Overactive bladder. Overactive bladder
Conditions
Interventions
Intervention 1: Intervention group: Vesicare® 5 mg tablets orally, once daily for 12 weeks. Intervention 2: Control group: Patients will receive Urinacin® 5 mg tablets orally, once daily for 12 weeks.
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adults aged 18 to 75 years. Clinical diagnosis of idiopathic overactive bladder (OAB) for 3 months or longer. Symptomatic, with a total ICIQ-OAB score of = 6 at study entry. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Known contraindications to solifenacin or other anticholinergics. Significant hepatic or renal impairment. Uncontrolled narrow-angle glaucoma, urinary retention, or gastric retention. Current use of other anticholinergic medications. Pregnant or breastfeeding women. Participation in another clinical trial within the past 30 days. Neurogenic cause of OAB (e.g., spinal cord injury, multiple sclerosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, type, and severity of treatment-related adverse events. Timepoint: Baseline, 4 weeks and 12 weeks after the intervention. Method of measurement: Adverse events checklists.;Change in the total ICIQ-OAB score and I-PA questionnaire. Timepoint: Baseline, 4 weeks and 12 weeks after the intervention. Method of measurement: ICIQ-OAB questionnaire.;Cost-effectiveness. Timepoint: 12 weeks after the intervention. Method of measurement: Average Cost-Effectiveness Ratio (ACER). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSakineh Hajebrahimi
Tabriz University of Medical Sciences
Outcome results
None listed