Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- Functional Bladder Capacity
研究概览
简要总结
The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.
详细描述
The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems.
This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incomplete upper motor neuron lesion
- •Detrusor overactivity
- •Two leaks or two notices of leaks per day
- •Mean functional bladder capacity (volume voided per episode) of ≥100 ml
排除标准
- •Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.
- •Degenerative disease of the central nervous system
研究组 & 干预措施
ON / OFF
Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.
干预措施: InterStim Therapy (Device)
OFF / ON
Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.
干预措施: InterStim Therapy (Device)
结局指标
主要结局
Functional Bladder Capacity
时间窗: Baseline, 4 weeks after implant, 8 weeks after implant
Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.
次要结局
未报告次要终点