NCT06252714已完成不适用
Impact of Defecation Posture on Ease of Bowel Movements in Patients With a Rectocele.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Straining with bowel movements
研究概览
简要总结
The study aims to determine if defecation posture, when using a defecation posture modification device (DPMD), will improve ease of bowel movements in patients with pelvic organ prolapse, specifically rectoceles.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with pelvic organ prolapse, including a rectocele (posterior compartment measurements to Stage 2 or greater) that endorse bowel dysfunction, based on our office standard screening questionnaires
排除标准
- •Anyone currently using a defecation posture modification device Unwillingness or unable to participate in the study Planned travel, inability to use device during the study period Patient preparing to undergo pelvic reconstructive surgery prior to the end of the study period Presence of ileostomy/colostomy Bowel disease such as Crohn's disease or Ulcerative Colitis Daily opiate use Wheelchair bound If device may pose fall or safety hazard risk to patient, such as need for walker or cane for ambulation.
- •Patients weighing over 250 lbs, per manufacturer guidelines for the device Inability to understand English Pregnant women
研究组 & 干预措施
Defecation Posture Modification Device
Experimental
Patients will be given a Squatty Potty Device
干预措施: Defecation Posture Modification Device (Device)
结局指标
主要结局
Straining with bowel movements
时间窗: 2 weeks
Patients will assess straining with bowel movement on a 0 -10 numeric scale. The scale is called straining or ease with bowel movements. The number 0 indicates no straining and the number 10 indicates maximal straining with bowel movement.
次要结局
- Colorectal-Anal Distress Inventory 8(2 weeks)
- Consistency of stool(2 weeks)
- Use of laxative medication(2 weeks)
- Ease of device use(2 weeks)
研究者
研究点 (3)
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