Proof of Concept: A Commode Assist Device for Excessive Perineal Descent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory constipation due to pelvic floor laxity and excessive perineal descent by means of a modified toilet seat, known as "the Bottom's Up".
详细描述
Efficacy and safety of a unique pelvic floor support device that fits into the Radiology defecography commode will be tested. Patients with refractory constipation due to known pelvic floor laxity and/or excessive perineal descent will be examined without, then with the device in place. Patients will complete questionnaires pertaining to device safety and efficacy before and after using the device. Radiographic images to document efficacy of support plus adequate emptying will be acquired during the study resulting in very low dose radiation exposure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10 Males and female subjects greater that 18 years of age with aggravated constipation due to pelvic floor laxity of at least 4 cm and excessive perineal descent of at least 4 cm will be evaluated.
- •Patients with constipation but no excessive laxity or descent will not be evaluated. Patients must be willing to sign consent, undergo defecography with and without "The Bottom's Up" device.
排除标准
- 未提供
研究组 & 干预措施
Experimental
Pelvic floor support device to treat refractory constipation.
干预措施: "the Bottom's Up" (Device)
结局指标
主要结局
Adverse Events
时间窗: through study completion, approximately one day
The number of participants to report adverse events.
次要结局
- Sense of Staining(post-defecography test, approximately 1 day)
- Ease of Evacuation(post-defecography test, approximately 1 day)
- Completeness of Evacuation(post-defecography test, approximately 1 day)