CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,718 enrolled
Drug / intervention
Pelvic floor muscle trainingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00970320
NCT00970320N/ACompleted

Prevalence and Treatment of Anal Incontinence in Primiparous Women

Ostfold Hospital Trust·interventional·Posted Sep 2, 2009·Updated Oct 18, 2016

In Brief

A clinical study evaluating Pelvic floor muscle training for Fecal Incontinence. Completed, enrolled 1,718 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNorway

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2009
Enrollment StartMay 1, 2009
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.8 years ago

Interventions

Pelvic floor muscle trainingother

6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.