Overactive Bladder
Conditions
Keywords
Antimuscarinic, β-agonist, Overactive Bladder, Risk factors, Treatment
Brief summary
This study evaluated the outcomes of women with detrusor overactivity treated with combined pharmacotherapy to identify risk factors for treatment failure.
Interventions
Combined pharmacotherapy with oral solifenacin 5 mg and mirabegron 25 mg once daily.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with either anticholinergics or β3-agonist medication for at least 1 month.
Exclusion criteria
* Neurological conditions or spinal cord injury, which could affect urologic function * Advanced pelvic organ prolapse (pelvic organ prolapse quantification system stage II or above) * Active urinary tract infection * Contraindications to taking anticholinergic and β3-agonist medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short form of Urinary Distress Inventory (UDI-6) | Assess before treatment and 12 weeks after treatment | UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence. |
| Short form of Incontinence Impact Questionnaire (IIQ-7) | Assess before treatment and 12 weeks after treatment | The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships & emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence. |
| Overactive Bladder Symptom Score (OABSS) | Assess before treatment and 12 weeks after treatment | The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of daily micturition | Assess before treatment and 12 weeks after treatment | Patients report daily lower urinary tract symptoms episodes |
| Episodes of daily nocturia | Assess before treatment and 12 weeks after treatment | Patients report daily lower urinary tract symptoms episodes |
| Episodes of daily urgency | Assess before treatment and 12 weeks after treatment | Patients report daily lower urinary tract symptoms episodes |
| Episodes of daily incontinence | Assess before treatment and 12 weeks after treatment | Patients report daily lower urinary tract symptoms episodes |
Countries
Taiwan