Clinical trial NCT03591393: Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function
Official title: Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function - A Prospective Study Through Pregnancy and Post-partum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image
Urinary Incontinence
Anal Incontinence
Anorectal Disorder
Constipation
Pelvic Organ Prolapse
Sexual Dysfunction
Pregnancy Related
Postpartum Disorder
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 328
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change Body Image during and after pregnancy
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
measure: Urethra mobility in cm
timeFrame: 11-13 weeks gestation
measure: Urethra mobility in cm
timeFrame: 28-33 weeks gestation
measure: genital hiatus in cm^2
timeFrame: 11-13 weeks gestation
measure: genital hiatus in cm^2
timeFrame: 28-33 weeks gestation
measure: levator ani avulsion
timeFrame: 11-13 weeks gestation
measure: levator ani avulsion
timeFrame: 28-33 weeks gestation
measure: anal sphincter injury
timeFrame: 11-13 weeks gestation
measure: anal sphincter injury
timeFrame: 28-33 weeks gestation
measure: Urinary Incontinence
timeFrame: 11-13 weeks gestation
measure: Urinary Incontinence
timeFrame: 28-33 weeks gestation
measure: Urinary Incontinence
timeFrame: 3 months postpartum
measure: Urinary Incontinence
timeFrame: 12 months postpartum
measure: Anal Incontinence
timeFrame: 11-13 weeks gestation
measure: Anal Incontinence
timeFrame: 28-33 weeks gestation
measure: Anal Incontinence
timeFrame: 3 months postpartum
measure: Anal Incontinence
timeFrame: 12 months postpartum
measure: Pelvic Organ Prolapse
timeFrame: 11-13 weeks gestation
measure: Pelvic Organ Prolapse
timeFrame: 28-33 weeks gestation
measure: Pelvic Organ Prolapse
timeFrame: 3 months postpartum
measure: Pelvic Organ Prolapse
timeFrame: 12 months postpartum
measure: Sexual function
timeFrame: 11-13 weeks gestation
measure: Sexual function
timeFrame: 28-33 weeks gestation
measure: Sexual function
timeFrame: 3 months postpartum
measure: Sexual function
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Jan Deprest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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)/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.
citation: 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.
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. doi: 10.1016/j.bodyim.2005.09.002. Epub 2005 Nov 21.
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.
citation: Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
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. doi: 10.1080/003655299750025327.
citation: 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.
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 Jan 21.
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.