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

Ostfold Hospital Trust

Status: Completed

Conditions: Fecal Incontinence

Treatments: Other: Pelvic floor muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT00970320

3170 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,718 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,718 participants in 5 patient groups

Control group, RCT2

No Intervention group

Description:

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.

Intervention group, RCT 2

Active Comparator group

Description:

Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).

Treatment:

Other: Pelvic floor muscle training

Control group, RCT3

No Intervention group

Description:

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.

Intervention group, RCT 3

Active Comparator group

Description:

Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).

Treatment:

Other: Pelvic floor muscle training

Prevalence Study

No Intervention group

Description:

1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.