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

NCT07646340 | Enrolling By Invitation

• 1 other identifier: R26016
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Pelvic floor symptoms

  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

  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 Outcomes (1)

• Satisfaction regarding the choice of mode of delivery in subsequent delivery

  5-26 years after the delivery complicated by OASI

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)