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Completed

NCT Number: NCT03591393

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

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.

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Key information

Conditions

Body Image Anal Incontinence Anorectal Disorder Behavior Behavioral Symptoms Constipation Digestive System Diseases Elimination Disorders Encopresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Genital Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Postpartum Disorder Pregnancy Complications Pregnancy Related Prolapse Puerperal Disorders Rectal Diseases Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Signs and Symptoms, Digestive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Diagnostic Test

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.

Other names: pelvic floor ultrasound

Primary outcomes

  1. Change Body Image during and after pregnancy

    Time frame: 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 outcomes

  1. Urethra mobility in cm

    Time frame: 11-13 weeks gestation

    Transperineal ultrasound

  2. Urethra mobility in cm

    Time frame: 28-33 weeks gestation

    Transperineal ultrasound

  3. genital hiatus in cm^2

    Time frame: 11-13 weeks gestation

    Transperineal ultrasound

  4. genital hiatus in cm^2

    Time frame: 28-33 weeks gestation

    Transperineal ultrasound

  5. levator ani avulsion

    Time frame: 11-13 weeks gestation

    TUI sequence

  6. levator ani avulsion

    Time frame: 28-33 weeks gestation

    TUI sequence

  7. anal sphincter injury

    Time frame: 11-13 weeks gestation

    TUI sequence

  8. anal sphincter injury

    Time frame: 28-33 weeks gestation

    TUI sequence

  9. Urinary Incontinence

    Time frame: 11-13 weeks gestation

    International Consultation Incontinence Questionnaire - short form

  10. Urinary Incontinence

    Time frame: 28-33 weeks gestation

    International Consultation Incontinence Questionnaire - short form

  11. Urinary Incontinence

    Time frame: 3 months postpartum

    International Consultation Incontinence Questionnaire - short form

  12. Urinary Incontinence

    Time frame: 12 months postpartum

    International Consultation Incontinence Questionnaire - short form

  13. Anal Incontinence

    Time frame: 11-13 weeks gestation

    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)

  14. Anal Incontinence

    Time frame: 28-33 weeks gestation

    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)

  15. Anal Incontinence

    Time frame: 3 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)

  16. Anal Incontinence

    Time frame: 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)

  17. Pelvic Organ Prolapse

    Time frame: 11-13 weeks gestation

    Pelvic Organ Prolapse Distress Inventory

  18. Pelvic Organ Prolapse

    Time frame: 28-33 weeks gestation

    Pelvic Organ Prolapse Distress Inventory

  19. Pelvic Organ Prolapse

    Time frame: 3 months postpartum

    Pelvic Organ Prolapse Distress Inventory

  20. Pelvic Organ Prolapse

    Time frame: 12 months postpartum

    Pelvic Organ Prolapse Distress Inventory

  21. Sexual function

    Time frame: 11-13 weeks gestation

    POP/UI Sexual Questionnaire - IUGA revised

  22. Sexual function

    Time frame: 28-33 weeks gestation

    POP/UI Sexual Questionnaire - IUGA revised

  23. Sexual function

    Time frame: 3 months postpartum

    POP/UI Sexual Questionnaire - IUGA revised

  24. Sexual function

    Time frame: 12 months postpartum

    POP/UI Sexual Questionnaire - IUGA revised

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: PFD-BI

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2018
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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