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

Not Applicable

Completed

• Conditions: Body Image; Anorectal Disorder; Postpartum Disorder; Pregnancy Related; Pelvic Organ Prolapse; Urinary Incontinence; Anal Incontinence; Constipation; Sexual Dysfunction
• Interventions: Diagnostic Test: questionnaire

• Registration Number: NCT03591393
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-07-06
• Study Start: 2018-07-19
• Study First Posted: 2018-07-19
• Primary Completion: 2024-06-04
• Study Completion: 2024-06-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	questionnaire	* questionnaire at 1st and 3rd trimester, 10-12 weeks postpartum and 12 months postpartum * pelvic floor ultrasound at 1st trimester and at 3rd trimester

Primary Outcome Measures

Name	Time	Method
Change Body Image during and after pregnancy	through study completion, an average of 18 months	Body Image Disturbance Questionnaire Score: 7-item questionnaire, each item is scored on a 5-point Likert-scale (1=no disturbance at all; 5=extreme disturbance), the final score is the mean of the 7-item ordinal scores.

Secondary Outcome Measures

Name	Time	Method
levator ani avulsion	28-33 weeks gestation	TUI sequence
Anal Incontinence	12 months postpartum	wexner score: 5-items questionnaire measuring the frequency of complaints. Each item is scored 0-4 (0=never, 4=always). The final score is the sum of the scores of the 5 items (total score 0-20)
Sexual function	12 months postpartum	POP/UI Sexual Questionnaire - IUGA revised
Urethra mobility in cm	28-33 weeks gestation	Transperineal ultrasound
genital hiatus in cm^2	28-33 weeks gestation	Transperineal ultrasound
anal sphincter injury	28-33 weeks gestation	TUI sequence
Urinary Incontinence	12 months postpartum	International Consultation Incontinence Questionnaire - short form
Pelvic Organ Prolapse	12 months postpartum	Pelvic Organ Prolapse Distress Inventory

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium