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Functional Anal SphinctEr ultrasound - An explorative study

Functional Anal SphinctEr ultrasound - An explorative study - FASE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53496
Enrollment
150
Registered
2022-11-30
Start date
2023-04-03
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sphincter dysfunction sphincter laesion Obstetric Anal Sfincter Injury

Interventions

None listed

Sponsors

Ziekenhuis Groep Twente (ZGT)
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: o Good knowledge of Dutch language o Women >=18 years of age o Signed informed consent Patients: o Previous anal sphincter injury (OASI) Additional inclusion criteria for each substudy will be described in the appendices.

Exclusion criteria

Exclusion criteria: We only list general exclusion criteria for the healthy controls, since patient characteristics will be sub-study dependent. • Known injury to the anal sphincter • Symptoms of pelvic floor dysfunction (e.g. urinary of fecal incontinence, obstipation, prolapse feeling, pelvic pain)

Design outcomes

Primary

MeasureTime frame
Primary outcome is to determine the added value of functional assessment of the external anal sphincter by means of 4D ultrasound strain measurements in diagnosis and treatment decision making for patients with anal sphincter dysfunction and/or fecal incontinence.

Secondary

MeasureTime frame
Secondary outcomes include: Relation between 4D ultrasound and other measurements Differences in EAS function and anatomy between groups Relation between physical complaints and the amount of anal trauma.

Countries

Netherlands

Contacts

Public ContactATM Grob

Ziekenhuis Groep Twente (ZGT)

an.grob@zgt.nl0534895345

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026