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Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

The Pelvic Floor Future Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05832268
Acronym
PFF
Enrollment
900
Registered
2023-04-27
Start date
2023-09-19
Completion date
2027-03-01
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERObstetric 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

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.5- 20 yearsNumber 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

MeasureTime frameDescription
Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury5-20 yearsNumber 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 yearsNumber of participants who report complaints about sexual dysfunction, the degree and type og dysfunction will be measured by study questionnaires (PISQ-12)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026