Fecal Incontinence
Conditions
Keywords
Anal Incontinence, urinary incontinence, primiparas, prevalence, pelvic floor exercise treatment, Quality of Life (QoL)
Brief 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.
Detailed description
The recruitment in RCT ( 2) has been lower than expected (49/72). Due to financial reasons and problems with logistics and preparations for the main hospital (Ostfold Hospital Trust) moving into a new hospital, we were unable to extend the recruitment period in study 1. In RCT (3) AI was not an inclusion criterion. However, as both RCTs had the same outcome measure; anal incontinence, and a joint randomization process, stratified on hospital site and whether the participants had sustained an obsteric anal sphincter injury at delivery or not, the results from these studies will be reported together.
Interventions
OTHERPelvic floor muscle training
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Ostfold Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anal Incontinence as Measured on the St. Mark's Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Incontinence as Measured on ICI-Q UI SF | 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. |
| Fecal Incontinence of Life (FIQL) Scale | 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. |
| Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale | 12 to 24 months postpartum | Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong). |
| Change in Manometry Measurements | 12 to 24 months postpartum | manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction |
Countries
Norway
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 24 |
| 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. | 48 |
| 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. | 50 |
| Prevalence Study 1571 primiparas delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010. | 1,571 |
| Total | 1,718 |
Baseline characteristics
| Characteristic | Intervention Group, RCT 3 | Prevalence Study | Total | Control Group, RCT2 | Intervention Group, RCT 2 | Control Group, RCT3 |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 1571 Participants | 1718 Participants | 25 Participants | 24 Participants | 48 Participants |
| Age, Continuous | 30.5 years STANDARD_DEVIATION 3.7 | 28.2 years STANDARD_DEVIATION 4.7 | 29.3 years STANDARD_DEVIATION 4.1 | 29.1 years STANDARD_DEVIATION 3.9 | 27.8 years STANDARD_DEVIATION 4.1 | 30.8 years STANDARD_DEVIATION 4 |
| Anal incontinence (AI) | 4.1 units on a scale STANDARD_DEVIATION 4.1 | 6.0 units on a scale STANDARD_DEVIATION 5 | 4.5 units on a scale STANDARD_DEVIATION 3.9 | 4.3 units on a scale STANDARD_DEVIATION 4 | 4.5 units on a scale STANDARD_DEVIATION 3.2 | 3.6 units on a scale STANDARD_DEVIATION 3.3 |
| Region of Enrollment Norway | 50 participants | 1571 participants | 1718 participants | 25 participants | 24 participants | 48 participants |
| Sex: Female, Male Female | 50 Participants | 1571 Participants | 1718 Participants | 25 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 24 | 0 / 48 | 0 / 50 | 0 / 1,571 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 48 | 0 / 50 | 0 / 1,571 |
Outcome results
Primary
Change in Anal Incontinence as Measured on the St. Mark's Score
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.
Time frame: 0 to 24 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group, RCT2 | Change in Anal Incontinence as Measured on the St. Mark's Score | 4.3 units on a scale | Standard Deviation 4 |
| Intervention Group, RCT 2 | Change in Anal Incontinence as Measured on the St. Mark's Score | 4.5 units on a scale | Standard Deviation 3.2 |
| Control Group, RCT3 | Change in Anal Incontinence as Measured on the St. Mark's Score | 3.6 units on a scale | Standard Deviation 3.3 |
| Intervention Group, RCT 3 | Change in Anal Incontinence as Measured on the St. Mark's Score | 4.1 units on a scale | Standard Deviation 4.1 |
| Prevalence Study | Change in Anal Incontinence as Measured on the St. Mark's Score | 6.0 units on a scale | Standard Deviation 5 |
Secondary
Change in Manometry Measurements
manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction
Time frame: 12 to 24 months postpartum
Secondary
Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale
Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong).
Time frame: 12 to 24 months postpartum
Secondary
Change in Urinary Incontinence as Measured on ICI-Q UI SF
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.
Time frame: 0 to 24 months postpartum
Secondary
Fecal Incontinence of Life (FIQL) Scale
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.
Time frame: 0 to 24 months postpartum