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Assessment of Faecal Incontinence With MAPLe

NCT03969069 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2019-05-31

No results posted yet for this study

Summary

Faecal incontinence (FI) is the involuntary passage of gas, liquid or solid stool and is experienced by an estimated 1-10% of the population. The symptom is multifactorial and associated with many medical conditions and diseases. The symptom is investigated using structural and functional testing of the pelvic floor. Current investigation techniques have poor correlation between symptom severity and investigation results. These techniques are unable to provide prognostic outcomes, resulting in undirected referrals for treatment based on symptoms alone. This study aims to improve the assessment of FI through additional testing using Multiple Array Probe Leiden (MAPLe). This is a non-invasive medically certified device that detects the electromyography of the pelvic floor, how muscles respond to voluntary nervous stimulus, to identify areas of weakness.

The aim of this study is firstly to identify which patient groups benefit from additional testing with MAPLe, and secondly to identify if directed treatment has been achieved.

The study will take place across two NHS trusts, both with specialist pelvic floor services. Participants referred to each trust with FI who meet the inclusion/exclusion criteria will be recruited from designated pelvic floor clinics and referrals for anorectal physiology (ARP). Each participant will undergo routine anorectal physiological assessment with Anal Ultrasound (AUS) and High Resolution Anal Manometry (HRAM) and additional assessment with MAPLe. Participation is complete unless treatment has been advised, these participants will undergo repeat assessment with MAPLe at 6 months. Average participation will be 12 months.

The results will be analysed to identify non-inferiority of MAPLe vs current techniques using Bland Altman method. Regression and correlation studies will be performed to identify which groups have benefited from assessment with MAPLe. An expert panel of specialists in the field of pelvic floor will be convened to determine the clinical utilisation of MAPLe.

Conditions

  • Faecal Incontinence
  • Fecal Incontinence
  • Faecal Incontinence With Faecal Urgency

Interventions

DEVICE

MAPLe

Additional assessment with MAPLe

Sponsors & Collaborators

  • University College London Hospitals

    lead OTHER

Principal Investigators

  • Rachael C Weatherburn, MBChB MRCS · Research Fellow

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2020-08-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03969069 on ClinicalTrials.gov