AzTrials
AzTrials

Body ImagePFD-BINCT03591393

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

A study testing questionnaire in people with Body Image and Urinary Incontinence, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
1 siteBelgium
Study dates
19 Jul 2018to 4 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

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

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.

Read more

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.

Being tested
questionnaire
Medical subject headings
Urinary Incontinence, Encopresis, Rectal Diseases, Constipation, Pelvic Organ Prolapse, Sexual Dysfunction, Physiological, Puerperal Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaireDiagnostic test

    Also called pelvic floor ultrasound

    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.

Study groups in NCT03591393
Study groupRoleWhat they receive
Pregnant womenExperimental* questionnaire at 1st and 3rd trimester, 10-12 weeks postpartum and 12 months postpartum * pelvic floor ultrasound at 1st trimester and at 3rd trimester
Receives: Diagnostic Test: questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 18 months

Secondary outcomes (24)

  1. Urethra mobility in cm

    Transperineal ultrasound

    Measured: 11-13 weeks gestation

  2. Urethra mobility in cm

    Transperineal ultrasound

    Measured: 28-33 weeks gestation

  3. genital hiatus in cm^2

    Transperineal ultrasound

    Measured: 11-13 weeks gestation

  4. genital hiatus in cm^2

    Transperineal ultrasound

    Measured: 28-33 weeks gestation

  5. levator ani avulsion

    TUI sequence

    Measured: 11-13 weeks gestation

  6. levator ani avulsion

    TUI sequence

    Measured: 28-33 weeks gestation

  7. anal sphincter injury

    TUI sequence

    Measured: 11-13 weeks gestation

  8. anal sphincter injury

    TUI sequence

    Measured: 28-33 weeks gestation

  9. Urinary Incontinence

    International Consultation Incontinence Questionnaire - short form

    Measured: 11-13 weeks gestation

  10. Urinary Incontinence

    International Consultation Incontinence Questionnaire - short form

    Measured: 28-33 weeks gestation

  11. Urinary Incontinence

    International Consultation Incontinence Questionnaire - short form

    Measured: 3 months postpartum

  12. Urinary Incontinence

    International Consultation Incontinence Questionnaire - short form

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 12 months postpartum

  17. Pelvic Organ Prolapse

    Pelvic Organ Prolapse Distress Inventory

    Measured: 11-13 weeks gestation

  18. Pelvic Organ Prolapse

    Pelvic Organ Prolapse Distress Inventory

    Measured: 28-33 weeks gestation

  19. Pelvic Organ Prolapse

    Pelvic Organ Prolapse Distress Inventory

    Measured: 3 months postpartum

  20. Pelvic Organ Prolapse

    Pelvic Organ Prolapse Distress Inventory

    Measured: 12 months postpartum

  21. Sexual function

    POP/UI Sexual Questionnaire - IUGA revised

    Measured: 11-13 weeks gestation

  22. Sexual function

    POP/UI Sexual Questionnaire - IUGA revised

    Measured: 28-33 weeks gestation

  23. Sexual function

    POP/UI Sexual Questionnaire - IUGA revised

    Measured: 3 months postpartum

  24. Sexual function

    POP/UI Sexual Questionnaire - IUGA revised

    Measured: 12 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2018
  2. Study start19 Jul 2018
  3. Primary completion4 Jun 2024
  4. Study completion4 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03591393
Sponsor's protocol ID
S60939
Acronym
PFD-BI
Status last verified
Jul 2024
First submitted
5 Jun 2018
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing questionnaire in people with Body Image and Urinary Incontinence, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Body Image during and after pregnancy (time frame: through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03591393, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in