Prevalence and Treatment of Anal Incontinence in Primiparous Women

This study has been completed.
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT00970320
First received: September 1, 2009
Last updated: February 10, 2016
Last verified: October 2014
  Purpose

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 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 Intervention
Fecal Incontinence
Other: Pelvic floor muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevalence and Treatment of Anal Incontinence in Primiparous Women

Resource links provided by NLM:


Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Change in anal incontinence as measured on the St. Mark's score [ Time Frame: 0 to 24 months postpartum ] [ Designated as safety issue: No ]
    Survey and interview using the questionnaires St. Mark's score for measuring anal incontinence.


Secondary Outcome Measures:
  • Change in urinary incontinence as measured on ICI-Q UI SF [ Time Frame: 0 to 24 months postpartum ] [ Designated as safety issue: No ]
    International Consultation of Incontinence Questionnaire, short form (ICI-Q SF)

  • Change in health-related quality of Life aas measured on FIQL [ Time Frame: 0 to 24 months postpartum ] [ Designated as safety issue: No ]
    Fecal Incontinence of Life (FIQL) scale

  • Change in pelvic floor muscle function test as measured on the ICS scale [ Time Frame: 12 to 24 months postpartum ] [ Designated as safety issue: No ]
    Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong)

  • Change in manometry measurements [ Time Frame: 12 to 24 months postpartum ] [ Designated as safety issue: No ]
    manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction


Enrollment: 1571
Study Start Date: May 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970320

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

Publications:
Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT00970320     History of Changes
Other Study ID Numbers: 3170 
Study First Received: September 1, 2009
Last Updated: February 10, 2016
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Social Science Data Services
Individual Participant Data  
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:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 25, 2016