Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland

NCT07646340 — Enrolling by invitation, 600 participants, Tampere University Hospital

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Registry	NCT07646340
Status	Enrolling by invitation
Study type	Observational
Enrollment	600 (Estimated)
Sponsor	Tampere University Hospital (Other)
Conditions	Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries, Pelvic Floor Disorders
Dates	start 2026-10-09 (estimated), primary completion 2027-07-31 (estimated), completion 2028-07-31 (estimated), first posted 2026-06-12, last updated 2026-10-15
Locations	1 site in Finland

-Summary

The goal of this observational study is to understand long-term pelvic floor symptoms and sexual dysfunction after childbirth-related anal sphincter injury in women who gave birth at Tampere University Hospital between 2009 and 2021. The main questions it aims to answer are:

How common are long-term pelvic floor symptoms and sexual dysfunction after sphincter injury? What factors are associated with an increased risk of long-term symptoms?

Additionally, the study explores whether sphincter injury affects desired family size and satisfaction with the mode of delivery in a subsequent pregnancy.

Participants will:

* Receive an information letter, consent form, and questionnaires by mail. They can respond via mail or complete them electronically via a secure online service
* Complete questionnaires on pelvic floor symptoms (PFDI-20), sexual function (PISQ-12), and preferences regarding childbirth and family size
* Allow researchers to use their medical record data related to pregnancy, childbirth, postpartum period, and newborn outcomes for research purposes

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+Arms and interventions

Arm	Type	Interventions	Description
No subsequent deliveries			No pregnancies ending in delivery after obstetric anal sphincter injury
Subsequent cesarean delivery			Only cesarean delivery/deliveries after obstetric anal sphincter injury
Subsequent vaginal delivery			Vaginal delivery/deliveries after obstetric anal sphincter injury

+Outcome measures

Primary outcomes

Pelvic floor symptoms [5-26 years after the delivery complicated by OASI]: Pelvic floor symptoms described in the short form of PFDI-20 (Pelvic floor distress inventory) questionnaire. The questionnaire consists of 20 items, each of which is scored from 0 to 4 points. The items are presented in domains describing different pelvic floor symptoms: those associated with pelvic organ prolapse, those associated with defecation, and urinary symptoms. Higher score indicates more distress associated with the symptom. In this study, individual items, domain scores and overall score are compared between the study groups.
Sexual dysfunction [5-26 years after the delivery complicated by OASI]: Sexual dysfunction symptoms described in the PISQ-12 (Pelvic organ prolapse/urinary incontinense sexual questionnaire). This instrument includes 12 items that are scored on a scale from 1 to 5, higher score indicating higher sexual function. In this study, each item score as well as total score will be compared between the groups.

Secondary outcomes

Satisfaction regarding the choice of mode of delivery in subsequent delivery [5-26 years after the delivery complicated by OASI]: Satisfaction assessed with a numerical rating scale (1 to 10)

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Obstetric anal sphincter injury in Tampere University Hospital during 2009-2021

Exclusion Criteria:

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+Locations (1)

Facility	City	Country	Status
Tampere University Hospital	Tampere	Finland

+Publications

Ristila E, Palomaki O, Huhtala H, Toivonen E. Mode of delivery and maternal outcome in subsequent delivery after an obstetric anal sphincter injury: a Finnish retrospective cohort study. BMC Pregnancy Childbirth. 2025 Jul 19;25(1):773. doi: 10.1186/s12884-025-07882-9. PMID 40684100

+Study documents

Study Protocol (PDF, 2026-01-26)