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Hollister Continence Care
Clinical and
Laboratory
Evidence
The
Hygienic Benefits of a No-Touch Intermittent Catheter with
a Protective Tip and/or Sleeve
FAQs
Included
Introduction
Intermittent catheterization (IC) refers to the insertion and removal of a catheter into the urinary
bladder approximately 4-6 times a day to provide complete bladder emptying.1,2,3
Three methods of IC are noted in the literature: clean, sterile, and aseptic intermittent
catheterization. Lapides introduced the clean IC (CIC) technique in 1972.4 Clean technique
is performed by the patient and involves the use of sterile, disposable, or washed reusable
catheters, soap and water hand washing, and perineal cleansing, only if there has been
contamination by stool or other wastes.5 Over the years CIC has been accepted in the medical
community as standard practice by patients in the community, for management of urine retention
and/or neurogenic bladder.6 Catheter associated urinary tract infections may be a serious
problem for people who perform intermittent self-catheterization. 2,3,5
Recent initiatives have focused on the potential role of reused catheters and the increased
incidence of urinary tract infections.1 As a result, the Centers for Medicare and Medicaid Services
(CMS) have revised their policies for coverage to support single use catheters for individuals who
perform clean intermittent catheterization.7
Guttman and Frankel first introduced the sterile IC method and showed it significantly reduced
the risk of urinary tract infections (UTI) and/or bacteriuria, compared to any method previously
reported.8 Sterile technique implies the use of sterile gloves and catheters, and other equipment,
as well as genital disinfection prior to insertion. Sterile and aseptic technique have been used
interchangeably.5,8
Aseptic technique using a “closed system” was introduced as an alternative to strict sterile
technique that reduces the UTI risks associated with CIC, but is easier and more economical
for use in the community than sterile IC.9 The European Association of Urology has recently
published guidelines for IC, stating aseptic technique should be considered the method of choice
for intermittent catheterization. This group defines aseptic technique as, ‘the catheters remain
sterile, the genitals are disinfected, and disinfecting lubricant is used’.10 Since the catheter is
a closed system, virtually “touchless”, it means the catheter is not likely to be inadvertently
contaminated by the environment or by handling the catheter system.5 The touch-free closed
catheter system offers a protective introducer tip and sleeve, which helps ensure aseptic
insertion of a single use sterile catheter. The protective introducer tip allows the catheter to
bypass the initial 15 mm of the urethra which harbors perineal bacteria,5,6, 11 helping reduce the
risk of pushing harmful bacteria into the bladder, thus causing a urinary tract infection.11 Gloves
may be required, but a sterile external environment with gown and mask is not required.10
• CAUTIs are a
serious problem
for those
who perform
intermittent
self-catheterization
• A no-touch,
aseptic technique
is the preferred
method
• A no-touch
catheter with
protective tip and
sleeve has been
shown to reduce
the introduction
of bacteria to the
urinary tract
• Reducing the
introduction of
bacteria may help
reduce the risk
of CAUTIs
• The Advance
Plus intermittent
catheter has
a protective tip
and sleeve
The following summary of clinical and laboratory evidence has shown that a no-touch catheter
with a protective tip and sleeve, has been shown to reduce the introduction of bacteria to the
urinary tract. Reducing the introduction of bacteria to the urinary tract may help reduce the
risk of catheter associated UTIs (CAUTI). The Advance Plus intermittent catheter from Hollister
is hygienic by design because of the protective introducer tip and protective sleeve which
facilitates no touch aseptic IC.
This summary of Clinical and Laboratory Evidence is based on a selection of literature, and did not include a full review of all literature.
Note: Introducer tip is also referred to as Protective tip by some authors, so these terms are used interchangeably in this document.
1. PVA. Bladder Management for Adults with Spinal Cord Injury: A Clinical Practice Guideline for Health Care Providers. 2006.
2. Wyndaele JJ. Complications of Intermittent Catheterization: Their Prevention and Treatment. Spinal Cord 2002; 40; 536-541.
3. Woodbury MG, Hayes KC, Askes HK.Intermittent Catheterization Practices following Spinal Cord Injury: A National Survey. Canadian Journal Urology 2008; 15(3), 4065-4071.
4. Lapides J, Diokno AC, Silber SJ, Lowe BS. Clean intermittent self-catheterization in the treatment of urinary tract disease. J Urol 1972; 107(3): 458-61.
5. Newman DK & Wein AJ. Managing and Treating Urinary Incontinence. Baltimore. Health Professions Press 2009;444-6,452-5.
6. Madersbacher H, Wyndaele JJ, Igawa Y, Chancellor M, Chartier-Kastler E & Kovindha A. Conservative management of neuropathic urinary incontinence. In: Abrams P, Khory S, Wein A (eds)
Incontinence 2nd edn. Health Publication Ltd: Plymouth 2002;pp 697-754.
7. Local Coverage Determination for Urological Supplies, L27219, CMS 4-01-08.
8. Guttman L, Frankel H. The value of intermittent catheterization in the early management of traumatic paraplegia and tetraplegia. Paraplegia 1966; 4(2): 63-84.
9. Hudson E, Murahata R. The “No-Touch” Method of Intermittent Catheter Insertion: Can it Reduce the Risk of Bacteria Entering the Bladder? Spinal Cord 2005;43;611-614.
10.Stöhrer M, Castro-Diaz D, Chartier-Kastler E, Karmer G, Mattiasson A, Wyndaele. J. Guidelines on neurogenic lower urinary tract dysfunction. Eur Assoc Urol Guidelines 2003; 1-40.
11.Bennet CJ, Young MN, Salman SR, Adkins R, Diaz F, McCrary. The effects of urethral introducer tip catheters on the incidence of urinary tract infection outcomes in spinal cord injured
patients. J Urology 1997; August, 158:519-521.
3
Clinical Study Summary
The Effect of Urethral Introducer Tip Catheters on the
Incidence of Urinary Tract Infection Outcomes in Spinal Cord
Injured Patients
Bennett CJ, Young MN, Razi SS, Adkins R, Diaz F, and McCrary A.
J Urol 158, No. 2 (1997): 519-21.
Objectives
The aim of this study was to determine whether catheters with an introducer tip reduced urinary
tract infections in spinal cord injured patients who performed self-intermittent catheterization.
Methods
11 tetraplegic and 16 paraplegic males participated in this study. The MMG/O’Neil catheter
system was used, which consists of a plastic catheter enclosed in a pre-lubricated plastic sleeve,
and introducer tip which protects the catheter from the first 15 mm of distal urethra bacteria.
All catheterizing patients were asked to use one of two systems: The MMG/O’Neil with the
introducer tip or the MMG/O’Neil with the introducer tip removed. Urodynamics, urine cultures,
and urinalyses were performed and tracked.
Subjects were enrolled into 4 groups based on their ability to reflex void:
• Group 1: Intermittent catheterization with introducer tip catheter; not spontaneously voiding
or wearing external urinary catheter
• Group 2: Intermittent catheterization with non-introducer tip catheter; not spontaneously
voiding or wearing external urinary catheter
• Group 3: Intermittent catheterization with introducer tip catheter; voiding by reflex and
wearing external urinary catheter
• Group 4: Intermittent catheterization with non-introducer tip catheter, voiding by reflex and
wearing external urinary catheter
Results
In comparable non-voiding groups, the difference between the introducer and non-introducer
tips was clearly significant (p < 0.0093), as was the overall difference between all introducer tip
catheter groups compared to all non-introducer tip catheter groups (p < 0.01).
4
Table 1 Number of Catheterizations and Significance According to Group*
Intermittent catheterization only
Intermittent catheterization, reflex voiding,
and external urinary catheter
Group 1 (tip)
n = 11
Group 3 (tip)
n=3
Group 2 (no tip)
n=9
Group 4 (no tip)
n=4
40
80
82 (28-256)
60
40
34 (20-84)
20
0
1
2
Mean Catheterizations/Infection (range)*
Mean Catheterizations/Infection (range)*
100
35
36 (21-56)
33 (22-46)
30
25
20
15
10
5
0
3
4
The above graphs show the mean number of catheterizations and range prior to an infection.
Between and within all groups p <0.0306. Group 3 versus group 4, and groups 1 and 2 versus groups 3 and 4 were not significant.
*Actual article mentioned additional statistics.
Conclusion
According to this study, the MMG/O’Neil catheter with introducer tip significantly decreased urinary tract
infections in hospitalized, spinal cord injured men who performed intermittent catheterization.
5
Clinical Study Summary
A New Catheter for the Female Patient
O’Neil AG, Jenkins DT, and Wells JI.
Aust. N.Z. J Obstet. Gynecol. 22 (1982): 151-152.
Objectives
The goal of this study was to determine if a new method of catheterizing female patients using
a new catheter with a sealed introducer tip (O’Neil) would reduce the transfer of organisms from
the distal urethra to the bladder at the time of catheterization.
Methods
132 female patients from 2 centers were enrolled in the study. Urine specimens were taken
before and after intermittent catheterization. 2 groups were formed:
• Control Group: Used a 14 Nelaton catheter
• Experimental Group: Used the new catheter with introducer tip
The O’Neil tip catheter and introducer tip consists of a plastic catheter enclosed in an introducer
tip, with a rubber flange, which prevents the tip from being introduced beyond the first 15 mm
(previous study showed potential pathogens in the distal urethra in 90% of females1). This tip
protects the catheter from the first 15 mm of distal urethra bacteria, and therefore the catheter
enters the bladder without being in contact with the distal urethra.
Results
25% of patients (17/67) who were catheterized in the Control Group developed bacteriuria as a
result of the catheterization. For those in the Experimental Group, using the O’Neil catheter with
introducer tip, only 4% of patients (2/52) developed bacteriuria. This was a statistically significant
result (p < 0.005).
Due to pre-existing bacteriuria, 13 of the 132 patients were excluded from the study.
Table 1 Urinary Infection Rates in the Experimental and Control Groups
Total No.
Pre-existing
Bacteriuria
>10 5
Infection Rate
Control Group
Glasgow
57
5
Perth
75
8
11/42
1/25
Total
132
13
17/67
2/52
6/25
Infection Rate
New Catheter
1/27
Conclusion
According to this study, the O’Neil catheter introducer tip reduced the transfer of organisms from the first
15 mm of the distal urethra to the bladder, which may help reduce catheter acquired urinary tract infections
(CAUTIs) in females.
6
Laboratory Study summary
The ‘No-Touch’ Method of Intermittent Urinary Catheter Insertion:
Can it Reduce the Risk of Bacteria Entering the Bladder?
Hudson E, and Murahata R.
Spinal Cord. 43; 611-614.
This study was authored by Hollister employees and funded by Hollister Incorporated.
Objectives
This in vitro model was conducted to determine whether the no-touch protective sleeve affects
the degree of contamination to the catheter while being prepared and inserted.
Methods
•6 different types of intermittent catheters were tested in triplicate
•Gloved hands were contaminated with known amounts of S. aureus or E. coli and intermittent
catheter preparation for insertions mimicked manufacturer’s instructions
•Bacteria transferred to the catheter was quantified and validated using a validated technique.
Negative controls were non-handled samples
Catheters A, B, C: Standard hydrophilic catheters
Catheter D: Hydrophilic catheter handled through the wrapper
Catheters E, F: Gel catheters with no-touch sleeve
Results
1000
100
240 410 260
10
1
210
17
A
B
400 440
32
7
5
C D E
E. coli
F
A
B
5
5
C D E
S. aureus
F
CFU (colony forming unit)
CFU (colony forming unit)
The bacteria count on catheter E and F was significantly lower than that recovered from the
traditional hydrophilic catheters (p < 0.05).
1000
100
330
78
1
73
20
E. coli
S. aureus
Catheter A – EasiCath (Coloplast, Humlebaek, Denmark)
Catheter B – SpeediCath (Coloplast, Humlebaek, Denmark)
Catheter C – LoFric (Astra Tech, Mölndal, Sweden)
Catheter D – LoFric H2O (Astra Tech, Mölndal, Sweden)
Catheter E – Hollister Advance Intermittent Catheter (Hollister, Illinois, USA)
Catheter F – VIALOG Mobile (Medical Service, Bad Liebenzell, Germany)
Conclusion
The in vitro model showed that intermittent catheters with the hygienic feature of a no-touch sleeve helped
reduce the potential for external contamination during preparation and insertion of an intermittent catheter.
This reduction may help reduce the risk of bacteria entering the bladder.
7
LABORATORY Study Summary
Benefits of Hygienic Design as Demonstrated
by Laboratory Testing
Murahata R, and Nichols T.
Presented at ICS, Toronto, Canada, August 2010.
Objectives
An in vitro laboratory test was conducted to compare degree of contamination transmitted to the
catheter with a protective tip and one without, when inserted through a laboratory urethral model.
Methods
•Commercially available sterile catheters with* and without** a protective tip were used
in the experiment.
•A centrifuge tube containing a 15 mm thick layer of agar, contaminated with either S. aureus
or E. coli, was designed as a model to simulate the urethra contaminated at the distal end
•The urethra pathway was simulated by leaving a pipette in situ until the agar had set
•Each catheter type was tested in triplicate for each of the test microorganisms. Negative
controls were tested the same way with uninoculated agar
•Suspensions of E. coli and S. aureus were prepared as the microbial challenge
•Using sterile gloves and scissors, the catheters were cut into sterile containers once the
catheters were extended through the agar
•The microorganisms present on all of the catheters and the negative controls were
determined via bioburden extraction and validated plate count procedure
Figure 1 Diagram of model designed to simulate urethra contaminated in the distal end.
1. .50 mL Centrifuge tube
2. Contaminated agar
3. Catheter with protective tip
4. Protective tip
5. Catheter without protective tip
* Advance Intermittent Catheter
** Lo-Fric Insti-Cath
8
Results
The number of bacteria found on catheter without protective tip, was 4 times that on catheter with protective tip for both
E. coli, and S. aureus, and the difference reached statistical significance for S. aureus (p = 0.0309).
Figure 2
2
5
5
D E
s
F
CFU (colony forming unit)
Catheter without
Protective Tip
Catheter with
Protective Tip
1000
100
330
78
1
73
20
E. coli
S. aureus
Conclusion
The results obtained using this in vitro model support the premise that catheters with introducer/protective
tip can help reduce the level of contamination from distal urethra on insertion of an intermittent catheter.
9
Frequently Asked Questions
1
Q: What is the importance of a protective tip when selecting a catheter?
A: Clinical evidence has shown that the protective tip on an intermittent catheter bypasses
the first 15 mm of the distal urethra, and in doing so, reduces the bacteria that are
pushed up into the bladder. The protective tip has been shown to reduce the potential
for catheter contamination which may help reduce the risk for infection.1,2,3
2
Q: What are the advantages of having both the protective tip and sleeve features
on an intermittent catheter? A: The protective tip and sleeve help guard against contamination both from the
environment and the distal urethra. The protective tip and sleeve allow a no-touch
technique to be used, which means there is no direct hand contact on the catheter,
thus reducing the introduction of bacteria into the urethra1,2,3 These features may help
reduce the risk for infection.
3
Q: Is there any clinical evidence that shows that a protective tip and/or protective
sleeve on an intermittent catheter helps reduce the risk of infection for patients
who self-catheterize?
A: Yes. Both the Bennett et al. and O’Neil clinical studies indicate that a protective
tip on a catheter may help reduce the risk of infection for those catheterizing.
The Hudson/Murahata laboratory studies suggested that a gel pre-lubricated
intermittent catheter with a true no-touch protective sleeve and protective tip may
help reduce the risk of bacteria being transmitted to the catheter.
4
Q: What catheterization technique does the European Association of Urology (EAU)
recommend in their Guidelines?
A: Aseptic technique is recommended by the EAU Guidelines as the method of choice.4
IC in general is the gold standard for the management of neurogenic lower urinary
tract dysfunction.
5
10
Q: What are the three methods of intermittent catheterization?
Sterile
(Hospital Aseptic)
Aseptic*
(Outside of Institution)
Clean
Hygienic hand disinfection
Yes
Yes
No
Sterile gloves
Yes
Sometimes
No
Sterile cover
Yes
No
No
Protective gown
Yes
No
No
Antisepsis of urethral opening
and surrounding area
Yes
Yes
No
Sterile intermittent catheter
Yes
Yes
No
Disinfecting lubricant*
Yes
Yes
No
* Some authors indicate sterile lubrication is sufficient for Aseptic technique. Aseptic technique is defined
differently by the EAU and by Knopf, the difference being the EAU includes use of a disinfecting lubricant.
References
1. Bennett CJ, Young MN, Raze SS, Adkins R, Diaz F, and McCrary A.
The Effect of Urethral Introducer Tip Catheters on the Incidence of Urinary Tract Infection Outcomes in Spinal Cord Injured Patients. Journal
Urology 158, No. 2 (1997): 519-21.
2. O’Neil AG, Jenkins DT, and Wells JI.
A New Catheter for the Female Patient. Aust. N.Z. J Obstet. Gynecol. 22 (1982): 151-152.
3. Catheter Contamination Study Using a Laboratory Urethral Model. Data on file at Hollister Incorporated. (Study conducted April 2006).
4. Stöhrer M, Castro-Diaz D, Chartier-Kastler E, Karmer G, Mattiasson A, Wyndaele. J.
Guidelines on neurogenic lower urinary tract dysfunction.
Eur Assoc Urol Guidelines 2003; 1-40.4.
5. Knopf HJ, Brühl P.
Intermittent Catheterization – Clean or Aseptic (German). Hyg Med. 2002, 27 Jan: 33-36.
6. Day R, Moore K, Albers M.
A Pilot Study Comparing Two Methods of Intermittent Catheterization: Limitations and Challenges. Urologic Nursing 2003: 23 (2); 143-147.
7. PVA.
Bladder Management for Adults with Spinal Cord Injury: A Clinical Practice Guideline for Health Care Providers. 2006.
8. Wyndaele JJ. Complications of Intermittent Catheterization: Their Prevention and Treatment. Spinal Cord 2002; 40; 536-541.
9. Woodbury MG, Hayes KC, Askes HK.
Intermittent Catheterization Practices following Spinal Cord Injury: A National Survey. Canadian Journal Urology 2008; 15(3), 4065-4071.
10.Lapides J, Diokno AC, Silber SJ, Lowe BS.
Clean intermittent self-catheterization in the treatment of urinary tract disease. Journal Urology 1972; 107(3): 458-61.
11.Newman DK & Wein AJ.
Managing and Treating Urinary Incontinence. Baltimore. Health Professions Press 2009; 444-6,452-5.
12.Guttman L, Frankel H.
The value of intermittent catheterization in the early management of traumatic paraplegia and tetraplegia. Paraplegia 1966; 4(2): 63-84.
13.Hudson E, Murahata R.
The “No-Touch” Method of Intermittent Catheter Insertion: Can it Reduce the Risk of Bacteria Entering the Bladder?
Spinal Cord 2005;43;611-614.
14.Madersbacher H, Wyndaele JJ, Igawa Y, Chancellor M, Chartier-Kastler E & Kovindha A.
Conservative management of neuropathic urinary incontinence. In: Abrams P, Khory S, Wein A (eds) Incontinence 2nd edn. Health Publication Ltd:
Plymouth 2002;pp 697-754.
11
Clinical and Laboratory Evidence
Support your Practice with Evidence-Based Research
The Hygienic Benefits of a No-Touch Intermittent Catheter
with a Protective Tip and/or Sleeve
No-Touch Features
Clinical and Laboratory Evidence
The Effect of Urethral Introducer Tip Catheters on
the Incidence of Urinary Tract Infection Outcomes in Spinal
Cord Injured Patients
Bennett CJ, Young MN, Raze SS, Adkins R, Diaz F, and McCrary A.
J Urol 158, No. 2 (1997): 519-21.
Protective
Tip
Protective
Sleeve

A New Catheter for the Female Patient
O’Neil AG, Jenkins DT, and Wells JI.
Aust. N.Z. J Obstet. Gynecol. 22 (1982): 151-152.

*
The ‘No-Touch’ Method of Intermittent Urinary
Catheter Insertion: Can it Reduce the Risk of Bacteria
Entering the Bladder?

Hudson E, Murahata R.
Spinal Cord: 43; 611-614.
*Day R, Moore K, Albers M. A Pilot Study Comparing Two Methods of Intermittent Catheterization: Limitations and Challenges.
Urologic Nursing 2003: 23 (2); 143 - 147.
Warning:
To help reduce the potential for infection and/or other complications, do not reuse. Dispose of appropriately after procedure.
If discomfort or any sign of trauma occurs, discontinue use immediately and consult your healthcare professional.
Caution:
Federal (USA) law restricts intermittent catheters to sale by or on the order of a licensed healthcare professional.
Prior to use of this device, be sure to read (i) the complete information on how to use this device including Warnings, Cautions, and
Instructions for Use, and (ii) all other package inserts and labels supplied with the product and accessories.
Please consult a medical professional before using this product if any of the following conditions are present:
Severed urethra, unexplained urethral bleeding, pronounced stricture, false passage, urethritis – inflammation of the urethra,
prostatitis – inflammation of the prostate gland, epididymitis – inflammation of the epididymis (testicle tube).
Self-catheterization should only be carried out after medical advice and only in accordance with the instructions provided. Always
follow the care plan and advice given by your healthcare professional. For urethral intermittent self-catheterization (ISC), it is typical
to catheterize at least 4 times a day at intervals of 6 to 8 hours. If you are unsure about your catheterization, please contact your
regular healthcare professional.
Hollister and logo, Advance, and Advance Plus are trademarks of Hollister Incorporated.
EasiCath and SpeediCath are trademarks of Coloplast A/S.
LoFric and LoFric H2O are trademarks of Astra Tech.
VIALOG Mobile is a trademark of Medical Service.
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Libertyville, IL 60048 USA
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