Randomized Controlled Study of Efficacy of Elitone Device For the Treatment of Mild-Moderate Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes
研究概览
简要总结
This is a randomized controlled study in which subjects are assigned to either a treatment group or a control (sham) group. Pre- and post-study outcome measures evaluate the change in incontinence episodes on women with mild-moderate stress urinary incontinence.
详细描述
The Elitone device delivers electrical muscle stimulation to pelvic floor muscles through a disposable surface electrode shaped to fit the perineal region. In typical use women self-administer treatment 20 minutes per day, 5x per week, for 6-12 weeks. Elidah is initiating a prospective, randomized clinical study to demonstrate device efficacy. The study expands a similar pilot to 60 subjects, adds a control arm (sham device) and includes additional outcome measures. Like the earlier study, subjects will self-administer treatment over multiple weeks while maintaining daily logs of their treatment and incontinence symptoms. This is a home-use study, which does not require clinic visits. Accordingly, this allows subject recruitment from across US.
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
The device looks identical, but the waveform is different. Randomization, programming and recording of which waveform is done by a third party separate from those listed above.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.
排除标准
- •Severe incontinence as determined by self-reported >5 accidents in 24-hr period
- •Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
- •Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
- •Cancer, epilepsy or cognitive dysfunction
- •Vaginal or pelvic surgery within previous 6 months
- •Complete denervation of the pelvic floor
- •History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
- •Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year)
- •Recurrent vaginitis (bacterial/fungal)
- •Pelvic pain/painful bladder syndrome
- •Underlying neurologic/neuromuscular disorder
- •Severe Obesity as defined by BMI >= 35
- •Chronic coughing
- •Impaired decision making, drug or alcohol dependence, or suicidal thoughts.
- •Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent.
研究组 & 干预措施
Treatment
Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz)
干预措施: Transcutaneous electrical stimulation (Elitone) (Device)
Control
Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles.
干预措施: Transcutaneous electrical stimulation (Elitone) (Device)
结局指标
主要结局
Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes
时间窗: 12 weeks
The percent reduction in average number of urinary incontinence episodes over 12 weeks.
次要结局
- Efficacy Assessed by Percent Reduction in Average Pad Weight(12 weeks)
- Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)(12 weeks)
- Pads Per Day(12 weeks)