Assessment of Faecal Incontinence With MAPLe

NCT03969069 | Unknown FDA Device

• 1 other identifier: 119731
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Adult; Human; Cohort

Outcome Measures

Primary Outcomes (2)

• Which patient groups benefit from assessment with MAPLe?

  Identity correlation between symptom profile and MAPLe results

  12 months

• Non-inferiority testing of MAPLe against current ano-rectal physiological tests.

  Blank Altman analysis of MAPLE vs HRAM and MAPLe vs AUS

  12 months

Secondary Outcomes (1)

• Has directed treatment been achieved?

  18 months

Study Arms (4)

Fistula/chronic perianal conditions

Participants symptomatic of FI with chronic perianal disease

Device: MAPLe

Obstetric injury <12 months

Participants symptomatic of FI \< 12 months following obstetric injury.

Device: MAPLe

Obstetric injury >12 months

Participants symptomatic of FI \>12 months following obstetric injury.

Device: MAPLe

Neurogenic

Participants symptomatic of FI with evidence/history of neurological condition.

Device: MAPLe

Interventions

MAPLe DEVICE

Additional assessment with MAPLe

Fistula/chronic perianal conditions; Neurogenic; Obstetric injury <12 months; Obstetric injury >12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All persons symptomatic of faecal incontinence with the capacity to consent and participate who meet the inclusion and exclusion criteria.

You may qualify if:

• Symptoms of faecal incontinence
• Capacity to consent

You may not qualify if:

• Anal surgery in the last 3 months
• Anal cancer
• Acute/painful perianal disease

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (2)

St Peter's Hospital

Chertsey, Surrrey, KT16 0PZ, United Kingdom

RECRUITING

University College Hospital

London, NW1 1BU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Encopresis; Fecal Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Rachael C Weatherburn, MBChB MRCS

  Research Fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael C Weatherburn, MBChB MRCS

CONTACT

020 3447 9130; rweatherburn@nhs.net

Anton V Emmanuel, BSc, MD, FRCP

CONTACT

020 3447 9130; a.emmanuel@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: May 31, 2019
• Study Start: May 30, 2019
• Primary Completion: August 1, 2020
• Study Completion: March 1, 2021
• Last Updated: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)