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

NCT00970320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1718

Last updated 2016-10-18

Study results available
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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.

Conditions

  • Fecal Incontinence

Interventions

OTHER

Pelvic floor muscle training

6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Arvid Stordahl, MD PhD · Ostfold Hospital Trust

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00970320 on ClinicalTrials.gov