Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function (PFD-BI)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Anal Incontinence; Body Image; Pregnancy Related; Sexual Dysfunction; Pelvic Organ Prolapse; Anorectal Disorder; Postpartum Disorder; Constipation; Urinary Incontinence

Treatments: Diagnostic Test: questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT03591393

S60939

Details and patient eligibility

About

The first objective to determinate the prevalence of pelvic floor dysfunction in pregnant women and in the first year postpartum. The second objective is to assess the anatomical (both clinical and ultrasound), demographic and obstetric variables in symptomatic women and their association with pelvic floor dysfunction, sexual function and Body Image.

This is a single center prospective cohort study. Women will be asked to fill out a questionnaire at the time of their 1st and 3rd trimester scan, at the postpartum checkup and 12 months postpartum. Furthermore, they will undergo a pelvic floor ultrasound at the time of their first and third trimester scan.

The presence of pelvic floor dysfunctions will be recorded through validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function.

The body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire.

The anatomy of the pelvic floor will be objectively assessed off line on 3D/4D transperineal ultrasound volumes and POP-Q examination. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.

Enrollment: 328 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age > or = 18 years
• dutch-speaking
• ongoing pregnancy before 14 weeks GA
• intending to deliver in UZ Leuven
• ICF

Exclusion criteria

• age < 18 years
• not dutch-speaking
• non evolutive pregnancy
• pregnancy over 14 weeks GA
• intention to deliver elsewhere

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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328 participants in 1 patient group

Pregnant women

Experimental group

Description:

* questionnaire at 1st and 3rd trimester, 10-12 weeks postpartum and 12 months postpartum * pelvic floor ultrasound at 1st trimester and at 3rd trimester

Treatment:

Diagnostic Test: questionnaire