NCT00970320

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

Prevalence and Treatment of Anal Incontinence in Primiparous Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,718 (actual)
• Sponsor: Ostfold Hospital Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
OTHER	Pelvic floor muscle training	6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.

Timeline

• Start date: 2009-05-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2009-09-02
• Last updated: 2016-10-18
• Results posted: 2016-10-18

Locations

1 site across 1 country: Norway