Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioSerenity
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- optical measurement of hemoglobin concentrations
研究概览
简要总结
NIRS technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. This hemodynamic response is measured in a completely non-invasive and silent manner, by the simple emission of light passing through different layers of biological tissue.
In the literature, some studies concerning the use of the NIRS method for the study of urodynamics exist. They seem to show a correlation between the data of the urodynamic assessment and the data obtained with the NIRS method. Certain trends seem to be repeated with, for example, an increase in oxyhemoglobin at the beginning of the filling phase and the beginning of the urination phase.
The aim of the study is to analyze the NIRS signal and find correlation with urodynamic data.
详细描述
The main objective is to detect a urodynamic variation of the detrusor muscle during a contraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Person whose urodynamic evaluation for diagnosis purposes is necessary
- •Male or female ≥ 18 years
- •Person affiliated with a social security scheme
- •ECBU / BU negative
排除标准
- •Pregnant or parturient or lactating women
- •Refusal of consent
- •Contraindications usually provided for the realization of a Urodynamic exam
- •Sensory disturbances making the participant insensitive to pain
- •Motor or mental disorders that prevent the participant from expressing pain
- •Behavioral problems that make the participant excessively agitated or aggressive
- •Irritation and / or erythema, or open sore in the area covered by the NIRS
- •Half-sitting position impossible
- •Tattoo or stretch mark in the lower abdomen or pubic area
- •External cutaneous or internal scar in the area covered by the NIRS
- •Allergy to a component of the textile part of the device: polyamide, cotton, polyester, elastane, silver, other synthetic materials
- •Simultaneous participation in another search
研究组 & 干预措施
NIRS module
Each patient has a NIRS module during a diagnosis urodynamic assessment provided for by the usual practice.
干预措施: NIRS recording (Device)
结局指标
主要结局
optical measurement of hemoglobin concentrations
时间窗: 9 months
concentrations of oxygenated O2Hb, provided from a NIRS module
detrusor pressure measurement (Pdet)
时间窗: 1 hour
Pdet during filling and emptying of the urodynamic exam
次要结局
- clinical annotations of the doctor performed on the report of the urodynamic exam(1 hour)
- optical measurement of hemoglobin concentrations(9 months)
- detrusor pressure measurement (Pdet)(1 hour)
- optical measurement of hemoglobin concentrations(1 hour)