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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1718 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group, RCT 2

Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).

Group Type ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type OTHER

6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group, RCT 3

Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).

Group Type ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type OTHER

6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.

Prevalence Study

1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic floor muscle training

6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes