Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use
研究概览
简要总结
The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System® affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System® for 8 weeks is as good as using it for 16 weeks.
Participants will complete surveys, and use the Leva device.
详细描述
This study will assess whether 8 weeks of use of the Leva Pelvic Health System (Leva) is non-inferior to 16 weeks of use for the treatment of chronic fecal incontinence (symptoms >/= 3 months) in adults with a vagina. Participants will be instructed to complete pelvic floor muscle training using the Leva for 8 or 16 weeks.
The hypothesis is that 8 weeks of use of Leva is non-inferior to 16 weeks of use, assessed by a validated FI symptom severity survey. Surveys will be completed at 0 weeks, 16 weeks, and 24 weeks. Long-term surveys will be completed at 1 year and 2 years from enrollment.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult, age ≥ 18years, assigned female at birth
- •Fecal incontinence, defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
- •Able to stand to perform daily training for at least 3 minutes
- •Able to speak and read English due to Leva smartphone application availability in only English at this time
- •Have an email address, owns a smartphone, and can download an app
排除标准
- •Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)
- •Current diagnosis of colorectal or anal malignancy
- •Diagnosis of uncontrolled inflammatory bowel disease
- •Current rectovaginal fistula or cloacal defect
- •Rectal prolapse (mucosal or full thickness)
- •Inability to utilize smart phone technology ("app" use)
- •Chronic Stool Types 6 or 7
- •Fecal impaction by exam
- •Stage 4 pelvic organ prolapse
- •Concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback
- •Presence of sacral neuromodulator
- •Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months
- •Currently pregnant
结局指标
主要结局
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use
时间窗: Baseline to 16 weeks
Treatment response as length of use on symptom improvement at 16 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by Vaizey Score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -4.3 ± 3 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use
时间窗: Baseline to 16 weeks
Treatment response as length of use on symptom improvement at 16 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by Vaizey Score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -4.3 ± 3 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.
次要结局
- Change in Fecal Incontinence Severity(Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years)
- Cumulative Adherence Correlation With Change in St. Mark's Score(Baseline to 24 weeks, long term follow up at 1 and 2 years)
- Patient Satisfaction and Usability of the Smartphone Application Component of the Leva Pelvic Health System(Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years)
- Change in Fecal Incontinence From Baseline to 24 Weeks After 8 or 16 Weeks of Treatment(Baseline to 24 weeks, long term follow up at 1 and 2 years)
- Change in Pelvic Organ Prolapse Quantification System (POP-Q)(Baseline to 16 weeks)
- Change in Brink Scale Score: Pressure(Baseline to 16 weeks)
- Change in Brink Scale Score: Vertical Displacement(Baseline to 16 weeks)
- Change in Fecal Incontinence Quality of Life (FIQoL)(Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years)
- Change in Sexual Function (PISQ-IR)(Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years)
- Change in Brink Scale Score: Duration Contraction(Baseline to 16 weeks)
- Change in Stool Consistency(Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years)
- Patient Global Impression of Improvement (PGI-I)(16 and 24 weeks, long term follow up at 1 and 2 years)
- Patient Satisfaction (PGI-I)(16 and 24 weeks, long term follow up at 1 and 2 years)
- Estimated Percentage of Change(16 and 24 weeks, long term follow up at 1 and 2 years)
- Change in Global Pelvic Floor Symptoms(Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years)
- Evaluate Self-continuation of Pelvic Floor Muscle Exercises(Baseline and 24 weeks, long term follow up at 1 and 2 years)
- Number of Cumulative Adverse Events(Baseline and 24 weeks, long term follow up at 1 and 2 years)
- mHealth App Usability Questionnaire (MAUQ)(16 weeks)