overactive bladder (OAB). Overactive bladder
Conditions
Interventions
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 wi
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
35 Years to 70 Years
Inclusion 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
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.?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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?. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Rezazadeh
Iran University of Medical Sciences
Outcome results
None listed