French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 16
- 主要终点
- Proportion of implanted patients with a reduction of at least 50% of incontinence episodes per week, compared to baseline.
研究概览
简要总结
The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal incontinence.
This study will provide additional data about safety and effectiveness of the usage of InterStim system in fecal incontinence environment and at the same time will confirm that results from clinical trials can be transposed to clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient willing to sign the Data Release Form stating the non opposition to the study conduct;
- •Patient able to understand information given by the investigator in terms of data collection and publication;
- •At least 18 years old or older.
- •Patient indicated to sacral neuromodulation testing with InterStim® system.
排除标准
- •Replacement of an existing sacral neuromodulation system (implanted before inclusion period) without any evidence of benefits during a testing period.
- •Patient unwilling to comply to data collection and publication rules.
结局指标
主要结局
Proportion of implanted patients with a reduction of at least 50% of incontinence episodes per week, compared to baseline.
时间窗: 6 months (4-8 months)
The primary objective will evaluate the proportion of implanted patients that do not experience any serious adverse event or serious adverse device effect at 4-8 months of follow-up and show a reduction of at least 50% of incontinence episodes per week at the same timeframe, compared to baseline.
次要结局
- Reduction of incontinence episodes per week(12 months (9-15 months))
- Reduction of evacuations per week(6 months (4-8 months) and 12 months (9-15 months))
- Quality of Life(3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months))
- Patient Satisfaction(6 months (5-8 months) and 12 months (9-15 months))
- Reduction of urgency episodes per week(6 months (4-8 months) and 12 months (9-15 months))
- Retention delay(3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months))
- Complications and Adverse Events(3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months))
- Fecal Incontinence severity(3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months))