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IRCT20230514058174N1 IRCT 2026-01-29 Tehran University of Medical Sciences 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 2026-02-04 anticipated 248 Recruiting https://irct.ir/trial/70101 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Sampling was first carried out purposively and then using block randomization or randomization software, in this study, randomization of patients to two intervention groups (mirabegron, anticholinergic drugs) will be done in a 1:1 ratio and using a variable-size block randomization method. In this study, 284 patients with overactive bladder will be randomly assigned to two different treatment groups. The treatment groups will include the mirabegron treatment group and the anticholinergic drug treatment group. 142 people will be equally assigned to each of these groups. 3 Overactive bladder, Urinary incontinence. 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 randomization with a size of 20 people (14 blocks of 20 people and a final block of 4 people), so that in each block, half of the patients will be placed in the first intervention group of mirabegron and half in the second intervention group of anticholinergic. The sequence of patient allocation in each block will be randomly selected from possible combinations, and allocation will be done using opaque, sealed, and numbered envelopes to maintain allocation concealment. Due to the clear difference in intervention type, blinding of participants is not possible; 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 daily for 8 weeks. Intervention 2: Intervention group 2: The treatment group with anticholinergic drugs will be assigned to 142 people. Randomization of participants will be done using block randomization with a size of 20 people (14 blocks of 20 people and a final block of 4 people), so that in each block, half of the patients will be placed in the first intervention group of mirabegron and half in the second intervention group of anticholinergic. The sequence of patient allocation in each block will be randomly selected from possible combinations, and allocation will be done using opaque, sealed, and numbered envelopes to maintain allocation concealment. Due to the clear difference in intervention type, blinding of participants is not possible; However, the assessor of the patients' symptoms will be unaware of their treatment group (single blind). The second group will take anticholinergic drugs such as Solifenacin 5mg or Vesicare (Behestan Daru Company, made in Iran) daily for 8 weeks. This intervention will be performed only once at the beginning of the study. Patients will be assessed twice (before the intervention and 8 weeks after). No - There is not a plan to make this available Justification or reason for not sharing IPD is The related data is not available.
public Narges Aghaesmaeili
No.13 , Sina Alley, Hafez Alley, Bijan Alley, Hakim Nezami Street
Esfahan Iran (Islamic Republic of) 8175976856 +98 31 3627 7163 dr.narges.aghaesmaeili@gmail.com Tehran University of Medical Sciences scientific Narges Aghaesmaeili
No.13 , Sina Alley, Hafez Alley, Bijan Alley, Hakim Nezami Street
Esfahan Iran (Islamic Republic of) 8175976856 +98 31 3627 7163 dr.narges.aghaesmaeili@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 70 years Female 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. N39.8 Other specified disorders of urinary system Treatment - Drugs Treatment - Drugs 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 randomization with a size of 20 people (14 blocks of 20 people and a final block of 4 people), so that in each block, half of the patients will be placed in the first intervention group of mirabegron and half in the second intervention group of anticholinergic. The sequence of patient allocation in each block will be randomly selected from possible combinations, and allocation will be done using opaque, sealed, and numbered envelopes to maintain allocation concealment. Due to the clear difference in intervention type, blinding of participants is not possible; 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 daily for 8 weeks. Intervention group 2: The treatment group with anticholinergic drugs will be assigned to 142 people. Randomization of participants will be done using block randomization with a size of 20 people (14 blocks of 20 people and a final block of 4 people), so that in each block, half of the patients will be placed in the first intervention group of mirabegron and half in the second intervention group of anticholinergic. The sequence of patient allocation in each block will be randomly selected from possible combinations, and allocation will be done using opaque, sealed, and numbered envelopes to maintain allocation concealment. Due to the clear difference in intervention type, blinding of participants is not possible; However, the assessor of the patients' symptoms will be unaware of their treatment group (single blind). The second group will take anticholinergic drugs such as Solifenacin 5mg or Vesicare (Behestan Daru Company, made in Iran) daily for 8 weeks. This intervention will be performed only once at the beginning of the study. Patients will be assessed twice (before the intervention and 8 weeks after). Body Mass Index(BMI). Timepoint: Prior to intervention. Method of measurement: Standard urinary incontinence questionnaire and testing Urodynamic. Urinary frequency. Timepoint: Prior to intervention. Method of measurement: Standard Urinary Incontinence Questionnaire and Flowmetry. Tehran University of Medical Sciences Approved 2025-12-02 Imam Khomeini Hospital Complex - Tehran University of Medical Sciences (Research Ethics Committee) Imam Khomeini Hospital Complex, Vali Asr Hospital, Bagherkhan Ave. Tehran Tehran Iran (Islamic Republic of)