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Trial Outcomes & Findings for Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women (NCT NCT00970320)

NCT ID: NCT00970320

Last Updated: 2016-10-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1718 participants

Primary outcome timeframe

0 to 24 months postpartum

Results posted on

2016-10-18

Participant Flow

Primiparas during the period May 2009 and December 2010 and women sustaining obstetric anal sphincter injuries during the period 2009 to 2011 at Ostfold Hospital Trust and St. Olav's Hospital were invited to participate in the prevalence and intervention studies, respectively.

Participant milestones

Participant milestones
Measure
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.
Intervention Group, RCT 2
Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
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.
Intervention Group, RCT 3
Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
Prevalence Study
1571 primiparas delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.
Overall Study
STARTED
25
24
48
50
1571
Overall Study
COMPLETED
25
13
35
36
1031
Overall Study
NOT COMPLETED
0
11
13
14
540

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group, RCT2
n=25 Participants
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.
Intervention Group, RCT 2
n=24 Participants
Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
Control Group, RCT3
n=48 Participants
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.
Intervention Group, RCT 3
n=50 Participants
Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
Prevalence Study
n=1571 Participants
1571 primiparas delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
Total
n=1718 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Age, Categorical
Between 18 and 65 years
25 Participants
n=5 Participants
24 Participants
n=7 Participants
48 Participants
n=5 Participants
50 Participants
n=4 Participants
1571 Participants
n=21 Participants
1718 Participants
n=8 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Age, Continuous
29.1 years
STANDARD_DEVIATION 3.9 • n=5 Participants
27.8 years
STANDARD_DEVIATION 4.1 • n=7 Participants
30.8 years
STANDARD_DEVIATION 4 • n=5 Participants
30.5 years
STANDARD_DEVIATION 3.7 • n=4 Participants
28.2 years
STANDARD_DEVIATION 4.7 • n=21 Participants
29.3 years
STANDARD_DEVIATION 4.1 • n=8 Participants
Sex: Female, Male
Female
25 Participants
n=5 Participants
24 Participants
n=7 Participants
48 Participants
n=5 Participants
50 Participants
n=4 Participants
1571 Participants
n=21 Participants
1718 Participants
n=8 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Region of Enrollment
Norway
25 participants
n=5 Participants
24 participants
n=7 Participants
48 participants
n=5 Participants
50 participants
n=4 Participants
1571 participants
n=21 Participants
1718 participants
n=8 Participants
Anal incontinence (AI)
4.3 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
4.5 units on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
3.6 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
4.1 units on a scale
STANDARD_DEVIATION 4.1 • n=4 Participants
6.0 units on a scale
STANDARD_DEVIATION 5.0 • n=21 Participants
4.5 units on a scale
STANDARD_DEVIATION 3.9 • n=8 Participants

PRIMARY outcome

Timeframe: 0 to 24 months postpartum

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.

Outcome measures

Outcome measures
Measure
Control Group, RCT2
n=20 Participants
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.
Intervention Group, RCT 2
n=18 Participants
Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
Control Group, RCT3
n=35 Participants
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.
Intervention Group, RCT 3
n=36 Participants
Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
Prevalence Study
n=1571 Participants
1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
Change in Anal Incontinence as Measured on the St. Mark's Score
4.3 units on a scale
Standard Deviation 4.0
4.5 units on a scale
Standard Deviation 3.2
3.6 units on a scale
Standard Deviation 3.3
4.1 units on a scale
Standard Deviation 4.1
6.0 units on a scale
Standard Deviation 5.0

SECONDARY outcome

Timeframe: 0 to 24 months postpartum

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 to 24 months postpartum

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 to 24 months postpartum

Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 to 24 months postpartum

manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction

Outcome measures

Outcome data not reported

Adverse Events

Control Group, RCT2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention Group, RCT 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group, RCT3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention Group, RCT 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Prevalence Study

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Hege Hølmo Johannessen

Ostfold Hospital Trust

Phone: +4799721345

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place