Pelvic Floor Function After Obstetric Injury to the Anal Sphincter (PFF)

University of Oslo (UIO)

Status: Invitation-only

Conditions: Anal Incontinence; Sexual Dysfunction; Urinary Incontinence; Obstetric Anal Sphincter Injury

Treatments: Other: Obstetric Anal Sphincter Injury

Study type: Observational

Funder types: Other

Identifiers

NCT05832268

2019/654

Details and patient eligibility

About

The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal musculature in their first pregnancy, with women who had two or more vaginal deliveries, but did not suffer such an injury.

The main questions we want to answer is:

• can the burden of a new pregnancy and delivery weaken the function of the repaired musculature in a way that might cause symptoms of anal incontinence later in life?
• can a tear in the anal musculature increase the risk of developing urinary incontinence and long term sexual dysfunction?
• should we recommend these women to have a caesarian section instead of a new vaginal delivery?

Participants will be asked to complete an electronic questionnaire with information regarding their pregnancies, deliveries and potential symptoms from anal incontinence, urinary incontinence and sexual dysfunction.

Researchers will compare these two groups to find out if a new vaginal delivery has a negative effect on the function of the anal musculature.

Enrollment: 900 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sphincter group: Previous obstetric anal sphincter injury during vaginal childbirth in 2002-2018 and having a subsequent vaginal delivery without such injury
• control group: Two or more vaginal deliveries without obstetric anal sphincter injury

Exclusion criteria

• under 18 years
• consent incompetency
• Obstetric anal sphincter injury in subsequent pregnancies
• caesarian section in subsequent pregnancy

Trial design

900 participants in 2 patient groups

Sphincter damage

Description:

Women who suffered an injury to anal sphincter after a vaginal delivery and had a subsequent delivery after this injury

Treatment:

Other: Obstetric Anal Sphincter Injury

Controls

Description:

Women who have had a at least two vaginal deliveries without suffering an injury to the anal sphincter

Treatment:

Other: Obstetric Anal Sphincter Injury