Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function (PFD-BI)

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.

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Constipation; Sexual Dysfunction; Pelvic Organ Prolapse; Pregnancy Related; Body Image; Anal Incontinence; Postpartum Disorder; Anorectal Disorder
• Intervention / Treatment: Diagnostic test: questionnaire

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urethra mobility in cm	Transperineal ultrasound	11-13 weeks gestation
Urethra mobility in cm	Transperineal ultrasound	28-33 weeks gestation
genital hiatus in cm^2	Transperineal ultrasound	11-13 weeks gestation
genital hiatus in cm^2	Transperineal ultrasound	28-33 weeks gestation
levator ani avulsion	TUI sequence	11-13 weeks gestation
levator ani avulsion	TUI sequence	28-33 weeks gestation
anal sphincter injury	TUI sequence	11-13 weeks gestation
anal sphincter injury	TUI sequence	28-33 weeks gestation
Urinary Incontinence	International Consultation Incontinence Questionnaire - short form	11-13 weeks gestation
Urinary Incontinence	International Consultation Incontinence Questionnaire - short form	28-33 weeks gestation
Urinary Incontinence	International Consultation Incontinence Questionnaire - short form	3 months postpartum
Urinary Incontinence	International Consultation Incontinence Questionnaire - short form	12 months postpartum
Pelvic Organ Prolapse	Pelvic Organ Prolapse Distress Inventory	11-13 weeks gestation
Pelvic Organ Prolapse	Pelvic Organ Prolapse Distress Inventory	28-33 weeks gestation
Pelvic Organ Prolapse	Pelvic Organ Prolapse Distress Inventory	3 months postpartum
Pelvic Organ Prolapse	Pelvic Organ Prolapse Distress Inventory	12 months postpartum
Sexual function	POP/UI Sexual Questionnaire - IUGA revised	11-13 weeks gestation
Sexual function	POP/UI Sexual Questionnaire - IUGA revised	28-33 weeks gestation
Sexual function	POP/UI Sexual Questionnaire - IUGA revised	3 months postpartum
Sexual function	POP/UI Sexual Questionnaire - IUGA revised	12 months postpartum
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)	11-13 weeks gestation
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)	28-33 weeks gestation
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)	3 months postpartum
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)	12 months postpartum

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jan Deprest, MD, PhD, UZ Leuven

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): June 4, 2024
• Study Completion (Actual): June 4, 2024

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Pathological Conditions, Anatomical; Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Constipation; Fecal Incontinence; Rectal Diseases; Puerperal Disorders
• Other Study ID Numbers: S60939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No