Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth (DeliverUU)

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Obstetric Trauma

Anal Incontinence

Pelvic Floor Disorders

Pelvic Pain

Sexual Dysfunction

Pelvic Organ Prolapse

Constipation

Anal Sphincter Injury

Urinary Incontinence

Treatments

Diagnostic Test: Pelvic floor ultrasound

Diagnostic Test: Questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT05530681

s66245

Details and patient eligibility

About

This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum.

The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS).

Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis.

Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.

The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women.

PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.

Enrollment

320 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age = or > 18 years
Dutch/English-speaking
> 33 weeks gestation
delivering in UZ Leuven
vaginal delivery

Exclusion criteria

age < 18 years
not Dutch/English-speaking
< 33 weeks gestation
not delivering in UZ Leuven
non-vaginal delivery
Any disorder, that independently from delivery, affects pelvic floor function or structure, such as, but not limited to musculoskeletal or neurologic diseases.
any women with drug addiction, cognitive deficit, language-barrier and illiteracy
any disorder or timing or circumstances, which in the Investigator's opinion represents an obstacle to proper informed consent, or safe and/or compliant participation.
any prior or simultaneous treatment(s) potentially jeopardising safety or compromising trial integrity.