Use of the Leva Incontinence System in Treating Bladder Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
研究概览
简要总结
This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must be female.
- •Subjects must be capable of giving informed consent.
- •Subjects should be at least 18 years of age and less than 89 years of age
- •Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.
排除标准
- •Absence of a vagina.
- •Positive drug or alcohol test at the screening visit.
- •Post-menopausal defined as absence of a period for over 12 months.
- •Pregnancy or being less than 12 months post-partum.
- •Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
- •Symptoms of stage II or greater pelvic organ prolapse.
- •BMI >31 kg/m
- •Diagnosis of any neurological disorder.
- •Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
- •Prior pelvic radiation.
- •Current or recurrent vaginal infections (>three per year).
- •Painful bladder syndrome, active or chronic pelvic pain.
- •Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
- •Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
- •Currently taking medication to treat incontinence.
- •Impaired cognitive function.
- •Unable to tolerate use of the leva device.
研究组 & 干预措施
Leva Arm
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
干预措施: Leva Incontinence System For Pelvic Floor Muscle strengthening (Device)
结局指标
主要结局
Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
时间窗: 6 weeks
A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.
次要结局
- Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.(6 weeks)
- Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)(6 weeks)
- Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)(At 6 weeks)