Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

• Conditions: Sexual Dysfunction; Obstetric Anal Sphincter Injury; Anal Incontinence; Urinary Incontinence
• Interventions: Other: Obstetric Anal Sphincter Injury

• Registration Number: NCT05832268
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-27
• Study Start: 2023-09-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Primary Completion: 2025-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Obstetric Anal Sphincter Injury	Women who have had a at least two vaginal deliveries without suffering an injury to the anal sphincter
Sphincter damage	Obstetric Anal Sphincter Injury	Women who suffered an injury to anal sphincter after a vaginal delivery and had a subsequent delivery after this injury

Primary Outcome Measures

Name	Time	Method
The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.	5- 20 years	Number of participants with previous OASI who had a new vaginal delivery will be compared to participants with similar parity, without previous OASI. Differences in anal incontinence symptom score and quality of life will be measured by study questionnaires (St. Marks score, PFDI-20 and PFIQ-7).

Secondary Outcome Measures

Name	Time	Method
Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury	5-20 years	Number of participants who report complaints about urinary incontinence, measured by study questionnaires (PFIQ-7, NFIR, PFDI-20).
The risk of long- term dyspareunia and sexual dysfunction after previous obstetric anal sphincter injury compared to women with similar parity without obstetric anal sphincter injury.	5-20 years	Number of participants who report complaints about sexual dysfunction, the degree and type og dysfunction will be measured by study questionnaires (PISQ-12)

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway