Prevalence and Treatment of Anal Incontinence in Primiparous Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,718
- 试验地点
- 2
- 主要终点
- Change in Anal Incontinence as Measured on the St. Mark's Score
研究概览
简要总结
Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary and anal incontinence, particularly in primiparas.
The efficacy of pelvic floor muscle exercise (PFME) in treating urinary incontinence (UI)is well documented, however, to date there is little evidence to support the efficacy of PFME in treating symptomatic anal incontinence.
This project consists of three separate studies. The prevalence survey/ study (1), investigates the prevalence of symptomatic anal incontinence among primiparas at Ostfold Hospital Trust Fredrikstad, Norway and St Olav's Hospital, Trondheim University Hospital, Norway, and the results in this study will form the basis of the two identical randomized controlled trials (RCT) investigating the treatment efficacy of PFME two groups of postpartum women. Women reporting symptomatic anal incontinence at six months postpartum (2) and women who have sustained a traumatic 3rd or 4th degree tear of the sphincter ani muscles during delivery (3), respectively, are randomized to an intervention group receiving PFME treatment for six months, or a control group. All RCT participants will undergo examination of PFM strength and activity, as well as anal ultrasound prior to randomization and after the intervention period.
详细描述
The recruitment in RCT ( 2) has been lower than expected (49/72). Due to financial reasons and problems with logistics and preparations for the main hospital (Ostfold Hospital Trust) moving into a new hospital, we were unable to extend the recruitment period in study 1. In RCT (3) AI was not an inclusion criterion. However, as both RCTs had the same outcome measure; anal incontinence, and a joint randomization process, stratified on hospital site and whether the participants had sustained an obsteric anal sphincter injury at delivery or not, the results from these studies will be reported together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •primiparas aged 18 years or over with adequate knowledge of the Norwegian Language (prevalence study)
- •Primiparas (Prevalence study and RCT 2)
- •Women with obstetric anal sphincter injury with primary repair at delivery (RCT 3)
排除标准
- •all studies:
- •Inadequate knowledge of the Norwegian language
- •Diabetes mellitus
- •Irritable bowel syndrome
- •Neurological diseases such as Multiple Sclerosis
- •Previous abdominal/colon surgery
- •In RCT studies:
- •Women who have already started pelvic floor muscle training postpartum due to severe anal incontinence or pelvic floor dysfunction
结局指标
主要结局
Change in Anal Incontinence as Measured on the St. Mark's Score
时间窗: 0 to 24 months postpartum
Survey and interview using the questionnaire St. Mark's incontinence score ranging from 0 (no incontinence) -24 (complete incontinence) points for measuring anal incontinence (AI). The A total of 1069 women responded to the questionnaires at 6 months postpartum and 1031 at 12 months postpartum. Discrepancies in the number of included and analysed participants in the PFME trials are related to the number of women who did not attend the follow-up appointments as described in the published paper.
次要结局
- Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale(12 to 24 months postpartum)
- Change in Manometry Measurements(12 to 24 months postpartum)
- Change in Urinary Incontinence as Measured on ICI-Q UI SF(0 to 24 months postpartum)
- Fecal Incontinence of Life (FIQL) Scale(0 to 24 months postpartum)