Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 692
- 试验地点
- 13
- 主要终点
- Difference in the % of patients maintaining persistence between no intervention and HEI group
研究概览
简要总结
Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to improve treatment outcomes
Study Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance and persistence, thereby can improve the treatment outcomes in conjunction with pharmacological therapy in OAB patients
Study Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals
详细描述
Treatment - Fesoterodine (Toviaz) 4 or 8mg
Interventions (2 arms)
- Arm 1: No intervention
Patients in this arm will not be given HEI in conjunction with pharmacotherapy (Toviaz) which was developed for this trial.
- Arm 2: Health education intervention (HEI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged ≥ 18 years with OAB symptoms for ≥ 3 months
- •The sum score of the OABSS ≥ 3 with the score of the question no.3 (urgency) ≥ 2
- •The sum score of the OAB V8 ≥ 8
排除标准
- •Any condition that would contraindication of anticholinergic treatment
- •Symptomatic acute UTI during the run-in period
- •Diagnosed or suspected interstitial cystitis
- •Treatment with anticholinergic drugs within 12 months prior to Screening and persist over 3 months
- •Treatment within the 14 days preceding Screening, or expected to initiate treatment during the study with any other treatment for overactive bladder.
- •An indwelling catheter or practicing intermittent self-catheterization
- •Pregnant or nursing women
研究组 & 干预措施
Health education intervention (HEI)
干预措施: Health education intervention (HEI) (Behavioral)
No intervention
结局指标
主要结局
Difference in the % of patients maintaining persistence between no intervention and HEI group
时间窗: 6 months
Definition of "Maintaining Persistence"= a gap of ≤ 30 days between successive prescription fills
次要结局
- Difference in the % of patients maintaining persistence between no intervention and HEI group(1, 2 and 4 months)
- Difference in changes in OAB symptoms between no intervention and HEI group(1, 2, 4, and 6 months)
- Difference in the compliance rate between no intervention and HEI group(1, 2, 4 and 6 months)
- Adverse events(1, 2, 4, and 6 months)
- Difference in the treatment satisfaction between no intervention and HEI group(1, 2, 4, and 6 months)
- Difference in the % of the patients with the compliance rate ≥ 80% between no intervention and HEI group(1, 2, 4, and 6 months)
- Reasons for non-persistence(1, 2, 4, and 6 months)