Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder
NCT Number: NCT06479720
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Effect of Drug|Urinary Bladder, Overactive
Interventions: DRUG: Combined pharmacotherapy with Solifenacin and Mirabegron|DRUG: Solifenacin with vaginal estrogen cream|DRUG: Mirabegron with vaginal estrogen cream
Sponsor: Mackay Memorial Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-16
Completion Date: 2025-06-30
Locations: Mackay Memorial Hospital, Taipei, Taiwan

Summary:
To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder

Primary Outcome Measures: Short form of Urinary Distress Inventory (UDI-6), 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., Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment|Short form of Incontinence Impact Questionnaire (IIQ-7), 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., Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment|Overactive Bladder Symptom Score (OABSS), 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., Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Secondary Outcome Measures: Episodes of daily micturition, Patients report daily lower urinary tract symptoms episodes, Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment|Episodes of daily urgency, Patients report daily lower urinary tract symptoms episodes, Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment|Episodes of daily incontinence, Patients report daily lower urinary tract symptoms episodes, Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment|Episodes of daily nocturia, Patients report daily lower urinary tract symptoms episodes, Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment