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

The Pelvic Floor Future Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Urinary Incontinence; Sexual Dysfunction; Anal Incontinence; Obstetric Anal Sphincter Injury
• Intervention / Treatment: Other: Obstetric Anal Sphincter Injury

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0464
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Study population will be women who had two or more vaginal deliveries at Oslo Universitetssykehus in the time period 2002-2018.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls; Women who have had a at least two vaginal deliveries without suffering an injury to the anal sphincter	Other: Obstetric Anal Sphincter Injury; We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively
Sphincter damage; Women who suffered an injury to anal sphincter after a vaginal delivery and had a subsequent delivery after this injury	Other: Obstetric Anal Sphincter Injury; We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.	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).	5- 20 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Kristine A Kilaas, M.D, Oslo University Hospital; Study Director: Rune Svenningsen, Ph.D, Oslo University Hospital; Principal Investigator: Sissel Oversand, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Fecal Incontinence
• Other Study ID Numbers: 2019/654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participant data will only be available to the researchers in charge of this project

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No