Download US Peristeen launch update January 2012

Encouraging Independence and Promoting Confidence Through
Improved Bowel and Bladder management.
30 January 2012
Update Peristeen US
About the presentation
The following materials are presented for general information purposes only.
They do not constitute medical advice and should not be a substitute for
consultation with a trained medical professional.
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Disclosure: Amy Dannels-McClure RN, ND
Amy Dannels-McClure is currently a Clinical Consultant for Coloplast
Corporation.
Amy has worked with patients with neurogenic bowel and bladders
since graduating from University of Colorado Health Sciences Center
in 2004 and continues her passion for this area of healthcare.
DISCLOSURE Amy Dannels-McClure discloses that she is a full time
employee of Coloplast Corp.
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What will we cover in this presentation?
The focus of the presentation is to give you tools to better understand
bowel and bladder function and provide you with the latest in
management options:
BLADDER
BOWEL
•
Bowel function-how exactly do
we evacuate stool?
•
Bowel health-preventing
constipation and bowel accidents
• Bladder management options
•
Bowel management options-
absorptive products, male external
catheters, intermittent catheters,
determining which product will help
Diet, medications, digital removal,
enemas, gaining independence
and confidence in your bowels
• Bladder function-how does the
bladder work?
• Bladder health and hygiene-
preventing UTIs
gain the most independence
What’s new in the world of bladder
management!
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What’s new for bowel
management!
How does SB affect the bladder?
Nerves below affected lesion do not work properly
• Neurogenic bowel: disruption of intrinsic nervous system control
• Neurogenic bladder: disruption of nervous system control on the bladder
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Neurogenic Bladder-a disconnect between the brain
and the bladder
Failure to Store: Incontinence
– Because of Bladder
– Because of Outlet
– Combined Bladder and Outlet
Failure to Empty: Retention
– Because of Bladder
– Because of Outlet
– Combined Bladder and Outlet
•
•
•
•
•
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Can lead to:
High pressure bladder
Secondary vesicoureteral reflux
Hydronephrosis
Renal Failure
Bladder Health: Preventing urinary tract infections
• Use proper hand washing
techniques-clean your hands to help
prevent germs from entering the
bladder when you cath.
• Discard the catheter after each use-
single use catheters are accessible to
most now.
• Regularly empty your bladder-
• Drink adequate fluids-you want to
keep the urine clear and the bladder
flushed.
• Use good hygiene when cleaning
area-wipe from front to back.
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empty the number of times prescribed
by your provider in order keep the
volume of fluid in your bladder low.
The Centers for Medicare and Medicaid Services expanded
catheters allowed per month for single use on April 1, 2008
Many other insurers have expanded policies
• CMS issued a change in policy for Medicare,
following initiatives already initiated for Medicaid
and the VA system
• Increased allowable number of catheters per
month to follow catheter labels for single use
• Medicare now allows a new catheter for each time
you catheterize, up to 200/month; other insurance
may have different numbers they allow per month,
but most have expanded coverage
• You may need to get a new prescription from your
doctor for insurance to cover single use
• Hydrophilic and uncoated catheters were both
included and covered the same
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Selecting a bladder management option best for the
patient
GOAL: Protect the kidneys!
Option based on patient condition and individualized needs
Behavioral Management
Catheterization
• Prompted toileting
• Indwelling (Foley) catheters
• Biofeedback
• Supra pubic catheters
• Devices (bedpans, urinals)
• Intermittent catheters
Containment
• Absorbent products
(underpads, briefs)
• Male external catheters
Pharma/ Surgical Options
• Medications
• Mitrofanoff procedure
• Bladder augmentation
• Bladder neck procedures
• Urinary diversion
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INTERMITTENT CATHETERS
IN
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OUT
Intermittent Catheters:
Alternative to indwelling catheter for long term management
A catheter is inserted into the bladder through the urethra or Mitofanoff channel
After the bladder is emptied, the catheter is removed and discarded.
Regular bladder emptying prevents the bladder from
overfilling and losing muscle tone.
 avoids urinary retention
 avoids overflow incontinence.
 preserves kidney function
Regular bladder emptying eliminates residual urine
♦ decreases bacterial growth
♦ avoids urinary leakage between episodes
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Regular emptying?
Which catheter will encourage this practice best?
Child
Adolescence
Adult
Your needs may change over time
Speak with your healthcare provider if you experience any the following or want to know about new products:
Problems
Possible Experiences
Possible Solutions
Dexterity
Difficulty handling the catheter or opening the
packaging
An easier to handle package or a catheter that is
pre-lubricated (hydrophilic) to encourage
independence and successful transition to self cathing.
Sensation
Catheterization uncomfortable or painful
Hydrophilic catheter (pre-lubricated)
Mobility
Challenges transferring to a toilet vs. cathing
in a wheelchair or while outside the home
Closed system / set (catheter w/bag)
extension tubing
Insertion
More difficulty passing the catheter
Hydrophilic catheter (pre-lubricated) or a
Coudé tip catheter
Infection
Experiencing more frequent UTI’s
Closed system / set (catheter w/bag)
Coverage or other insurance issues
Dealers are experts in insurance billing.
Manufacturers of catheters know which suppliers carry
their catheters.
Insurance
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Why were hydrophilic catheters developed?
Hydrophilic coated catheters developed to:
Minimize risk of complications
•
Reduce friction on insertion and withdrawal
•
Minimize risk of urethral trauma
•
Prevent catheter sticking to urethral mucosa
•
Easier to do catheterization
•
Improve compliance
Offer comfort and security
•
Allow for ease of use
•
Promote quality of life
Stensballe, et al, 2005 and Chartier-Kastler et. Al, 2011
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Convenience very important to consider
Convenience and ease-of-use
includes many characteristics
• Packaging easy to open
• Quiet to open and use
• Catheter easy to hold
• Catheter easy to insert
• Less friction—in and out
• Fewer steps to catheterize
• Portability of catheters
• Don’t have to wash catheters
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“Catheters that are
more convenient
and easy to use
may result in better
long-term
compliance.”
Chartier-Kastler E and Denys P,
Neurourol and Urodyn 2011;
30:21-31
Patient Considerations
Benefits of Intermittent Catheterization for bladder management include:
• Continence
• No need for a urine collection (drainage) bag
• The need for absorbent products is minimized
• Less moisture associated skin care issues
• Promotes control, confidence and self esteem
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Be your own best advocate
Do you take
my insurance/
Medicare/Medicaid plan?
Are there
other/new catheter
options that might
work better for me?
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Do you accept
assignment for my
preferred brand
of catheter?
How does SB affect the bowel?
Nerves below affected lesion do not work properly
• Neurogenic bowel: disruption of intrinsic nervous system control
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When the bowel and brain disconnect
• Rectum and Sigmoid colon
contract to push feces into
anal canal
• Full anal canal causes
internal sphincter to relax
• Voluntary external sphincter
is relaxed AND pelvic floor
relaxes
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Neurogenic Bowel
Disruption of normal intrinsic nervous systemloss of control of bowel emptying:
Increased colonic transit time
• Constipation
Relaxation of anal sphincter
• Fecal Incontinence
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Patients with neurogenic bowel have limited or no anal
sphincter control
Intact control
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No/limited control
Bowels…MAJOR impact on Quality of life!
66% of children over age 6 with fecal incontinence
report major influence on social activities
Pediatric patients with neurogenic bowel dysfunction have lower
quality of life expression
•
emotional, physical, psychological distress
•
school absences
•
social discrimination
•
low self-esteem
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When do we start bowel program?
Medical deicisions: KUB to assess fullness of stool in the colon, stool
diary to develop pattern, history of bowel management treatments.
• Are they struggling with frequent UTIs?
• Is skin breakdown an issue from either continence products or
accidents?
• Are they having GI complaints (such as abdominal pain, anorexia or
poor weight gain)?
Usually a social concern rather than medical
• Each child will have a different tolerance to when they want to
begin a program
• Child should lead the initiative for intervention
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Factors to be considered when selecting a bowel regime
Development
• Has child met other
developmental milestones
appropriately?
• Has a toileting process been
taught by the family?
• Is the child continent of urine?
• Any confounding learning
disabilities?
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Psychosocial
• Self-esteem
• What is child’s peer support
group like? Bullies?
• Are peers/school aware of
medical needs?
• Are their extracurricular
events and social activities
that a child isn’t doing
because of bowel concerns?
• Are peers detecting odor
from diapers or fecal
incontinence?
Management options
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Conservative Measures
(After a good clean-out!)
• Diet (fiber) and water intake
• Toileting 2-3 times per day after meals
• Proper positioning
• Supported feet
• Biofeedback
• Inconclusive success but creates an awareness of defecation process
• If child has strength of external sphincter this may increase
• Digital stimulation is an inexpensive way of eliciting rectal
emptying but works only if the reflex arc is intact.
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Transanal Irrigations
• Cone Enema and Peristeen® Enema systems
• More of the colon is washed out
• Decreases fecal incontinence episodes over use of
conservative measures alone
• Less invasive than surgical intervention
• Often used in conjunction with laxative/
softeners to keep good stool consistency
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Peristeen vs. traditional large volume enemas
Peristeen Anal Irrigation System
Large volume Enema1
Class II
Class I
Yes
No
Device used to hold water in rectum
Catheter with built in retention balloon
designed for the rectal vault
Cone shaped device (indicated
for stoma irrigation) or catheter
without rectal retention balloon
Documented level of colon cleansed
Complete descending colon, sigmoid and
rectum2
Rectum & sigmoid colon
Expected outcomes
Free of feces/flatus for up to 2 days2
Rectum will be free of
feces/flatus-stool may be still
present and expelled at any time
Method of delivery
Manual control pump-encourages
independence and allows for control of the
flow of water
Lubricate required
No- catheter has a hydrophilic coating
yes
Dwell time of fluid in colon
None
Most recommendations state 1030 minutes or as long as one can
retain the fluid
Volume of fluid to instill
1-1000mL customized per patient
500-1000mL
Position of user during procedure
Sitting on toilet
Preferrably on their side
FDA classification
Prescription required
1 Christensen
Gravity only
P, et al. Scientigraphic Assessment of retrograde Colonic Washout in
30 January 2012
Fecal Incontinenece
Update Peristeen US and Constipation. Diseases of the Colon & Rectum 2003: 46:
2 Foundations
27
68-76.Page
of Nursing Third Edition, Lois White RN, PhD delmar Cengage
Learning 2011, Nursing Procedures Chapter 29; procedure 29-29: pages 762-766.
Peristeen® System
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How....... does Peristeen work?
• Peristeen assists the evacuation of feces from the
bowel by introducing water into the rectum via a
catheter (with retention balloon) inserted in the rectum.
Other characteristics:
• Only requires tap water
• May be used daily or every other day
• May be used by people with limited manual dexterity
• Self-administered or with assistance from a caregiver
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Transanal irrigation difference
Works to empty contents of rectum, sigmoid and
descending colon
Feces present in
descending colon
and rectum before
TAI
Descending colon
and rectum empty
Christensen P, et al. Dis Colon Rectum. 2003 Jan;46(1):68-76. Scientific assessment of retrograde colonic washout in fecal
after TAI
Incontinence & constipation.
K.Krogh, N.Olsen et al Colorectal transport in normal defaecation Colorectal desease 2003 5, 185 - 192
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First patient’s feedback US....
The best part is we are able to skip some nights which is a huge help on those
busy weekends! “We started a bowel management routine with Brianna when she was
2 ½ years old. The main reason why we started was to reduce urinary tract
infections. Before the bowel management routine, we were using Miralax and Brianna
always had something in her diaper. We thought it was the cause of the UTI’s. We
started with the cone enema. It was working; however, we had to do the enema nightly
and it took about an hour and a half to administer and sit on the toilet. In December
2012, we went to Cincinnati Children’s to fine tune the cone enema. They had us try a
balloon enema. This balloon enema did not work because the balloon would not stay
during the transfer from the floor to the toilet. We had a mess all over! This routine also
took about an hour and a half to perform.
In April 2013, we started using the Peristeen product for bowel management. I am able
to perform this on the toilet. The best part is we are able to skip some nights which is a
huge help on those busy weekends! We are even thinking about going camping for a
weekend! With the other products, Brianna would need to be near a toilet every
day. The other benefit is the whole routine takes less time. We are able to complete it in
about an hour. I have noticed that I am able to clean her out better more often. Before I
would have a successful clean out about 70% of the time. With the Peristeen, we have a
successful cleanout about 95% of the time. This product has eliminated accidents.”
Thanks Angela
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Where do we go from here…
University of Iowa Children’s Hospital and Clinics Iowa City, Iowa
• Kris Bonnett NP
Josh Petersen NP
• Dr. Eyed M. Hanna Division of Gastroenterology
• Dr. Chris Cooper
Dr. Doug Storm
Omaha Children’s Hospital Omaha, Neb (Peds only and current pt)
• Jill Bell NP
Dr. Steven Raynor
• Kristin Madden NP Megan Enebach NP
Genesis Rehab Hospital Davenport, Iowa (Adults only)
• Shani Marland RN
• Dr. Conway Chin
Madonna Rehab Hospital Lincoln, Nebraska (Peds and Adults)
• Dr. Krabbenhoft
• Dr. Kafka
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THANK YOU!!
Questions?
How much
Longer!?
30 January 2012
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