An interventional study of Questionnaire and Pelvic floor ultrasound in Pelvic Floor Disorders, Obstetric Trauma and Urinary Incontinence, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic
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.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's planned enrollment of 320 is above the median of 63 across 148 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Questionnaire · Diagnostic Test: Pelvic floor ultrasound
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.
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.
Also known as: Transperineal ultrasound, Pelvic floor sonography
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)
Time frame: one year postpartum
Anal Incontinence
St Mark's Incontinence Score (SMIS) ≥1 (score range 0-24, higher scores mean worse anal incontinence)
Time frame: 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)
Time frame: 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
Time frame: one year postpartum
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
Time frame: 1 year
levator hiatus antero-posterior diameter (cm)
Time frame: 1 year
levator hiatus latero-lateral diameter (cm)
Time frame: 1 year
levator hiatus surface (cm2)
Time frame: 1 year
anal sphincter injury
residual defect of at least 30 degrees on Tomographic Ultrasound Imaging
Time frame: 1 year
co-contraction
approximation of the dorsal puborectalis to the symphysis pubis during Valsalva manoeuvre
Time frame: 1 year
pelvic organ descent
descent of bladder/cervix/ampulla rectalis under the level of the symphysis pubis
Time frame: 1 year
bladder neck mobility
axial descent of the bladder neck during Valsalva manoeuvre
Time frame: 1 year
Plan to share: No
Started Aug 2022 (actual). Primary completion is estimated for Sep 2024, 24 months after the start.
Of 101 non-industry interventional studies with no phase under Pelvic Floor Disorders, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 107 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
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