Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- St. Mark's Incontinence Score
研究概览
简要总结
Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women
详细描述
Subjects meeting inclusion/exclusion criteria at screening will complete training in behavioral therapy for the treatment of fecal incontinence and training in the use of the Leva pelvic digital health system.
Subjects will then participate in 10 weeks of at home pelvic floor muscle training using the leva device twice daily for 2 ½ minutes of training.
Adherence to the training protocol will be observed digitally, and subjects will receive phone calls every other week from research assistants reviewing their adherence.
Subjects are expected to participate in at least 80% of the weekly exercises (11 weekly).
Subjects will return to clinic at 5- and 10-weeks during the study to complete questionnaires. At 5-weeks, subjects will review the use of the device with the study assistant, who will answer any questions and repeat training if the subject desires additional training.
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
- •Age ≥18 years
- •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
排除标准
- •Absence of a vagina
- •Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)
- •Current or past diagnosis of colorectal or anal malignancy
- •Diagnosis of inflammatory bowel disease
- •Current or history of rectovaginal fistula or cloacal defect
- •Rectal prolapse (mucosal or full thickness)
- •Prior removal or diversion of any portion of colon or rectum
- •Prior pelvic floor or abdominal radiation
- •Refusal or inability to provide written consent
- •Inability to utilize smart phone technology ("app" use)
- •Fecal impaction by exam
- •Stage 3 or 4 pelvic organ prolapse
- •Incontinence only to flatus
- •Supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months.
- •Childbirth within the last 6 months
- •Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
- •Chronic abdominal pain in the absence of diarrhea
- •Presence of an active (turned on) sacral neuromodulator within the last 6 months
- •Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.
结局指标
主要结局
St. Mark's Incontinence Score
时间窗: Baseline to 10 weeks
Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms
次要结局
- Fecal Incontinence Quality of Life Scale (FIQoL)(Change in score from baseline to 10 weeks)
- Cumulative adherence correlation with change in St. Mark's score(baseline to 10 weeks)
- Change in Fecal incontinence episodes(Baseline to 10 weeks)