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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• Women only
• No healthy volunteers
• Adult, Older adult

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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Medical subject headings

Sexual Dysfunction, Physiological, Pelvic Floor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: 5-26 years after the delivery complicated by OASI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 Jun 2026
2. Study start9 Oct 2026 (estimated)
3. Primary completion31 Jul 2027 (estimated)
4. Study completion31 Jul 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.