Clinical Trials Directory

Trials / Completed

CompletedNCT03591393

Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function

Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function - A Prospective Study Through Pregnancy and Post-partum

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
328 (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTquestionnaireValidated 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.

Timeline

Start date
2018-07-19
Primary completion
2024-06-04
Completion
2024-06-04
First posted
2018-07-19
Last updated
2024-07-03

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03591393. Inclusion in this directory is not an endorsement.