Evaluation of Mirabegron Versus Tamsulosin or Their Combination in Treatment of Lower Urinary Tract Symptoms
NCT ID: NCT07307261
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2024-10-10
2025-10-10
Brief Summary
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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
Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Tamsulosin
to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity
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
Tamsulosin
to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity
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
Tamsulosin
to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity
Interventions
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Tamsulosin
to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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 .
18 Years
50 Years
ALL
No
Sponsors
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Avraiem Talaat
OTHER
Responsible Party
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Avraiem Talaat
Resident at Urology Department
Principal Investigators
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Mohammad Sayed Abdel-kader, Professor
Role: STUDY_CHAIR
Urology Department,faculty of Medicine, South Valley university.
Locations
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Qena Hospital
Qina, , Egypt
Countries
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Other Identifiers
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Mirabegron Vs Tamsulosin
Identifier Type: -
Identifier Source: org_study_id