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

August 24, 2016 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1718

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ostfold
      • Sarpsborg, Ostfold, Norway, 1714
        • Ostfold Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Active Comparator: Intervention group, RCT 2
Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
No Intervention: 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.
Active Comparator: Intervention group, RCT 3
Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
No Intervention: Prevalence Study
1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anal Incontinence as Measured on the St. Mark's Score
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urinary Incontinence as Measured on ICI-Q UI SF
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arvid Stordahl, MD PhD, Ostfold Hospital Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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