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

NCT00970320 | Completed Results

• 1 other identifier: 3170
• Study Type: interventional
• Target: 1,718
• Locations: 1 country
• Sites: 1

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 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

Keywords

Anal Incontinence; urinary incontinence; primiparas; prevalence; pelvic floor exercise treatment; Quality of Life (QoL)

Outcome Measures

Primary Outcomes (1)

• Change in Anal Incontinence as Measured on the St. Mark's Score

  Survey and interview using the questionnaire St. Mark's incontinence score ranging from 0 (no incontinence) -24 (complete incontinence) points for measuring anal incontinence (AI). The A total of 1069 women responded to the questionnaires at 6 months postpartum and 1031 at 12 months postpartum. Discrepancies in the number of included and analysed participants in the PFME trials are related to the number of women who did not attend the follow-up appointments as described in the published paper.

  0 to 24 months postpartum

Secondary Outcomes (4)

• Change in Urinary Incontinence as Measured on ICI-Q UI SF

  0 to 24 months postpartum

• Fecal Incontinence of Life (FIQL) Scale

  0 to 24 months postpartum

• Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale

  12 to 24 months postpartum

• Change in Manometry Measurements

  12 to 24 months postpartum

Study Arms (5)

Control group, RCT2

NO INTERVENTION

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

ACTIVE COMPARATOR

Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).

Other: Pelvic floor muscle training

Control group, RCT3

NO INTERVENTION

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

ACTIVE COMPARATOR

Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).

Other: Pelvic floor muscle training

Prevalence Study

NO INTERVENTION

1571 primiparae delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.

Interventions

Pelvic floor muscle training OTHER

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

Intervention group, RCT 2; Intervention group, RCT 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• St. Olavs Hospital: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Ostfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

Location

Related Publications (3)

• Johannessen HH, Wibe A, Stordahl A, Sandvik L, Backe B, Morkved S. Prevalence and predictors of anal incontinence during pregnancy and 1 year after delivery: a prospective cohort study. BJOG. 2014 Feb;121(3):269-79. doi: 10.1111/1471-0528.12438. Epub 2013 Sep 10.

  PMID: 24021090 RESULT

• Johannessen HH, Morkved S, Stordahl A, Sandvik L, Wibe A. Anal incontinence and Quality of Life in late pregnancy: a cross-sectional study. BJOG. 2014 Jul;121(8):978-87. doi: 10.1111/1471-0528.12643. Epub 2014 Mar 4.

  PMID: 24589074 RESULT

• Johannessen HH, Wibe A, Stordahl A, Sandvik L, Morkved S. Anal incontinence among first time mothers - what happens in pregnancy and the first year after delivery? Acta Obstet Gynecol Scand. 2015 Sep;94(9):1005-13. doi: 10.1111/aogs.12689. Epub 2015 Jun 23.

  PMID: 26052628 RESULT

MeSH Terms

Conditions

Fecal Incontinence; Encopresis; Urinary Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr Hege Hølmo Johannessen
• Organization: Ostfold Hospital Trust

hege.holmo.johannessen@so-hf.no

+4799721345

Study Officials

• Arvid Stordahl, MD PhD

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 18, 2016
• Results First Posted: October 18, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)