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CompletedNCT03591393PFD-BIUpdated Jul 3, 2024

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

An interventional study of questionnaire in Body Image, Urinary Incontinence and Anal Incontinence, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
328
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Body Image
  • Urinary Incontinence
  • Anal Incontinence
  • Anorectal Disorder
  • Constipation
  • Pelvic Organ Prolapse
  • Sexual Dysfunction
  • Pregnancy Related
  • Postpartum Disorder
03

In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's enrollment of 328 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Universitaire Ziekenhuizen KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age > or = 18 years
  • dutch-speaking
  • ongoing pregnancy before 14 weeks GA
  • intending to deliver in UZ Leuven
  • ICF

Exclusion criteria

Exclusion Criteria:

  • age \< 18 years
  • not dutch-speaking
  • non evolutive pregnancy
  • pregnancy over 14 weeks GA
  • intention to deliver elsewhere
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
328 participants (actual)

Study arms

  • Experimental
    Pregnant women

    * 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

Interventions

  • Diagnostic testquestionnaire

    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.

    Also known as: pelvic floor ultrasound

06

What researchers measure

Primary outcomes

  1. Change Body Image during and after pregnancy

    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.

    Time frame: through study completion, an average of 18 months

Secondary outcomes

  1. Urethra mobility in cm

    Transperineal ultrasound

    Time frame: 11-13 weeks gestation

  2. Urethra mobility in cm

    Transperineal ultrasound

    Time frame: 28-33 weeks gestation

  3. genital hiatus in cm^2

    Transperineal ultrasound

    Time frame: 11-13 weeks gestation

  4. genital hiatus in cm^2

    Transperineal ultrasound

    Time frame: 28-33 weeks gestation

  5. levator ani avulsion

    TUI sequence

    Time frame: 11-13 weeks gestation

  6. levator ani avulsion

    TUI sequence

    Time frame: 28-33 weeks gestation

  7. anal sphincter injury

    TUI sequence

    Time frame: 11-13 weeks gestation

  8. anal sphincter injury

    TUI sequence

    Time frame: 28-33 weeks gestation

  9. Urinary Incontinence

    International Consultation Incontinence Questionnaire - short form

    Time frame: 11-13 weeks gestation

  10. Urinary Incontinence

    International Consultation Incontinence Questionnaire - short form

    Time frame: 28-33 weeks gestation

  11. Urinary Incontinence

    International Consultation Incontinence Questionnaire - short form

    Time frame: 3 months postpartum

  12. Urinary Incontinence

    International Consultation Incontinence Questionnaire - short form

    Time frame: 12 months postpartum

  13. Anal Incontinence

    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)

    Time frame: 11-13 weeks gestation

  14. Anal Incontinence

    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)

    Time frame: 28-33 weeks gestation

  15. Anal Incontinence

    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)

    Time frame: 3 months postpartum

  16. Anal Incontinence

    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)

    Time frame: 12 months postpartum

  17. Pelvic Organ Prolapse

    Pelvic Organ Prolapse Distress Inventory

    Time frame: 11-13 weeks gestation

  18. Pelvic Organ Prolapse

    Pelvic Organ Prolapse Distress Inventory

    Time frame: 28-33 weeks gestation

  19. Pelvic Organ Prolapse

    Pelvic Organ Prolapse Distress Inventory

    Time frame: 3 months postpartum

  20. Pelvic Organ Prolapse

    Pelvic Organ Prolapse Distress Inventory

    Time frame: 12 months postpartum

  21. Sexual function

    POP/UI Sexual Questionnaire - IUGA revised

    Time frame: 11-13 weeks gestation

  22. Sexual function

    POP/UI Sexual Questionnaire - IUGA revised

    Time frame: 28-33 weeks gestation

  23. Sexual function

    POP/UI Sexual Questionnaire - IUGA revised

    Time frame: 3 months postpartum

  24. Sexual function

    POP/UI Sexual Questionnaire - IUGA revised

    Time frame: 12 months postpartum

07

Study locations

1 site
  • UZ Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
08

References and documents

Publications

  • Lagaert L, Weyers S, Van Kerrebroeck H, Elaut E. Postpartum dyspareunia and sexual functioning: a prospective cohort study. Eur J Contracept Reprod Health Care. 2017 Jun;22(3):200-206. doi: 10.1080/13625187.2017.1315938. Epub 2017 Apr 27. PubMed 28447919 ↗
  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. PubMed 19941278 ↗
  • Reimers C, Staer-Jensen J, Siafarikas F, Saltyte-Benth J, Bo K, Ellstrom Engh M. Change in pelvic organ support during pregnancy and the first year postpartum: a longitudinal study. BJOG. 2016 Apr;123(5):821-9. doi: 10.1111/1471-0528.13432. Epub 2015 Jun 26. PubMed 26113145 ↗
  • Skouteris H, Carr R, Wertheim EH, Paxton SJ, Duncombe D. A prospective study of factors that lead to body dissatisfaction during pregnancy. Body Image. 2005 Dec;2(4):347-61. doi: 10.1016/j.bodyim.2005.09.002. Epub 2005 Nov 21. PubMed 18089200 ↗
  • Clark A, Skouteris H, Wertheim EH, Paxton SJ, Milgrom J. The relationship between depression and body dissatisfaction across pregnancy and the postpartum: a prospective study. J Health Psychol. 2009 Jan;14(1):27-35. doi: 10.1177/1359105308097940. PubMed 19129334 ↗
  • Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307. PubMed 8416784 ↗
  • Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327. PubMed 10522604 ↗
  • Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041. PubMed 15227649 ↗
  • Utomo E, Blok BF, Steensma AB, Korfage IJ. Validation of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) in a Dutch population. Int Urogynecol J. 2014 Apr;25(4):531-44. doi: 10.1007/s00192-013-2263-z. Epub 2014 Jan 21. PubMed 24445668 ↗
  • Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018. PubMed 20350640 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03591393
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Jul 19, 2018
Start date
Jul 19, 2018
Primary completion
Jun 4, 2024
Completion
Jun 4, 2024
Last update
Jul 3, 2024

Study contacts

Jan Deprest, MD, PhD
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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