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Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women

2016年8月24日 更新者：Ostfold Hospital Trust

Prevalence and Treatment of Anal Incontinence in Primiparous Women

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

1718

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 挪威
    • Ostfold
      • Sarpsborg、Ostfold、挪威、1714
        • Ostfold Hospital Trust

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 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)

Exclusion Criteria 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：Control group, RCT2
Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
有源比较器：Intervention group, RCT 2
Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
其他：Pelvic floor muscle training
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
无干预：Control group, RCT3
Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
有源比较器：Intervention group, RCT 3
Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
其他：Pelvic floor muscle training
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
无干预：Prevalence Study
1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Anal Incontinence as Measured on the St. Mark's Score
大体时间：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.
0 to 24 months postpartum

次要结果测量

结果测量
措施说明
大体时间
Change in Urinary Incontinence as Measured on ICI-Q UI SF
大体时间：0 to 24 months postpartum

International Consultation of Incontinence Questionnaire, short form (ICI-Q SF) ranges from 0 (Complete continence) to 21 (Complete incontinence) and measures the frequency of UI, amount of leakage and impact on quality of life.

Data have not been analysed.
0 to 24 months postpartum
Fecal Incontinence of Life (FIQL) Scale
大体时间：0 to 24 months postpartum
Change in health-related quality of Life as measured on the fecal incontinence quality of life scale (FIQL). There is no total scale, only four sub scales ranging from 4 (complete continence, no impact on QoL) to 1 (complete incontinence, severe impact on QoL) Data from the postpartum period has not and will not be analysed due to low numbers.
0 to 24 months postpartum
Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale
大体时间：12 to 24 months postpartum
Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong).
12 to 24 months postpartum
Change in Manometry Measurements
大体时间：12 to 24 months postpartum
manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction
12 to 24 months postpartum

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ostfold Hospital Trust

合作者

Norwegian University of Science and Technology
St. Olavs Hospital

调查人员

  • 首席研究员：Arvid Stordahl, MD PhD、Ostfold Hospital Trust

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年5月1日

初级完成 (实际的)

2014年4月1日

研究完成 (实际的)

2014年4月1日

研究注册日期

首次提交

2009年9月1日

首先提交符合 QC 标准的

2009年9月1日

首次发布 (估计)

2009年9月2日

研究记录更新

最后更新发布 (估计)

2016年10月18日

上次提交的符合 QC 标准的更新

2016年8月24日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 3170 (其他标识符：CTEP)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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