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

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ClinicalTrials.gov Identifier: NCT00970320
Recruitment Status : Completed
First Posted : September 2, 2009
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Ostfold Hospital Trust

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Fecal Incontinence Other: Pelvic floor muscle training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1718 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Prevalence and Treatment of Anal Incontinence in Primiparous Women
Study Start Date : May 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014
Arms and Interventions
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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).
 Other: Pelvic floor muscle training
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).
 Other: Pelvic floor muscle training
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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).

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970320


Locations
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Norway
Ostfold Hospital Trust
Sarpsborg, Ostfold, Norway, 1714
Sponsors and Collaborators
Ostfold Hospital Trust
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Arvid Stordahl, MD PhD Ostfold Hospital Trust
More Information
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Publications of Results:

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Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT00970320    
Other Study ID Numbers: 3170
First Posted: September 2, 2009    Key Record Dates
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ostfold Hospital Trust:
Anal Incontinence
urinary incontinence
primiparas
 prevalence
pelvic floor exercise treatment
Quality of Life (QoL)
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases