Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

Study Overview
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Brief Summary
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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.

Official Title
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Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

Conditions
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Pelvic Floor Disorders, Obstetric Trauma, Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse, Pelvic Pain, Sexual Dysfunction, Constipation, Anal Sphincter Injury

Intervention / Treatment
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* Diagnostic Test: Questionnaire
* Diagnostic Test: Pelvic floor ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br> | Diagnostic Test: Questionnaire<br>* The survey consists in standardized and validated questionnaires on urinary function (ICIQ-SF, 4 items), bowel function (SMIS, 7 items and PAC-SYM, 12 items), symptoms of prolapse (POPDI, 6 items) and sexual function (Female Sexual Function Index FSFI, 19 items and Female Sexual Distress Scale - Revised FSDS-R, 13 items). questionnaire will be used at recruitment, at the postpartum visit, at the first annual follow-up visit.<br>Diagnostic Test: Pelvic floor ultrasound<br>* Pelvic floor ultrasound is the preferred imaging modality for documenting pelvic floor anatomy during pregnancy or after delivery. This examination is routinely performed in the outpatient clinic during patient visits (including the one year check-up after delivery). The technique used to assess the pelvic floor is described in detail in the 2019 practice parameters issued by IUGA.<br>* Other names: Pelvic floor sonography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) score of ≥1 (score range 0-21, higher scores mean worse urinary incontinence) | one year postpartum | 
| Anal Incontinence | St Mark's Incontinence Score (SMIS) ≥1 (score range 0-24, higher scores mean worse anal incontinence) | one year postpartum | 
| Sexual dysfunction | Female Sexual Function Index (FSFI) score ≤ 26.55 (score range 2 to 36, worse scores mean worse sexual function) OR FSDS-R score ≥11 (score range 0 to 52, with higher scores indicating more sexually related distress) | one year postpartum | 
| Constipation according to the Rome IV criteria | Must include two or more of the following:** Straining during more than ¼ (25%) of defecations Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations Sensation of incomplete evacuation more than ¼ (25%) of defecations Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) Fewer than three SBM per week Loose stools are rarely present without the use of laxatives Insufficient criteria for irritable bowel syndrome | one year postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levator avulsion | complete avulsion is defined as complete detachment of the puborectalis part of the levator ani muscle from the inferior pubic ramus on 3 out of 8 tomographic ultrasound imaging slices of the pelvic floor during contraction | 1 year | 
| levator hiatus antero-posterior diameter (cm) |  | 1 year | 
| levator hiatus latero-lateral diameter (cm) |  | 1 year | 
| levator hiatus surface (cm2) |  | 1 year | 
| anal sphincter injury | residual defect of at least 30 degrees on Tomographic Ultrasound Imaging | 1 year | 
| co-contraction | approximation of the dorsal puborectalis to the symphysis pubis during Valsalva manoeuvre | 1 year | 
| pelvic organ descent | descent of bladder/cervix/ampulla rectalis under the level of the symphysis pubis | 1 year | 
| bladder neck mobility | axial descent of the bladder neck during Valsalva manoeuvre | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum, urinary incontinence, anal incontinence, pelvic organ prolapse, sexual dysfunction, constipation, levator avulsion, anal sphincter injury