Prevalence and Treatment of Anal Incontinence in Primiparous Women
Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary and anal incontinence, particularly in primiparas. A prolonged 2nd stage of delivery is the most common complication during labour and appears to be an important risk factor for traumatic tears of the pelvic floor muscles (PFM) and subsequent problems with incontinence.
The efficacy of pelvic floor muscle exercise (PFME) in treating urinary incontinence 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 Sykehuset Østfold Fredrikstad and St Olav's Hospital, Trondheim, and the results in this study will form the basis of the two randomized controlled trials (RCT) investigating the treatment efficacy of PFME. Women with a prolonged 2nd stage of delivery and symptomatic anal incontinence (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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prevalence and Treatment of Anal Incontinence in Primiparous Women|
- Anal incontinence [ Time Frame: 0, 6 and 12 months post partum ] [ Designated as safety issue: No ]Survey using the questionnaires St. Mark's score for measuring anal incontinence, ICI-Q SF score measuring urinary incontinence and the Fecal Incontinence Quality of Life score.
- St. Mark's score [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]St. Mark's score and prevalence of symptoms of anal incontinence
- Urinary incontinence [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]ICI-Q SF score
- Quality of Life [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]Fecal Incontinence of Life (FIQL) score
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Females with symptomatic anal insufficiency undergo clinical examination but are not offered intervention the first 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
Other: Control group
Clinical examination, no intervention for the first 6 months. Then PFMT treatment for the nest 6 months
Other Name: No intervention for 6 months. Then PFMT for 6 months
Active Comparator: Intervention group
Females with symptomatic anal incontinence randomized to the intervention group for the first 6 months receive Pelvic floor muscle training (PFMT) for 6 months before new clinical tests are carried out. They follow the same PFMT for another 6 months, before the third and final clinical tests are performed.
Other: Pelvic floor muscle training
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist. After clinical tests this intervention is continued for another 6 months.
To be added in November 2011
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970320
|Contact: Hege H Johannessen, MSc||+69 86 00 firstname.lastname@example.org|
|Contact: Siv Morkved, Professor||+47 73 59 75 email@example.com|
|Ostfold Hospital Trust||Recruiting|
|Fredrikstad, Ostfold, Norway, 1603|
|Contact: Hege H Johannessen, MSc +47 69 86 00 38 firstname.lastname@example.org|
|Principal Investigator: Hege H Johannessen, MSc|
|Principal Investigator:||Arvid Stordahl, MD PhD||Ostfold Hospital Trust|