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Search / Trial NCT05832268

Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

Launched by OSLO UNIVERSITY HOSPITAL · Apr 14, 2023

Trial Information

Current as of November 09, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This study, called The Pelvic Floor Future Study (PFF), is an observational, long-term look at how a new vaginal birth after a previous obstetric anal sphincter injury (a tear to the muscles surrounding the anus during a prior delivery) may affect pelvic floor function. Researchers will follow about 900 adult women who have had two or more vaginal deliveries at Oslo University Hospital between 2002 and 2018. They will compare two groups: (1) women who had a prior anal sphincter injury and then had another vaginal delivery, and (2) similar women who had two or more vaginal deliveries but did not have such an injury. The main question is whether a new vaginal delivery after an initial injury could weaken the anal muscles and lead to symptoms like anal incontinence or lower quality of life, 5–20 years later. They’ll also look at urinary incontinence and sexual function as secondary questions.

If you take part, you’ll fill out online questionnaires about your pregnancies and deliveries and any symptoms you have, such as leakage with bowel movements, urinary leakage, and sexual health. The study will measure changes over time using simple questionnaires and scales. Participation is purely observational and involves answering questions; there is no experimental treatment. The researchers plan to enroll up to 900 people, with follow-up potentially lasting many years (through at least 5–20 years after the latest delivery). Data stay with the study team at Oslo University Hospital, and this is not a drug or device trial.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Sphincter group: Previous obstetric anal sphincter injury during vaginal childbirth in 2002-2018 and having a subsequent vaginal delivery without such injury
  • control group: Two or more vaginal deliveries without obstetric anal sphincter injury
  • Exclusion Criteria:
  • under 18 years
  • consent incompetency
  • Obstetric anal sphincter injury in subsequent pregnancies
  • caesarian section in subsequent pregnancy

About Oslo University Hospital

Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.

Locations

Oslo, Norway

Patients applied

0 patients applied

Trial Officials

Kristine A Kilaas, M.D

Study Director

Oslo University Hospital

Rune Svenningsen, Ph.D

Study Director

Oslo University Hospital

Sissel Oversand

Principal Investigator

Oslo University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported