Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women
Launched by OSTFOLD HOSPITAL TRUST · Sep 1, 2009
Trial Information
Current as of May 06, 2025
Completed
Keywords
ClinConnect Summary
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 t...
Gender
FEMALE
Eligibility criteria
- 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
About Ostfold Hospital Trust
Østfold Hospital Trust is a leading healthcare institution in Norway, dedicated to providing high-quality medical care and advancing clinical research. With a commitment to innovation and patient-centered practices, the trust facilitates a wide range of clinical trials aimed at improving treatment outcomes and enhancing healthcare delivery. By collaborating with multidisciplinary teams and leveraging state-of-the-art facilities, Østfold Hospital Trust plays a pivotal role in contributing to medical knowledge and improving the health of the communities it serves. Its focus on ethical standards and rigorous scientific methodology ensures that all research activities uphold the highest quality and safety standards.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sarpsborg, Ostfold, Norway
Patients applied
Trial Officials
Arvid Stordahl, MD PhD
Principal Investigator
Ostfold Hospital Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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