EFFECTIVENESS OF THE NEUROADAPTATIVE REGULATION TECHNIQUE FOR THE TREATMENT OF URGE INCONTINENCE AND MIXED INCONTINENCE
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Resultant value achieved in the assessment scale of urge incontinence.
研究概览
简要总结
In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence
详细描述
In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence and mixted incontinence
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Urge incontinence or mixed incontinence without urethral hypermobility
- •Over 3 months of disease evolves.
排除标准
- •Severe physical limitations that might interfere with applying the treatment.
- •Severe mental disorders that need pharmacology treatments that may influence in neuronal activity
- •Oncological processes in the lower abdomen that had required radical surgery.
- •Neurogenic bladder.
- •Blockage of the bladder
- •Vaginal infection
- •Bladder infection or disorder of kidney function
- •Have received, in the last year, botulinum toxin in bladder or pelvic organs.
- •Have received pharmacological treatment for urge incontinence in the last month (before entry date in the trial)
- •Be receiving pharmacological treatment for urge incontinence.
- •Stress incontinence due to urethral hypermobility which was treatable with surgery.
- •Pregnant women
- •Patients with pacemarker
结局指标
主要结局
Resultant value achieved in the assessment scale of urge incontinence.
时间窗: 2 years
Resultant value achieved in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence. Question items: Frequency or urinary incontinence; Amount of leakage; Overall impact of urinary incontinence; Self-diagnostic ítem. Scoring scale: 0-21. Higher score mean a worse outcome.
Sandvik Test for Urinary Incontinence
时间窗: 2 years
It is a severity indez score of symptoms to calculate severity of urinary incontinence in women. Scores are from 0 to 12. The higher score: the more severe the urinary incontinence.
次要结局
- Satisfaction with the treatment (Visual analogue scale.)(2 years)
- Quality of life index (Potenziani-14-CI-IO-QOL-2000 index)(2 years)
- Duration of the response to treatment(2 years)
- Intervals between voiding(2 years)
- Frequency of nocturia(2 years)