Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

NCT05832268 | Enrolling By Invitation

• 1 other identifier: 2019/654
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury

  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.

  5-20 years

Study Arms (2)

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

Controls

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

Other: Obstetric Anal Sphincter Injury

Interventions

Obstetric Anal Sphincter Injury OTHER

We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively

Controls; Sphincter damage

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0464, Norway

Location

MeSH Terms

Conditions

Encopresis; Urinary Incontinence; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

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; Genital Diseases

Study Officials

• Kristine A Kilaas, M.D

  Oslo University Hospital

  STUDY DIRECTOR

• Rune Svenningsen, Ph.D

  Oslo University Hospital

  STUDY DIRECTOR

• Sissel Oversand

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 27, 2023
• Study Start: September 19, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)