The Pelvic Floor Future Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstetric Anal Sphincter Injury
- Sponsor
- Oslo University Hospital
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
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.
Investigators
Sissel Oversand
Principal investigator
Oslo University Hospital
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
Outcomes
Primary Outcomes
The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.
Time Frame: 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 Outcomes
- 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)