Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Success
研究概览
简要总结
Currently, guidelines from the Royal College of Obstetricians and Gynaecologists stipulate that all women who have sustained an obstetric anal sphincter injury in a previous pregnancy and who are symptomatic or have abnormal endoanal ultrasonography and/ or manometry should be counselled regarding the option of an elective Caesarean section. An abnormal endoanal ultrasonography is currently considered to be a defect of the external anal sphincter (EAS) of more than 30 degrees while an abnormal anorectal manometry would be an incremental squeeze pressure of less than 20mmHg.
This study aims to evaluate if a course of guided pelvic floor exercises could improve anal sphincter function on those with suboptimal or abnormal anal incremental squeeze pressures, and subsequently expand their options for future modes of delivery (vaginal delivery not contraindicated)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
- •Are at least 6 weeks postpartum
- •Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist 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
- •Inclusion Criteria
- •Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
- •Are at least 6 weeks postpartum
- •Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist 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.
- •Exclusion Criteria
- •Women who have sustained an obstetric anal sphincter injury more than a year ago
- •Women who have had another vaginal delivery after sustaining an obstetric anal sphincter injury in a previous delivery.
- •Existing anal pain precluding anorectal examination
- •Existing neurological, musculoskeletal disorders which impedes ability to perform pelvic floor muscle exercises
- •Age <18 years old
- •Currently pregnant
- •Inability to comply with pelvic floor muscle exercises
结局指标
主要结局
Success
时间窗: 4 months
1. Change of incremental squeeze pressure from abnormal (\<20mmHg) or suboptimal (20-40mmHg) to normal (\>40mmHg) 2. Change of incremental squeeze pressure from abnormal (\<20mmHg) to suboptimal (20-40mmHg)
次要结局
- Change or recommended mode of delivery(4 months)
- Change in St Mark's Score(4 months)
- Change in International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)(4 months)
- Change in Faecal Incontinence Quality of life Scale(4 months)
研究者
Kar Yee Lor
Dr. Kar Yee Lor
King's College Hospital NHS Trust