ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00970320
Recruitment Status : Completed
First Posted : September 2, 2009
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Ostfold Hospital Trust

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Fecal Incontinence
Intervention Other: Pelvic floor muscle training
Enrollment 1718
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.
Pre-assignment Details  
Arm/Group Title Control Group, RCT2 Intervention Group, RCT 2 Control Group, RCT3 Intervention Group, RCT 3 Prevalence Study
Hide 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
Arm/Group Title Control Group, RCT2 Intervention Group, RCT 2 Control Group, RCT3 Intervention Group, RCT 3 Prevalence Study Total
Hide 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 Number of Baseline Participants 25 24 48 50 1571 1718
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 48 participants 50 participants 1571 participants 1718 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
24
 100.0%
48
 100.0%
50
 100.0%
1571
 100.0%
1718
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 24 participants 48 participants 50 participants 1571 participants 1718 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 48 participants 50 participants 1571 participants 1718 participants
Female
25
 100.0%
24
 100.0%
48
 100.0%
50
 100.0%
1571
 100.0%
1718
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 25 participants 24 participants 48 participants 50 participants 1571 participants 1718 participants
25 24 48 50 1571 1718
Anal incontinence (AI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 24 participants 48 participants 50 participants 1571 participants 1718 participants
4.3  (4.0) 4.5  (3.2) 3.6  (3.3) 4.1  (4.1) 6.0  (5.0) 4.5  (3.9)
[1]
Measure Description: The St Mark's score ranges from 0-24 points and measures the frequency of AI complaints. There is no standard grading of the scale. A change of +/- 5 points has been suggested as a minimal clinical important difference in severe AI patients, and +/- 2-3 points in less severely affected populations.
1.Primary Outcome
Title Change in Anal Incontinence as Measured on the St. Mark's Score
Time Frame 0 to 24 months postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group, RCT2 Intervention Group, RCT 2 Control Group, RCT3 Intervention Group, RCT 3 Prevalence Study
Hide 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.
Overall Number of Participants Analyzed 20 18 35 36 1571
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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 Not Reported
3.Secondary Outcome
Title Fecal Incontinence of Life (FIQL) Scale
Hide 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 Not Reported
4.Secondary Outcome
Title Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale
Hide 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 Not Reported
5.Secondary Outcome
Title Change in Manometry Measurements
Hide 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 Not Reported
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group, RCT2 Intervention Group, RCT 2 Control Group, RCT3 Intervention Group, RCT 3 Prevalence Study
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/24 (0.00%)   0/48 (0.00%)   0/50 (0.00%)   0/1571 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group, RCT2 Intervention Group, RCT 2 Control Group, RCT3 Intervention Group, RCT 3 Prevalence Study
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/24 (0.00%)   0/48 (0.00%)   0/50 (0.00%)   0/1571 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Hege Hølmo Johannessen
Organization: Ostfold Hospital Trust
Phone: +4799721345
Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT00970320     History of Changes
Other Study ID Numbers: 3170
First Submitted: September 1, 2009
First Posted: September 2, 2009
Results First Submitted: June 9, 2016
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016