NCT00333073已完成不适用
Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
Contura10 个研究点 分布在 5 个国家目标入组 125 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 10
- 主要终点
- Subjective responder rate after 12 months follow-up
研究概览
简要总结
To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Informed consent
- •Symptomatic stress or mixed urinary incontinence for at least 12 months
- •Having at least 1 incontinence episode per day over three days
排除标准
- •Regular or intermittent users of an urethral catheter
- •Pregnant women
- •Suffer from severe allergies or anaphylaxis
- •Suffer from autoimmune diseases or any unstable or sever cardio-vascular disease
- •History of any cancer within the last 5 years
- •Previous surgery for the treatment of urinary incontinence, including bulking
结局指标
主要结局
Subjective responder rate after 12 months follow-up
时间窗: 12 months
次要结局
- ICIQ(Baseline, treatment, 1-, 6-, 12- and 24-months)
- 24 hour urine leakage(Baseline, treatment, 1-, 6-, 12- and 24-months)
- daily incidence of incontinence episodes(Baseline, treatment, 1-, 6-, 12- and 24-months)
- Qol(Baseline, treatment, 1-, 6-, 12- and 24-months)
研究者
研究点 (10)
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