Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth (DeliverUU)
Primary Purpose
Pelvic Floor Disorders, Obstetric Trauma, Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaire
Pelvic floor ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Pelvic Floor Disorders focused on measuring urinary incontinence, anal incontinence, pelvic organ prolapse, sexual dysfunction, constipation, postpartum, levator avulsion, anal sphincter injury
Eligibility Criteria
Inclusion Criteria:
- age = or > 18 years
- Dutch/English-speaking
- > 33 weeks gestation
- delivering in UZ Leuven
- vaginal delivery
Exclusion Criteria:
- age < 18 years
- not Dutch/English-speaking
- < 33 weeks gestation
- not delivering in UZ Leuven
- non-vaginal delivery
- Any disorder, that independently from delivery, affects pelvic floor function or structure, such as, but not limited to musculoskeletal or neurologic diseases.
- any women with drug addiction, cognitive deficit, language-barrier and illiteracy
- any disorder or timing or circumstances, which in the Investigator's opinion represents an obstacle to proper informed consent, or safe and/or compliant participation.
- any prior or simultaneous treatment(s) potentially jeopardising safety or compromising trial integrity.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants
Arm Description
Outcomes
Primary Outcome Measures
Urinary incontinence
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) score of ≥1 (score range 0-21, higher scores mean worse urinary incontinence)
Anal Incontinence
St Mark's Incontinence Score (SMIS) ≥1 (score range 0-24, higher scores mean worse anal incontinence)
Sexual dysfunction
Female Sexual Function Index (FSFI) score ≤ 26.55 (score range 2 to 36, worse scores mean worse sexual function) OR FSDS-R score ≥11 (score range 0 to 52, with higher scores indicating more sexually related distress)
Constipation according to the Rome IV criteria
Must include two or more of the following:** Straining during more than ¼ (25%) of defecations Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations Sensation of incomplete evacuation more than ¼ (25%) of defecations Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) Fewer than three SBM per week Loose stools are rarely present without the use of laxatives Insufficient criteria for irritable bowel syndrome
Secondary Outcome Measures
levator avulsion
complete avulsion is defined as complete detachment of the puborectalis part of the levator ani muscle from the inferior pubic ramus on 3 out of 8 tomographic ultrasound imaging slices of the pelvic floor during contraction
levator hiatus antero-posterior diameter (cm)
levator hiatus latero-lateral diameter (cm)
levator hiatus surface (cm2)
anal sphincter injury
residual defect of at least 30 degrees on Tomographic Ultrasound Imaging
co-contraction
approximation of the dorsal puborectalis to the symphysis pubis during Valsalva manoeuvre
pelvic organ descent
descent of bladder/cervix/ampulla rectalis under the level of the symphysis pubis
bladder neck mobility
axial descent of the bladder neck during Valsalva manoeuvre
Full Information
NCT ID
NCT05530681
First Posted
July 6, 2022
Last Updated
September 1, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05530681
Brief Title
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Acronym
DeliverUU
Official Title
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2025 (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
Yes
5. Study Description
Brief Summary
This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum.
The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS).
Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis.
Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.
The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women.
PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Obstetric Trauma, Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse, Pelvic Pain, Sexual Dysfunction, Constipation, Anal Sphincter Injury
Keywords
urinary incontinence, anal incontinence, pelvic organ prolapse, sexual dysfunction, constipation, postpartum, levator avulsion, anal sphincter injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Questionnaire
Intervention Description
The survey consists in standardized and validated questionnaires on urinary function (ICIQ-SF, 4 items), bowel function (SMIS, 7 items and PAC-SYM, 12 items), symptoms of prolapse (POPDI, 6 items) and sexual function (Female Sexual Function Index FSFI, 19 items and Female Sexual Distress Scale - Revised FSDS-R, 13 items). questionnaire will be used at recruitment, at the postpartum visit, at the first annual follow-up visit.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pelvic floor ultrasound
Other Intervention Name(s)
Transperineal ultrasound, Pelvic floor sonography
Intervention Description
Pelvic floor ultrasound is the preferred imaging modality for documenting pelvic floor anatomy during pregnancy or after delivery. This examination is routinely performed in the outpatient clinic during patient visits (including the one year check-up after delivery). The technique used to assess the pelvic floor is described in detail in the 2019 practice parameters issued by IUGA.
Primary Outcome Measure Information:
Title
Urinary incontinence
Description
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) score of ≥1 (score range 0-21, higher scores mean worse urinary incontinence)
Time Frame
one year postpartum
Title
Anal Incontinence
Description
St Mark's Incontinence Score (SMIS) ≥1 (score range 0-24, higher scores mean worse anal incontinence)
Time Frame
one year postpartum
Title
Sexual dysfunction
Description
Female Sexual Function Index (FSFI) score ≤ 26.55 (score range 2 to 36, worse scores mean worse sexual function) OR FSDS-R score ≥11 (score range 0 to 52, with higher scores indicating more sexually related distress)
Time Frame
one year postpartum
Title
Constipation according to the Rome IV criteria
Description
Must include two or more of the following:** Straining during more than ¼ (25%) of defecations Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations Sensation of incomplete evacuation more than ¼ (25%) of defecations Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) Fewer than three SBM per week Loose stools are rarely present without the use of laxatives Insufficient criteria for irritable bowel syndrome
Time Frame
one year postpartum
Secondary Outcome Measure Information:
Title
levator avulsion
Description
complete avulsion is defined as complete detachment of the puborectalis part of the levator ani muscle from the inferior pubic ramus on 3 out of 8 tomographic ultrasound imaging slices of the pelvic floor during contraction
Time Frame
1 year
Title
levator hiatus antero-posterior diameter (cm)
Time Frame
1 year
Title
levator hiatus latero-lateral diameter (cm)
Time Frame
1 year
Title
levator hiatus surface (cm2)
Time Frame
1 year
Title
anal sphincter injury
Description
residual defect of at least 30 degrees on Tomographic Ultrasound Imaging
Time Frame
1 year
Title
co-contraction
Description
approximation of the dorsal puborectalis to the symphysis pubis during Valsalva manoeuvre
Time Frame
1 year
Title
pelvic organ descent
Description
descent of bladder/cervix/ampulla rectalis under the level of the symphysis pubis
Time Frame
1 year
Title
bladder neck mobility
Description
axial descent of the bladder neck during Valsalva manoeuvre
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age = or > 18 years
Dutch/English-speaking
> 33 weeks gestation
delivering in UZ Leuven
vaginal delivery
Exclusion Criteria:
age < 18 years
not Dutch/English-speaking
< 33 weeks gestation
not delivering in UZ Leuven
non-vaginal delivery
Any disorder, that independently from delivery, affects pelvic floor function or structure, such as, but not limited to musculoskeletal or neurologic diseases.
any women with drug addiction, cognitive deficit, language-barrier and illiteracy
any disorder or timing or circumstances, which in the Investigator's opinion represents an obstacle to proper informed consent, or safe and/or compliant participation.
any prior or simultaneous treatment(s) potentially jeopardising safety or compromising trial integrity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Deprest, MD, PhD
Phone
+3216344269
Email
jan.deprest@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Deprest, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
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