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

Pregnancy Related Clinical Trial

— PFD-BI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03591393
• Other study ID #: S60939
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Jan Deprest, MD, PhD
• Phone: +3216344269
• Email: jan.deprest[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 622
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Incontinence
• Anorectal Disorder
• Body Image
• Constipation
• Disease
• Enuresis
• Fecal Incontinence
• Pelvic Organ Prolapse
• Postpartum Disorder
• Pregnancy Related
• Prolapse
• Puerperal Disorders
• Rectal Diseases
• Sexual Dysfunction
• Urinary Incontinence

Intervention

Diagnostic Test:
• questionnaire
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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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)/Internation — View Citation

Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. Review. — View Citation

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. — View Citation

Reimers C, Staer-Jensen J, Siafarikas F, Saltyte-Benth J, Bø K, Ellström 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 — View Citation

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. Epub 2005 Nov 21. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Body Image during and after pregnancy	Body Image Disturbance Questionnaire Score	through study completion, an average of 18 months
Secondary	Urethra mobility in cm	Transperineal ultrasound	11-13 weeks gestation
Secondary	Urethra mobility in cm	Transperineal ultrasound	28-33 weeks gestation
Secondary	genital hiatus in cm^2	Transperineal ultrasound	11-13 weeks gestation
Secondary	genital hiatus in cm^2	Transperineal ultrasound	28-33 weeks gestation
Secondary	levator ani avulsion	TUI sequence	11-13 weeks gestation
Secondary	levator ani avulsion	TUI sequence	28-33 weeks gestation
Secondary	anal sphincter injury	TUI sequence	11-13 weeks gestation
Secondary	anal sphincter injury	TUI sequence	28-33 weeks gestation
Secondary	Urinary Incontinence	International Consultation Incontinence Questionnaire - short form	11-13 weeks gestation
Secondary	Urinary Incontinence	International Consultation Incontinence Questionnaire - short form	28-33 weeks gestation
Secondary	Urinary Incontinence	International Consultation Incontinence Questionnaire - short form	3 months postpartum
Secondary	Urinary Incontinence	International Consultation Incontinence Questionnaire - short form	12 months postpartum
Secondary	Anal Incontinence	wexner score	11-13 weeks gestation
Secondary	Anal Incontinence	wexner score	28-33 weeks gestation
Secondary	Anal Incontinence	wexner score	3 months postpartum
Secondary	Anal Incontinence	wexner score	12 months postpartum
Secondary	Pelvic Organ Prolapse	Pelvic Organ Prolapse Distress Inventory	11-13 weeks gestation
Secondary	Pelvic Organ Prolapse	Pelvic Organ Prolapse Distress Inventory	28-33 weeks gestation
Secondary	Pelvic Organ Prolapse	Pelvic Organ Prolapse Distress Inventory	3 months postpartum
Secondary	Pelvic Organ Prolapse	Pelvic Organ Prolapse Distress Inventory	12 months postpartum
Secondary	Sexual function	POP/UI Sexual Questionnaire - IUGA revised	11-13 weeks gestation
Secondary	Sexual function	POP/UI Sexual Questionnaire - IUGA revised	28-33 weeks gestation
Secondary	Sexual function	POP/UI Sexual Questionnaire - IUGA revised	3 months postpartum
Secondary	Sexual function	POP/UI Sexual Questionnaire - IUGA revised	12 months postpartum