Last Updated: December 29, 2025

Record last verified: 2024-10

Locations

EG (1)