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

Avraiem Talaat

Status: Completed

Conditions: Ureteric Stent-related Morbidity

Treatments: Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT07307261

Mirabegron Vs Tamsulosin

Details and patient eligibility

About

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

Full 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

Enrollment: 300 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Tamsulosin 0.4mg

Active Comparator group

Description:

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

Treatment:

Drug: Tamsulosin

Mirabegron 50mg

Active Comparator group

Description:

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

Treatment:

Drug: Tamsulosin

combination of tamsulosin 0.4mg and Mirabegron 50mg

Active Comparator group

Description:

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

Treatment:

Drug: Tamsulosin