Clinical Study to Evaluate the Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in Average Number of Urinary Incontinence Episodes Per Day
研究概览
简要总结
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.
详细描述
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence in women. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence. This is a randomized prospective controlled study of two active groups with a stimulation frequency difference between the groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Device looks identical. A third person masks which software is coded.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Predominant urge urinary incontinence as determined by responses to a series of three standard questions from the King's Health Questionnaire; specifically:
- •An affirmative response to "Is it very difficult to control when you have a strong urge to urinate?",
- •An affirmative or negative response to "Do you lose urine with physical activities such as coughing, sneezing, running?",
- •And, if an affirmative response to the second question, an affirmative response to "Are more of your incontinence episodes due to a strong urge to urinate than to abdominal pressure such as sneezing?"
- •Mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. Symptom severity is later verified with data from the Daily Log (See 5.4)
排除标准
- •Less than 1 incontinence accident (leak) per day*
- •Severe incontinence as determined by self-reported >5 accidents per day
- •Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
- •Vaginal or pelvic surgery within previous 6 months
- •Severe Obesity as defined by BMI >= 35
- •Change in incontinence medication type or dosing within the last 3 months.
- •History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
- •Pelvic pain/painful bladder syndrome
- •Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year), or recurrent vaginitis (bacterial/fungal)
- •Tissues protruding outside the vagina at rest
- •Presence of incontinence-associated dermatitis or other perineal skin disorders or lesions,
- •Complete denervation of the pelvic floor
- •Conductive inter-uterine devise (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine,
- •Chronic coughing
- •Previous use of Interstim device or Botox for UI
- •Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
- •Cancer, epilepsy or cognitive dysfunction
- •Underlying neurologic/neuromuscular disorder
- •Impaired decision making, suicidal thoughts, or drug/alcohol dependence
- •Lacks capacity to consent for themselves.
结局指标
主要结局
Change in Average Number of Urinary Incontinence Episodes Per Day
时间窗: 6 weeks
The efficacy of a treatment for urinary incontinence measures how much the treatment changed urinary incontinence leakage from the beginning to the end of the 6 week period.
Safety Assessed by Number of Serious Adverse Events
时间窗: 6 weeks
Any serious adverse events recorded during the trial.
次要结局
- Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)(6 weeks)
- Efficacy Assessed by Reduction in Average Pads Used Per Day(6 weeks)
- Efficacy Assessed by Reduction in Average Bathroom Visits(6 weeks)