A Pilot Study to Evaluate the Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of steps per day, during 7 days at 3 months of the AUS activation
研究概览
简要总结
The management of urinary incontinence seems to improve daily activities and the practice of physical activity, according to the literature. Unfortunately, all of these studies are based on self-questionnaires with the disadvantages of self-evaluation, more subjective.
For several years activity sensors have been used in the medical field (rheumatology, cardiology, diabetology, etc.). They allowed the evaluation of physical activity in real life situations, whether to evaluate the degree of severity of a pathology or the impact of a new treatment on the resumption of activities.
Activity sensors are devices that transform body motion into digital measurements. They provide detailed information on the frequency, duration, intensity and type of movement to determine, for example, the number of steps taken, the distance traveled, calories burned and the quality of sleep.
It is hypothesized that urinary incontinence treatment can increase physical activity and so improve the quality of life of patients, that can be measure by activity sensors.
详细描述
The management of urinary incontinence seems to improve daily activities and the practice of physical activity, according to the literature. Unfortunately, all of these studies are based on self-questionnaires with the disadvantages of self-evaluation, more subjective.
The artificial urinary sphincter (AUS) implantation is an effective treatment on stress urinary incontinence in men and women. Currently the PadTest/24 hours is the reference for his evaluation.
For several years activity sensors have been used in the medical field (rheumatology, cardiology, diabetology, etc.). They allowed the evaluation of physical activity in real life situations, whether to evaluate the degree of severity of a pathology or the impact of a new treatment on the resumption of activities.
Activity sensors are devices that transform body motion into digital measurements. They provide detailed information on the frequency, duration, intensity and type of movement to determine, for example, the number of steps taken, the distance traveled, calories burned and the quality of sleep.
It is hypothesized that urinary incontinence treatment can increase physical activity and so improve the quality of life of patients, that can be measure by activity sensors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥ 18 years
- •Surgical indication of urinary incontinence treatment with artificial urinary sphincter implantation
- •Patient informed and not opposed to the research
- •Reading and speaking comprehension of the French language
排除标准
- •Patient under guardianship or curators
- •Contraindication to the placement of an artificial urinary sphincter
- •Patients requiring walking assistance (canes, walker, wheelchair)
- •Revisions of artificial urinary sphincter already implanted
- •Cognitive impairment deemed incompatible with research
结局指标
主要结局
Number of steps per day, during 7 days at 3 months of the AUS activation
时间窗: Through the study completion, an average of 8 months
Number of steps per day measured 24h/24 for 7 consecutive days by the activity sensor, at 3 months after activation of the AUS. 3 months after activation of the AUS is corresponding to 32 weeks from the inclusion (8 months).
次要结局
- PAD-test / 24h(Through the study completion, an average of 8 months)
- Other activity sensor data (heart rate)(Through the study completion, an average of 8 months)
- Other activity sensor data (sedentary and activity percentage in the day)(Through the study completion, an average of 8 months)
- International Physical Activity Questionnaire (IPAQ)(Through the study completion, an average of 8 months)
- Number of steps per day, during 7 days, at 1 month of the AUS activation(Through the study completion, an average of 6 months)
- Incontinence Quality of Life (I-QOL)(Through the study completion, an average of 8 months)