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Comparing the Efficacy of Mirabegron and Anticholinergic Medications in the Treatment of Urinary Dysfunction in Patients with Overactive Bladder

A Randomized Clinical Trial Comparing the Efficacy of Mirabegron and Anticholinergic Medications in the Treatment of Urinary Dysfunction in Patients with Overactive Bladder

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230514058174N1
Enrollment
248
Registered
2026-01-29
Start date
2026-02-04
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder, Urinary incontinence. Other specified disorders of urinary system

Interventions

Intervention 1: Intervention group 1: The treatment group includes the mirabegron treatment group, 142 people will be allocated to this group. Randomization of participants will be done using block ra
However, the assessor of the patients' symptoms will be unaware of their treatment group (single blind). The first group will be treated with Mirabegron (Tasnim Gostar Company, made in Iran) 50 mg dai
However, the assessor of the patients' symptoms will be unaware of their treatme

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Diagnosis of OAB by a gynecologist based on the following criteria: Urination more than eight times in a 24 hour period, Urinary urgency with or without urge incontinence, aged 20-70 years, Providing written informed consent.

Exclusion criteria

Exclusion criteria: Active urinary tract infection, pregnancy, breastfeeding or less than 6 months after giving birth, history of surgery to treat incontinence or pelvic prolapse, fecal incontinence or spinal cord lesions, serious illnesses: cancer, Kidney, heart, lung disease, diabetes, epilepsy or history of seizures, uncontrolled blood pressure, rheumatism, physical disabilities, dementia or severe psychiatric disorders, drug, alcohol or tobacco use Unwillingness or inability to follow treatment, occurrence of serious drug side effects (especially to anticholinergics), presence of anatomical abnormalities resulting from surgery in the urinary system (ductal stricture, prolapse, obstructive tumor, fibrosis after radiation therapy, trauma, or iatrogenic surgery), Dysfunction of the lower nervous system of the bladder.

Design outcomes

Primary

MeasureTime frame
Urinary frequency. Timepoint: Prior to intervention. Method of measurement: Standard Urinary Incontinence Questionnaire and Flowmetry.;Body Mass Index(BMI). Timepoint: Prior to intervention. Method of measurement: Standard urinary incontinence questionnaire and testing Urodynamic.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarges Aghaesmaeili

Tehran University of Medical Sciences

dr.narges.aghaesmaeili@gmail.com+98 31 3627 7163

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026