Behavior Enhances Drug Reduction of Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 307
- 试验地点
- 9
- 主要终点
- Proportion of Women Who Meet Definition of Success
研究概览
简要总结
The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combination therapy
Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
干预措施: Tolterodine (Drug)
Combination therapy
Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
干预措施: Behavioral training (Behavioral)
Drug therapy alone
Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.
干预措施: Tolterodine (Drug)
结局指标
主要结局
Proportion of Women Who Meet Definition of Success
时间窗: 8 months
Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a \>70% reduction in number of incontinence episodes as compared to baseline.
次要结局
- Change in Incontinence Episodes(Baseline and 10 weeks)
- Change in Voids Per Day(baseline and 10 weeks)
- Symptom Distress(baseline, 10 weeks and 8 months)
- Symptom Bother(baseline, 10 weeks and 8 months)
- Satisfaction(8 months)
- Symptom Improvement(8 months)