Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 13
- 主要终点
- Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
研究概览
简要总结
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating.
If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent.
- •18 years of age or older.
- •Patient is diagnosed with chronic fecal incontinence of a duration greater than 6 months (>12 months post-vaginal childbirth) and defined as > 2 incontinent episodes on average per week of more than staining recorded during the baseline diary period.
- •Failed or are not candidates for more conservative treatments.
- •Willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.
排除标准
- •Congenital anorectal malformations.
- •Active participation in another bowel disorder investigational study.
- •Present rectal prolapse.
- •Previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done < 12 months prior to study enrollment (24 months for cancer).
- •Neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e. paraplegia).
- •Grade III hemorrhoids.
- •Known or suspected organic disorders of the bowel (i.e. Inflammatory bowel disease such as Crohn's or ulcerative colitis).
- •Chronic watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. (Incontinent episodes with a Bristol stool consistency of > 6 for > 4 days during the baseline diary period will be exclusionary, unless the investigator determines that the diary is not indicative of chronic watery diarrhea.)
- •Pregnancy or planned pregnancy.
- •Patients for whom patient materials are not available in a language understood by the patient.
- •Life expectancy of less than one year.
- •Patient characteristics indicating a poor understanding of the study or poor compliance with the study protocol (i.e., patients unable to adequately operate equipment, patients unwilling or unable to return for scheduled follow-up visits).
- •Patients with a history of pelvic irradiation who present with visible or functional effects of irradiation.
- •Patients with active anal abscesses or fistulas.
- •Patients with anatomical limitations that would prevent the successful placement of an electrode.
- •Patients with knowledge of planned MRIs, diathermy, microwave, or RF energy.
- •Patients with other implantable neurostimulators, pacemakers or defibrillators.
- •Defect of external anal sphincter of >60 degrees or amenable to surgical repair.
结局指标
主要结局
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
时间窗: Baseline and 12 months
The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes." The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months.
次要结局
- Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week(Baseline and 12 months)
- Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle(Baseline and 12 months)
- Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior(Baseline and 12 Months)
- Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception(Baseline and 12 Months)
- Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment(Baseline and 12 Months)
- Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week(Baseline and 12 months)