Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

NCT05530681 | Recruiting DMC

• 1 other identifier: s66245
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• levator avulsion

  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

  1 year

Study Arms (1)

Participants

EXPERIMENTAL

Diagnostic Test: Questionnaire; Diagnostic Test: Pelvic floor ultrasound

Interventions

Questionnaire DIAGNOSTIC_TEST

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.

Participants

Pelvic floor ultrasound DIAGNOSTIC_TEST

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

Participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence; Encopresis; Pelvic Organ Prolapse; Pelvic Pain; Sexual Dysfunction, Physiological; Constipation

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Prolapse; Pathological Conditions, Anatomical; Pain; Neurologic Manifestations; Genital Diseases

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jan Deprest, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Deprest, MD, PhD

CONTACT

+3216344269; jan.deprest@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: September 7, 2022
• Study Start: August 17, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)