Clinical trial NCT05832268: Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
Official title: The Pelvic Floor Future Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obstetric Anal Sphincter Injury
Anal Incontinence
Urinary Incontinence
Sexual Dysfunction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.
timeFrame: 5- 20 years
Secondary outcomes:
measure: Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury
timeFrame: 5-20 years
measure: 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.
timeFrame: 5-20 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kristine A Kilaas, M.D
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Rune Svenningsen, Ph.D
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Sissel Oversand
role: PRINCIPAL_INVESTIGATOR
References: