Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07646340

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

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Obstetric Anal Sphincter Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Male Urogenital Diseases Pelvic Floor Disorders Pregnancy Complications Sexual Dysfunction and the Mode of Deliveries Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tampere University Hospital

Tampere, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Pelvic floor symptoms

    Time frame: 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.

  2. Sexual dysfunction

    Time frame: 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

  1. Satisfaction regarding the choice of mode of delivery in subsequent delivery

    Time frame: 5-26 years after the delivery complicated by OASI

    Satisfaction assessed with a numerical rating scale (1 to 10)

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.