Faecal IncontinenceNCT03969069
Assessment of Faecal Incontinence With MAPLe
An observational study of Faecal Incontinence and Fecal Incontinence, run by University College London Hospitals at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence, Fecal Incontinence, Faecal Incontinence With Faecal Urgency
- What is being tested?
- MAPLe
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 May 2019to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All persons symptomatic of faecal incontinence with the capacity to consent and participate who meet the inclusion and exclusion criteria.
Who may be able to join
- Symptoms of faecal incontinence
- Capacity to consent
Who cannot join
- Anal surgery in the last 3 months
- Anal cancer
- Acute/painful perianal disease
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
St Peter's Hospital
Chertsey, Surrrey, KT16 0PZ
Rachael C Weatherburn, MBChB, MRCS, 01932872000, rweatherburn@nhs.net
Prateesh Trivedi, MBBS, FRCS, 01932872000, prateesh.trivedi@nhs.net
- Recruiting
University College Hospital
London, NW1 1BU
Rachael C Weatherburn, MBChB, MRCS, 020 3447 9130, rweatherburn@nhs.net
Anton V Emmanuel, BSc,MD,FRCP, 020 3447 9130, a.emmanuel@ucl.ac.uk
About this study
Official title: Improving the Assessment of Faecal Incontinence: Which Patient Groups Would Benefit From Assessment With Multiple Array Probe Leiden (MAPLe)?
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.
Read more
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.
Read the detailed description
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.
- Being tested
- MAPLe
- Keywords
- Adult, Human, Cohort
- Medical subject headings
- Encopresis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAPLeDevice
Additional assessment with MAPLe
| Study group | Role | What they receive |
|---|---|---|
| Fistula/chronic perianal conditions | Participants symptomatic of FI with chronic perianal disease Receives: Device: MAPLe | |
| Obstetric injury <12 months | Participants symptomatic of FI < 12 months following obstetric injury. Receives: Device: MAPLe | |
| Obstetric injury >12 months | Participants symptomatic of FI >12 months following obstetric injury. Receives: Device: MAPLe | |
| Neurogenic | Participants symptomatic of FI with evidence/history of neurological condition. Receives: Device: MAPLe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Which patient groups benefit from assessment with MAPLe?
Identity correlation between symptom profile and MAPLe results
Measured: 12 months
Non-inferiority testing of MAPLe against current ano-rectal physiological tests.
Blank Altman analysis of MAPLE vs HRAM and MAPLe vs AUS
Measured: 12 months
Secondary outcomes (1)
Has directed treatment been achieved?
Identify EMG activity in participants who underwent treatment, compare with pre-treatment EMG
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start30 May 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Weatherburn, University College London Hospitals
- Investigators
- Rachael C Weatherburn, MBChB MRCS, Principal investigator, Research Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969069
- Sponsor's protocol ID
- 119731
- Status last verified
- May 2019
- First submitted
- 13 Feb 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Student research project, data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Assessment of Faecal Incontinence: Which Patient Groups Would Benefit From Assessment With Multiple Array Probe Leiden (MAPLe)?
- ClinicalTrials.gov ID
- NCT03969069
- Acronym / sponsor ID
- 119731
- Keywords
- Adult, Human, Cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 30 May 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fistula/chronic perianal conditions | – | Device: MAPLeParticipants symptomatic of FI with chronic perianal disease |
| Obstetric injury <12 months | – | Device: MAPLeParticipants symptomatic of FI < 12 months following obstetric injury. |
| Obstetric injury >12 months | – | Device: MAPLeParticipants symptomatic of FI >12 months following obstetric injury. |
| Neurogenic | – | Device: MAPLeParticipants symptomatic of FI with evidence/history of neurological condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All persons symptomatic of faecal incontinence with the capacity to consent and participate who meet the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Symptoms of faecal incontinence
- Capacity to consent
Key exclusion criteria (3 listed)
- Anal surgery in the last 3 months
- Anal cancer
- Acute/painful perianal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAPLeAdditional assessment with MAPLe | Device | Fistula/chronic perianal conditions, Neurogenic, Obstetric injury <12 months, Obstetric injury >12 months |
Primary outcome
Which patient groups benefit from assessment with MAPLe?
Time frame: 12 months
Identity correlation between symptom profile and MAPLe results
Non-inferiority testing of MAPLe against current ano-rectal physiological tests.
Time frame: 12 months
Blank Altman analysis of MAPLE vs HRAM and MAPLe vs AUS
1 secondary outcome
Has directed treatment been achieved?
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: No. Student research project, data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael C Weatherburn, MBChB MRCS principal investigator
Research Fellow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Faecal Incontinence and Fecal Incontinence, run by University College London Hospitals at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachael C Weatherburn, MBChB MRCS (020 3447 9130, rweatherburn@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Which patient groups benefit from assessment with MAPLe? (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019; AzTrials last refreshed its copy on 26 Oct 2026.