N/A
N=1,718
Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00970320 ↗Enrolled (actual)
1,718
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Change in Anal Incontinence as Measured on the St. Mark's Score — 4.3; 4.5; 3.6; 4.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pelvic floor muscle training (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ostfold Hospital Trust
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Anal Incontinence as Measured on the St. Mark's Score |
4.3; 4.5; 3.6; 4.1; 6.0 | — |
| SECONDARY Change in Urinary Incontinence as Measured on ICI-Q UI SF |
— | — |
| SECONDARY Fecal Incontinence of Life (FIQL) Scale |
— | — |
| SECONDARY Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale |
— | — |
| SECONDARY Change in Manometry Measurements |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00970320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.