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NCT Number: NCT00970320

Prevalence and Treatment of Anal Incontinence (AI) 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.

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Key information

Conditions

Fecal Incontinence Behavior Behavioral Symptoms Digestive System Diseases Elimination Disorders Encopresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ostfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic Floor Muscle training

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Norwegian University of Science and Technology
  • St. Olavs Hospital

Registry information

Official study title

Prevalence and Treatment of Anal Incontinence in Primiparous Women

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2009
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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