Risk Factors for the Failure of Combined Pharmacotherapy in Women With Refractory Detrusor Overactivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 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
This study evaluated the outcomes of women with detrusor overactivity treated with combined pharmacotherapy to identify risk factors for treatment failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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 either anticholinergics or β3-agonist medication for at least 1 month.
排除标准
- •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
研究组 & 干预措施
Women with urodynamic DO refractory to combined pharmacotherapy
We enrolled women with refractory detrusor overactivity, defined as ongoing symptoms after at least 1 month of treatment with either an anticholinergic or a β3-agonist. Eligible women received combined pharmacotherapy with oral solifenacin 5 mg and mirabegron 25 mg once daily for 12 weeks.
干预措施: Combined pharmacotherapy (Drug)
结局指标
主要结局
Short form of Urinary Distress Inventory (UDI-6)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Episodes of daily incontinence(Assess before treatment and 12 weeks after treatment)
- Episodes of daily nocturia(Assess before treatment and 12 weeks after treatment)
- Episodes of daily micturition(Assess before treatment and 12 weeks after treatment)
- Episodes of daily urgency(Assess before treatment and 12 weeks after treatment)
研究者
Hui-Hsuan Lau, MD
Head of urogynecology, Associate Professor
Mackay Memorial Hospital