?Overactive bladder in menopausal women?. Overactive bladder
Conditions
Interventions
Intervention 1: ?Intervention group: The intervention group received 50 mg extended-release mirabegron tablets manufactured by Teb Mofid Nikan Pharmaceutical Company (Mirabegral) daily, along with vag
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: ?Menopause and at least 12 months since the last menstruation? ?Urgency to urinate? ?Frequent urination? ?Nocturia? ?Urgency urinary incontinence? ?Presence of overactive bladder symptoms for at least 3 months prior to study entry? ?At least 8 urinations in 24 hours? ?Presence of at least one episode of urgency incontinence in 24 hours? ?Ability to follow and continue treatment for 8 weeks? ?Providing written informed consent to participate in the study?
Exclusion criteria
Exclusion criteria: Unwillingness to use the medications under investigation in this study Concurrent use of medications known to have drug–drug interactions with the study medications. Simultaneous participation in other clinical trials or research studies. Failure or refusal to provide written informed consent for study participation or treatment follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life assessment. Timepoint: Standard questionnaires (e.g., OAB-q) At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: Standard questionnaires OAB-q. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of daytime urinary frequency. Timepoint: At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: OAB-V8 questionnaire.;Severity of discomfort associated with urinary urgency. Timepoint: At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: OAB-V8 questionnaire.;Severity of sudden onset urinary urgency without prior warning. Timepoint: At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: OAB-V8 questionnaire.;Severity of mild urinary incontinence (small-volume urine leakage). Timepoint: At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: OAB-V8 questionnaire.;Severity of nocturnal urinary frequency. Timepoint: At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: OAB-V8 questionnaire.;Severity of nocturnal awakening due to the need to urinate (nocturia). Timepoint: At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: OAB-V8 questionnaire.;Severity of uncontrollable urinary urgency. Timepoint: At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: OAB-V8 questionnaire.;Severity of urinary incontinence associated with severe urgency (urge incontinence). Timepoint: At baseline, 4 weeks after the start of the study, and 8 weeks after the start of the study. Method of measurement: OAB-V8 questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Rezazadeh
Iran University of Medical Sciences
Outcome results
None listed