Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

Urinary Incontinence Clinical Trial

— DeliverUU  

Official title:

Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05530681
• Other study ID #: s66245
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Jan Deprest, MD, PhD
• Phone: +3216344269
• Email: jan.deprest[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anal Incontinence
• Anal Sphincter Injury
• Constipation
• Enuresis
• Fecal Incontinence
• Obstetric Trauma
• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Pelvic Pain
• Prolapse
• Sexual Dysfunction
• Urinary Incontinence

Intervention

Diagnostic Test:
• Questionnaire
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.
• Pelvic floor ultrasound
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	one year postpartum
Primary	Anal Incontinence	St Mark's Incontinence Score (SMIS) =1 (score range 0-24, higher scores mean worse anal incontinence)	one year postpartum
Primary	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)	one year postpartum
Primary	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	one year postpartum
Secondary	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	1 year
Secondary	levator hiatus antero-posterior diameter (cm)		1 year
Secondary	levator hiatus latero-lateral diameter (cm)		1 year
Secondary	levator hiatus surface (cm2)		1 year
Secondary	anal sphincter injury	residual defect of at least 30 degrees on Tomographic Ultrasound Imaging	1 year
Secondary	co-contraction	approximation of the dorsal puborectalis to the symphysis pubis during Valsalva manoeuvre	1 year
Secondary	pelvic organ descent	descent of bladder/cervix/ampulla rectalis under the level of the symphysis pubis	1 year
Secondary	bladder neck mobility	axial descent of the bladder neck during Valsalva manoeuvre	1 year