Effect of Drug, Urinary Bladder, Overactive
Conditions
Keywords
Detrusor overactivity, Combined pharmacotherapy, Estrogens, Effectiveness
Brief summary
To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.
Detailed description
Women with detrusor overactivity who were refractory to anti-muscarinics were enrolled for prospective study. Patients were divided into two groups: one receive combined pharmacotherapy with solifenacin and mirabegron, and the other received solifenacin and 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.
Interventions
Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg
DRUGCombination pharmacotherapy
Solifenacin 5mg and Mirabegron 25mg
Sponsors
Mackay Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 90 Years
Healthy volunteers
No
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 anti-muscarinics were enrolled for prospective study.
Exclusion criteria
* Postvoid urine retention before treatment * Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension * Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding. * Women who were on hormone replacement therapy within 3 months were also excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short form of Urinary Distress Inventory (UDI-6) | Assess before treatment and 1 month, 3 months, 6 months and 1 year 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 1 month, 3 months, 6 months and 1 year 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 1 month, 3 months, 6 months and 1 year 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 1 month, 3 months, 6 months and 1 year after treatment | Patients report daily lower urinary tract symptoms episodes |
| Episodes of daily nocturia | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment | Patients report daily lower urinary tract symptoms episodes |
| Episodes of daily urgency | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment | Patients report daily lower urinary tract symptoms episodes |
| Episodes of daily incontinence | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment | Patients report daily lower urinary tract symptoms episodes |
Countries
Taiwan
Contacts
Primary ContactHui-Hsuan Lau, MD
Outcome results
None listed