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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-10-10

Brief Summary

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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

Detailed Description

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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

Conditions

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Ureteric Stent-related Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Mirabegron

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avraiem Talaat

OTHER

Sponsor Role lead

Responsible Party

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Avraiem Talaat

Resident at Urology Department

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Egypt

Other Identifiers

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Mirabegron Vs Tamsulosin

Identifier Type: -

Identifier Source: org_study_id