Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function
NCT03591393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328
Last updated 2024-07-03
Summary
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.
Conditions
- Body Image
- Urinary Incontinence
- Anal Incontinence
- Anorectal Disorder
- Constipation
- Pelvic Organ Prolapse
- Sexual Dysfunction
- Pregnancy Related
- Postpartum Disorder
Interventions
- DIAGNOSTIC_TEST
-
questionnaire
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.
Sponsors & Collaborators
-
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Principal Investigators
-
Jan Deprest, MD, PhD · UZ Leuven
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-07-19
- Primary Completion
- 2024-06-04
- Completion
- 2024-06-04
Countries
- Belgium
Study Locations
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