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Enrolling by invitationNCT07646340Updated Oct 15, 2026

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

An observational study in Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries and Pelvic Floor Disorders, sponsored by Tampere University Hospital. Enrolling by invitation at 1 site in Finland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Tampere University Hospital · Observational

Updated Oct 15, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
Female
01

Study 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
02

Conditions studied

  • 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
03

In context

Sexual Dysfunction, Physiological

385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.

This study's planned enrollment of 600 is above the median of 176 across 113 observational studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

Tampere University Hospital is the lead sponsor of 212 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

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

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

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

07

Study locations

1 site
08

References and documents

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. PubMed 40684100 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Finnish legislation prohibits sharing individual participant data.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.

Of 37 non-industry observational studies under Sexual Dysfunction, Physiological, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 55. This study's planned 9 months is below that.

Counting every sponsor, half of 40 studies reached it within 42 months; a quarter within 11 and three quarters within 65.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 15, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2026
First posted
Jun 12, 2026
StartEst.
Oct 9, 2026was Aug 2026
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2028
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 1, 2026→Oct 9, 2026
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Start date Aug 1, 2026→Oct 9, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07646340
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Oct 9, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Oct 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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