Efficacy and Safety of Solifenacin or Mirabegron With Local Estrogen Versus Combination Treatment With Mirabegron and Solifenacin for Refractory Overactive Bladder
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Short form of Urinary Distress Inventory (UDI-6)
研究概览
简要总结
To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Solifenacin and mirabegron
Solifenacin 5mg and Mirabegron 25mg
干预措施: Combined pharmacotherapy with Solifenacin and Mirabegron (Drug)
Solifenacin with vaginal estrogen cream
Solifenacin 5mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.
干预措施: Solifenacin with vaginal estrogen cream (Drug)
Mirabegron with vaginal estrogen cream
Mirabegron 25mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.
干预措施: Mirabegron with vaginal estrogen cream (Drug)
结局指标
主要结局
Short form of Urinary Distress Inventory (UDI-6)
时间窗: 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.
Overactive Bladder Symptom Score (OABSS)
时间窗: 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.
Short form of Incontinence Impact Questionnaire (IIQ-7)
时间窗: 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.
次要结局
- Episodes of daily urgency(Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment)
- Episodes of daily nocturia(Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment)
- Episodes of daily micturition(Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment)
- Episodes of daily incontinence(Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment)
研究者
Hui-Hsuan Lau, MD
Head of urogynecology, Associate Professor
Mackay Memorial Hospital