Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function (PFD-BI)
Primary Purpose
Body Image, Urinary Incontinence, Anal Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Body Image
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
Sites / Locations
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pregnant women
Arm Description
questionnaire at 1st and 3rd trimester, 10-12 weeks postpartum and 12 months postpartum pelvic floor ultrasound at 1st trimester and at 3rd trimester
Outcomes
Primary Outcome Measures
Change Body Image during and after pregnancy
Body Image Disturbance Questionnaire Score
Secondary Outcome Measures
Urethra mobility in cm
Transperineal ultrasound
Urethra mobility in cm
Transperineal ultrasound
genital hiatus in cm^2
Transperineal ultrasound
genital hiatus in cm^2
Transperineal ultrasound
levator ani avulsion
TUI sequence
levator ani avulsion
TUI sequence
anal sphincter injury
TUI sequence
anal sphincter injury
TUI sequence
Urinary Incontinence
International Consultation Incontinence Questionnaire - short form
Urinary Incontinence
International Consultation Incontinence Questionnaire - short form
Urinary Incontinence
International Consultation Incontinence Questionnaire - short form
Urinary Incontinence
International Consultation Incontinence Questionnaire - short form
Anal Incontinence
wexner score
Anal Incontinence
wexner score
Anal Incontinence
wexner score
Anal Incontinence
wexner score
Pelvic Organ Prolapse
Pelvic Organ Prolapse Distress Inventory
Pelvic Organ Prolapse
Pelvic Organ Prolapse Distress Inventory
Pelvic Organ Prolapse
Pelvic Organ Prolapse Distress Inventory
Pelvic Organ Prolapse
Pelvic Organ Prolapse Distress Inventory
Sexual function
POP/UI Sexual Questionnaire - IUGA revised
Sexual function
POP/UI Sexual Questionnaire - IUGA revised
Sexual function
POP/UI Sexual Questionnaire - IUGA revised
Sexual function
POP/UI Sexual Questionnaire - IUGA revised
Full Information
NCT ID
NCT03591393
First Posted
June 5, 2018
Last Updated
July 6, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03591393
Brief Title
Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function
Acronym
PFD-BI
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Image, Urinary Incontinence, Anal Incontinence, Anorectal Disorder, Constipation, Pelvic Organ Prolapse, Sexual Dysfunction, Pregnancy Related, Postpartum Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
622 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pregnant women
Arm Type
Experimental
Arm Description
questionnaire at 1st and 3rd trimester, 10-12 weeks postpartum and 12 months postpartum
pelvic floor ultrasound at 1st trimester and at 3rd trimester
Intervention Type
Diagnostic Test
Intervention Name(s)
questionnaire
Other Intervention Name(s)
pelvic floor ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change Body Image during and after pregnancy
Description
Body Image Disturbance Questionnaire Score
Time Frame
through study completion, an average of 18 months
Secondary Outcome Measure Information:
Title
Urethra mobility in cm
Description
Transperineal ultrasound
Time Frame
11-13 weeks gestation
Title
Urethra mobility in cm
Description
Transperineal ultrasound
Time Frame
28-33 weeks gestation
Title
genital hiatus in cm^2
Description
Transperineal ultrasound
Time Frame
11-13 weeks gestation
Title
genital hiatus in cm^2
Description
Transperineal ultrasound
Time Frame
28-33 weeks gestation
Title
levator ani avulsion
Description
TUI sequence
Time Frame
11-13 weeks gestation
Title
levator ani avulsion
Description
TUI sequence
Time Frame
28-33 weeks gestation
Title
anal sphincter injury
Description
TUI sequence
Time Frame
11-13 weeks gestation
Title
anal sphincter injury
Description
TUI sequence
Time Frame
28-33 weeks gestation
Title
Urinary Incontinence
Description
International Consultation Incontinence Questionnaire - short form
Time Frame
11-13 weeks gestation
Title
Urinary Incontinence
Description
International Consultation Incontinence Questionnaire - short form
Time Frame
28-33 weeks gestation
Title
Urinary Incontinence
Description
International Consultation Incontinence Questionnaire - short form
Time Frame
3 months postpartum
Title
Urinary Incontinence
Description
International Consultation Incontinence Questionnaire - short form
Time Frame
12 months postpartum
Title
Anal Incontinence
Description
wexner score
Time Frame
11-13 weeks gestation
Title
Anal Incontinence
Description
wexner score
Time Frame
28-33 weeks gestation
Title
Anal Incontinence
Description
wexner score
Time Frame
3 months postpartum
Title
Anal Incontinence
Description
wexner score
Time Frame
12 months postpartum
Title
Pelvic Organ Prolapse
Description
Pelvic Organ Prolapse Distress Inventory
Time Frame
11-13 weeks gestation
Title
Pelvic Organ Prolapse
Description
Pelvic Organ Prolapse Distress Inventory
Time Frame
28-33 weeks gestation
Title
Pelvic Organ Prolapse
Description
Pelvic Organ Prolapse Distress Inventory
Time Frame
3 months postpartum
Title
Pelvic Organ Prolapse
Description
Pelvic Organ Prolapse Distress Inventory
Time Frame
12 months postpartum
Title
Sexual function
Description
POP/UI Sexual Questionnaire - IUGA revised
Time Frame
11-13 weeks gestation
Title
Sexual function
Description
POP/UI Sexual Questionnaire - IUGA revised
Time Frame
28-33 weeks gestation
Title
Sexual function
Description
POP/UI Sexual Questionnaire - IUGA revised
Time Frame
3 months postpartum
Title
Sexual function
Description
POP/UI Sexual Questionnaire - IUGA revised
Time Frame
12 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Deprest, MD, PhD
Phone
+3216344269
Email
jan.deprest@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Leen Mortier
Phone
+3216345123
Email
leen.mortier@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Deprest, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Deprest, MD, PhD
Phone
+3216344269
Email
jan.deprest@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Leen Mortier
Phone
+3216345123
Email
leen.mortier@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Jan Deprest, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laura Cattani, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28447919
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.
Results Reference
result
PubMed Identifier
19941278
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.
Results Reference
result
PubMed Identifier
26113145
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.
Results Reference
result
PubMed Identifier
18089200
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.
Results Reference
result
PubMed Identifier
19129334
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.
Results Reference
result
PubMed Identifier
8416784
Citation
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
Results Reference
result
PubMed Identifier
10522604
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.
Results Reference
result
PubMed Identifier
15227649
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.
Results Reference
result
PubMed Identifier
24445668
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.
Results Reference
result
PubMed Identifier
20350640
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.
Results Reference
result
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Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function
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