Prevalence and Treatment of Anal Incontinence in Primiparous Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Ostfold Hospital Trust
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT00970320
First received: September 1, 2009
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary and anal incontinence, particularly in primiparas. A prolonged 2nd stage of delivery is the most common complication during labour and appears to be an important risk factor for traumatic tears of the pelvic floor muscles (PFM) and subsequent problems with incontinence.

The efficacy of pelvic floor muscle exercise (PFME) in treating urinary incontinence 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 Sykehuset Østfold Fredrikstad and St Olav's Hospital, Trondheim, and the results in this study will form the basis of the two randomized controlled trials (RCT) investigating the treatment efficacy of PFME. Women with a prolonged 2nd stage of delivery and symptomatic anal incontinence (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.


Condition Intervention
Incontinence
Other: Pelvic floor muscle training
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevalence and Treatment of Anal Incontinence in Primiparous Women

Resource links provided by NLM:


Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Anal incontinence [ Time Frame: 0, 6 and 12 months post partum ] [ Designated as safety issue: No ]
    Survey using the questionnaires St. Mark's score for measuring anal incontinence, ICI-Q SF score measuring urinary incontinence and the Fecal Incontinence Quality of Life score.

  • St. Mark's score [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]
    St. Mark's score and prevalence of symptoms of anal incontinence


Secondary Outcome Measures:
  • Urinary incontinence [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]
    ICI-Q SF score

  • Quality of Life [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]
    Fecal Incontinence of Life (FIQL) score


Estimated Enrollment: 1000
Study Start Date: May 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control group
Females with symptomatic anal insufficiency undergo clinical examination but are not offered intervention the first 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
Other: Control group
Clinical examination, no intervention for the first 6 months. Then PFMT treatment for the nest 6 months
Other Name: No intervention for 6 months. Then PFMT for 6 months
Active Comparator: Intervention group
Females with symptomatic anal incontinence randomized to the intervention group for the first 6 months receive Pelvic floor muscle training (PFMT) for 6 months before new clinical tests are carried out. They follow the same PFMT for another 6 months, before the third and final clinical tests are performed.
Other: Pelvic floor muscle training
6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist. After clinical tests this intervention is continued for another 6 months.
Other Names:
  • pelvic floor muscle strengthening exercises
  • biofeedback/ electrical stimulation

Detailed Description:

To be added in November 2011

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primiparas

Exclusion Criteria:

  • Diabetes mellitus
  • Irritable bowel syndrome
  • Neurological diseases such as Multiple Sclerosis
  • Previous abdominal/colon surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970320

Contacts
Contact: Hege H Johannessen, MSc +69 86 00 38 xegjoh@so-hf.no
Contact: Siv Morkved, Professor +47 73 59 75 84 siv.morkved@ntnu.no

Locations
Norway
Ostfold Hospital Trust Recruiting
Fredrikstad, Ostfold, Norway, 1603
Contact: Hege H Johannessen, MSc    +47 69 86 00 38    xegjoh@so-hf.no   
Principal Investigator: Hege H Johannessen, MSc         
Sponsors and Collaborators
Ostfold Hospital Trust
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Arvid Stordahl, MD PhD Ostfold Hospital Trust
  More Information

No publications provided

Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT00970320     History of Changes
Other Study ID Numbers: 3170
Study First Received: September 1, 2009
Last Updated: October 24, 2012
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Social Science Data Services

Keywords provided by Ostfold Hospital Trust:
Anal Incontinence
urinary incontinence
primiparas
prevalence
pelvic floor exercise treatment

ClinicalTrials.gov processed this record on September 29, 2014