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IRCT20230629058615N11 IRCT 2026-01-11 Iran University of Medical Sciences Evaluation of the combined effectiveness of mirabegron and biofeedback therapy in the treatment of overactive bladder in women 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. 2026-03-05 anticipated 50 Complete https://irct.ir/trial/88430 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 overactive bladder (OAB). Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The final results of scoring the inflammation status, pain, and related parameters When: After publishing the related article in international journals To whom: Researchers in the field of medicine and pharmacy Conditions: Development of science and expand evidence related to treatment in further research Where to obtain: Related journal How to obtain: Using the journal email to communicate and register a request to use the study data Comments:
public Amir Rezazadeh
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway ,Tehran ,Iran
Tehran Iran (Islamic Republic of) 1475886671 +98 21 6044 8161 rezazadeh.am@iums.ac.ir Iran University of Medical Sciences scientific Amir Rezazadeh
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway ,Tehran ,Iran
Tehran Iran (Islamic Republic of) 1475886671 +98 912 729 8761 rezazadeh.am@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 35 years 70 years Female 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.‬ N32.81 Overactive bladder Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. 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. 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. ‪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. 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. 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. 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. Iran University of Medical Sciences Approved 2025-10-31 Ethics committee of Iran University of Medical Sciences 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 Tehran Tehran Iran (Islamic Republic of)