Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women
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.
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ostfold
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Sarpsborg, Ostfold, Norsko, 1714
- Ostfold Hospital Trust
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Control group, RCT2
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.
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Aktivní komparátor: Intervention group, RCT 2
Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
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6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
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Žádný zásah: Control group, RCT3
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.
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Aktivní komparátor: Intervention group, RCT 3
Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
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6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
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Žádný zásah: Prevalence Study
1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Anal Incontinence as Measured on the St. Mark's Score
Časové okno: 0 to 24 months postpartum
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Survey and interview using the questionnaire St. Mark's incontinence score ranging from 0 (no incontinence) -24 (complete incontinence) points for measuring anal incontinence (AI).
The A total of 1069 women responded to the questionnaires at 6 months postpartum and 1031 at 12 months postpartum.
Discrepancies in the number of included and analysed participants in the PFME trials are related to the number of women who did not attend the follow-up appointments as described in the published paper.
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0 to 24 months postpartum
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Urinary Incontinence as Measured on ICI-Q UI SF
Časové okno: 0 to 24 months postpartum
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International Consultation of Incontinence Questionnaire, short form (ICI-Q SF) ranges from 0 (Complete continence) to 21 (Complete incontinence) and measures the frequency of UI, amount of leakage and impact on quality of life. Data have not been analysed. |
0 to 24 months postpartum
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Fecal Incontinence of Life (FIQL) Scale
Časové okno: 0 to 24 months postpartum
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Change in health-related quality of Life as measured on the fecal incontinence quality of life scale (FIQL).
There is no total scale, only four sub scales ranging from 4 (complete continence, no impact on QoL) to 1 (complete incontinence, severe impact on QoL) Data from the postpartum period has not and will not be analysed due to low numbers.
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0 to 24 months postpartum
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Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale
Časové okno: 12 to 24 months postpartum
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Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong).
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12 to 24 months postpartum
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Change in Manometry Measurements
Časové okno: 12 to 24 months postpartum
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manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction
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12 to 24 months postpartum
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Arvid Stordahl, MD PhD, Ostfold Hospital Trust
Publikace a užitečné odkazy
Obecné publikace
- Johannessen HH, Wibe A, Stordahl A, Sandvik L, Backe B, Morkved S. Prevalence and predictors of anal incontinence during pregnancy and 1 year after delivery: a prospective cohort study. BJOG. 2014 Feb;121(3):269-79. doi: 10.1111/1471-0528.12438. Epub 2013 Sep 10.
- Johannessen HH, Morkved S, Stordahl A, Sandvik L, Wibe A. Anal incontinence and Quality of Life in late pregnancy: a cross-sectional study. BJOG. 2014 Jul;121(8):978-87. doi: 10.1111/1471-0528.12643. Epub 2014 Mar 4.
- Johannessen HH, Wibe A, Stordahl A, Sandvik L, Morkved S. Anal incontinence among first time mothers - what happens in pregnancy and the first year after delivery? Acta Obstet Gynecol Scand. 2015 Sep;94(9):1005-13. doi: 10.1111/aogs.12689. Epub 2015 Jun 23.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 3170 (Jiný identifikátor: CTEP)
Plán pro data jednotlivých účastníků (IPD)
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