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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women<br>questionnaire at 1st and 3rd trimester, 10-12 weeks postpartum and 12 months postpartum pelvic floor ultrasound at 1st trimester and at 3rd trimester | Diagnostic Test: questionnaire<br>* 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.<br>* Other names: pelvic floor ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Body Image during and after pregnancy | Body Image Disturbance Questionnaire Score | through study completion, an average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethra mobility in cm | Transperineal ultrasound | 11-13 weeks gestation | 
| Urethra mobility in cm | Transperineal ultrasound | 28-33 weeks gestation | 
| genital hiatus in cm^2 | Transperineal ultrasound | 11-13 weeks gestation | 
| genital hiatus in cm^2 | Transperineal ultrasound | 28-33 weeks gestation | 
| levator ani avulsion | TUI sequence | 11-13 weeks gestation | 
| levator ani avulsion | TUI sequence | 28-33 weeks gestation | 
| anal sphincter injury | TUI sequence | 11-13 weeks gestation | 
| anal sphincter injury | TUI sequence | 28-33 weeks gestation | 
| Urinary Incontinence | International Consultation Incontinence Questionnaire - short form | 11-13 weeks gestation | 
| Urinary Incontinence | International Consultation Incontinence Questionnaire - short form | 28-33 weeks gestation | 
| Urinary Incontinence | International Consultation Incontinence Questionnaire - short form | 3 months postpartum | 
| Urinary Incontinence | International Consultation Incontinence Questionnaire - short form | 12 months postpartum | 
| Anal Incontinence | wexner score | 11-13 weeks gestation | 
| Anal Incontinence | wexner score | 28-33 weeks gestation | 
| Anal Incontinence | wexner score | 3 months postpartum | 
| Anal Incontinence | wexner score | 12 months postpartum | 
| Pelvic Organ Prolapse | Pelvic Organ Prolapse Distress Inventory | 11-13 weeks gestation | 
| Pelvic Organ Prolapse | Pelvic Organ Prolapse Distress Inventory | 28-33 weeks gestation | 
| Pelvic Organ Prolapse | Pelvic Organ Prolapse Distress Inventory | 3 months postpartum | 
| Pelvic Organ Prolapse | Pelvic Organ Prolapse Distress Inventory | 12 months postpartum | 
| Sexual function | POP/UI Sexual Questionnaire - IUGA revised | 11-13 weeks gestation | 
| Sexual function | POP/UI Sexual Questionnaire - IUGA revised | 28-33 weeks gestation | 
| Sexual function | POP/UI Sexual Questionnaire - IUGA revised | 3 months postpartum | 
| Sexual function | POP/UI Sexual Questionnaire - IUGA revised | 12 months postpartum |