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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Control Group, RCT2   Intervention Group, RCT 2   Control Group, RCT3   Intervention Group, RCT 3   Prevalence Study
STARTED   25   24   48   50   1571 
COMPLETED   25   13   35   36   1031 
NOT COMPLETED   0   11   13   14   540 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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. Olavs Hospital during the period May 2009 to December 2010.
Total Total of all reporting groups

Baseline Measures
   Control Group, RCT2   Intervention Group, RCT 2   Control Group, RCT3   Intervention Group, RCT 3   Prevalence Study   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   24   48   50   1571   1718 
Age 
[Units: Participants]
           
<=18 years   0   0   0   0   0   0 
Between 18 and 65 years   25   24   48   50   1571   1718 
>=65 years   0   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.1  (3.9)   27.8  (4.1)   30.8  (4)   30.5  (3.7)   28.2  (4.7)   29.3  (4.1) 
Gender 
[Units: Participants]
           
Female   25   24   48   50   1571   1718 
Male   0   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
           
Norway   25   24   48   50   1571   1718 
Anal incontinence (AI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 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] 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.


  Outcome Measures

1.  Primary:   Change in Anal Incontinence as Measured on the St. Mark's Score   [ Time Frame: 0 to 24 months postpartum ]

2.  Secondary:   Change in Urinary Incontinence as Measured on ICI-Q UI SF   [ Time Frame: 0 to 24 months postpartum ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Fecal Incontinence of Life (FIQL) Scale   [ Time Frame: 0 to 24 months postpartum ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale   [ Time Frame: 12 to 24 months postpartum ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change in Manometry Measurements   [ Time Frame: 12 to 24 months postpartum ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


Results Point of Contact:  
Name/Title: Dr Hege Hølmo Johannessen
Organization: Ostfold Hospital Trust
phone: +4799721345
e-mail: hege.holmo.johannessen@so-hf.no


Publications of Results:

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