Sphincter Pressures in Women With Obstetric Anal Sphincter Injury: A Comparison of THD® Anopress With High Resolution Anorectal Manometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Main voluntary squeeze increment
研究概览
简要总结
Currently, high resolution anorectal manometry (HDARM) is used as gold standard to measure anal sphincter pressures in women who have sustained a third or fourth degree perineal tears (obstetric anal sphincter injuries). This test is performed to help advise patients on future pregnancies or deliveries. However, HDRM catheters are very expensive and they also need to be performed in a dedicated procedure room. THD® Anopress in comparison is a lightweight, portable device which has a comparatively shorter investigation time and is more cost- effective.
However, although THD® Anopress is currently used in the colorectal population, there is currently no validated research that compares the measurements obtained by HDARM with that of THD® Anopress with women with a history of obstetric anal sphincter injuries.
The primary aim of this study is to compare pressure measurements from HDARM to that of THD® Anopress in women with obstetric anal sphincter injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Female patients with a history of obstetric anal sphincter injury and are:
- •a) At least 6 weeks postpartum
- •Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment.
- •Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits.
- •Able and willing to complete the St Mark's Score, ICIQ-UI SF and other trial related questionnaires, comply with scheduled clinic visits and manometry studies.
排除标准
- •Existing anal pain precluding anorectal examination
- •Neurological conditions such as stroke, multiple sclerosis, spinal cord injury or Parkinson's disease
- •Age <18 years old
- •Currently pregnant -
研究组 & 干预措施
THD® Anopress (Sensyprobe) first
干预措施: THD® Anopress (Sensyprobe) first (Device)
High Resolution Anorectal Manometry first
干预措施: High Resolution Anorectal Manometry first (Device)
结局指标
主要结局
Main voluntary squeeze increment
时间窗: Day 1
Difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg)
次要结局
- Anal resting pressure (mmHg)(Day 1)
- Endurance squeeze pressure(Day 1)
- Total duration of procedure(Day 1)
- Main voluntary squeeze increment(Day 1)
- Straining pressure(Day 1)
- Visual Analogue Scale (VAS)(Day 1)
- Adverse events(Day 1)