Prevalence and Treatment of Anal Incontinence in Primiparous Women

Fecal Incontinence Clinical Trial

Official title:

Prevalence and Treatment of Anal Incontinence in Primiparous Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970320
• Other study ID #: 3170
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: February 10, 2016
• Start date: May 2009
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1571
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Other:
• Pelvic floor muscle training
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Sarpsborg	Ostfold

Sponsors (3)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Norwegian University of Science and Technology, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Johannessen HH, Mørkved S, Stordahl A, Sandvik L, Wibe A. Anal incontinence and Quality of Life in late pregnancy: a cross-sectional study. BJOG. 2014 Jul;121(8):978-87. doi: 10.1111/1471-0528.12643. Epub 2014 Mar 4. — View Citation

Johannessen HH, Wibe A, Stordahl A, Sandvik L, Backe B, Mørkved S. Prevalence and predictors of anal incontinence during pregnancy and 1 year after delivery: a prospective cohort study. BJOG. 2014 Feb;121(3):269-79. doi: 10.1111/1471-0528.12438. Epub 2013 — View Citation

Johannessen HH, Wibe A, Stordahl A, Sandvik L, Mørkved S. Anal incontinence among first time mothers - what happens in pregnancy and the first year after delivery? Acta Obstet Gynecol Scand. 2015 Sep;94(9):1005-13. doi: 10.1111/aogs.12689. Epub 2015 Jun 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anal incontinence as measured on the St. Mark's score	Survey and interview using the questionnaires St. Mark's score for measuring anal incontinence.	0 to 24 months postpartum	No
Secondary	Change in urinary incontinence as measured on ICI-Q UI SF	International Consultation of Incontinence Questionnaire, short form (ICI-Q SF)	0 to 24 months postpartum	No
Secondary	Change in health-related quality of Life aas measured on FIQL	Fecal Incontinence of Life (FIQL) scale	0 to 24 months postpartum	No
Secondary	Change in pelvic floor muscle function test as measured on the ICS scale	Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong)	12 to 24 months postpartum	No
Secondary	Change in manometry measurements	manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction	12 to 24 months postpartum	No