Clinical trial NCT00970320: Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women
Official title: Prevalence and Treatment of Anal Incontinence in Primiparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Anal Incontinence
urinary incontinence
primiparas
prevalence
pelvic floor exercise treatment
Quality of Life (QoL)
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian University of Science and Technology
First posted: 2009-09-02
Enrollment: 1718
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Change in Anal Incontinence as Measured on the St. Mark's Score
timeFrame: 0 to 24 months postpartum
Secondary outcomes:
measure: Change in Urinary Incontinence as Measured on ICI-Q UI SF
timeFrame: 0 to 24 months postpartum
measure: Fecal Incontinence of Life (FIQL) Scale
timeFrame: 0 to 24 months postpartum
measure: Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale
timeFrame: 12 to 24 months postpartum
measure: Change in Manometry Measurements
timeFrame: 12 to 24 months postpartum
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Ostfold Hospital Trust
state: Ostfold
Study officials:
affiliation: Ostfold Hospital Trust
name: Arvid Stordahl, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johannessen HH, Wibe A, Stordahl A, Sandvik L, Backe B, Morkved 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 Sep 10.
citation: Johannessen HH, Morkved 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.
citation: Johannessen HH, Wibe A, Stordahl A, Sandvik L, Morkved 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 23.