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

NCT03591393 | Completed

• 1 other identifier: S60939
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  through study completion, an average of 18 months

Secondary Outcomes (24)

• Urethra mobility in cm

  11-13 weeks gestation

• Urethra mobility in cm

  28-33 weeks gestation

• genital hiatus in cm^2

  11-13 weeks gestation

• genital hiatus in cm^2

  28-33 weeks gestation

• levator ani avulsion

  11-13 weeks gestation

Study Arms (1)

Pregnant women

EXPERIMENTAL

* 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

questionnaire DIAGNOSTIC_TEST

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

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (10)

• 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.

  PMID: 28447919 RESULT

• 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.

  PMID: 19941278 RESULT

• 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.

  PMID: 26113145 RESULT

• 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.

  PMID: 18089200 RESULT

• 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.

  PMID: 19129334 RESULT

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

  PMID: 8416784 RESULT

• 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.

  PMID: 10522604 RESULT

• 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.

  PMID: 15227649 RESULT

• 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.

  PMID: 24445668 RESULT

• 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.

  PMID: 20350640 RESULT

MeSH Terms

Conditions

Urinary Incontinence; Encopresis; Rectal Diseases; Constipation; Pelvic Organ Prolapse; Sexual Dysfunction, Physiological; Puerperal Disorders

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Prolapse; Pathological Conditions, Anatomical; Genital Diseases; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jan Deprest, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 19, 2018
• Study Start: July 19, 2018
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)