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Functional Ultrasound and the success of Sacral NeuroModulation in Fecal Incontinence

Functional Ultrasound and the success of Sacral NeuroModulation in Fecal Incontinence - SNM study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57156
Enrollment
20
Registered
2024-08-01
Start date
2024-12-27
Completion date
Unknown
Last updated
2025-11-10

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

Conditions

fecal incontinence fecal incontinence

Interventions

4D transperineal ultrasound (TPUS) and anal electromygraphy (EMG)

Sponsors

Ziekenhuis Groep Twente (ZGT)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Complaints of fecal incontinence and eligible for sacral neuromodulation - Able to read and understand Dutch. - Signed informed consent - Female

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Difference in muscle function before and after SNM placement.

Secondary

MeasureTime frame
• Difference in myofeedback (MAPLe) before SNM and after SNM placement. • Correlation between symptom improvement (PGI-I, diaries, FIQL and ODS) and anal sphincter functional measurements (strain and MAPLe). • Difference in anal sphincter functional strain measurements between patients with fecal incontinence and without fecal incontinence (data of the previous FASE study*) • Difference in anal sphincter functional strain measurements and anatomy between patients with successful (>50% complaint reduction) and without successful SNM test period. * The patients in the previous FASE study all agreed that their data could be used for additional pelvic floor research in the consent form.

Countries

Netherlands

Contacts

Public ContactJ.A. Simmering

Ziekenhuis Groep Twente (ZGT)

j.simmering@zgt.nl0534898185

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)