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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07646340
Enrollment
600
Registered
2026-06-12
Start date
2026-08-01
Completion date
2028-07-31
Last updated
2026-06-12

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

Conditions

Obstetric Anal Sphincter Injury, Pelvic Floor Disorders, Sexual Dysfunction and the Mode of Deliveries

Keywords

obstetric anal sphincter injury, sexual dysfunction, vaginal delivery, pelvic floor symptoms

Brief 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

Interventions

None listed

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Pelvic floor symptoms5-26 years after the delivery complicated by OASIPelvic 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 dysfunction5-26 years after the delivery complicated by OASISexual 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

MeasureTime frameDescription
Satisfaction regarding the choice of mode of delivery in subsequent delivery5-26 years after the delivery complicated by OASISatisfaction assessed with a numerical rating scale (1 to 10)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026