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© The Author(s), under exclusive license to Springer Nature
Switzerland AG 2025
D. Z. Bliss (ed.), Management of Fecal Incontinence for the Advanced Practice
Nurse, https://doi.org/10.1007/978-3-031-94526-7_16
16
Scanning theHorizon forPatient Needs
andNew Technologies forFecal
Incontinence
NicoleO’Connor
, FionaPearson
, SeanGill
,
SoheilaGhasri
, SheilaA.Wallace
,
andKatieH.Thomson
Abstract
Innovations in healthcare aim to enhance the quality of life and treatment for
individuals. Innovative technologies encompass among others, new medicines,
medical devices, and care pathways that improve access and patient outcomes.
Recent innovations in managing fecal incontinence include wearables, physio-
therapy, educational initiatives, and pharmaceutical treatments. Horizon scan-
ning is a research method that is used to systematically identify emerging
innovations to anticipate future trends that are likely to be important. This chap-
ter focuses on emerging evidence from a systematic search of technologies in
clinical development for diagnosing or treating fecal incontinence. This update
builds on a horizon scan rst conducted in 2020 and published in 2022. The most
recent search identied 196 new records; after screening, 72 were added to the
existing 136, resulting in 208 trial records. These records were categorized
according to fecal incontinence intervention topics dened by the 6th International
N. O’Connor (*) · F. Pearson · S. Gill · S. Ghasri · S. A. Wallace · K. H. Thomson
NIHR Innovation Observatory, Population Health Sciences Institute, Faculty of Medical
Sciences, Newcastle University, Newcastle upon Tyne, UK
e-mail: Nicole.OConnor@newcastle.ac.uk; Fiona.Pearson2@newcastle.ac.uk; sean.gill@io.
nihr.ac.uk; soheila.ghasri@io.nihr.ac.uk; Sheila.Wallace@newcastle.ac.uk;
Katie.Thomson@newcastle.ac.uk
370
Consultation on Incontinence. Commonly studied interventions included pelvic
oor muscle training and sphincter exercises (12.0%), electrical stimulation
(11.1%), complementary therapies (10.5%), and sacral nerve stimulation (9.6%).
Other trials focused on laxatives, educational, and lifestyle interventions. This
chapter presents ndings related to pharmacological therapies, mechanical
devices, and new surgical approaches and stakeholder engagement activities to
identify unmet need. This horizon scan highlighted promising advances in man-
aging fecal incontinence, including drug repurposing, new devices, and app-
based tools. However, addressing stigma, increasing awareness, and focusing on
psychological support are crucial for progress. Stakeholder feedback emphasizes
the need for both technological innovation and better education to improve
patient outcomes and quality of life.
16.1 Introduction
Innovations in health care, in their broadest sense, aim to improve the quality of life
or quality of treatment for the public. These innovations can take various forms,
including novel medicines and devices to treat conditions, modications to health-
care pathways to improve access to care or reduce patient wait times, and educa-
tional or training initiatives for the public or healthcare providers. Recent innovations
in fecal incontinence have been diverse, encompassing wearables, physiotherapy,
educational campaigns, and pharmaceutical treatments. Many aim to help people
manage their FI symptoms by increasing the time between bowel evacuations, giv-
ing pre-warning through device monitoring, or strengthening the pelvic oor mus-
cles with exercise tools and regimens.
Horizon scanning is a research method used to examine emerging innovations,
their goals, development stages, and trends in funding or regulations, providing an
early glimpse of the future technology landscape. Depending on the scope, horizon
scanning can focus on developments within the coming months or extend to pro-
jections up to 5years ahead. The data and insights gathered are valuable for various
purposes, such as enabling regulators and policymakers to make informed deci-
sions earlier or identifying innovation gaps that scientists and healthcare profes-
sionals can address through new research, development projects, or funding
opportunities.
The National Institute for Health and Social Care Research (NIHR) Innovation
Observatory (IO) is a national horizon scanning center in England, within the United
Kingdom (UK). The IO’s research focus involves the use of horizon scanning,
alongside other health innovation futures scanning methods, to provide early aware-
ness signals and timely intelligence to support the national decision making of
stakeholders such as the National Institute for Health and Care Excellence (NICE)
N. O’Connor et al.
371
and the National Health Service (NHS) both in England, UK.The IO also aims to
bring public and patient insights into its research projects, when possible, to enhance
and contextualize research results. By combining horizon scanning methods with
the perspectives, ideas, and needs of the public, the IO can better identify innovation
gaps—key areas of priority or unmet patient needs where few innovations are cur-
rently being developed to address these challenges.
16.2 Aims andObjectives
The overall aim of the priority-setting exercise was to identify research gaps that
should be addressed to support evidence-based practice in fecal incontinence. To
achieve this, the research team assessed the breadth of existing evidence and emerg-
ing evidence, while also engaging with patients, carers, and healthcare professionals
to capture areas of uncertainty or interest for stakeholders internationally. The focus
of this chapter is on emerging evidence which was identied by systematically
searching for and identifying technologies, such as medicines, medical devices, sur-
gical procedures, or diagnostics, in late-stage clinical development for the diagno-
sis, or treatment of fecal incontinence. The work presented here is an update to a
horizon scan conducted in 2020 and published in 2022 [1].
16.3 Horizon Scanning Approach
The original search was updated on May 6, 2024, using ScanMedicine (https://scan-
medicine.com/), and results were combined with the records from the original
search that was conducted in August 2020. The methods used throughout the initial
horizon scan and results have been previously published and can be viewed here [1].
The search strategy used to identify the records in the 2024 search can be viewed
here: https://osf.io/2etv9/. The screening of trial records relevant to fecal inconti-
nence was carried out in two stages. In the rst stage, two reviewers independently
assessed the trial’s title and primary indication. During the second stage, more
detailed information, such as primary endpoints and eligibility criteria, was evalu-
ated. If there were any disagreements at either stage, a third reviewer arbitrated to
make a nal decision. Only trials that specically focused on fecal incontinence and
met the full eligibility criteria were included in the nal map, full details of the eli-
gibility criteria have previously been published [2]. Figure16.1 shows the PRISMA
ow diagram of the trial records identied and screened throughout the updated
horizon scanning and selection process. A total of 196 new records were identied
in the updated search; 108 records were excluded in the rst screening stage, with
16 more excluded in the second stage. As a result, 72 new records were added to the
16 Scanning the Horizon for Patient Needs and New Technologies for Fecal…
372
Records identified from:
ScanMedicine (n = 196)
Records removed before
screening:
Duplicate records removed
(n = 0)
Records screened
(n = 196)
Records excluded
(n = 108)
Reports sought for retrieval
(n = 88)
Reports not retrieved
(n = 0 )
Reports assessed for eligibility
(n = 88)
Reports excluded:
Wrong population (n = 7)
Wrong study design (n = 4)
Out of scope (n = 4)
Wrong/no intervention (n =1)
New studies included in horizon
scan
(n = 72)
Identification of new studies via databases and re
g
isters
Identification
Screening
Included
Total studies included in the
horizon scan domain of the
evidence map
(n = 208)
Studies included in
previous version of
review (n = 136)
Previous studies
Fig. 16.1 A PRISMA ow diagram of the updated literature search for the updated evidence map
for the emerging evidence/horizon scanning domain. Details of the original search can be found
in [1, 2]
existing 136 records in the evidence map, bringing the total number of trial records
to 208 within the horizon scanning domain. The trial records were categorized and
mapped to the FI intervention topics identied by the 6th International Consultation
on Incontinence [3].
The nal updated evidence gap map with details of the horizon scanning results
is presented in Fig.16.2 alongside the systematic review evidence and the stake-
holder engagement, which is discussed elsewhere [1, 2, 4]. An electronic version
can also be accessed using the following URL: https://osf.io/2etv9/. The included
clinical trials were mapped to one or more fecal incontinence domains and are pre-
sented in tabular form in Table16.1.
N. O’Connor et al.
373
Fig. 16.2 The evidence gap map was generated using v.2.1.0 of the EPPI-Mapper powered by
EPPI Reviewer and created by the Digital Solution Foundry team. The evidence gap map demon-
strates the volume of existing evidence/evidence synthesis (11 August 2020; n=114), emerging
evidence/horizon scanning (updated 06 May 2024; n=208) and stakeholder insights (11 August
2020; n=68). Evidence streams are mapped against a modied version of the intervention domains
described in the sixth International Consultation on Incontinence [3]. The size of the orange circles
in the evidence gap map are proportional to the amount of information available and details of each
study can be viewed by clicking on a circle in the online interactive version
Table 16.1 The number of trials by fecal incontinence domain (trials could fall into more than
one fecal incontinence domain)
Number of
trials Fecal incontinence domain
97 Bowel management
65 Bladder and bowel dysfunctions
43 Surgical techniques
35 Drug treatments
33 Bowel management for neurogenic conditions
18 Mechanical devices
19 Fecal incontinence interventions in particular populations
4 Fecal incontinence interventions in particular settings
2 Models of care
38 Trial records were termed “other” and comprised a range of issues including
incontinence associated dermatitis, nancial support, psychological support, and
quality of life
16.4 New Health andCare Technologies intheField
ofFecal Incontinence
The most frequently investigated fecal incontinence intervention topics were
(Fig.16.3): pelvic oor muscle training/biofeedback/sphincter exercises (n= 25,
12.0%); complementary therapies (n=22, 10.5%); electrical stimulation (n=23,
11.1%); and implanted sacral nerve stimulation (n=20, 9.6%). Several trials also
looked at the effect of laxatives on fecal incontinence (n=11), and the impact of
16 Scanning the Horizon for Patient Needs and New Technologies for Fecal…
374
Fig. 16.3 Chart showing number of clinical trials found during the Horizon Scanning search that
encompassed bowel management strategies (not including those targeting neurogenic patients
only). (Abbreviations: PFMT Pelvic Floor Muscle Training)
educational (n=8) and lifestyle interventions (n=10) on bowel management. The
trials generating evidence on specic bowel management strategies and educational
interventions may ll a gap and address an unmet need identied by the patients,
caregivers, and healthcare professionals who participated in a survey and workshop.
Their insights highlighted the importance of tackling misunderstandings and
improving education in both primary and secondary care, as well as in society more
generally.
The impact of various interventions trialed for the treatment or management of
fecal incontinence in cancer patients included pelvic oor rehabilitation, physical
exercise, and trans-anal irrigation (n=15). There was also evidence of tailored fol-
low-up approaches offered to patients following rectal cancer surgery (e.g., pelvic
oor muscle training, dietary education, and personalized care pathways). The most
novel treatment option highlighted was the use of plasma-rich platelet injections to
initiate and accelerate reconstruction following low anterior resection of the
bowel [5].
There is evidence of clinical trials, both randomized and non-randomized, com-
paring the effectiveness of different therapeutic interventions and pharmacological
treatments, including nerve stimulation, laxatives, supplements, and cell transplan-
tation. However, previous priority setting exercises highlighted the need for ran-
domized trials to assess combined treatments, [6, 7] and in our rapid horizon
scanning, we found limited evidence of this.
N. O’Connor et al.
375
16.5 Emerging Developments andNovel
Health Technologies
The horizon scan of the clinical trial landscape identied 43 pharmacological tech-
nologies. Some of these trials focused on evaluating existing technologies that have
been advanced, such as repurposed approved drugs for a new therapeutic use or
within an alternate patient population and the evolution of neurostimulation devices
(e.g., improving control mechanisms).
16.6 Pharmacological Therapies
There was limited emerging evidence of new drugs in the development pipeline (35
unique records) (Fig.16.4). Most emerging evidence was on the effectiveness of
repurposed drugs (n = 14) in treating and managing fecal incontinence. During
stakeholder workshops, participants noted that research topics are often driven by
research sponsors, with product development heavily inuenced by potential invest-
ment returns. In 2018, the median capitalized cost to bring a new drug to market,
factoring in failed trials, was estimated at $985.3million [8]. Given the substantial
research and development costs, stakeholders suggest that pharmaceutical compa-
nies may be hesitant to invest in innovations for FI, possibly due to the perception
that the condition affects a smaller, older population with limited market potential.
Repurposing licensed drugs for new indications outside of their original purpose
may be attractive to companies as it de-risks potential investment since compounds
that are already licensed will have a partially established safety prole, shorter
development timeline, and lower associated costs [9].
Fig. 16.4 Chart showing number of clinical trials found during the Horizon Scanning search that
encompassed pharmacological technologies (not including those targeting neurogenic patients only)
16 Scanning the Horizon for Patient Needs and New Technologies for Fecal…
376
The evaluated repurposed drugs for the treatment or management of fecal incon-
tinence included linaclotide, colesevelam, imipramine and mosapride citrate, and
ondansetron, all of which were originally indicated for various other conditions, for
example, linaclotide and mosapride citrate and ondansetron, were developed for
gastrointestinal disorders. Some trials also evaluate the effect of laxatives in improv-
ing fecal incontinence in the pediatric population, such as lubiprostone, lactitol,
polyethylene glycol, and lactulose. More recently, a combination therapy with low
volume trans anal irrigation alongside oral laxative is being investigated to deter-
mine efcacy [10].
ENT-01 (Kenterin) is a new investigational drug for the treatment of constipa-
tion, which may present a potential treatment option for some fecal incontinence
patients, depending on the cause or symptoms of their fecal incontinence. ENT-01
is a series of small compounds that aims to prevent the accumulation of alpha synu-
clein (a neuronal protein) in the nerves of the gastrointestinal tract and improve
neural signaling and gut motility in patients with constipation related to Parkinson’s
disease (PD) [11]. Results from the small (n = 34), open-label, phase II study
(RASMET) reported that ENT-01 was thus far safe and “improved bowel function”
in over 80% of patients. The reported systemic absorption was <0.3%, suggesting
improvements resulted from local stimulation of the enteric nervous system [12]. A
randomized phase II trial (KARMET) (n=152) is currently in progress to evaluate
the effect of orally administered ENT-01 compared with placebo on neurologic
symptoms and constipation [13]. Results from larger, randomized trials will be
needed to fully assess the efcacy and safety of ENT-01.
Ondansetron is a medicinal product currently under investigation as a potential
treatment for complete bowel incontinence in patients with low anterior resection
syndrome (LARS) after rectal cancer treatment [14]. Ondansetron is a potent, highly
selective 5HT3RA, which blocks 5HT3 receptors in the gastrointestinal tract. The
drug is normally indicated to treat nausea and vomiting induced by cytotoxic che-
motherapy and radiotherapy and for the prevention and treatment of post-operative
nausea and vomiting [15, 16]. Research in irritable bowel syndrome (IBS) has dem-
onstrated that ondansetron is both safe and effective in managing symptoms of
urgency and diarrhea which are similar to symptoms observed in patients with
LARS [14]. Results from a small, randomized trial (46 participants) demonstrated
ondansetron as a safe and simple treatment that appears to improve both symptoms
and quality of life in LARS patients [17]. Currently, a randomized phase II trial (134
participants) is being conducted to further evaluate the efcacy of ondansetron in
reducing symptoms and improving quality of life in patients with LARS [14].
16.7 Mechanical Devices
Fecobionics is a novel device that simulates feces by integrating a balloon expulsion
test (BET) and anorectal manometry to assess/diagnose defecatory functions in
patients with chronic constipation and FI [18]. The integration of several technolo-
gies and tests into one Fecobionics device aims to save time and reduce test
N. O’Connor et al.
377
variability. The innovations of this device compared to current anorectal functional
assessment techniques include mechanical properties that mimic feces, electronic
(objective) measurement of the anorectal angle, and pressure measurements in the
orientation of the feces trajectory. Early study results (randomized study, crossover
design, 20 participants) suggest that Fecobionics may be an effective method for
evaluating anorectal physiology and evacuatory efcacy [19]. Larger, randomized
trials would be needed to fully assess the efcacy and safety of this device. Current
developments in neurostimulation devices for fecal incontinence are focusing on
increasing portability and patient use, as well as ease of use.
Geko™ is a self-adhesive, internally powered, disposable tibial nerve stimulator
device. Intended for patient use, it is already marketed for the prevention and/or
treatment of venous thrombosis and oedema. As a wound therapy device, it is also
used to increase blood circulation and promote wound healing. Powered by
OnPulse™ technology, the device provides 11 stimulation settings and 60 muscle
contractions per 1min at 1Hz [20]. Geko™ was being trialed in 13 patients for the
treatment of fecal incontinence in older people living at home or in residential care,
potentially providing a feasible option for the elderly or their care givers to manage
fecal incontinence in these settings [21].
Interestingly, limited improvements in containment technologies were found in
the original trial records, which was a disappointment to stakeholders attending our
workshop [22] who felt such innovations were being sidelined compared to pharma-
cological innovations. Furthermore, stakeholders felt some products were not
designed to promote dignity among the heterogeneous populations using them. In
the update, we identied one feasibility trial that assessed the leakage performance
of an absorbent hygiene product [22].
Navina Smart™ is an electronic device that comprises a hydrophilic rectal cath-
eter with an inatable balloon for retention, tubing, connectors, a water container, a
handheld electrical control unit, and a smartphone or tablet application [23]. It is
already marketed for transanal irrigation in patients with neurogenic bowel dys-
function. In this device, the software-controlled pumps inate a balloon and trans-
fers water into the bowel, allowing the user to manage the entire procedure by
pressing the buttons, ensuring complete control throughout. Navina Smart™ is cur-
rently undergoing a randomized trial involving 92 participants to evaluate its effec-
tiveness for trans anal irrigation in patients with multiple sclerosis, compared to
standard bowel care [24].
16.8 Therapeutic Technologies andSurgical or Procedural
Treatment Approaches
Clinical trials are currently investigating the role of regenerative medicine and cel-
lular therapy in the treatment and management of fecal incontinence in patients with
neurological disorders. Novel developments in regenerative medicine may provide
sustainable techniques that address the limitations of injectable bulking agents and
their need for repeat treatment. The investigational surgical techniques in early
16 Scanning the Horizon for Patient Needs and New Technologies for Fecal…