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

• Sponsor: Ostfold Hospital Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT00970320
• Collaborator: St. Olavs Hospital (Other), Norwegian University of Science and Technology (Other)
• Enrollment: 1,718
• Location: 1
• Arms: 5
• Duration (Months): 59
• Patients Per Site Per Month: 29.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	Other: Pelvic floor muscle training	N/A

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

• Study Type: Interventional
• Actual Enrollment: 1718 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Prevalence and Treatment of Anal Incontinence in Primiparous Women
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Active Comparator: Intervention group, RCT 2 Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).	Other: Pelvic floor muscle training; 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
No Intervention: 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.
Active Comparator: Intervention group, RCT 3 Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).	Other: Pelvic floor muscle training; 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
No Intervention: Prevalence Study 1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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).

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ostfold Hospital Trust	Sarpsborg	Ostfold	Norway	1714

Sponsors and Collaborators

• Ostfold Hospital Trust
• St. Olavs Hospital
• Norwegian University of Science and Technology

Investigators

• Principal Investigator: Arvid Stordahl, MD PhD, Ostfold Hospital Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ostfold Hospital Trust
• ClinicalTrials.gov Identifier: NCT00970320
• Other Study ID Numbers: 3170
• First Posted: Sep 2, 2009
• Last Update Posted: Oct 18, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Ostfold Hospital Trust: Anal Incontinence; urinary incontinence; primiparas; prevalence; pelvic floor exercise treatment; Quality of Life (QoL)
• Additional relevant MeSH terms: Fecal Incontinence

Study Results

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.

Arm/Group Title	Control Group, RCT2	Intervention Group, RCT 2	Control Group, RCT3	Intervention Group, RCT 3	Prevalence Study
Arm/Group Description	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.	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.	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.	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.	1571 primiparas delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.
Period Title: Overall Study
STARTED	25	24	48	50	1571
COMPLETED	25	13	35	36	1031
NOT COMPLETED	0	11	13	14	540

Baseline Characteristics

Arm/Group Title	Control Group, RCT2	Intervention Group, RCT 2	Control Group, RCT3	Intervention Group, RCT 3	Prevalence Study	Total
Arm/Group Description	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.	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.	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.	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.	1571 primiparas delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.	Total of all reporting groups
Overall Participants	25	24	48	50	1571	1718
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	24 100%	48 100%	50 100%	1571 100%	1718 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.1 (3.9)	27.8 (4.1)	30.8 (4)	30.5 (3.7)	28.2 (4.7)	29.3 (4.1)
Sex: Female, Male (Count of Participants)
Female	25 100%	24 100%	48 100%	50 100%	1571 100%	1718 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Norway	25 100%	24 100%	48 100%	50 100%	1571 100%	1718 100%
Anal incontinence (AI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.3 (4.0)	4.5 (3.2)	3.6 (3.3)	4.1 (4.1)	6.0 (5.0)	4.5 (3.9)

Outcome Measures

1. Primary Outcome

Title	Change in Anal Incontinence as Measured on the St. Mark's Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group, RCT2	Intervention Group, RCT 2	Control Group, RCT3	Intervention Group, RCT 3	Prevalence Study
Arm/Group Description	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.	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.	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.	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.	1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
Measure Participants	20	18	35	36	1571
Mean (Standard Deviation) [units on a scale]	4.3 (4.0)	4.5 (3.2)	3.6 (3.3)	4.1 (4.1)	6.0 (5.0)

2. Secondary Outcome

Title	Change in Urinary Incontinence as Measured on ICI-Q UI SF
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Fecal Incontinence of Life (FIQL) Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Change in Manometry Measurements
Description	manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction
Time Frame	12 to 24 months postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Throughout the studyperiod from 2009 to 2013
Adverse Event Reporting Description	no adverse events were registered during the study period
Arm/Group Title	Control Group, RCT2		Intervention Group, RCT 2		Control Group, RCT3		Intervention Group, RCT 3		Prevalence Study
Arm/Group Description	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.		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.		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.		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.		1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
All Cause Mortality
	Control Group, RCT2		Intervention Group, RCT 2		Control Group, RCT3		Intervention Group, RCT 3		Prevalence Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group, RCT2		Intervention Group, RCT 2		Control Group, RCT3		Intervention Group, RCT 3		Prevalence Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)		0/48 (0%)		0/50 (0%)		0/1571 (0%)
Other (Not Including Serious) Adverse Events
	Control Group, RCT2		Intervention Group, RCT 2		Control Group, RCT3		Intervention Group, RCT 3		Prevalence Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)		0/48 (0%)		0/50 (0%)		0/1571 (0%)

Limitations/Caveats

Due to financial restrictions and Ostfold Hospital moving to a new hospital, the number of included participants were not as high as expected in RCT 2.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.