Measuring Safety, Effectiveness and Ease of Use of PureWick in the Management of
Urinary Incontinence in Bedbound Women: Case Studies
Camille Newton, M.D. Evan Call, M.S. CSM (NRM)
Kelvin S. L. Chan, PhD
08 January 2016
1
Measuring Safety, Effectiveness and Ease of Use of PureWick in the Management of
Urinary Incontinence in Bedbound Women: Case Studies
Camille Newton, M.D. Evan Call, M.S. CSM (NRM)
Kelvin S. L. Chan, PhD
08 January 2016
Abstract
Studies on 16 bedbound women were performed to determine effectiveness, ease of use, comfort
and any limitations resulting from the PureWick female urinary incontinence management
system. Patients and caregivers were surveyed about experiences while using the PureWick
system and patients were monitored for problems such as discomfort and irritation. Studies
covered a variety of PureWick models that were developed over the course of the study period.
The PureWick system was found to be effective and comfortable in managing urinary
incontinence, with later-generation wick models often capturing 95% or more of urine. Users
were not required to be awakened for diaper changes, allowing improved sleep quality for both
patient and caregiver. PureWick was found easy to use in 14 out of 16 patients surveyed. Urine
capture was hindered in 3 studies because of significant fecal incontinence, or dementia patients
tampering with the wicks.
PureWick was not found to cause skin irritation. In instances where tape was used to secure a
wick in place, a DuoDerm or Tegaderm patch was determined to serve as a barrier to prevent
irritation from the tape. There were no cases where PureWick was found to cause urinary tract
infection.
Introduction
Bedbound and chairbound women who require assistance with toileting are at risk of lying or
sitting in wet diapers or bedding. Diapers hold urine next to the skin, making a woman
susceptible to rashes and pressure sores.i ii When a woman is wearing a diaper, she must be
lifted or rolled to change the diaper, pads and bedding. This is a labor-intensive activity risking
back injuries to caregivers and causing workman’s compensation claims in the healthcare
industry to rise higher than all other industries.iii
Catheters are often inappropriately used in the management of female urinary incontinence.iv
Having a foreign body inside the bladder makes a woman susceptible to repeated urinary tract
infections. The National Institutes of Health reports that “urinary tract infection (UTI) is the
single most common hospital-acquired infection, and the majority of cases of nosocomial UTI
are associated with an indwelling urinary catheter”.v Catheters also require a skilled nurse to
insert and to manage, costing Medicare a minimum of $1,000 per month for each patient.vi
Prevention of catheter-induced UTIs has been a National Patient Safety Goal since 2012. Many
hospitals now avoid using them.
2
By design, urine cups and funnels are intended for use while standing, or seated over a toilet.
Nurses and other caregivers included in this study were not using cups or funnels to control urine
in bedbound and chairbound patients.
The presence of urinary incontinence, the increased use of adult incontinence aids and lapses in
proper care significantly increase the number of events when moisture is held at the skin
interface. This increases the risk of Incontinence Associated Dermatitis (IAD). The use of an
external urine collection device reduces the risk of IAD and the associated tissue breakdown
risks. It is a well-established fact that IAD is a risk factor for pressure ulcer development.vii
Maintaining a dry skin surface is essential in preventing skin breakdown and the formation of
IAD.viii
The presence of moisture is more damaging than even solid stool, particularly when the skin
stays moist for sustained periods and contains body waste and other irritating substances.ix This
drives the need for removal of fluids, rather than trapping fluid in layers close to the skin.
PureWick is a new incontinence management solution for women who have difficulty going to a
toilet. It is composed of an elongated tube, wrapped in wicking material, attached to a
continuous vacuum source. A “wick” is tucked between the labia and the gluteus muscles,
external to the body.
In a series of case studies, PureWick was evaluated for effectiveness and ease of use. Patients
were monitored for skin conditions and any skin changes were immediately reported to
PureWick.
Materials and Methods
Patients were selected based on immobility, significant risk of falls during toileting excursions,
risk of IAD, and the availability of a caregiver to place and monitor the PureWick performance.
Care staff training included personal instruction and provision of written instruction. Contact
information was provided to caregivers to allow them access to physician assistance by phone
during the test period. Patients or their representatives signed written consent forms. Both care
staff and patients were questioned about the effectiveness, comfort and ease of use of PureWick.
Patients were placed in a reclined position during testing. The PureWick was tucked externally
between the labia and the gluteal cleft approaching the anus, with the wicking side of the
PureWick facing toward the midline of the body. Some patients were resting on a disposable
incontinence pad, some were dressed in an adult incontinence aid (diaper), and some used both.
Tubing connected the PureWick to a continuous vacuum, and the urine output was collected in a
urine collection jar of 1000cc to 2000cc volume, depending on the needs of the patient. The
urine collection jar included an overflow shutoff valve to prevent urine capture from exceeding
the volume of the container. Excessive movement or side lying sleep introduced the potential of
dislodging the wick and decreasing effective urine collection. To prevent this, some wicks were
held in position by applying a Duoderm or Tegaderm patch on the sacral, gluteal, and/or
3
abdominal regions, then taping the wick to the patch. Wicks were replaced after 8 to 12 hours,
generally in the morning when the patient awakened.
Several different style wicks were used in this study. The wick type and the description is listed
in the table below. The specific patient’s wick is listed in the summary table in the results
section.
PureWick Models Types Used in Testing
Wick Type
Straight wick
Rigid Curve
Flex Curve
Rigid Taper
Wick Length in inches
5
5, 6, 7, 8
6
6, 8
Soft Flex
6
Description
Rigid tubular container
Curve added to conform to body shape
Engineered flexible wick;3D printed
Engineered rigid curve with taper at top; 3D
printed
Flexible spun plastic wick
Volunteer patients were fitted with the PureWick model indicated in the Volunteer Summary
table. The Wick Effectiveness was determined by calculating the urine collected as a percent of
total urine. This was accomplished by weighing the adult incontinence aid (or diaper) prior to
use, weighing the urine collected in the collection jar and dividing the jar weight by the sum of
the urine in the jar and the weight of urine in the incontinence aid.
Caregiver and volunteer feedback were also collected and tabulated. These are subjective values
and were not scored numerically, but were freely offered comments upon feedback request. The
demographics of the participants are listed in the table below.
Volunteer Demographics Table
ID
Age
Diagnosis/ Health
Status
Skin Breakdown Prior
to Use
1
2
70
61
Alzheimer’s
Dementia
None
None
Skin
Breakdown
During Use
None
None
3
90
None
None
4
93
None
None
5
91
None
None
6
83
Cerebral vascular
accident, left
hemiparesis,
altered cognition
Severe arthritis in
knees, mild
dementia
Advanced
dementia
Long term
catheterization
None
None
Other
Hyperkinesia or
Dyskinesias
Contractures of
left arm and
hand.
Nonambulatory due
to arthritic pain
Limited
ambulation
Foley catheter
limited mobility
4
7
8
72
82
9
65
10
99
11
101
12
87
13
14
80
94
15
16
92
99
patient (5 mo.)
AK amputation
Advanced
dementia
Advanced Multiple
Sclerosis
None
None
None
None
None
None
Late stage COPD,
PVD
Previous Stage IV,
currently healed
None
Advanced
dementia
Advanced
dementia
Vascular Dementia
Congestive heart
failure
Dementia
Macular
degeneration,
Dementia
None
None
Stage II
None
None
Un-stageable
w/ tunneling*
None
None
None
None
None
None
Complete
paralysis and
contractures
Edema,
dehydration,
advanced aortic
stenosis.
Edema and
dehydration
Osteoporosis,
abnormal gait
and uses a
walker
*Pressure ulcer worsened during period of non-use. It is unknown if incontinence in the absence
of the PureWick contributed to the ulcer’s condition change.
Results
The percent effectiveness, tissue breakdown, Cystitis and Bactiuria occurrence were recorded in
the Results Table below. It is important to note that no cases of cystitis occurred, and only one
preexisting case of Bactiuria was observed. Measurement of urinary output was not performed
for volunteers 6-9 and 11.
Results Table
I.D.
Percent Effectiveness
Tissue Breakdown/
Dermatitis
1
2
2
2
3
3
4
99 to >99%
75 to 94%*
66 to 91%*
95 to 99%
72 to 97%
66 to 91%
41 to 84%
None
None
None
None
None
None
None
Cystitis Status
(P=prior to use,
D=developed
during use, None=
not present
None
None
None
None
None
None
None
Bactiuria
Yes
None
None
None
None
None
None
5
4
45 to 90%**
None
None
5
92 to 98%
None
None
5
28 to 90%
None
None
5
85 to 99%
None
None
6
“Good” (Subjective)
None
None
7
“Good” (Subjective)
None
None
8
NA
None
None
9
NA
None
None
10
95 to 99%
None
None
11
“Good” (Subjective)
None
None
12
95%
Stage II to Unstageable
None
13
“Good” (Subjective)
None
None
14
“Good” (Subjective)
None
None
15
“Good” (Subjective)
None
None
16
“Good” (Subjective)
None
None
*Early designs most likely contributed to poor performance in these tests.
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
** Urine output exceeded container, effectiveness estimates.
In the one case where a pressure ulcer increased in depth, the worsening was noted to occur after
a 4 day period when the PureWick system was not used, due to running out of wicks.
Review of application of the wick and evaluation of proper fit showed that the effectiveness of
the PureWick was significantly better when it was fit properly to the anatomy of the user. When
calculated for volunteers where the wick was properly fitted, the effectiveness was 95 to >99%.
The presence of potentially complicating conditions is listed in the comments column of the
Volunteer Summary Table below. Note that some volunteer patients used multiple models of the
wick and are represented multiple times in the table.
Volunteer Summary Table
Vol.
Days
Use
Wick
Type
Ambulatory
Cooperative
Effective
P1
1155
P2
2
P2
P2
Comfort
UTI
Yes
Easy
to
Use
Yes
#5
straight,
#5 rigid
curve
#6 rigid
curve
No
Yes
No
4
#6 rigid
curve
32
#6 soft
flex
Comment
Yes
No
Chronic bacturia,
no symptomatic
uti
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
None (success was
variable and
caregiver
dependent)
Small spot,
suprapubic area
No
Yes
Yes
Yes
Yes
No
None
6
P3
2
#7 ridged
curve
No
No
Yes
Yes
Yes
No
Tampered with
vacuum hose
P3
3
No
No
No
Yes
Yes
No
Fecal incontinence
P4
3
#6 ridged
taper
#8 ridged
curve
#6 flex
curve
#7 ridged
curve
#6 soft
flex
#6 soft
flex
No
Yes
Yes
Yes
Yes
No
Fecal incontinence
No
Yes
Yes
Yes
Yes
No
None
No
Yes
Yes
Yes
Yes
No
None
No
Yes
Yes
Yes
Yes
No
None
No
Yes
Yes
Yes
Yes
No
Small spot,
suprapubic area
#6 flex
curve
#6 flex
curve
Yes
Yes
Yes
Yes
Yes
No
None
No
Yes
Yes
No
Yes
No
Multiple untrained
caregivers
#6 ridged
taper
#6 soft
flex
#6 and #8
soft flex,
hybrids
#6 soft
flex
No
No
No
Yes
Yes
No
Combative
No
Yes
Yes
Yes
Yes
Yes(a)
Yes
Yes
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
Restless
movement
overnight
None
Yes
No
No
Yes
Yes
No
Gets out of bed
Yes
Yes
Yes
No
Yes
No
Facility staff will
not assist
No
Yes
Yes
Yes
Yes
No
None
No
Yes
Yes
Yes
Yes
No
None
57
P5
3
P5
8
P5
66
P6
17
P7
56
P8
1
P9
1
P10
187
P11
21
P12
179
P13
14
P14
10
P15
19
P16
3
#6 soft
flex
#6 soft
flex
#6 soft
flex
#6 soft
flex
#6 soft
flex
Supra-pubic
catheter
Side sleeper, small
tape abrasion
(a) UTI was present prior to test. Patient has chronic UTIs due to supra-pubic
catheter.
Caregiver and user feedback are very positive with indications of improved sleep, reduced diaper
changes, reduced bedding changes, greater comfort and a high level of tolerance for the presence
of the wick. These comments can be found in the appendix at the end of this document.
Discussion
PureWick was found to be safe and effective in the management of female urinary incontinence.
7
The effectiveness increased over time as the wick design evolved from rigid and semi-flexible
designs (80 to 95% effective), to a soft flexible wick made of spun plastic (90 to >99%
effective).
In 1,843 days of PureWick use by 16 patients, there were no skin problems, rashes or pressure
sores attributable to PureWick. One volunteer (P2, test period b) developed a small abrasion in
the suprapubic area first noted a few days after PureWick was discontinued. It is unknown what
the cause of the abrasion was, but it should be noted that the PureWick did not come in contact
with the skin in the region of the abrasion.
Another volunteer (P10) developed a small abrasion from the tape that was used to hold the
PureWick in place. The volunteer was using the same tape to hold her oxygen tubing, and
developed an abrasion from the tape in the sacral region at the same time she noted skin
breakdown from the tape in the facial region – where she had not previously had problems. The
problems from the tape were alleviated by using a Duoderm patch on the sacral region as well as
the abdominal region. This is something that can be recommended for patients who move
around more or sleep on their side.
Another volunteer (P5) in her third trial using PureWick developed a small abrasion in the supra
pubic region. This was noted several days after the PureWick had been held in place with an
inverted sanitary pad. It was possible that this method may have caused the volunteer some
pruritis so use of the inverted sanitary pad was discontinued. Caregivers later noted that she had
had these ‘scratches’ in the supra pubic region on multiple previous occasions.
Some evidence was noted that PureWick protected against advancement of skin breakdown.
Volunteer (P12) developed worsening of a pressure ulcer during a 4 day period of non-use.
There were no instances where a symptomatic urinary tract infection (UTI) developed from the
PureWick system. One volunteer (P9) had a symptomatic UTI prior to trying PureWick.
Another volunteer (P1) had a long history of asymptomatic bacturia. The volunteer’s urine was
cultured repeatedly in her multiple years of use, and the culture results were not affected by use
of PureWick. A third volunteer (P5) had weekly urinalyses done and these were not affected.
This is consistent with other tests performed with urine from healthy volunteers, where an 11
item dip urinalyses was unaffected by use of PureWick.
Volunteers who were able to get out of the bed in the middle of the night and were not able to
put the PureWick back in place were found to be poor candidates for using PureWick. (P13,
P14). Early studies were discontinued on several occasions due to frequent night time bowel
movements, as the cost of 3D printed wicks at the time were very expensive (P3, P4).
Volunteers who were overly active or combative were not as successful in using PureWick, but
still can benefit from use of this system (P8, P11).
PureWick was found to capture a large amount of urine, generating the need to increase the
minimum jar size from 1000 to 1200 cc. There were some occasions when the shut off valve
was activated on a 1200 cc canister from very small women (less than 100 lbs).
8
There were no episodes when the noise from the pump (45 – 48 dB) was reported to be
bothersome.
There were no episodes when the volunteer reported discomfort from using PureWick. The
volunteers with dementia did not seem to notice that it was in place.
It is important to note that two volunteers who were not incontinent, but who had significant
nocturia quickly adapted to sleeping through urinations while using PureWick (P10, P15). This
has provided huge benefit to patients and caregivers who had been previously getting up multiple
times at night to assist with toileting.
There were no cases when the caregivers found PureWick difficult to use once shown how to
turn it on and put the wick in place. In two instances, the volunteers had multiple caregivers and
poor transfer of instructions between caregivers resulted in difficulties managing the PureWick
(P7, P14).
Appendix – Caregiver and Volunteer Feedback
Volunteer
User Preference
Caregiver Preference
P2
tolerated
PureWick well
P3
tolerated, seemed
comfortable, did
pull out of place
several times
tolerated well at
night, doesn’t
know it’s there
P5
P6
Sleep through night
does not wear a
diaper due to
PureWick
P1
P4
Simplified Care
did not appear
bothered by it, did
not seem to notice
it was there;
tolerated the use
of inverted
sanitary pad
delighted because
she wasn’t tied to
her bed
caregivers liked using
it, helpful with
providing info
highly desirable for this
patient
enjoyed using it,
provided detailed
information; care staff
were consistently
pleased with results
caregiver asked, ‘Why
didn’t the hospital
provide this?’
reduced diaper
changes from
2/night; discharged
from home health
during study due to
pressure sores
healing
alleviated patients
fear of falling during
diaper changes
improved sleep through the
night--instead of 2 diaper
changes with volunteer
awake for an hour after;
volunteer slept a few hours
later than normal
weaned off the
Foley catheter,
regained some
urination control,
began to walk to the
restroom; two weeks
into the trial was
able to consistently
9
go to the toilet and
patient discontinued
using PureWick
P7
excited with the
results
P8
did not seem to
notice the wick,
did not tolerate
tubing from the
wick when placed
where she could
see it
no discomfort
P9
P10
proud of her full
jars of urine in the
morning
P11
tolerated well
P12
P13
P14
P15
P16
no discomfort, did
not mind using it
no discomfort
new caregivers were
unwilling to attempt
using PureWick due to
unfamiliarity
increased fluid
intake and urine
output, better sleep,
improved energy
level, improved
appetite discharged
from hospice;
pressure sore
remains healed,
hasn’t developed
any more
learned to use it
quickly, gave positive
feedback
system was working
perfect, happy to not
wake up the volunteer
to change diaper
very enthusiastic and
supportive of use
enthusiastic about the
success
easy to use system
sleeping through the night
several days after starting the
trial
slept through the night half
the time, was restless and
active the rest of the nights
slept through the night,
previously awakened
2x/night for diaper changes
quickly adapted to sleeping
through urinations
volunteer has
retained caregivers
since using
PureWick system
Easy to learn and use
“diaper was always
dry”
10
National Institutes of Health (2013), “Skin Care and Incontinence” available at:
http://www.nlm.nih.gov/medlineplus/ency/article/003976.htm
i
Lambert, D. (2012), “Prevention of Incontinence-Associated Dermatitis in Nursing Home Residents”, available at:
http://www.annalsoflongtermcare.com/article/prevention-incontinence-associated-dermatitis-nursing-home-residents
ii
Ohio Bureau of Worker’s Compensation (2009), “Extended Care Facilities Safety Manual”, available at
https://www.bwc.ohio.gov/downloads.pdf
iii
Chen, YT. et al. (2009) “Potentially inappropriate urinary catheter indwelling among long-term care facilities
residents”, available at http://www.ncbi.nlm.nih.gov/pubmed/19522728
iv
National Institutes of Health (2010), Trautner, B. “Management of Catheter Associated Urinary Tract Infection
(CAUTI)” available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2865895/
v
Centers for Medicare and Medicaid Services (2011), “Home Health Study Report”, available at:
https://www.cms.gov/Medicare/Medicare-Fee-forServicePayment/HomeHealthPPS/Downloads/HHPPS_LiteratureReview.pdf
vi
Beeckman D, Van Lancler A, Van Hecke A, Verhaeghe S. (2014), “A systematic review and meta-analysis of
incontinence-associated dermatitis, incontinence and moisture as risk factors for pressure ulcer development”,
available at: http://onlinelibrary.wiley.com/doi/10.1002/nur.21593/abstract
vii
Doughty D, JunkinJ, Kurz P et al. (2012), “Incontinence-associated dermatitis. Consensus statements, evidencebased guidelines for prevention and treatment, current challenges”, available at:
http://journals.lww.com/jwocnonline/Citation/2012/09000/Incontinence_Associated_Dermatitis___Consensus.17.as
px
viii
Gray M, Bhoachek L, Weir D, Zdanuk J. (2007), “Moisture vs Pressure, Making sense out of perineal wounds”,
available at:
http://journals.lww.com/jwocnonline/Citation/2007/03000/Moisture_vs_Pressure__Making_Sense_Out_of_Perineal
.7.aspx
ix
11