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

June 9, 2026 updated by: Tampere University Hospital

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

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of individuals who gave birth at Tampere University Hospital (Tays) between 2009 and 2021 and whose delivery was complicated by an anal sphincter injury (n = 580).

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5-26 years after the delivery complicated by OASI
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.
5-26 years after the delivery complicated by OASI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5-26 years after the delivery complicated by OASI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R26016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Finnish legislation prohibits sharing individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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