Fecal IncontinenceNCT00970320
Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women
A study testing Pelvic floor muscle training in people with Fecal Incontinence, run by Ostfold Hospital Trust at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Pelvic floor muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,718 participants
- Where
- 1 siteNorway
- Study dates
- May 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- Pelvic floor muscle training
- Keywords
- Anal Incontinence, urinary incontinence, primiparas, prevalence, pelvic floor exercise treatment, Quality of Life (QoL)
- Medical subject headings
- Fecal Incontinence, Encopresis, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle trainingOther
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Control group, RCT2 | No intervention | 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 | Active comparator | Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). Receives: Other: Pelvic floor muscle training |
| Control group, RCT3 | No intervention | 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 | Active comparator | Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). Receives: Other: Pelvic floor muscle training |
| Prevalence Study | No intervention | 1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 24 months postpartum
Secondary outcomes (4)
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.
Measured: 0 to 24 months postpartum
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.
Measured: 0 to 24 months postpartum
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).
Measured: 12 to 24 months postpartum
Change in Manometry Measurements
manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction
Measured: 12 to 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arvid Stordahl, MD PhD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970320
- Sponsor's protocol ID
- 3170
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2009
- Last updated
- 18 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24021090Johannessen 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.
PubMed 24589074Johannessen 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.
PubMed 26052628
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Treatment of Anal Incontinence in Primiparous Women
- ClinicalTrials.gov ID
- NCT00970320
- Acronym / sponsor ID
- 3170
- Conditions
- Fecal Incontinence
- Keywords
- Anal Incontinence, urinary incontinence, primiparas, prevalence, pelvic floor exercise treatment, Quality of Life (QoL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,718 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian University of Science and Technology
- Study start
- May 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Posted 18 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group, RCT2 | No intervention | –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 | Active comparator | Other: Pelvic floor muscle trainingParticipants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). |
| Control group, RCT3 | No intervention | –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 | Active comparator | Other: Pelvic floor muscle trainingWomen with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months). |
| Prevalence Study | No intervention | –1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- Inadequate knowledge of the Norwegian language
- Diabetes mellitus
- Irritable bowel syndrome
- Neurological diseases such as Multiple Sclerosis
- Previous abdominal/colon surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist. | Other | Intervention group, RCT 2, Intervention group, RCT 3 |
Primary outcome
Change in Anal Incontinence as Measured on the St. Mark's Score
Time frame: 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.
4 secondary outcomes
Change in Urinary Incontinence as Measured on ICI-Q UI SF
Time frame: 0 to 24 months postpartum
Fecal Incontinence of Life (FIQL) Scale
Time frame: 0 to 24 months postpartum
Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale
Time frame: 12 to 24 months postpartum
Change in Manometry Measurements
Time frame: 12 to 24 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24021090Johannessen 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.
- Results publication: PubMed 24589074Johannessen 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.
- Results publication: PubMed 26052628Johannessen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvid Stordahl, MD PhD principal investigator
Ostfold Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training in people with Fecal Incontinence, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anal Incontinence as Measured on the St. Mark's Score (time frame: 0 to 24 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970320, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.