Status:
COMPLETED
Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women
Lead Sponsor:
Ostfold Hospital Trust
Collaborating Sponsors:
St. Olavs Hospital
Norwegian University of Science and Technology
Conditions:
Fecal Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1718 Patients enrolled
Trial Details
Trial ID
NCT00970320
Start Date
May 1 2009
End Date
April 1 2014
Last Update
October 18 2016
Active Locations (1)
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1
Ostfold Hospital Trust
Sarpsborg, Østfold fylke, Norway, 1714