Improving the Assessment of Faecal Incontinence: Which Patient Groups Would Benefit From Assessment With Multiple Array Probe Leiden (MAPLe)?
Conditions: Faecal Incontinence, Fecal Incontinence, Faecal Incontinence With Faecal Urgency
Sponsor: University College London Hospitals

Short title: Assessment of FI with MAPLe 
Sponsor code: 119731   
Protocol  IRAS 239383 Version 2 13/02/19         
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Full title of trial 
Improving the Assessment of Faecal Incontinence: which patient 
groups would benefit from assessment with Multiple Array Probe 
Leiden (MAPLe)? 
This is a student study as part of a Research MD 
Short title 
 
Assessment of Faecal Incontinence with MAPLe 
Version and date of protocol 
 
 Version 1 29/01/19  
  
Sponsor: 
University College London (UCL) 
Sponsor protocol number 
119731 
 
Funder (s): 
 
UCL 
Ashford and St Peter’s NHS Foundation Trust 
 
Clinicaltrials.gov no:  
 
Submitted a/w approval 
 
 
Intervention: 
Additional assessment of participants with faecal incontinence with 
MAPLe  
 
Single site/multi-site: 
Multi site 

Short title: Assessment of FI with MAPLe 
Sponsor code: 119731   
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Chief investigator: 
Prof Anton Emmanuel 
Consultant Gastoenterologist 
University College Hospital 
235 Euston Road 
London 
NW1 2BU 
 
 
 
Sponsor: 
Nikkayla Dixon , uclh.randd@nhs.net  
Joint Research Office, UCL, 1st Floor Maple House, 
149 Tottenham Court Road, 
London W1T 7NF 
Postal address: 
Joint Research Office, UCL 
Gower Street,  
London WC1E 6BT 
 
Student Researcher: 
Rachael Weatherburn 
Research Fellow 
University College Hospital 
235 Euston Road 
London  
NW1 2BU 
 

Short title: Assessment of FI with MAPLe 
Sponsor code: 119731   
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Protocol Version History 
 
Version Number 
Date 
Protocol Update 
Finalised By (insert 
name of person):  
Reasons for Update 
1 
19/01/19 
Rachael Weatherburn 
Peer Review 
2 
13/02/19 
Rachael Weatherburn 
Following JRO review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Short title: Assessment of FI with MAPLe 
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Signatures 
The Chief Investigator and the JRO have discussed this protocol. The investigator agrees to perform 
the investigations and to abide by this protocol.  
The investigator agrees to conduct the trial in compliance with the approved protocol, the UK Data 
Protection Act (2018), the Trust Information Governance Policy (or other local equivalent), the 
current UK Policy Framework for Research, the Sponsor’s SOPs, and other regulatory requirements 
as amended. 
 
Chief investigator 
     12/2/19 
 
UCL 
Signature 
Date 
Sponsor  
Sponsor representative 
 
 
 
13/02/19 
UCL 
Signature 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Short title: Assessment of FI with MAPLe 
Sponsor code: 119731   
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Contents 
Protocol Version History................................................................................................. 3 
Signatures ......................................................................................................................... 4 
List of abbreviations ........................................................................................................ 7 
1. 
Trial personnel ..................................................................................................... 9 
2. 
Summary ............................................................................................................ 10 
3. 
Background and Rationale ............................................................................... 12 
3.1 
Assessment and Management of Risk .............................................................. 18 
4. 
Objectives ........................................................................................................... 18 
5. 
Trial design ......................................................................................................... 18 
6. 
Selection of Participants .................................................................................... 19 
6.1  
 Inclusion criteria ............................................................................................... 19 
6.2 
Exclusion criteria ............................................................................................... 19 
6.3 
Recruitment ........................................................................................................ 20 
6.4 
Informed consent ............................................................................................... 20 
7. 
Product/Interventions ........................................................................................ 20 
8. 
Study procedures ............................................................................................... 21 
8.1 
Pre-intervention assessments ............................................................................ 21 
8.2    Registration Procedures .................................................................................... 21 
8.3 
Intervention procedures .................................................................................... 21 
8.4 
Subsequent assessments and procedures ......................................................... 21 
8.5 
Discontinuation/withdrawal of participants.................................................... 22 
8.6 
Definition of End of Study ................................................................................ 22 
9. 
Recording and reporting of adverse events ..................................................... 22 
9.1 
Definitions ........................................................................................................... 22 
9.2 
Assessments of Adverse Events ........................................................................ 23 
9.2.1    Severity ............................................................................................................... 23 
9.2.2  Causality ............................................................................................................ 23 
9.2.3  Expectedness ...................................................................................................... 24 
9.3  
Recording adverse events .................................................................................. 24 

Short title: Assessment of FI with MAPLe 
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9.4      Procedures for recording and reporting Serious Adverse Events ................. 24 
9.5      Reporting Urgent Safety Measures ................................................................... 26 
9.6 
Notification of reportable protocol violations ................................................. 26 
9.7 
Reporting incidents involving a medical device .............................................. 26 
9.8  
Trust Incidents and Near Misses ...................................................................... 26 
10. 
Data management .............................................................................................. 27 
10.1 
 Confidentiality................................................................................................... 27 
10.2 
Data collection tools and source document identification .............................. 27 
10.3    Completing Case Report Forms ........................................................................ 27 
10.4 
Data handling ..................................................................................................... 27 
11 
Statistical Considerations .................................................................................. 28 
11.1    Primary Outcome ............................................................................................... 28 
11.2 
Secondary outcome(s) ........................................................................................ 28 
11.3 
Sample size calculation ...................................................................................... 28 
11.4 
Planned recruitment rate .................................................................................. 28 
11.5     Statistical analysis .............................................................................................. 28 
11.5.1 Primary outcome analysis .................................................................................. 28 
11.5.2 Secondary outcome analysis .............................................................................. 28 
12. 
Record keeping and archiving .......................................................................... 29 
13. 
Oversight Committees ....................................................................................... 29 
13.1 
Trial Management Group (TMG) .................................................................... 29 
13.2 
Other committees ............................................................................................... 29 
14. 
Ethical requirements and patient and public involvement ............................ 29 
15. 
Monitoring .......................................................................................................... 30 
16. 
Finance ................................................................................................................ 30 
17. 
Insurance ............................................................................................................ 30 
18. 
Intellectual property .......................................................................................... 31 
19 
Appendices.......................................................................................................... 32 
Appendix 1 - Schedule of assessments ......................................................................... 32 
Appendix 2 - CE Certificate ......................................................................................... 33 
Appendix 3 - St Mark’s Incontinence Score ............................................................... 34 
Appendix 4 - Quality of Life Questionnaire ................................................................ 35 

Short title: Assessment of FI with MAPLe 
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Appendix 5 - Protocol for MAPLe ............................................................................... 39 
References....................................................................................................................... 40 
 
List of abbreviations 
 
AE 
Adverse Event 
CI 
Chief Investigator 
CRF 
Case Report Form 
FI 
Faecal Incontinence 
MAPLe 
Multiple Array Probe Leiden 
AUS 
Anal Ultra Sound 
HRAM 
High Resolution Anal Manometry 
ARP 
Anorectal Physiology 
EMG 
Electromyography  
sEMG 
Surface Electromyogrphy 
GCP 
Good Clinical Practice 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ISF 
Investigator Site File 
MDT 
Multi-Disciplinary Team 
NHS R&D 
National Health Service Research & Development   
PI 
Principal Investigator 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
QC 
Quality Control 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SDV 
Source Document Verification 
SOP 
Standard Operating Procedure   
TMG 
Trial Management Group 
TSC 
Trial Steering Committee 

Short title: Assessment of FI with MAPLe 
Sponsor code: 119731   
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Short title: Assessment of FI with MAPLe 
Sponsor code: 119731   
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1. 
Trial personnel 
See protocol cover page for Chief Investigator and Sponsor contact details. 
 
Statistician 
Hiba Ismail 
e-mail:  hiba.ismail@nhs.net 
tel:  01932 872000 
 
 
 
 
 

Short title: Assessment of FI with MAPLe 
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2. 
Summary 
 
Objectives: 
Primary Objective: To determine the role of MAPLe in the 
assessment of Faecal Incontinence (FI) in defined patient groups. 
Secondary Objective: Identify which patient groups benefit from 
physiological testing with MAPLe and receive targeted treatment 
 
Type of trial: 
This is a multi-centre cohort study investigating FI 
Trial design and 
methods: 
The study will take place across two trusts with specialist pelvic floor 
services. 
Participants will be recruited via referrals for anorectal physiology 
(ARP) with symptoms of FI meeting the inclusion/exclusion criteria. 
Participants will complete incontinence and quality of life 
questionnaires, undergo routine ARP with high resolution manometry 
(HRAM) and anal ultrasound (AUS), and additional assessment with 
MAPLe. Each assessment will be performed in accordance with a 
standardised protocol.  
ARP results will be discussed at the local MDT, should treatment be 
offered, the participant will undergo further testing with MAPLe, if 
no treatment if offered participation is complete. 
Trial duration per 
participant: 
12 months 
Estimated total trial 
duration: 
18 months 
Planned trial sites: 
Multi-Site: University College London Hospitals (UCLH)   
Ashford and St Peter’s NHS Foundation Trust (ASPH) 
Total number of 
participants planned: 
120 

Short title: Assessment of FI with MAPLe 
Sponsor code: 119731   
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Main inclusion/exclusion 
criteria: 
Inclusion: Symptoms of FI, aged over and including 18, capacity to 
consent, male/female. 
Exclusion: anal cancer, anal surgery in the last 3 months, 
acute/painful perianal disease. 
Statistical methodology 
and analysis: 
Non-inferiority testing of MAPLe in the assessment of FI will be 
performed using Bland Altman method.  MAPLe will be tested 
against HRAM and AUS. 
Participants 
will 
be 
grouped 
according 
their 
pathology: 
Fistula/chronic perianal disease, Obstetric injury <12 months, 
Obstetric injury >12 months, neuropathic sphincter. Correlation 
studies and regression analysis to identify which groups benefitted 
from MAPLe assessment. 
The clinical utilisation of MAPLe will be determined by the outcome 
of an expert panel. 
Comparative analysis of participant pre and post treatment MAPLe 
results will identify if targeted treatment has been achieved. 
   
 
 

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3. 
Background and Rationale 
Burdon of Disease 
 
Faecal incontinence (FI) is defined as the involuntary passage of gas, liquid or solid stool. The 
symptom is experienced by an estimated 1-10% of the population. FI is associated with a multitude of 
disease pathologies and prevalent in vulnerable patient groups, the elderly, learning disabilities or 
severe co-morbidities, and most prevalent in multiparous females.  The degree of symptomatic 
severity is varied and can result in psychological destress and social withdrawal, severely impacting 
quality of life in up to 22% of suffers(1). 
 
There is significant economic burden associated with FI.  Health economic studies have identified 
US$4110 as an average annual cost per person, with an increased cost associated with increased 
symptom severity(2).  Further studies estimated a US $11 billion annual expenditure and a 55% 
increase in personal cost of health for sufferers(3).  Treatment is symptom orientated, further research 
would improve understanding of the symptom and direct treatment for more effective outcomes. 
  
Anatomy and Physiology of the Pelvic Floor 
 
FI is the result of impairment to the structure or function of the pelvic floor(4).  The pelvic floor, 
levator ani, is a sheet of muscle supporting the weight of the abdominal cavity. It is divided into four 
muscle groups: pubococcygeus, ilio-coccygeus, coccyges and puborectalis, assisting the maintenance 
of faecal and urinary continence.  
 
The anal canal is an opening in the levator ani to allow for passage of stool. The rectum, supported by 
puborectalis, opens into the anal canal.  The anal canal is 4cm long and surrounded by two groups of 
muscles forming the anal sphincter.  The involuntary muscles of the internal anal sphincter (IAS), a 
continuation of the circular muscle of the rectum.  The voluntary muscles of the external anal 
sphincter (EAS), derived from levator ani.  The IAS provides 80% of the resting pressure of the anal 
sphincter(5). 
 
The sphincter responds to local stimulation via the recto-anal reflex arc, stimulation of the internal 
sphincter to relax upon distension of the rectum, as well as higher neural stimulation via the spinal 
cord to relax the external sphincter(6).  Damage to the structure of the sphincter complex or its 
nervous supply reduces the anal tone and results in FI of varying degrees: gas, liquid or solid stool. 
 
Pathogenesis and Aetiology of FI 
 
The pathogenesis of FI is associated with the pathological process of the underlying disease and 
classified by clinical findings: Anal sphincter weakness, anatomical disturbances of the pelvic floor, 
anorectal inflammation, central nervous system disease, and bowel disturbances.  The most common 
cause of FI in females is anal sphincter weakness following obstetric injury(7) by direct damage to the 
sphincter or indirect damage to the pudendal nerve.  
 
Due to the complex and multi-factorial pathogenesis(8), FI is commonly classified by the 
predominant symptom: passive, urge or mixed. 
 
Current Assessment of the Pelvic Floor 
 
FI is initially assessed in primary care to identify and address lifestyle or medical causes.  Patients 
with persistent symptoms are referred to specialist centres for structural and functional assessment of 
the pelvic floor(9).  Structural assessment includes endoscopy, MRI and Anal ultrasound (AUS)(10).  
Function, including sensitivity and compliance, is assessed by anorectal physiology studies: anorectal 
manometry, balloon expansion and expulsion, and barostat investigation(11).  Following clinical 

Short title: Assessment of FI with MAPLe 
Sponsor code: 119731   
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review, patients are referred for the appropriate investigation. Patients with symptoms of FI undergo 
thorough assessment of the structure and function of the anal sphincter. 
 
Structural assessment of the anal sphincter is performed using an anal ultrasound (AUS). The AUS 
probe is placed into the anal canal.  The transducer at the tip of the probe emits sound waves at a 
frequency between 2.5-6MHz, these reflect against the surrounding tissue and received by the 
transducer.  The volume of sound waves reflected is dependent on the density of the tissue 
surrounding the probe.  The differing structural integrities of the IAS and EAS give distinct 
appearances.  The IAS is seen as a hypoechoic band approximately 1-3 mm in thickness.  The EAS 
appears as a hyperechoic band surrounding the IAS with a thickness of 4-10mm.  Abnormalities seen 
within each band such as lucencies or opacities represent pathology(12).  Due to its low risk, low cost 
and high sensitivity, AUS is the imaging modality of choice for assessing the anal sphincter(13). 
 
Functional assessment of the anal canal is undertaken using anorectal manometry.  The technique 
measures the closing pressures of the anal canal.  The test is performed using a probe with between 6-
12 pressure sensors along its length.  The manometry system can either be solid state or water 
perfused(14). 
 
The probe is placed within the anal canal and pressures within the anal canal are recorded at rest, 
voluntary contraction and coughing.  The pressures are measured in mmHg and represents the cross-
sectional pressure of the canal at each level.  The individual structures attributing to the pressure are 
not identified and the results are representation of the pressures of the pelvic floor as a whole. 
 
Studies have been performed to identify a range for normal results of pressures within the anal canal.  
The results are dependent on gender and parity.  Carrington et al undertook a study of 112 
asymptomatic participants using high resolution anal manometry (HRAM) and identified a mean 
resting pressure of 33-110mmHg in females and 33-114 mmHg in males(15). Further studies have 
found disparity between age groups (16).  Therefore, results require close and careful interpretation by 
the clinician, taking into account patient symptoms. 
 
Treatment 
 
The NHS spends an estimated £100 million on treatment for FI and it is thought patients experience 
symptoms for 5 years before seeking treatment.  If community management of dietary advice, simple 
anti-diarrhoeal medication and good toileting (17) fail patients are refereed to secondary care. Choice 
of treatment can vary between trusts due to resources and expertise.  The treatment options for FI 
include: medications, biofeedback, rectal irrigation, neuromodulation and other surgical interventions.  
Patients are referred in a stepwise progressive pattern.  This directed by their response to treatment, 
quantified by FI scores. 
 
Biofeedback is the process of electronically monitoring an autonomic function to acquire voluntary 
control.  Biofeedback treatment for FI has three elements: rectal sensitivity training to improve 
awareness and response to stool in the rectum, strength training of the pelvic floor using manometric 
or electromyographic stimulus, or co-ordination training.  Biofeedback treatment protocols are 
varied(18), however 70-80% experience a 50% improvement of symptoms (19).  More recent studies 
have found no significant improvement in symptoms following treatment with biofeedback(20) and 
biofeedback has been shown to have the same symptom improvement as dietary advice and routine 
pelvic floor exercises(21).  
 
Rectal irrigation is a treatment for both constipation and FI.  The treatment aim is to maintain an 
empty rectum(22) preventing incontinence episodes(23). Irrigation is performed using a catheter 
placed in the rectum through which fluid is irrigated resulting in evacuation of the rectum.  The 
treatment has been found to improve symptoms by 44%.  
 

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Neuromodulation is a second line treatment for FI in patients with persistent symptoms of FI(24).  
There are two forms of treatment: sacral nerve stimulation (SNS) and percutaneous tibial nerve 
stimulation (PTNS). The mode of action is unclear, the treatment applies stimulation to the sacral 
nerves improving anal sphincter function(25).  SNS is an implantable neuromodulator.  Prior to 
implantation, patients undergo a trial period by placement of a temporary wire into the 3rd sacral 
foramen.  If a 50% reduction in symptoms is experienced the patient is offered a permanent 
implantable device.  Studies have shown an 83% continue to have improved symptoms at the 3 
years(26).  PTNS is a non-implantable form of neuromodulation.  The technique was initially 
developed for the treatment of urinary incontinence; however following reports of improved 
symptoms of FI further research has been undertaken. NICE references 53% of patients have a good 
outcome following treatment.   However, a recent randomized control trial comparing outcomes 
following treatment with PTNS vs sham stimulation identified no significant clinical benefit 
following PTNS treatment(27).  Currently PTNS is not recommended for the treatment of FI. 
  
Surgery is performed on the anal sphincter when structural defects are present, most commonly 
following obstetric injury.  The two main surgical techniques used are sphincter repair and 
sphincteroplasty.  Sphincter repair occurs directly after child birth, and is commonly performed by the 
attending obstetric doctors. Sphincteroplasty is performed by specialist pelvic floor surgeons when 
large deficits are found on AUS. 
  
Following treatment repeat physiological assessment is not performed as studies have found no 
improvement(28).  Patients who continue to be symptomatic are referred for further treatments. 
 
Rationale  
 
FI is a symptom requiring structural and functional assessment of the anal sphincter to direct choice of 
treatment.  Structural assessment using AUS has been proven to be sensitive(12)(29).  Functional 
assessment can result in a disparity between symptom profile and investigation findings(30) as well as 
an overlap of results between healthy and symptomatic persons(31).This was shown by Lam et al who 
identified no correlation between ARP and FI scores in a study of 218 patients.  These findings were 
also reflected in a study undertaken by Zutshi et al on 53 symptomatic females(28).  The role of 
investigatory tests is to guide treatment(30) and although these tests can establish a baseline , both 
HRAM and AUS are poor predictors of treatment outcome(32).  This identifies a need for further 
study into the assessment of FI. 
 
Novel techniques investigating other properties of the anal canal have been developed.  These include 
assessing elasticity of the anal canal and anal acoustic reflectivity.  These techniques are in their early 
stages and studies so far have shown limited clinical utilisation(33). 
 
Electromyography (EMG) is a technique used to assess the innervation and response of a voluntary 
muscle fibre to a stimulus. Traditionally EMG is performed using a single needle electrode inserted 
into a muscle. Following stimulus to voluntarily contract, an action potential is generated along a 
somatic nerve resulting in a synapse at the neuromuscular junction (NMJ), also called innervation 
zone, and the release of acetylcholine (ACh).  ACh acts on voltage gated channels in the sarcolemma 
causing depolarisation from the resting potential of -60—90 mV to + 75mV (motor unit potential) 
resulting in contraction of the muscle fibre.  The EMG needle electrode detects the depolarization and 
records the amplitude (mV) and frequency (Hz).  This provides information on individual motor unit 
potentials resulting from the innervation zone but limited information on overall muscular function.  
EMG of the EAS requires multiple circumferential punctures into the muscle this is both invasive and 
painful, limiting the investigation to research and specialist cases. 
 
Studies performed at other centers have investigated the use of surface electrodes (sEMG) on 
probes(34) placed anally to identify abnormalities or abnormal variants in the innervation and 
propagation of stimulus within the EAS(35).  The anal probes have a series of circumferential sensors 
that identify the origin and direction of propagation of an action potential.  The origin correlates to the 

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location of an NMJ and innervation zone(19).  This technique has been used to investigate 
asymmetric innervation of the anal canal, particularly important in obstetric medicine(36), but has not 
progressed from research into clinical utilisation. 
 
The MAPLe device is a new medically certified device distributed by Novuqare using the principals 
of sEMG in the diagnosis and management of pelvic floor complaints (figure 1).  
 
 
 
Figure 1 MAPLe device: anal probe, sEMG detector and charging station. 
 
The probe l has 24 surface electrodes positioned in circumferential bands along its length (figure 2), it 
is placed in the anal canal.  Each sensor detects the sEMG activity in mV for the most proximal 
muscle fibers (figure 3).   
 
 
 
 
Figure 2 Each band corresponds to a circumferential group of sensors along the probe. 
 
 

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Figure 3 MRI of pelvis with anal probe in situ, confirming correct placement for sEMG detection. 
 
The results are analysed by the receiver to provide numerical values.  The values are displayed as a 
target shaped diagram depicting locational functionality (figure 4 & 5), giving a clear representation 
of precise areas of weakness in the pelvic floor. 
 
 
Figure 4 The results can be displayed in three views. 
 

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Figure 5 Sensors are grouped together according to the muscle they represent. 
 
The results are displayed on a hand held device in both numerical and diagrammatic formats (figure 
6). 
 
  
 
Figure 6 Results are displayed on screen in greyscale on target or numerical value. 
 
An independent study tested MAPLe on 229 asymptomatic healthy participants.  The study confirmed 
accurate probe placement to ensure sEMG correlated with correct muscular group, and identified a 
normal range (27).  MAPLe is currently used to provide biofeedback for patients with FI by 
identifying and targeting muscles with reduced sEMG via visual and electrical stimulation. 
 
The role of sEMG in clinical assessment of FI has been limited to research and has not been 
correlated with current gold standard techniques.  This study aims to investigate the sEMG of 
symptomatic patients using MAPLe.  The study will test the non-inferiority of MAPLe against 
HRAM and AUS in assessing FI.  Non-inferiority of a test is defined as the test being no worse than 
the competitor.  The study will aim to identify if particular patient groups have closer correlation 

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between symptom profiles and FI scores and sEMG results, and whether sEMG improves following 
treatment.  The study will endeavor to identify the clinical utilisation of sEMG in FI.  
 
3.1 Assessment and Management of Risk  
The table below summarise the risks and mitigations of all test above standard care that are being 
performed in a table: 
 
Intervention  
Potential risk 
Risk Management 
Assessment with 
MAPLe device 
The device will be placed anally and 
record sEMG, not providing 
stimulation.  As the device will be 
used in the same nature as current 
assessment devices no additional risk 
is perceived. 
Performed by trained operator. 
 
4. 
Objectives 
Primary: To determine the role of MAPLe in the assessment of FI in defined patient groups. 
 
Secondary: To determine if targeted treatment is achieved following assessment with MAPLe. 
 
5. 
Trial design 
This is cohort study of participants with symptoms of faecal incontinence. It will take place across 
two hospital trusts, both able to provide specialist pelvic floor services and 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.  The sample size for the study is 120 participants. 
 
Following a stringent selection and recruitment process, participants will be invited to a designated 
ARP session where they will be consented, complete an incontinence and quality of life questionnaire, 
and undergo ARP assessment.  This will comprise of the current gold standard, AUS and HRAM, and 
additional assessment with MAPLe using a standardised protocol.  Through undertaking all three tests 
participants will act at their own controls.  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, 

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each specialist will be provided with literature on the background of MAPLe and how to analyse the 
results.  The panelists 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? 
 Panelists 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 
 Panelists 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 
 Panelists 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. 
 
6. 
Selection of Participants 
6.1   Inclusion Criteria 
1. 
Over and including 18 years 
2. 
Male and female 
3. 
Symptoms of faecal incontinence 
4. 
Willing and able to provide written informed consent. 
6.2 Exclusion Criteria  
1. Painful or acute perianal conditions: fissures/perianal abscess/recent trauma 
2. Anal cancer 
3. Anorectal surgery in the last 3 months 
 
 

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6.3 Recruitment 
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 for 
review by the student researcher. 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 student researcher, 
should they wish to enroll 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. 
 
Participant recruitment at a site will only commence when the trial has:  
1. Been confirmed by the Sponsor (or it’s delegated representative), and  
2. Been issued an ‘NHS permission letter’. 
 
6.4 Informed consent  
It is the responsibility of the Investigator, or a person delegated by the Investigator to obtain written 
informed consent from each participant prior to participation in the trial, following adequate 
explanation of the aims, methods, anticipated benefits and potential hazards of the trial.  
 
The student researcher is suitably qualified and experienced in the consent process, and has been 
delegated this duty by the CI/ PI on the Staff Signature and Delegation of Tasks. 
 
“Adequate time” must be given for consideration by the participant before taking part. Consent will 
be sought at least 24 hours after being given the study documentation It must be recorded in the 
medical notes when the participant information sheet (PIS) has been given to the participant.  
 
The Investigator or designee will explain that participants are under no obligation to enter the trial and 
that they can withdraw at any time during the trial, without having to give a reason. 
 
No trial procedures will be conducted prior to the participant giving consent by signing the Consent 
form. Consent will not denote enrolment into trial.  
 
A copy of the signed Informed Consent form will be given to the participant.  The original signed 
form will be retained in the trial file at site and a copy placed in the medical notes. 
The PIS and consent form will be reviewed and updated if necessary throughout the trial (e.g. where 
new safety information becomes available) and participants will be re-consented as appropriate.  
7. 
Product/Interventions 
The study is investigating the use of the MAPLe device in the assessment of FI.  The MAPLe is a 
medically certified device distributed by Novuqare (Appendix 2). The certification covers the 
diagnosis and management of faecal and urinary incontinence; it will be used within in its 
certification. 
 
The MAPLe device consists of a probe that can be used vaginally or anally and an electric receiving 
device. The probe has 24 surface electrodes that detect the electromyography (EMG) of the different 
groups of muscles of the pelvic floor. These results are analysed by the receiver to provide numerical 
values and greyscale depiction of the EMG of each muscle group and location of reduced or increased 
activity.   
 
For the assessment of faecal incontinence the probe will be placed anally.  The participant will be 
asked to perform a set protocol of maneuvers to identify areas of weakness in the pelvic floor. 
Participants will undergo assessment with MAPLe at the ARP session. 

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8. 
Study procedures  
8.1 Pre-intervention assessments  
The following study specific procedures will be carried out after consent to assess the participant’s 
eligibility:  
 
Medical History recorded 
 
Surgical History recorded  
 
Concomitant Medication recorded 
All pre-treatment procedures will be carried out as specified in the schedule of assessments (appendix 
1). 
 
8.2 Registration Procedures 
Participant registration will be undertaken centrally by the student researcher when booking ARP.  
Eligibility will be confirmed and participants will be allocated an individual study number. At ARP 
participants will complete a pre-filed consent form. 
 
Participants are considered to be enrolled into the study following: consent, pre-treatment assessments 
(see section 8.1), confirmation of eligibility, completion of the registration process, allocation of the 
participant study number by the central coordinating team. 
 
8.3 Intervention procedures 
Participants will be asked to attend an ARP session at their recruiting trust to undertake assessment 
by the student researcher.  During this session each participant will complete an incontinence 
questionnaire (appendix 3), quality of life questionnaire(37) (appendix 4), provide a prescribed history 
(appendix 5) and undergo standardised ARP studies (appendix 6, 7): 
 
 
Anal ultrasound 
 
UCLH: performed in the radiology department by trained sonographer. 
 
ASPH: performed during anorectal physiology session by trained study representative  
 
HRAM 
 
Performed at anorectal physiology session by trained study representative  
 
MAPLe 
 
Performed at anorectal physiology session by trained study representative. 
 
8.4 Subsequent assessments and procedures 
The ARP results for each participant will be discussed at their local multi disciplinary team meeting in 
accordance with current practice.  Participants who are offered treatment will be followed up at 6 
months in their recruiting trust for repeat assessment with MAPLe.  Participants who are offered 
neuromodulation will receive interval assessment with MAPLe during the placement of the implanted 
device.  Should not follow up be offered participation is complete. 
 
A schedule of all trial assessments and procedures is set-out in Appendix 1. 
 

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8.5 Discontinuation/withdrawal of participants 
In consenting to participate in the study, participants are consenting to intervention, assessments, 
follow-up and data collection.  
 
A participant may be withdrawn from trial whenever continued participation is no longer in the 
participant’s best interests, but the medical reasons for doing so will be recorded. Personal reasons 
will not be recorded. Reasons for discontinuing the trial may include: 
 Ineligibility undetected at screening 
 Deviation from protocol 
 Significant non-compliance with study requirements (refusal/difficult examination) 
 Withdrawal of consent 
The participants will remain in the study for the purpose of data analysis and the reason for 
withdrawal recorded in the CRF and medical notes. If a participant explicitly states they do not wish 
to contribute further data to the trial their decision must be respected and recorded in the CRF and 
medical notes. 
 
8.6 Definition of End of Study 
The expected duration of the study is 18 months from recruitment of the first participant. 
The end of study is 6 months following the date of the last visit of the last participant.  
 
9. 
Recording and reporting of adverse events  
9.1 Definitions 
Term 
Definition 
Adverse Event (AE) 
Any untoward medical occurrence in a patient or trial participant, which 
does not necessarily have a causal relationship with the intervention 
involved.  
Serious Adverse Event 
(SAE). 
Any adverse event that: 
 
results in death 
 
is life-threatening* 
 
requires hospitalisation or prolongation of existing 
hospitalisation** 
 
results in persistent or significant disability or incapacity, or 
 
consists of a congenital anomaly or birth defect. 
* 
A life- threatening event, this refers to an event in which the participant was at risk of death at 
the time of the event; it does not refer to an event which hypothetically might have caused death 
if it were more severe. 
** Hospitalisation is defined as an in-patient admission, regardless of length of stay. Hospitalisation 
for pre-existing conditions, including elective procedures do not constitute an SAE. 

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9.2 Assessments of Adverse Events 
Each adverse event will be assessed for severity, causality, seriousness and expectedness as described 
below. 
 
9.2.1 
Severity 
Category 
Definition 
Mild 
The adverse event does not interfere with the participant’s daily routine, and 
does not require further intervention; it causes slight discomfort 
Moderate 
The adverse event interferes with some aspects of the participant’s routine, or 
requires further intervention, but is not damaging to health; it causes moderate 
discomfort 
Severe 
The adverse event results in alteration, discomfort or disability which is clearly 
damaging to health 
 
9.2.2 Causality 
The assessment of relationship of adverse events to the intervention is a clinical decision based on all 
available information at the time of the completion of the case report form.   
 
The following categories will be used to define the causality of the adverse event: 
 
Category 
Definition 
Definitely: 
There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. 
Probably: 
There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely 
Possibly 
There is some evidence to suggest a causal relationship (e.g. the event occurred 
within a reasonable time after administration of the trial intervention). 
However, the influence of other factors may have contributed to the event (e.g. 
the participant’s clinical condition, other concomitant events). 
Unlikely 
There is little evidence to suggest there is a causal relationship (e.g. the event 
did not occur within a reasonable time after administration of the trial 
intervention). There is another reasonable explanation for the event (e.g. the 
participant’s clinical condition, other concomitant treatments). 
Not related 
There is no evidence of any causal relationship. 
Not Assessable 
Unable to assess on information available. 
 

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9.2.3 
Expectedness 
There are no expected adverse events. 
 
9.3 Recording adverse events 
All Adverse events will be recorded in the CRF following consent. 
 
9.4 Procedures for recording and reporting Serious Adverse Events 
All serious adverse events will be recorded in the medical records and the CRF, and the sponsor’s AE 
log.  The AE log of SAEs will be reported to the sponsor at least once per year. 
 
All SAEs must be recorded on a serious adverse event (SAE) form. The PI or designated will 
complete the sponsor’s SAE form and the form will be emailed to the Sponsor within 5 working days 
of becoming aware of the event. The Chief or Principal Investigator will respond to any SAE queries 
raised by the sponsor as soon as possible.  
 
Where the event is unexpected and thought to be related to the intervention, this must be reported by 
the Investigator to the Health Research Authority within 15 days. 
 
 
 
 
 
 
 
SAEs will be reported to the sponsor until the end of the trial.  
 
Participants must be followed up until clinical recovery is complete.  Follow-up SAE forms (clearly 
marked as follow-up) should be completed and emailed to the JRO as further information becomes 
available.  
Completed SAE forms must be sent within 5 working days of becoming 
aware of the event to the Sponsor  
Email forms to Research-incidents@ucl.ac.uk 

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Flow Chart for SAE reporting 
 
 
AE occurs 
Assign Severity Grade 
Was the event Serious? 
Was the event an Other 
Notifiable event?  
 
See section 9.5 for notifiable events 
which should also be reported as 
serious 
No 
No 
Yes 
Yes 
Yes 
No 
Submit SAE form to Sponsor within 24 hours 
Email forms to uclh.randd@nhs.net 
Record in medical records,  
And CRF in accordance with the protocol  
Record in medical records 
and CRF (if applicable) 
Is the event specified as an adverse event which does not require immediate reporting as an SAE?  
Record in medical records, CRF (and AE Log if required) 
if device related contact manufacturer 
Complete an SAE report form 

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9.5 Reporting Urgent Safety Measures  
If any urgent safety measures are taken the CI/ PI shall immediately and in any event no later than 3 
days from the date the measures are taken, give written notice to the relevant REC and Sponsor of the 
measures taken and the circumstances giving rise to those measures. 
 
9.6 Notification of reportable protocol violations 
 A reportable protocol violation is a breach which is likely to effect to a significant degree:  
 the safety or physical or mental integrity of the participants of the study; or 
 the scientific value of the study. 
The sponsor will be notified immediately of any case where the above definition applies during the 
trial conduct phase.   
 
9.7 Reporting incidents involving a medical device 
All adverse event reporting will be undertaken by a study representative.  If the event is in relation to 
MAPLe the event will be reported to the manufacturer Medtronic via the Sales support worker 
Rosemary Ledger. 
 
Adverse events involving routine devices, AUS and HRAM, will be reported locally within each trust 
in accordance with local trust guidelines.   
 
All incidents will be reported as soon as possible (usually within 24 hours). 
 
9.8 Trust Incidents and Near Misses 
An incident or near miss is any unintended or unexpected event that could have or did lead to harm, 
loss or damage that contains one or more of the following components: 
a) 
It is an accident or other incident which results in injury or ill health. 
b) 
It is contrary to specified or expected standard of patient care or service. 
c) 
It places patients, staff members, visitors, contractors or members of the public at 
unnecessary risk. 
d) 
It puts the Trust in an adverse position with potential loss of reputation. 
e) 
It puts Trust property or assets in an adverse position or at risk. 
Incidents and near misses must be reported to the Trust through DATIX as soon as the individual 
becomes aware of them. 
 
A reportable incident is any unintended or unexpected event that could have or did lead to harm, loss 
or damage that contains one or more of the following components: 
 
a) It is an accident or other incident which results in injury or ill health. 
b) It is contrary to specified or expected standard of patient care or service. 
c) It places patients, staff members, visitors, contractors or members of the public at unnecessary 
risk. 
d) It puts the Trust in an adverse position with potential loss of reputation. 
e) It puts Trust property or assets in an adverse position or at risk of loss or damage. 

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10. Data management  
10.1 Confidentiality 
All data will be handled in accordance with the UK Data Protection Act 2018.  
 
The Case Report Forms (CRFs) will not bear the participant’s name or other personal identifiable 
data.  The study identification number will be used for identification and this will be clearly explained 
to the patient in the PIS.  Patient consent for this will be sought. 
 
10.2 Data collection tools and source document identification 
Data will be collected from sites on study specific case report forms (CRFs) or data collection tools 
such as electronic CRFs.   
 
Source data are contained in source documents and must be accurately transcribed on to the CRF.  All 
data will be recorded in the local notes and CRF. 
 
All data required for the study will be obtained during the anorectal physiology session, minimising 
the risk of incomplete data sets. 
 
10.3 Completing Case Report Forms  
All CRFs must be completed and signed by staff that are listed on the site staff delegation log and 
authorised by the CI/ PI to perform this duty.  The CI/PI is responsible for the accuracy of all data 
reported in the CRF.  
 
Once completed CRFs will remain within each parent trust and stored in a designated locked filing 
cabinet.  They will not be removed from their trust site. 
 
10.4 Data handling  
The study is compliant with the requirements of General Data Protection Regulation (2016/679) and 
the Data Protection Act (2018). All investigators and study site staff will comply with the 
requirements of the General Data Protection Regulation (2016/679) with regards to the collection, 
storage, processing and disclosure of personal information, and will uphold the Act’s core principles. 
UCL is the data controller; the UCL Data Protection Officer is Lee Shailer data-protection@ucl.ac.uk. 
The data processors are the Student Researcher and the Chief Investigator. The study will be 
collecting the following data: Age, gender, parity, medical and surgical history, drug history. 
 
Once a participant is enrolled, they will be allocated an individual study number. No record of 
name/date of birth/address/telephone number will be made. A list of individual study number and 
associated hospital numbers will be recorded in an encrypted database on a computer within each 
trust.  The list will only comprise of participants recruited from that trust. Data will be provided 
directly by the participants and recorded on a CRF by the student investigator. Investigation results 
will be recorded on the CRF.   The CRF will not record personal data. The CRF and completed 
questionnaires will be stored in a locked filing cabinet in the GI physiology department at each trust 
only accessible to study personnel. The anonymised research data will be collated by the student 
researcher in an encrypted database on each trust computer.  For analysis, a copy of the research data 
obtained at ASPH will be made and placed on an encrypted USB.  This will be transferred to UCLH 
and combined with the research data from this site. This will be undertaken by the student researcher. 
The CRF and associated documents will be destroyed 2 years following completion of study by their 
trust.  The electronic database will be stored for 5 years. 
 

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11. 
Statistical Considerations  
11.1 Primary Outcome 
They primary outcome is to determine which participant groups benefit from assessment with 
MAPLe.  Benefit will be determined by correct identification of abnormalities in symptomatic 
participants using MAPLe, correlation between symptom profile and MAPLe results, and the outcome 
of the expert panel.  It will be measured once the end of recruitment is reached. 
 
11.2 Secondary outcome(s) 
The secondary outcome is to determine if following assessment with MAPLe targeted treatment is 
achieved.  This will be defined by improvement in physiological assessment with MAPLe and 
incontinence questionnaires. This will be measured at 6 months following the end of recruitment at 
the end of study. 
 
11.3 Sample size calculation 
The sample size has not been formally calculated at this time. This is due to no previous studies on 
this area being performed.  A pilot study to identify the ‘normal’ measurements for the MAPLe 
stipulated 30 participants per group to identify a statistically significant result.  Accounting for 4 
participant groups a sample size of 120 has been set. 
 
11.4 Planned recruitment rate 
Participants will be recruited throughout the duration of the study. An anticipated recruitment rate is 
2-3 participants per week over 12 months to meet the sample size. 
 
11.5 Statistical analysis 
11.5.1 Primary outcome analysis 
Non-inferiority testing of MAPLe will be performed using Bland-Altman method.  
Correlation between MAPLe and AUS for location of sphincter abnormality will be 
identified. Correlation between MAPLe and HRAM for functional abnormalities will be 
identified. 
 
Participants will be allocated a patient group dependent on the cause of FI: 
 
Fistula/ chronic perianal conditions 
 
Obstetric injury <12 months 
 
Obstetric injury > 12 months 
 
Neuropathic  
Each group will be analysed using correlation studies and regression analysis to determine 
which groups benefit from MAPLe assessment. 
 
The clinical benefit of the addition of MAPLe assessment will be determined from the 
analysis of the results of the expert panel. 
 
11.5.2 Secondary outcome analysis 
To determine if targeted treatment has been achieved participants will be grouped according 
to the treatment received: biofeedback, neuromodulation, rectal irrigation, and surgery. 

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Statistical comparison between MAPLe results pre and post treatment for each participant per 
group will be performed and analysed. 
 
12. Record keeping and archiving 
At the end of the trial, all essential documentation will be archived securely by the CI for a minimum 
of 20 years from the declaration of end of trial.  
 
Essential documents are those which enable both the conduct of the trial and the quality of the data 
produced to be evaluated and show whether the site complied with all applicable regulatory 
requirements.  
 
The sponsor will notify sites when trial documentation can be archived. All archived documents must 
continue to be available for inspection by appropriate authorities upon request.  
13. Oversight Committees  
13.1 Trial Management Group (TMG)  
The TMG will include the Chief Investigator and trial staff.  The TMG will be responsible for 
overseeing the trial.  The group will meet regularly, once per week at each site and will send updates 
to PIs.  
 
The TMG will review recruitment figures, SAEs and substantial amendments to the protocol prior to 
submission to the REC.  All PIs will be kept informed of substantial amendments through their 
nominated responsible individual. 
 
13.2 Other committees 
The role of the TSC is to provide overall supervision of the trial.  The TSC will review the data, 
adverse events and any other issues identified and recommend any appropriate amendments/actions 
for the study as necessary.  The TSC acts on behalf of the funder and Sponsor. 
 
14. Ethical requirements and patient and public involvement 
Ethics 
The sponsor will ensure that the trial protocol, participant information sheet, consent form, GP letter 
and submitted supporting documents have been approved by the appropriate research ethics 
committee, prior to any participant recruitment. The protocol, all other supporting documents 
including and agreed amendments, will be documented and submitted for ethical and regulatory 
approval as required. Amendments will not be implemented prior to receipt of the required 
approval(s).  
 
Before any NHS site may be opened to recruit participants, the Chief Investigator/Principal 
Investigator or designee must receive confirmation of capacity and capability in writing from the 
Trust Research & Development (R&D).  It is the responsibility of the CI/ PI or designee at each site to 
ensure that all subsequent amendments gain the necessary approvals, including confirmation of 
capacity and capability at the site.  This does not affect the individual clinician’s responsibility to take 
immediate action if thought necessary to protect the health and interest of individual participants (see 
section 9.6 for reporting urgent safety measures). 

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An annual progress report (APR) will be submitted to the REC within 30 days of the anniversary date 
on which the favorable opinion was given, and annually until the trial is declared ended. The chief 
investigator will prepare the APR. 
 
Within 90 days after the end of the trial, the CI/Sponsor will ensure that the main REC is notified that 
the trial has finished.  If the trial is terminated prematurely, those reports will be made within 15 days 
after the end of the trial. 
 
The CI will supply the Sponsor with a summary report of the trial, which will then be submitted to the 
REC within 1 year after the end of the trial.  
 
Patient and public involvement (PPI) 
The study recognises the importance of patient involvement in.  A patient survey in outpatient clinic 
was performed.   The survey asked the following questions: 
 
 How does FI Impact your life? 
 Do you therein there is a role for further investigating FI? 
 Would additional testing at a routine appointment be an acceptable method for the study? 
 If a study was recruiting would you participate? 
 
The patient response was positive, with all those surveyed expressing need for investigation and 
willingness to participate.  The method was also identified as acceptable. 
15. Monitoring  
 
The sponsor has determined the study to be low risk and has advised the following monitoring 
process: 
 
Each site to e-mail the sponsor annually: 
 
Delegation log 
 
Adverse event log 
 
Deviation log 
 
Minutes of Trial Steering Committee 
 
Annual progress report (Lead site only) when sent to Ethics Committee 
 
16. Finance 
The study has been funded by the GI Physiology Unit at UCLH. 2 MAPLe devices have been 
purchased by the departmental charity.  Ongoing funding has been agreed by each trust for the 
purchasing of probes to be used within each trust. There are no financial interests in they study. 
17. Insurance 
University College London holds insurance against claims from participants for injury caused by their 
participation in the trial. Participants may be able to claim compensation if they can prove that UCL 
has been negligent. However, as this trial is being carried out in a hospital, the hospital continues to 
have a duty of care to the participant of the trial.  University College London does not accept liability 

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for any breach in the hospital’s duty of care, or any negligence on the part of hospital employees. This 
applies whether the hospital is an NHS Trust or otherwise.   
 
Participants may also be able to claim compensation for injury caused by participation in this trial 
without the need to prove negligence on the part of University College London or another party.  
Participants who sustain injury and wish to make a claim for compensation should do so in writing in 
the first instance to the Chief Investigator, who will pass the claim to the Sponsor’s Insurers, via the 
Sponsor’s office. 
 
Hospitals selected to participate in this trial shall provide negligence insurance cover for harm caused 
by their employees and a copy of the relevant insurance policy or summary shall be provided to 
University College London, upon request. 
 
The MAPLe is covered by a 3 year indemnity. Should the device break or malfunction it will be 
returned to the manufacturer for repairs and a replacement provided.  Should the original device be 
irreparable it will be replaced free of charge. 
 
18. Intellectual property 
All background intellectual property rights (including licenses) and know-how used in connection 
with the study shall remain the property of the party introducing the same and the exercise of such 
rights for purposes of the study shall not infringe any third party’s rights. 
 
All intellectual property rights and know-how in the protocol and in the results arising directly from 
the study, but excluding all improvements thereto or clinical procedures developed or used by each 
participating site, shall belong to UCLH.  Each participating site agrees that by giving approval to 
conduct the study at its respective site, it is also agreeing to effectively assign all such intellectual 
property rights (“IPR”) to UCL and to disclose all such know-how to UCL.  
 
Each participating site agrees to, at the request and expense of UCL execute all such documents and 
do all acts necessary to fully vest the IPR in UCL.  
 
Nothing in this section shall be construed so as to prevent or hinder the participating site from using 
know-how gained during the performance of the study in the furtherance of its normal activities of 
providing or commissioning clinical services, teaching and research to the extent that such use does 
not result in the disclosure or misuse of confidential information or the infringement of an intellectual 
property right of UCL.  This does not permit the disclosure of any of the results of the study, all of 
which remain confidential. 
 
 

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19 
Appendices 
Appendix 1 - Schedule of assessments 
 
Screening 
(Pre-
treatment 
assessment) 
Intervention phase  
Final visit 
Visit No: 
1 
2 
3 
4 
 
Day – X to 
Day -X 
Day 1 
Day 7 
6 Months 
Window of flexibility for 
timing of visits: 
 
 
+/- 7 Days 
+/- 14 days 
Informed Consent 
 
X 
 
 
Medical History 
X 
 
 
 
Physical Examination 
 
 
 
 
Eligibility confirmation 
X 
X 
 
 
Faecal incontinence 
Questionnaire 
 
X 
 
 
Quality of Life Questionnaire 
X 
 
 
 
Anal Ultrasound 
 UCLH 
X 
ASPH 
X 
 
 
Prescribed History 
 
X 
 
 
HRAM 
 
X 
 
 
MAPLe 
 
X 
 
If treatment advised  
x 
MDT 
 
 
X 
 
Adverse Events review 
X 
X 
X 
X 
Concomitant Medication 
review (if applicable) 
X 
X 
 
 
 

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Appendix 2 - CE Certificate 
Please see attached PDF 
 
 

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Appendix 3 - St Mark’s Incontinence Score 
St Mark’s Incontinence Score 
 
 
 
 
Never 
Rarely  
Sometimes 
Weekly 
Daily 
Incontinence for 
solid stool 
0 
1 
2 
3 
4 
Incontinence for 
liquid stool 
0 
1 
2 
3 
4 
Incontinence for 
gas 
0 
1 
2 
3 
4 
Alteration in 
lifestyle 
0 
1 
2 
3 
4 
 
Yes 
No 
Need to wear pad or plug 
0 
2 
Taking constipating medications 
0 
2 
Lack of ability to defer defacation for 
15 mins 
0 
4 
  
 
Definitions 
 
Never: No episodes in the past 4 weeks 
 
Rarely: One episode in the past 4 weeks 
 
Sometimes: More than one episode in the past 4 weeks but less than once per week 
 
Weekly: One or more episodes per week but less than one per day 
 
Daily:  One or more episodes per day 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 4 - Quality of Life Questionnaire 
 
Quality of life Questionnaire 
 
Q 1: In general, would you say your health is: 
 
1 [] Excellent 
 
2 [] Very Good 
 
3 [] Good 
 
4 [] Fair 
 
5 [] Poor 
 
Q2:  For each of the items, please indicate how much of the time the issue is a concern for you due 
to accidental bowel leakage. (If it is a concern for you for reasons other than accidental bowel leakage 
then check the box under Not Apply, (N/A).) 
 
Due to accidental bowel leakage 
Most of the 
Time 
Some of the 
Time 
A little of the 
time 
None of the 
Time 
N/A 
I am afraid to go out  
1 
2 
3 
4 
I avoid visiting friends 
1 
2 
3 
4 
I avoid staying overnight away 
from home  
1 
2 
3 
4 
It is difficult for me to get out and 
do things like going to a movie or 
to church 
1 
2 
3 
4 
I cut down on how much I eat 
before I go out  
1 
2 
3 
4 
Whenever I am away from home, I 
try to stay near a restroom as much 
as possible 
1 
2 
3 
4 
near a restroom as much as 
possible  
1 
2 
3 
4 
It is important to plan my schedule 
around my bowel pattern 
1 
2 
3 
4 
I avoid traveling  
1 
2 
3 
4 
I worry about not being able to get 
to the toilet in time 
1 
2 
3 
4 
I feel I have no control over my 
bowels  
1 
2 
3 
4 
I can't hold my bowel movement 
long enough to get to the bathroom 
1 
2 
3 
4 
I leak stool without even knowing 
it 
1 
2 
3 
4 
I try to prevent bowel accidents by 
staying very near a bathroom 
1 
2 
3 
4 
 
 

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Q3: 
Due to accidental bowel leakage, indicate the extent to which you AGREE or DISAGREE with 
each of the following items. (If it is a concern for you for reasons other than accidental bowel leakage 
then check the box under Not Apply, N/A). 
 
Due to accidental bowel leakage: 
Strongly 
Agree 
Somewhat 
Agreee 
Somewhat 
Disagree 
Strongly 
Disagree 
N/A 
I feel ashamed 
1 
2 
3 
4 
I an not do many of things I want to do  
1 
2 
3 
4 
I worry about bowel accidents  
1 
2 
3 
4 
I feel depressed 
1 
2 
3 
4 
worry about others smelling stool on me  
1 
2 
3 
4 
I feel like I am not a healthy person 
1 
2 
3 
4 
I enjoy life less 
1 
2 
3 
4 
I have sex less often than I would like to 
1 
2 
3 
4 
I feel different from other people 
1 
2 
3 
4 
The possibility of bowel accidents is always 
on my mind 
1 
2 
3 
4 
I am afraid to have sex  
1 
2 
3 
4 
I avoid traveling by plane or train 
1 
2 
3 
4 
I avoid going out to eat  
1 
2 
3 
4 
Whenever I go someplace new, I specifically 
local where the bathrooms are. 
1 
2 
3 
4 
 
Q 4: During the past month, have you felt so sad, discouraged, hopeless, or had so many problems 
that you wondered if anything was worthwhile? 
 
1 [] Extremely So - To the point that I have just about given up 
2 [] Very Much So 
3 [] Quite a Bit 
4 [] Some - Enough to bother me 
5 [] A Little Bit 
6 [] Not At All 
 
 
 

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Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. Scale scores 
are the average (mean) response to all items in the scale (e.g., add the responses to all questions in a 
scale together and then divide by the number of items in the scale. Not Apply is coded as a missing 
value in the analysis for all questions.) 
Scale 1. Lifestyle, ten items: Q2a Q2b Q2c Q2d Q2e Q2g Q2h Q3b Q31 Q3m 
Scale 2. Coping/Behaviour, nine items: Q2f Q2i Q2j Q2k Q2m Q3d Q3h Q3j Q3n 
Scale 3. Depression/Self Perception, seven items: Q1 Q3d Q3f Q3g Q3i Q3k Q4, (Question 1 is 
reverse coded.) 
Scale 4. Embarrassment, three items: Q21 Q3a Q3e  
 
 

Short title: Assessment of FI with MAPLe 
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Appendix 4 – London protocol for performing HRAM 
 
(1) Stabilisation – a minimum of 3 minutes stabilisation period should be allowed. The patient 
should be asked to lie still, relaxed, without talking if possible. During this time it is useful to 
mark the limits of the anal canal for future reference;  
(2) Resting period – a 1-minute period of measurement at rest should be taken, again with the 
patient relaxed and without talking. Any sudden movement (e.g. talking, coughing etc.) should be 
noted on the trace to prevent confusion during post hoc analysis;  
(3) Squeeze manoeuvre – three squeezes, each of 5 seconds duration and separated by 30 second 
rest periods, should be performed in response to the (suggested) following command “please 
squeeze in tight with the muscles around your bottom and hold until I say stop”. A 30 second rest 
period should also be allowed following the third manoeuvre;  
(4) Endurance squeeze manoeuvre – a single 30 second endurance squeeze should be 
performed in response to the (suggested) following command “please squeeze in tight with the 
muscles around your bottom. This time I would like you to hold on for 30 seconds, or as long as 
you can”. The patient should be encouraged to continue squeezing during the 30 second period to 
aid compliance. A 60 second rest period should be allowed following this manoeuvre;  
(5) ‘Push’ manoeuvre – three 15 second pushes (simulated defaecation), each separated by a 30 
second rest period, should be performed in response to the (suggested) following command 
“please push / bear down as if you were going to the toilet to open your bowels”. A 30 second 
rest period should be allowed following the third manoeuvre;  
(6) Cough manoeuvre – two single coughs, separated by a 30 second rest period, should be 
performed, with the patient encouraged to cough as forcefully as possible. The patient should be 
instructed to refrain from coughing multiple times, as this impairs data interpretation. A 30 
second rest period should be allowed following the second manoeuvre;  
(7) Rectoanal inhibitory reflex (RAIR) – if this test is to be performed, the balloon should be 
inflated (ideally with an automated pump) at a rate of 30 ml/second to a volume of 60 ml. If the 
reflex is absent, increase the inflation volume in 60 ml increments (to a maximum of 240 ml) 
until the reflex is observed and sustained;  
(8) Rectal sensory testing – rectal sensory testing should ideally be performed with an 
automated pump attached to the anorectal catheter. Using a ramp (continuous) inflation paradigm, 
the balloon should be inflated at a rate of 2 ml/second and the patient asked to report: (1) volume 
for first constant sensation, (2) desire to defaecate volume, and (3) maximum tolerated volume;  
(9) Rest period – a final 30 second post-procedure period of rest should be recorded.  
 
 

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Appendix 5 - Protocol for MAPLe 
 
(1) Stabilisation – a minimum of 3 minutes stabilisation period should be allowed. The patient 
should be asked to lie still, relaxed, without talking if possible. During this time it is useful to 
mark the limits of the anal canal for future reference;  
(2) Squeeze manoeuvre – three squeezes, each of 5 seconds duration and separated by 30 second 
rest periods, should be performed in response to the (suggested) following command “please 
squeeze in tight with the muscles around your bottom and hold until I say stop”. A 30 second rest 
period should also be allowed following the third manoeuvre;  
(3) Endurance squeeze manoeuvre – a single 30 second endurance squeeze should be 
performed in response to the (suggested) following command “please squeeze in tight with the 
muscles around your bottom. This time I would like you to hold on for 30 seconds, or as long as 
you can”. The patient should be encouraged to continue squeezing during the 30 second period to 
aid compliance. A 60 second rest period should be allowed following this manoeuvre;  
(4) ‘Push’ manoeuvre – three 15 second pushes (simulated defaecation), each separated by a 30 
second rest period, should be performed in response to the (suggested) following command 
“please push / bear down as if you were going to the toilet to open your bowels”. A 30 second 
rest period should be allowed following the third manoeuvre;  
(5) Cough manoeuvre – two single coughs, separated by a 30 second rest period, should be 
performed, with the patient encouraged to cough as forcefully as possible. The patient should be 
instructed to refrain from coughing multiple times, as this impairs data interpretation. A 30 
second rest period should be allowed following the second manoeuvre;  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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