Issues in Emerging Health Technologies

Smart-e-Pants: Using Intermittent Electrical

Stimulation to Prevent Pressure Ulcers
Issue 132 March 2015

Summary
Pressure ulcers are a serious health problem
for many patients, and treating those ulcers
incurs substantial health care costs.

Most pressure ulcers are preventable.

Initial studies suggest that muscle stimulation
delivered through electrodes in a specially
designed undergarment Smart-e-Pants
may reduce the risk for developing pressure
ulcers in the sacrum (area at the base of the
spine). This could improve care of individuals
confined to beds or wheelchairs.

Initial studies of the device have been shortterm, non-randomized ones carried out in a
small number of patients. The studies mainly
measured pressure relief and patient and
caregiver acceptability of the technology.

The Smart-e-Pants device would be used in

addition to standard care practices, such as
pressure relief mattresses, wheelchair
cushions, repositioning, and skin care.

The technology is still undergoing clinical

trials and is not yet commercially available.

Background
Pressure ulcers are injuries to the skin or underlying
tissue caused by pressure, shear, or friction.1 They are
common in individuals with reduced mobility or
sensation, such as those who are bedridden or confined
to wheelchairs.2,3 The US National Pressure Ulcer
Advisory Panel defines a pressure ulcer as an area of
unrelieved pressure over a defined area, usually over a
bony prominence, resulting in ischemia, cell death, and
tissue necrosis.4 Pressure ulcers, also known as
bedsores or decubitus ulcers, may form externally,
from the skin inwards (due to pressure, abrasion, poor
nutrition or hygiene, or excessive moisture or dryness
of the skin), or internally, from the soft tissue outwards
(due to the accumulation of pressure between a bone,
the adjoining tissue, and the supporting surface).5

Image courtesy of UAlberta Medicine, Faculty of Medicine &

Dentistry, University of Alberta.

Most pressure ulcers are assessed with a four-stage

classification system developed by the US National
Pressure Ulcer Advisory Panel. This system categorizes
ulcers into one of four stages, from intact reddened skin
to severe wounds extending beyond the skin into the
subcutaneous tissue (stage III) or involving the muscle,
tendon, or bone (stage IV), with two additional
categories for suspected and unstageable wounds.4,6
Pressure ulcers that affect the deep tissue may not be
recognized until the wound is externally visible, by
which time extensive injury may have occurred.5 These
ulcers often develop from the constant pressure between
the ischial tuberosities (the pair of sitz or sitting bones
of the pelvis) and the surrounding tissue in individuals
confined to beds or wheelchairs. Up to 70% of pressure
ulcers develop on the hips or buttocks.4
In Canada, the estimated incidence of pressure ulcers is
approximately 15% in community care, 22% in mixed
care, 25% in acute care, and 30% in non-acute care
facilities.7 The prevalence of pressure ulcers in all
Canadian health care settings is estimated to be 26%.7
1

Individuals with spinal cord injuries are particularly

affected by pressure ulcers. An estimated 86,000
Canadians have spinal cord injuries and there are more
than 4,300 new cases of spinal cord injury in Canada
each year.8 The prevalence of pressure ulcers in
individuals with spinal cord injuries ranges from 14%
to 33%.5,9 More than 85% of individuals with spinal
cord injuries will develop a pressure ulcer at least once
during their lifetime.10
Because they are painful and debilitating, pressure
ulcers have a negative effect on physical, psychological,
and social domains of quality of life.1,11-14 Pressure
ulcers are an adverse event that also increases the risk
for further adverse events, including infection,
osteomyelitis (infection of the bone), sepsis, and death.9
A summary of recent UK National Institute for Health
and Care Excellence (NICE) guidance notes that not
only do pressure ulcers increase mortality, result in
extended hospital stays, and consume substantial health
care resources, they are often an example of avoidable
harm.15 In 2008, the US Centers for Medicare &
Medicaid Services (CMS) adopted a nonpayment policy
for the costs of treating stage III and IV pressure ulcers
that develop in hospital these are now considered
never events or preventable, hospital-acquired
conditions.16,17
Patients with pressure ulcers need additional medical
care and have longer hospital stays for wound
treatment and to prevent recurrence.4,13,18 Severe
pressure ulcers may require months or years of wound
care treatments, including surgical interventions, such
as muscle flaps or skin grafts.14,19
Due to the intensive treatments involved, pressure
ulcers are costly.20 An Ontario study estimated that the
net hospitalization costs of treating hospital-acquired
pressure ulcers in patients older than 65 years ranged
from $44,000 for stage II pressure ulcers to $90,000 for
stage IV pressure ulcers.18 This study also determined
that the treatment costs of pressure ulcers that
developed before individuals were admitted to hospital
ranged from $11,000 for a stage II pressure ulcer to
$18,500 for a stage IV pressure ulcer.18 A small
Canadian study (n = 12) of the cost of caring for
community-dwelling individuals with pressure ulcers
due to spinal cord injury found an average monthly
cost per patient of $4,745 (ranging between $3,400 and
$18,000).20
Several economic analyses have concluded that,
despite the additional costs of the interventions,

effective pressure ulcer prevention offers overall cost

savings.1,9,21-24 For example, recent Ontario costeffectiveness analyses determined that providing
pressure redistribution mattresses to all long-term care
residents would be cost-effective. Using pressure support
overlays on operating tables for patients undergoing
lengthy surgical procedures and for elderly patients in
the emergency room would also be cost-effective. These
interventions could reduce overall hospital costs and
improve patient care.25-27 When multi-faceted
interventions are used, the development of most pressure
ulcers can be prevented.22
A recent commentary in CMAJ (the journal of the
Canadian Medical Association) noted, one underrecognized opportunity for both reducing health care
expenditures and improving patient care is better
prevention of pressure ulcers.17 The prevention and
treatment of pressure ulcers is now an accepted indicator
of health system quality and patient safety.17,28
Prevention is essential because successfully treating
pressure ulcers is costly and difficult.2,20

The Technology
Researchers at the University of Alberta are studying the
use of intermittent electrical stimulation (IES) to relieve
accumulated pressure and improve tissue oxygenation in
patients at risk for pressure ulcers. In the past, different
modes of electrical stimulation have been used to promote
pressure ulcer wound healing, but the Smart-e-Pants
technology is intended to prevent pressure ulcers.
Smart-e-Pants incorporates electrodes into specially
designed underwear that delivers electrical stimulation
to the underlying muscles.14 The device consists of:
The undergarment a cotton and Lycra fabric,
similar to biking shorts, with a front zipper to
accommodate patients needing catheterization,
markers on the thighs to guide alignment, and belt
loops for the electrode leads
The surface electrodes two for each buttock,
contained in mesh panels on the back of the pants
A small, battery-operated stimulator housed in a
pocket at the waist.29,30
When activated, the electrodes deliver 10 seconds of
stimulation every 10 minutes, causing the gluteal
muscles to contract and redistribute seating pressure.29
The stimulation achieves an effect similar to the
subconscious fidgeting and shifts in body positioning
that individuals without mobility issues make to relieve
pressure.31 The longer period of no stimulation
(measured in minutes) relative to the stimulation period
2

(measured in seconds) minimizes muscle fatigue.31 In

addition to redistributing pressure, the regular muscle
activation improves tissue oxygenation, which also
helps to prevent pressure ulcers.31,32
Various styles of the Smart-e-Pants undergarments
have been developed, including modified designs for
incontinent patients.

Regulatory Status
PrevBiotech is the company working to bring the
Smart-e-Pants technology to market
(http://www.prevbiotech.com). Efforts to obtain
Health Canada and US Food and Drug Administration
regulatory approval are under way, and the developers
expect Smart-e-Pants will be commercially available
in 2015.14

Patient Group
Elderly residents in nursing homes; individuals in
long-term care; those with diabetes; and individuals
confined to beds or wheelchairs due to spinal cord
injuries, head trauma, or musculoskeletal disease are
particularly at risk for developing pressure ulcers, but
all patients are potentially at risk.5,15,24 In addition to
the constant pressure, the muscle atrophy and poor
tissue oxygenation associated with many of these
conditions further increases the risk of developing
pressure ulcers.5
With an aging population and rising rates of diabetes,
the number of patients at risk for pressure ulcers is
likely to increase.24,33,34

Current Practice
Many different interventions are used to reduce the
risk for developing pressure ulcers. Some interventions
are labour intensive, such as timed repositioning or
turning of patients by nursing staff. Other interventions
involve costly equipment, such as specialized beds and
mattresses.19,35,36
Current guidelines recommend the use of an
interprofessional team using multiple interventions to
prevent pressure ulcers. These interventions include
careful patient assessment, pressure relief through
repositioning and the use of cushioned support
surfaces, ensuring adequate nutrition and fluid intake,
and meticulous skin care regimens for cleansing,
moisturizing, and protection.1,6,37-39 Recent Canadian

guidelines for the prevention and management of

pressure ulcers in people with spinal cord injuries also
note the importance of involving the patient in selfmanagement interventions (such as weight-shifting
manoeuvres for those in wheelchairs).39

Methods
Literature Search Strategy
A peer-reviewed literature search was conducted by an
information specialist using the following bibliographic
databases: MEDLINE, PubMed, Embase, and the
Cochrane Library (2014, Issue 11). Grey literature
was identified by searching relevant sections of
the CADTH Grey Matters checklist
(http://www.cadth.ca/resources/grey-matters).
No methodological filters were applied. Conference
abstracts were excluded from the search results. The
search was limited to English language documents
published between January 1, 2010 and December 8,
2014. Regular alerts were established to update the
search until March 9, 2015.
Study Selection Criteria
Published studies that assessed the use of the
Smart-e-Pants technology were selected for the review
of clinical evidence. Studies of alternative devices or
methods for pressure ulcer prevention and other sources
were also included, where appropriate, to place this
technology in the context of current clinical practice.

The Evidence
One of the pilot studies for Smart-e-Pants investigated
the use of two different regimens of IES in 17 patients
with spinal cord injuries.32 Surface electrodes (rather
than the prototype undergarments) were used to deliver
the stimulation to the gluteus maximus muscles. The
researchers found evidence that both regimens of
stimulation reduced surface pressure over the ischial
tuberosities and increased tissue oxygenation. The range
of pressure reduction varied between participants,
depending on the wheelchair cushions used and their
level of body fat, but all patients experienced pressure
reduction. These findings were similar to those of earlier
IES studies conducted in able-bodied participants.3,40
The largest published trial to date reported the results of
a single-group safety and feasibility study of a prototype
of the Smart-e-Pants undergarments.30 (During this trial,
the investigators noted that the prototype undergarment
was not suitable for patients with incontinence and a
new undergarment was subsequently designed for these
3

patients.) This study included 48 participants in acute

and tertiary rehabilitation hospitals, long-term care,
and homecare who were at risk of developing deep
tissue injury pressure ulcers. Each study patient
received IES for 12 hours per day, four days per week
for four weeks, or, in hospital patients until discharge.
(Some patients chose to continue using the system
after hospital discharge.) In the safety and feasibility
study, IES was administered to the gluteal muscles
through pairs of surface electrodes on each side of the
buttocks. Incontinent patients had the electrodes placed
directly on their skin, while continent patients received
the IES with electrodes placed both directly on the
skin and as contained in the Smart-e-Pants
undergarments.
The main outcome measures for the study were the
demands on caregivers (effort and time involved in
placing the electrodes, setting the stimulator, and
checking for muscle contractions once it was
activated); daily skin monitoring after removal of the
device; system performance (stability of the electrodes
and sustainability of muscle contractions); and patient
acceptability of the system in their everyday life. 30
Most caregivers rated the effort required as easy
(74% in long-term care settings, 79% in homecare
settings, and 87% in rehabilitation settings).30 Muscle
contractions were more difficult to elicit and detect in
patients with greater muscle atrophy due to age or a
longer history of immobility.30 In all health care
settings, the time it took to put on the Smart-e-Pants
(less than 18 minutes) and to remove them (usually
less than 10 minutes, including the documentation time
for completing the daily trial questionnaire) was
deemed acceptable by patients and their caregivers.29
Very few skin reactions were noted, either with direct
application of the electrodes or with use of the
garment. When asked whether they found the electrical
stimulation to cause irritation, distraction, or
discomfort, almost all patients in all care settings (in
96% of 648 IES sessions) responded not at all or
very little.30
For most study patients and caregivers, use of the
undergarment made the system less cumbersome to
use. Six patients reported that the use of IES reduced
the pain they experienced while sitting for long
periods. None of the study patients developed a
pressure ulcer during the time they used the IES
system.30
To date, more than 70 patients have used the
Smart-e-Pants undergarment. Most patients used the

device for a one-month period (a few patients have

continued to use it for up to 16 months), 12 hours per
day, in various settings, including rehabilitation units,
long-term care settings, and at home.14,29 Comments
from patients with spinal cord injuries who used the
Smart-e-Pants during the early clinical trial indicate they
find the technology easy to use, and some patients
reported additional benefits, such as reduced pain,
decreased spasticity, reduced fluid retention in the legs,
and stronger muscle contractions.14
Shorts that deliver IES to both the gluteal and hamstring
muscles have been tested in small pilot studies (n = 10)
by Dutch researchers using technology developed by
US-based Axiobionics.41,42 The researchers concluded
that providing electrical stimulation to both the gluteal
and the hamstring muscles provided better pressure
relief around the ischial tuberosities.41,42
A 2014 systematic review included five studies that
looked at the longer-term effect of electrical stimulation
on pressure ulcer prevention in individuals with spinal
cord injuries. Three of the five studies found beneficial
changes with electrical stimulation; for example,
increased muscle thickness, reduced seating pressure,
improved tissue oxygenation and sitting tolerance, or a
decreased incidence of pressure ulcers.20 The two other
studies found no statistically significant difference with
electrical stimulation; however, these studies only had a
short follow-up period (eight or 12 weeks), in
comparison with the studies that found benefit (which
included a follow-up period of more than one, two, and
five years).20 However, the quality of the evidence was
generally weak (mostly case reports or case series, and
only one randomized controlled trial that was considered
to be of good quality). They concluded that the evidence
of the long-term benefits of electrical stimulation in
preventing pressure ulcers was still inconclusive.18
The 2014 National Pressure Ulcer Advisory Panel
guidelines concluded there was sufficient evidence of
effectiveness to consider the use of electrical stimulation
to prevent pressure ulcers in patients with spinal cord
injuries.6
The Canadian Best Practice Guidelines for the
Prevention and Management of Pressure Ulcers in
People with Spinal Cord Injury recommend that the use
of electrical stimulation be considered to decrease
ischial pressure and increase blood circulation.39,43 (Note
that the supporting evidence was mainly from studies of
electrical stimulation delivered through implanted
devices.)
4

The current evidence on the Smart-e-Pants technology

indicates it can reduce surface pressure and improve
tissue oxygenation. Whether Smart-e-Pants can
prevent pressure ulcers has not yet been demonstrated
in longer-term randomized controlled trials. A phase 2,
multi-centre clinical trial of Smart-e-Pants is
reportedly under way.14 Researchers at the Universities
of Alberta and Calgary are also planning a study to
assess the potential cost savings of the technology.14

Adverse Effects
Some patients (ranging from 1% to 24% in the
different health care settings) experienced minor skin
irritation that resolved within 30 minutes after removal
of the electrodes that had been placed directly against
the skin.30 Two incontinent patients with compromised
skin quality had minor skin tears: one was an elderly
long-term care resident with fragile skin and the other
was a middle-aged patient who experienced the tear
when the clinical tape used to secure the electrode
edges to her skin was removed. Both of these patients
had the electrodes directly against their skin. None of
the patients who wore the Smart-e-Pants
undergarments containing the electrodes experienced
adverse effects.30
In a recent systematic review of electrical stimulation
for pressure ulcer prevention and treatment, only four
of 16 studies reported on adverse events. No patients
in these four studies experienced adverse events.20

Administration and Cost

Smart-e-Pants is intended for use by patients in all
health care settings: acute care hospitals, rehabilitation,
or long-term care facilities, as well as at home.
Because Smart-e-Pants is not yet commercially
available, the cost is not yet known. Published
estimates of the potential cost of the Smart-e-Pants
range from C$500 to C$2,000.44,45 The main cost will
be the stimulator pack. Once the electrodes are
removed, the underwear is washable and reusable, and
may cost approximately C$70.45

Concurrent Developments
The 2014 US National Pressure Ulcer Advisory Panel
guidelines include assessments of the evidence on new
preventive and treatment interventions, including
microclimate control using special support surfaces
that adjust the levels of moisture, evaporation and heat

dissipation against the skin, prophylactic polyurethane

foam dressings, and the use of silk-like fabrics (instead
of cotton) to reduce shear and friction.6
NICE recently issued guidance on the use of Parafricta
bootees (socks) and undergarments made of this special
fabric to reduce the risk of pressure ulcers. The guidance
concluded that these garments show potential to
reduce the development and progression of skin damage
caused by friction and shear in people with, or at risk of,
pressure ulcers. Research is recommended to address
uncertainties about the claimed patient and system
benefits of using the garments.46 Preliminary studies of
new fabrics for bedding, underpads, patient gowns, and
coverlets indicate that these can reduce heat, moisture,
and friction against the skin and may help prevent
pressure ulcers.47-49 Other research into smart textiles
includes the use of biosensors to detect chemical
changes that may indicate pressure ulcer formation.50
Other recent developments in emerging interventions for
pressure ulcers include devices such as mats and
wearable sensors that monitor pressure points or provide
reminders for repositioning patients to health care
providers.51-53 New types of pressure-relieving
mattresses are also commercially available, such as
Dolphin System beds and overlay pads that simulate
fluid immersion to relieve pressure.54
Implanted neuromuscular electrical stimulation devices,
intended for long-term use in individuals with spinal
cord injuries, are also under investigation.29

Rate of Technology Diffusion

The Smart-e-Pants technology has not yet been used
outside of research studies.

Implementation Issues
The additional staff time required to help patients
position and remove the Smart-e-Pants may be a
consideration for health care facilities.30
Although further evidence is needed, the Smart-e-Pants
technology may be an important advance in pressure
ulcer prevention.

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Cite as: Topfer, LA. Smart-e-Pants: Using Intermittent Electrical Stimulation to Prevent Pressure Ulcers [Issues in emerging health
technologies, Issue 132]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2015.
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