Protocol summary

Study aim
Evaluating the effectiveness of combined mirabegron therapy and biofeedback sessions in the treatment of overactive bladder syndrome in women aged 35–70 years.
Design
This is a single-center, randomized, parallel-group clinical trial using block randomization.
Settings and conduct
Participants will be recruited from Nikan Aghdasieh Clinic and randomly allocated to one of the two study groups after eligibility assessment and informed consent.
Participants/Inclusion and exclusion criteria
Eligible participants are women with at least a 3-month history of urinary urgency, urinary frequency of more than times per 24 hours, and at least one urgency urinary incontinence episode per day. Exclusion criteria include unwillingness to participate or lack of informed consent, psychiatric or cognitive disorders affecting cooperation, and physical disabilities preventing study interventions.
Intervention groups
Participants in the intervention group will receive mirabegron 50 mg daily plus biofeedback therapy (two sessions per week, 30–45 minutes each). The control group will receive mirabegron 50 mg daily alone.
Main outcome variables
severity of overactive bladder symptoms; quality of life associated with overactive bladder syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230629058615N11
Registration date: 2026-01-11, 1404/10/21
Registration timing: prospective

Last update: 2026-01-11, 1404/10/21
Update count: 0
Registration date
2026-01-11, 1404/10/21
Registrant information
Name
Amir Rezazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 729 8761
Email address
rezazadeh.am@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-05, 1404/12/14
Expected recruitment end date
2026-05-14, 1405/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the combined effectiveness of mirabegron and biofeedback therapy in the treatment of overactive bladder in women between 35 and 70 years old in a randomized clinical trial.
Public title
Evaluation of the combined effectiveness of mirabegron and biofeedback therapy in the treatment of overactive bladder in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female participants Age range from 35 to 70 years old Participants who are diagnosed with Overactive Bladder Syndrome ‪Visitors to Nikan Aghdasieh Clinic‬ Urinary urgency for at least 3 months prior to study entry Urinary frequency of 8 or more times in 24 hours At least 1 episode of urge incontinence in 24 hours
Exclusion criteria:
Unwillingness to participate in the study or failure to provide informed consent ‪The presence of mental or cognitive disorders such as schizophrenia, panic disorder, severe obsessive-compulsive disorder, alcohol abuse, and drug abuse that could interfere with the ability to cooperate with the study protocol or affect study outcomes.‬ Physical problems or disabilities that prevent the implementation of study interventions ‪Having specific medical conditions or comorbidities, including urinary tract infection, pelvic or bladder malignancy, pelvic prolapse, bladder and pelvic surgery in the last 6 months, multiple sclerosis, Parkinson's disease, spinal cord injury, diabetic neuropathy, pregnancy or breastfeeding, pelvic radiotherapy and endometriosis that affects the study results.‬
Age
From 35 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
‪Eligible participants will be randomly assigned to one of two treatment groups: Mirabegron with biofeedback or Mirabegron alone, after screening for inclusion and exclusion criteria and providing written informed consent.‬ Randomization will be conducted using Sealed Envelope (www.sealedenvelope.com) with a block randomization method to ensure balanced allocation across groups. Block sizes may be fixed or variable, minimizing the risk of predicting the sequence of assignments. Randomization is performed in 11 variable blocks of 2, 4, and 6.. Each participant will receive a unique identifier generated by the system to maintain confidentiality and facilitate accurate tracking of study data.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Research and Technology Deputy, 5th floor, Central Headquarters, Iran University of medical sciences, Shahid Hemmat Gharb Highway between Sheikh Fadlallah and Shahid Chamran intersections, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2025-10-31, 1404/08/09
Ethics committee reference number
IR.IUMS.REC.1404.803

Health conditions studied

1

Description of health condition studied
overactive bladder (OAB)
ICD-10 code
N32.81
ICD-10 code description
Overactive bladder

Primary outcomes

1

Description
Urinary urgency severity
Timepoint
‪Assessment in three time intervals: at the beginning of the study in week zero after the start of the intervention, week four after the start of the intervention, week eight after the start of the intervention.
Method of measurement
OAB-V8 questionnaire and OAB-q questionnaire

2

Description
Frequency of urinary incontinence episodes
Timepoint
‪Assessment in three time intervals: at the beginning of the study in week zero after the start of the intervention, week four after the start of the intervention, week eight after the start of the intervention.
Method of measurement
OAB-V8 questionnaire and OAB-q questionnaire

3

Description
Improvement of urinary symptoms
Timepoint
‪Assessment in three time intervals: at the beginning of the study in week zero after the start of the intervention, week four after the start of the intervention, week eight after the start of the intervention.
Method of measurement
OAB-V8 questionnaire and OAB-q questionnaire

Secondary outcomes

1

Description
Comparison of the number of urinations in 24 hours cumulatively
Timepoint
‪Assessment within 2 weeks after the start of the intervention between the two study groups‬
Method of measurement
‪observation and checklist‬

2

Description
‪Comparison of the cumulative number of urinations in 24 hours between two study groups
Timepoint
‪Assessment within 2 weeks after the start of the intervention between the two study groups‬
Method of measurement
‪observation and checklist‬

3

Description
Evaluation of the cumulative reduction in the number of urinary urgency episodes
Timepoint
‪Assessment within 2 weeks after the start of the intervention between the two study groups‬
Method of measurement
‪observation and checklist‬

4

Description
Evaluation of the cumulative reduction in the number of bedwetting episodes
Timepoint
‪Assessment within 2 weeks after the start of the intervention between the two study groups‬
Method of measurement
‪observation and checklist‬

5

Description
Evaluation of the safety and tolerability of the treatment related complications
Timepoint
‪Assessment within 2 weeks after the start of the intervention between the two study groups‬
Method of measurement
‪observation and checklist‬

Intervention groups

1

Description
Intervention group: Participants in this group will receive 50 mg extended-release mirabegron tablets manufactured by Teb Mofid Nikan Pharmaceutical Company (Mirabegral) daily along with biofeedback sessions. Biofeedback sessions will be held 2 sessions per week and each session will last 30 to 45 minutes.
Category
Treatment - Drugs

2

Description
Control group: The control group will include those receiving 50 mg extended-release mirabegron tablets manufactured by Teb Mofid Nikan Pharmaceutical Company (Mirabegral) daily alone and without biofeedback sessions.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Nikan Aghdasieh Clinic
Full name of responsible person
Bahareh Farajvajari
Street address
No.6, 22 Bahman street, Artesh Blvd., Aghdasieh, Tehran
City
Tehran
Province
Tehran
Postal code
1694817311
Phone
+98 21 2912 1060
Email
Bahare.vajari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Fifth Floor, Central Building, Iran University of Medical Sciences, Hemmat Highway Near Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 8670 2504
Email
safa.m@iums.ac.ir
Web page address
https://vcr.iums.ac.ir/%D9%85%D8%B9%D8%A7%D9%88%D9%86-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Amir Rezazadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1475886671
Phone
+98 21 6044 8161
Email
rezazadeh.am@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Rezazadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1475886671
Phone
+98 912 729 8761
Email
rezazadeh.am@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kamyab Andarzbakhsh
Position
Clinical cooperator of the study
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran, Gholhak, Dr. Shariati St., Yakhchal St., School of Pharmacy
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
rezazadeh.am@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The final results of scoring the inflammation status, pain, and related parameters
When the data will become available and for how long
After publishing the related article in international journals
To whom data/document is available
Researchers in the field of medicine and pharmacy
Under which criteria data/document could be used
Development of science and expand evidence related to treatment in further research
From where data/document is obtainable
Related journal
What processes are involved for a request to access data/document
Using the journal email to communicate and register a request to use the study data
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