Assessment of Faecal Incontinence With MAPLe

This is cohort study of participants with symptoms of faecal incontinence. The study will take place across two hospital trusts, Ashford and St Peter's NHS Foundation Trust (ASPH) and University Hospital London Hospitals NHS Foundation Trust (UCLH). These trusts have been selected as both provide specialist pelvic floor services and have the facilities required to meet the needs of the study and follow up required by the participants. The use of two sites aims to increase the yield and diversity of participants.

Referrals to each trust are triaged by the overseeing consultant. Potential participants for the study will be identified. At ASPH suitable referrals will be tracked to a dedicated pelvic floor clinic run by a trial representative with medical training. Participants who meet the inclusion/exclusion criteria will be offered a patient information sheet and given an appointment in a dedicated anorectal physiology session (ARP). At UCLH suitable referrals will be contacted via telephone by the PI, should they wish to enrol they will receive a PIS and given an appointment in a dedicated ARP session. Participants will only be assessed and followed up in their recruiting trust.

All participants will complete an incontinence questionnaire and a quality of life questionnaire. Each participant will attend a designated ARP session. At ASPH this will comprise of the current gold standard, Anal Ultrasound (AUS) and High resolution manometry (HRAM) and additional assessment with MAPLe using a standardised protocol. At UCLH participants will undergo AUS in the radiology department, and HRAM and MAPLe in the GI Physiology unit. Through undertaking all three tests participants will act at their own controls. The results will be made available to their overseeing consultant and discussed at their local MDT. Participant participation will conclude following ARP assessment unless treatment is deemed necessary by their local MDT. These participants will be followed up at 6 months with interval MAPLe assessment and incontinence and quality of life questionnaire.

The results will undergo statistical analysis to determine non-inferiority of MAPLe in assessing FI. For analysis participants will be allocated to the following groups: fistula/chronic perianal conditions, obstetric injury <12 months, obstetric injury >12months, neurogenic. Each group will be analysed using symptoms profile and MAPLe results to identify correlation. Comparison of MAPle results pre and post treatment will determine if targeted treatment has been achieved.

An expert panel of pelvic floor specialists will be formed to determine the additional benefit of MAPLe in a clinical context. The panel will consist of 3-6 specialists within the field. To reduce bias, each specialist will be provided with literature on the background of MAPLe and how to analyse the results. The panellists will receive up to date guideline on the management of FI. The panel will be provided with cases and ARP results to answer the following questions:

Question 1: What is the additional benefit of MAPLe?

• Panellists will be provided with clinical history HRAM and AUS results

  ▪ What is the diagnosis and how will you manage this patient?

• MAPLe results provided

  • Has the management changed?

  • How beneficial on scale 1-10 has the addition been? Question 2 : HRAM and AUS vs MAPLe and AUS

• Panellists will be provided with a series of paired histories set one with HRAM and AUS results, set two with MAPLe and AUS results

  • What is the diagnosis and treatment?

  • How confident do you feel in your diagnosis and treatment for set two? Question 3: MAPLe alone

• Panellists will be provided with history and MAPLe results

• What is the diagnosis and treatment?

• Do you feel enough information is provided by the MAPLe to allow for a management plan?

The outcomes of the expert panel will undergo statistical analysis. determine if there is a perceived benefit.