First Time Mothers and Anal Incontinence Six Years Postpartum (FiTMAI6)

Previous studies show that incontinence is relatively common during pregnancy and after delivery. Experiencing incontinence during pregnancy or in the first year after delivery increases the risk of long term incontinence. There is scarce documentation of the long term prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and risk factors for incontinence approximately six years after delivery among the 1718 who participated in two previous studies exploring the prevalence and predictors of anal incontinence in late pregnancy and during the first year after first delivery, and the effect of pelvic floor muscle exercises as treatment for anal incontinence after delivery. Increased awareness and knowledge about risk factors and long term prevalence of anal incontinence among health professionals as well as pregnant and parous women may give indications about which women to target for preventative measures to reduce the risk of new onset of postpartum AI during pregnancy and after delivery. Further, increased knowledge may aid in planning individualized follow-up during pregnancy and the first year as well as in the long term among women with existing AI symptoms.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Urinary Incontinence; Fecal Incontinence

• Study Type: Observational
• Enrollment (Actual): 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Parous women participating in two previous studies (1. primiparae delivering their first child between May 2009 and December2010 and 2. women with anal incontinence postpartum)

Description

Inclusion Criteria:

• Participants in previous studies

Exclusion Criteria:

• Women not participating in previous studies

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anal incontinence	St. Mark's score measuring frequency and severity of anal incontinence	Anal incontinence six years postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary incontinence	ICI-Q UI SF measuring frequency and severity of urinary incontinence	urinary incontinence six years postpartum

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Norwegian University of Science and Technology; St.Olavs Hospital, Trondheim University Hospital, Norway
• Investigators: Principal Investigator: Hege H Johannessen, PhD, Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (ESTIMATE): June 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Rectal Diseases; Urinary Incontinence; Fecal Incontinence
• Other Study ID Numbers: AB3299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO