Clinical trial NCT05530681: Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Official title: Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Floor Disorders
Obstetric Trauma
Urinary Incontinence
Anal Incontinence
Pelvic Organ Prolapse
Pelvic Pain
Sexual Dysfunction
Constipation
Anal Sphincter Injury
Keywords: urinary incontinence
anal incontinence
pelvic organ prolapse
sexual dysfunction
constipation
postpartum
levator avulsion
anal sphincter injury
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Urinary incontinence
timeFrame: one year postpartum
measure: Anal Incontinence
timeFrame: one year postpartum
measure: Sexual dysfunction
timeFrame: one year postpartum
measure: Constipation according to the Rome IV criteria
timeFrame: one year postpartum
Secondary outcomes:
measure: levator avulsion
timeFrame: 1 year
measure: levator hiatus antero-posterior diameter (cm)
timeFrame: 1 year
measure: levator hiatus latero-lateral diameter (cm)
timeFrame: 1 year
measure: levator hiatus surface (cm2)
timeFrame: 1 year
measure: anal sphincter injury
timeFrame: 1 year
measure: co-contraction
timeFrame: 1 year
measure: pelvic organ descent
timeFrame: 1 year
measure: bladder neck mobility
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Deprest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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