Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of HFVI analysed through HRV at baseline and during standardized stimulation protocol randomly delivered at the level of the 4contact points of the quadripolar lead at the time of lead implantation between the effective and noneffective groups
研究概览
简要总结
Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB.
The mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract.
The aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male of female ≥ 18 years
- •OAB syndrome
- •Indication for a two-staged SNM
- •Under general anaesthesia with Remifentanil and Propofol
- •Patient who has given written consent to participate in the trial
- •Patient willing to comply with all study procedures and duration
排除标准
- •Tibial neuro-stimulation (last 3 months)
- •Sacral neuromodulation (last 3 months)
- •Botulinum toxin A intra-detrusor injection (last 9 months)
- •Pregnancy in progress
- •Administrative reasons
- •Guardianship/curatorship
研究组 & 干预措施
ANI (Analgesia nociception index) will be recorded during the SNM (Sacral neuromodulation).
干预措施: Medical device for SNM: Interstim X or Interstim micro (Device)
结局指标
主要结局
Comparison of HFVI analysed through HRV at baseline and during standardized stimulation protocol randomly delivered at the level of the 4contact points of the quadripolar lead at the time of lead implantation between the effective and noneffective groups
时间窗: 1 year
Comparison of HFVI (high frequence variability index) analysed through heart rate variability (HRV) at baseline and during a standardized stimulation protocol (14 Hz, 210 mcs, amplitude to elicit anal motor response) randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation, between the effective and non-effective groups.
次要结局
- Comparison of other HRV parameters at baseline and during a standardized stimulation protocol randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation(1 year)
- SDNN (Standard Deviation of all normal-to-normal RR intervals (milliseconds)) and RMSSD (Root Mean Square of Successive Differences between normal-to-normal RR intervals (milliseconds)) at baseline and during standardized electrical stimulation(1 year)
- LF (Low-Frequency power of heart rate variability (ms²)) and HF (High-Frequency power of heart rate variability (ms²)) components of heart rate variability at baseline and during standardized electrical stimulation(1 year)