To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder
Women with detrusor overactivity who were refractory to anti-muscarinics or mirabegron were enrolled for prospective study. Patients were divided into three groups: combined pharmacotherapy with solifenacin and mirabegron, solifenacin with vaginal estrogen cream and mirabegron with vaginal estrogen cream. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in episodes of daily micturition, urgency, urinary incontinence and nocturia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Solifenacin (5mg) is anticholinergic and Mirabegron (25mg) is a beta-3 adrenergic agonist.
Solifenacin (5mg) is anticholinergic. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).
Mirabegron (25mg) is a beta-3 adrenergic agonist. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).
Mackay Memorial Hospital
Taipei, Taiwan
RECRUITINGShort 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.
Time frame: 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.
Time frame: 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.
Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Episodes of daily micturition
Patients report daily lower urinary tract symptoms episodes
Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Episodes of daily urgency
Patients report daily lower urinary tract symptoms episodes
Time frame: 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
Time frame: 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
Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment