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

Protocol summary

Study aim
Comparison of the effects of two treatment approaches (mirabegron , anticholinergic drugs) on changes in urinary dysfunction in patients with overactive bladder.
Design
A phase 2, parallel-group, single-blind, randomized clinical trial on 284 patients. All statistical analyses will be performed using Stata software (StataCorp LLC, College Station, TX, Version 17.
Settings and conduct
The aim of this randomized, single-blind study is to compare the effects of two therapeutic approaches (mirabegron and anticholinergic drugs) on changes in urinary dysfunction in patients with overactive bladder referring to the Pelvic Clinic of Imam Khomeini Hospital located in Tehran. Half of the patients will be assigned to the mirabegron group and half to the anticholinergic group. The sequence of patient allocation in each block will be randomly selected from among the possible combinations. Allocation will be done using opaque, sealed, waxed, and numbered envelopes to maintain allocation concealment.
Participants/Inclusion and exclusion criteria
The main inclusion 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. The main 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 injuries, 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
Intervention groups
Intervention 1 Group 1; Anticholinergic drug solifenacin 5 mg or Vesicare daily; for 8 weeks Intervention 2 Group 2; Mirabegron 50 mg oral tablet daily for 8 weeks
Main outcome variables
Improve urinary dysfunction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230514058174N1
Registration date: 2026-01-29, 1404/11/09
Registration timing: prospective

Last update: 2026-01-29, 1404/11/09
Update count: 0
Registration date
2026-01-29, 1404/11/09
Registrant information
Name
Narges Aghaesmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 7163
Email address
dr.narges.aghaesmaeili@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-02-04, 1404/11/15
Expected recruitment end date
2027-02-04, 1405/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Clinical Trial Comparing the Efficacy of Mirabegron and Anticholinergic Medications in the Treatment of Urinary Dysfunction in Patients with Overactive Bladder
Public title
Comparing the Efficacy of Mirabegron and Anticholinergic Medications in the Treatment of Urinary Dysfunction in Patients with Overactive Bladder
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 20 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 248
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Imam Khomeini Hospital Complex - Tehran University of Medical Sciences (Research Ethics Committee)
Street address
Imam Khomeini Hospital Complex, Vali Asr Hospital, Bagherkhan Ave.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2025-12-02, 1404/09/11
Ethics committee reference number
IR.TUMS.IKHC.REC.1404.397

Health conditions studied

1

Description of health condition studied
Overactive bladder, Urinary incontinence
ICD-10 code
N39.8
ICD-10 code description
Other specified disorders of urinary system

Primary outcomes

1

Description
Body Mass Index(BMI)
Timepoint
Prior to intervention
Method of measurement
Standard urinary incontinence questionnaire and testing Urodynamic

2

Description
Urinary frequency
Timepoint
Prior to intervention
Method of measurement
Standard Urinary Incontinence Questionnaire and Flowmetry

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex, Vali Asr Hospital
Full name of responsible person
Narges Aghaesmaeili
Street address
Imam Khomeini Hospital Complex, Vali Asr Hospital, Bagherkhan Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2271
Email
dr.narges.aghaesmaeili@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Central Organization of Tehran University of Mesical Sciences, corner of Qods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges Aghaesmaeili
Position
Assistant Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.13 , Sina Alley, Hafez Alley, Bijan Alley, Hakim Nezami Street
City
Esfahan
Province
Isfehan
Postal code
8175976856
Phone
+98 31 3627 7163
Email
dr.narges.aghaesmaeili@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges Aghaesmaeili
Position
Assistant Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.13 , Sina Alley, Hafez Alley, Bijan Alley, Hakim Nezami Street
City
Esfahan
Province
Isfehan
Postal code
8175976856
Phone
+98 31 3627 7163
Email
dr.narges.aghaesmaeili@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges Aghaesmaeili
Position
Assistant Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.13 , Sina Alley, Hafez Alley, Bijan Alley, Hakim Nezami Street
City
Esfahan
Province
Isfehan
Postal code
8175976856
Phone
+98 31 3627 7163
Email
dr.narges.aghaesmaeili@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The related data is not available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some part of above research is possible to be shared.
When the data will become available and for how long
The possibility for sharing of related data will be after 6 months of publishing article.
To whom data/document is available
Only for employed researchers in university and scientific institutes
Under which criteria data/document could be used
The carry out of analysis based on specified values in this research
From where data/document is obtainable
Narges Aghaesmaeili Email: dr.narges.aghaesmaeili@gmail.com Address: No.13 , Sina Alley, Hafez Alley, Bijan Alley, Hakim Nezami Street
What processes are involved for a request to access data/document
The based on approval of Professor
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