Intermittent catheterisation with hydrophilic and non-hydrophilic urinary catheters: systematic literature review and meta-analyses
Rognoni and Tarricone BMC Urology
Intermittent catheterisation with hydrophilic and non-hydrophilic urinary catheters: systematic literature review and meta-analyses
Carla Rognoni 0
Rosanna Tarricone 0 1
0 Centre for Research on Health and Social Care Management (CERGAS), Bocconi University , Via Roentgen 1, Milan 20136 , Italy
1 Department of Policy Analysis and Public Management, Bocconi University , Via Roentgen 1, Milan 20136 , Italy
Background: Intermittent catheterisation is the method of choice for the management of bladder dysfunctions. Different urinary catheters are available, but there is conflicting evidence on which type of catheter is best. The present study provides an objective evaluation of the clinical effectiveness of different subsets of urinary catheters. Methods: A systematic literature review was performed for published RCTs regarding hydrophilic coated and PVC (standard) catheters for intermittent catheterisation. Separate meta-analyses were conducted to combine data on frequencies of urinary tract infections (UTIs) and haematuria. Two separate analyses were performed, including or excluding reused standard catheters. Results: Seven studies were eligible for inclusion in the review. The meta-analyses exploring UTI frequencies showed a lower risk ratio associated with hydrophilic catheters in comparison to standard ones (RR = 0.84; 95% CI, 0.75-0.94; p = 0.003). Results for the “reuse” scenario were consistent with the ones related to “single-use” scenario in terms of frequency of UTIs. The meta-analyses exploring haematuria were not able to demonstrate any statistically significant difference between hydrophilic catheters in comparison to standard ones. Conclusions: The findings confirm previously reported benefits of hydrophilic catheters but a broader evaluation that takes into account also patient preferences, compliance of therapy, quality of life and costs would be needed to assess the economic sustainability of these advanced devices.
Intermittent catheterisation; Urinary catheters; Hydrophilic catheters; Urinary tract infections; Haematuria
Normal bladder functionality can be lost due to
neurogenic or non-neurogenic causes. Neurogenic
bladder disorders are seen secondary to spinal cord injury
(SCI), multiple sclerosis or spina bifida. Common
nonneurogenic bladder disorders include outlet obstructions
(e.g. benign prostate hyperplasia) and post-operative
Management of bladder dysfunctions aims to improve
continence and bladder functionality, protect the upper
urinary tract and improve patients’ quality of life.
Antimuscarinic agents are the preferred treatment for
patients with storage dysfunction, while intermittent
catheterisation (IC) is the preferred choice for patients
with significant voiding problems [1, 2].
Although antimuscarinic agents are effective, well
tolerated and safe, they have no long-lasting therapeutic
effects and bladder dysfunction recurs immediately after
therapy suspension. As a result, treatment should be
continued for the patient’s lifetime. Available alternative
treatments include intra-detrusor injection of botulinum
toxin and neuromodulation. Botulinum toxin causes a
reversible chemical denervation, lasting for approximately 9
months, which can significantly improve bladder
functionality. Electrical stimulation of peripheral nerves (e.g. sacral
or pudendal nerve), interrupting inappropriate detrusor
contractions, has proved to be effective in managing the
idiopathic overactive bladder , but for patients with an
underlying neurological disorder, its role still remains
In patients with bladder storage dysfunction, urinary
catheterisation can be required in combination with
antimuscarinic agents, botulinum toxin or
neuromodulation if voiding problems occur. Incomplete bladder
emptying can either be managed by a permanent
urethral/suprapubic catheter or IC. European guidelines
focusing on neurogenic lower urinary tract dysfunctions
[4–6] report that IC is the option of choice for patients
resulting in high post-void residual volumes, especially
for patients with SCI . IC is a manual bladder
emptying technique performed regularly about four to six
times a day by a patient themselves or a caregiver; the
catheter is inserted through the urethra and removed
once the bladder has been drained from urine. This
method limits the complications and improves the
prognosis of the patients .
One of the major advantages of IC is the significant
reduction in the risk of catheter-induced UTIs, resulting
in maintenance of urinary tract health and protection of
the kidneys [9, 10]. In 2010 the International
Consultation on Incontinence concluded that IC is effective and
safe for emptying the bladder both in the short and long
terms, but that bladder and urethral complications
increase in the long term . These complications are
mainly represented by recurrent UTIs, which are one of
the most important problems of patients with lower
urinary tract dysfunction. These infections, if not treated
properly, can lead to kidney infections, resulting in
kidney failure and risk of sepsis . UTIs also cause high
morbidity and result in frequent hospitalisations .
Moreover, repeated cycles of antibiotic therapy necessary
in patients with a recurrent UTI cause the onset of
“antibiotic resistance” in various strains of
microorganisms involved in the infection . For these reasons,
UTIs impose in general a relevant economic burden on
patients and their families as well as on the healthcare
IC performed several times a day places the individual
at risk also for urethral trauma, often measured by the
occurrence of haematuria. Urethral trauma is associated
with an increase in UTI risk [15, 16].
There are different catheters suitable for IC, for
example, disposable catheters with a hydrophilic polymer
surface coating, disposable catheters with pre-packaged
water based lubricant, and uncoated catheters. Uncoated
catheters may be discarded after use or washed and
reused for different days.
Two possible advantages of hydrophilic coated catheters
over uncoated ones are the reduction of urethral trauma
(e.g., haematuria) and the incidence of symptomatic UTIs.
Currently, although there are trends in favour of
hydrophilic coated catheters with respect to UTIs [17–19] in
the short term, there is little consensus on which type of
catheter is best. Four meta-analyses have been previously
published investigating the impact of hydrophilic coated
catheters (and other catheter types) on UTI rate and
urethral trauma among patients practicing IC [20–23]. Two
meta-analyses concluded that hydrophilic coated catheters
are associated with a risk reduction of UTI [20, 23] and
trauma  as compared to non-hydrophilic catheters,
while two others were inconclusive and unable to
differentiate between catheter types or techniques [21, 22].
According to Clark et al.  the effect size of UTI reduction
were 21% in hospital setting and 53% in the long-term
community setting  while Li et al.  reported a risk
reduction of 64%  associated to hydrophilic coated
catheters. The other two meta-analyses [21, 22] allowed
more catheter types in the comparison and as such the
included studies were more heterogeneous and, accordingly,
they showed no treatment difference between catheter
types or catheter techniques in terms of UTI rate. In
addition, they concluded that the number of randomised
controlled trials were too low and compromised by quality
issues [21, 22]. Two studies added cost-effectiveness data
based on the results of the meta-analyses [20, 22]; one
study concluded that hydrophilic coated catheters is a
cost-effective choice when considering long-term
treatment of IC  while the other one concluded that there
are no therapy or economic benefits associated to a
specific catheter type or technique .
The aim of the present study was to confirm/reject
the conflicting evidence of previously published
metaanalyses and again try to compare complication rates
(UTI and urethral trauma/haematuria) related to
hydrophilic coated catheters as compared to
nonhydrophilic catheters for users who practice IC. In
addition, a separate analysis including reused
uncoated catheters was performed to evaluate
differences between catheter types and their use in IC.
The present review adopts the Preferred Reporting Items
for Systematic Reviews and Meta-Analysis (PRISMA)
statement . In June 2016 a systematic search was
conducted on MEDLINE/PUBMED, EMBASE, the
Cochrane Library, and Web of Science databases to
retrieve clinical evidence. The search strategy was
developed using the PICO (Patient, Intervention, Comparator,
Outcome) Study framework.
Boolean operators “AND” and “OR” were used to
combine terms while the “NOT” operator, following
Cochrane indications, was not included.
Studies were considered if published in English and if
they referred to an adult or adolescent population. Studies
were included provided that they directly compared the
use of the two devices on clinical evidence. Both
singleuse and re-used catheters were considered. Case reports,
letters, comments, editorials, and non-systematic review
Inclusion criteria are shown in Table 1 (see Appendix
for detailed search query).
Abstracts and full-text selection was conducted
independently by two expert reviewers (CR, RT). In case of
debate on eligibility, studies were verified collaboratively
until a consensus was obtained. Clinical data were
extracted using a customised template developed in
Microsoft Excel, including study features, participants’
characteristics, and clinical outcomes. Studies
considering single-use catheters have been separated from the
ones considering reused catheters.
Clinical data directly comparing hydrophilic and
nonhydrophilic catheters were considered for meta-analysis.
The meta-analysis focused on two clinical outcomes:
symptomatic UTIs and haematuria (bleeding episodes).
For symptomatic UTIs we mainly referred to the
definition supplied by the National Institute on Disability and
Rehabilitation Research : positive urine culture with
pyuria and one or more systemic symptoms as fever, loin
pain, dysuria, urgency, haematuria. In any case, we also
evaluated studies reporting symptomatic UTIs according
to other definitions or studies where an exact definition
for symptomatic UTI was not provided. As regards
haematuria, we considered the following definitions:
presence of red blood cells in the urine, urethral
bleeding, gross haematuria. Studies reporting microscopic
haematuria were also considered.
Separate meta-analyses were conducted to combine the
results of the retrieved studies on relative risk (RR) of
Table 1 PICO inclusion criteria
Studies considering adult or adolescent population
with bladder dysfunctions requiring IC
Hydrophilic catheters – single-use
Non-hydrophilic catheters – single-use or multiple-use
Randomised controlled trials or randomised
English; full text
Time and place Date and place limits were not set for this review
developing UTIs and haematuria using Review Manager
(RevMan5) software (Version 5.1. Nordic Cochrane
Centre, Cochrane Collaboration, 2011.
Since the considered studies were performed by
researchers working independently, a random-effect model
was applied assuming that the true effect size varies
from one study to the other . A test on the summary
effect measure is given, as well as a test for heterogeneity
quantified by I2 (range 0–100%). Higher values of it
represent higher heterogeneity among the studies .
Results are displayed in forest plots according to
different catheter subgroups and employments.
The evaluation of potential biases in the selected studies is
an essential element of a systematic literature review or
meta-analysis. The methodological quality of included
studies was assessed according to the Cochrane
Collaboration’s Risk of Bias tool in Review Manager software
(RevMan 5 -
http://community.cochrane.org/tools/reviewproduction-tools/revman-5). Following CRD guidance
, no scoring system was adopted; rather, quality
assessments were used for descriptive purposes. The risk of bias
assessment was performed in the following domains:
sequence generation; allocation concealment; blinding of
participants and personnel and outcome assessors;
blinding of outcome assessment; incomplete outcome data;
selective outcome reporting.
A total of 561 studies were found through PUBMED
(197), EMBASE (19), Web of Science (202) and
Cochrane (143). After the removal of duplicates (180),
381 studies were obtained. Reference lists of the most
relevant retrieved articles were screened to find
additional studies (7) not identified through the initial
database search. Figure 1 shows the selection process
and reasons for the exclusion of studies at each step,
while Table 2 shows the nine studies eligible for the final
evaluation with their characteristics (studies included in
quantitative synthesis are marked with ‘*’).
Most studies included a population with neurological
disorders. Cardenas and colleagues considered both
patients with SCI occurred at least 6 months  and less
than 3 months  before study inclusion. Also other
studies included patients with neurogenic bladder due to
SCI [19, 29, 30]. Other two studies [31, 32] included
patients with neurogenic bladder without specifying the
origin. Pachler and colleagues  considered males
with urinary retention due to prostatic enlargement,
while Sutherland et al.  involved in the study boys
Fig. 1 Study selection process
with voiding dysfunctions due to different causes (spinal
dysraphism, spinal cord injury or Hinman syndrome).
The first meta-analysis was performed on the subset of
studies considering single-use of both hydrophilic
catheters and the comparators. Other studies referred to a
control group of PVC catheters used generally 4–5 times
per day and then discarded (i.e. reuse). After each use,
the catheter is rinsed under lukewarm water and left to
dry on a clean towel. Since there is a lack of evidence
about the impact of single- or multiple-use catheters on
the incidence of UTIs and haematuria , two separate
meta-analyses were carried out, one including only
single-use control and one including all available studies.
a) Single-use only sub-analysis
Three trials reported the number of patients with at
least one symptomatic UTI [17, 19, 30]. Among them,
one study  was designed to compare the use of
standard polyvinyl chloride, hydrophilic-coated, and
gellubricated non-hydrophilic catheters and only data
related to the first two items were used due to the
predefined aim of the study.
One study  reported the total number of UTIs for
both groups for the full study period for both strict and
clinical definitions of UTI. These data couldn’t be used
since there was no indication on the number of patients
experiencing UTIs. On the other hand, the percentages
of patients experiencing at least one UTI were retrieved
by digitalising (TechDig software) figures reporting the
time from the first catheterisation to the onset of the
first symptomatic UTI for both devices. From that
figure, percentages of patients reporting UTIs of 75 and 87
were estimated respectively for the use of hydrophilic
and non-hydrophilic catheters.
Another study  refers to the same population of
 and was excluded from the analysis. Moreover, this
study reported only the total number of UTIs per type
of catheter that were not usable for this analysis.
b e n
m th o 7 1 N je a U 4 N
u m :1 :H = ub ad en :1 :H = A
2 S c t T
Fig. 2 Meta-analysis results related to UTIs (single-use catheters)
The meta-analysis results are reported in Fig. 2. The
estimate from these trials highlights a statistically significant
decreased risk ratio of UTIs associated with hydrophilic
catheters in comparison with non-hydrophilic ones (RR =
0.84; 95% CI, 0.75–0.94; p = 0.003). There was no evidence
of significant heterogeneity across the studies (p = 0.52).
Three trials reported the number of patients experiencing
episodes of haematuria or urethral bleeding [18, 19, 31].
The incidence of haematuria was 31% (62/199) in
patients using hydrophilic catheters and 22% (47/212) in
patients using non-hydrophilic catheters. Although
not statistically significant, the estimate from these
trials point to a higher risk of developing haematuria
with hydrophilic catheters versus the standard ones
(RR = 1.35; 95% CI, 0.97–1.89; p = 0.07). This analysis
didn’t report a significant heterogeneity among the
considered studies (Fig. 3).
b) Single-use/multiple-use sub-analysis
A second step meta-analysis including all the available
evidence (i.e. also studies with a control group where
non-hydrophilic catheters were reused).
In one study , the number of patients experiencing
at least one UTI or haematuria was not estimable due to
how the data were described. As to UTIs, only the mean
number per patient was reported, while the degree of
haematuria was classified as none, mild, moderate, and
heavy, and to each category a code from 0 to 3 was
assigned. The mean code per urinalysis during the study
period was reported.
Only the results reported by  and  were added
for the second step meta-analysis.
The results on UTIs (Fig. 4) showed the same results
as the initial analysis performed considering only
singleFig. 3 Meta-analysis results related to haematuria (single-use catheters)
use in the control group, i.e. a risk reduction associated
to hydrophilic coated catheters was verified.
The results from the two meta-analyses on haematuria
(Figs. 3 and 5) differed slightly and the added
reusestudies seemed to reduce the risk of experiencing
In the studies, it was not possible to blind participants, but
the non-blinding of participants was considered unlikely to
introduce bias in six of them. Three trials [17, 19, 30]
reported high percentages of dropouts that were more
frequent in the hydrophilic catheter arm, thus resulting in an
imbalance and in potentially biased results. In particular,
only 43% vs. 60% and 41% vs. 53% of patients in the
hydrophilic and non-hydrophilic arms remained in the study
respectively for  and  studies. Sarica and colleagues
 reported missing data from 15 participants on a total of
25 on one or more catheters. The assessment of potential
biases for the considered clinical studies is reported in
Additional file 1: Figure S1 and Additional file 2: Figure S2.
The aim of the present study was to confirm or reject the
conflicting evidence of previously published meta-analyses
[20–23] and again try to evaluate complication rates (UTI
and urethral trauma/haematuria) related to hydrophilic
coated catheters as compared to non-hydrophilic catheters
for users who practice IC. In addition, a separate analysis
including reused uncoated catheters was included to
evaluate the possibility to further differentiate between
catheter types and their use in IC.
The results from the study showed that hydrophilic
coated catheters are associated with a reduced risk of
UTIs among patients performing IC. The estimated risk
Fig. 4 Meta-analysis results related to UTIs (single- and multiple-use catheters)
reduction was 16% considering both single-use and
single-use plus reused catheters scenarios. No difference
in the results is due to the low number of patients
involved in the two additional studies considering reused
devices, which accounted for low study weights (0.2%
each) in the overall analysis.
As regards the second considered outcome,
haematuria, the meta-analyses were not able to verify a risk
reduction associated to hydrophilic coated catheters.
However, the results from the two meta-analyses suggest
that there may be differences related to types of
hydrophilic coated catheters. It should be noted that
hydrophilic catheters considered in the single-use scenario all
referred to the same brand (i.e. Coloplast), while both
additional studies included to consider the extended
scenario referred to another brand (i.e. LoFric). The
inclusion in the analysis of these hydrophilic coated catheters
with high osmolality  seemed to lower the risk of
haematuria, although statistical significance could not be
The present study provided objective data to support
the use of hydrophilic catheters in clinical practice to
reduce UTIs; however, the opinion of the patient regarding
the choice of the type of device should also be taken into
account; he/she has to find the product agreeable,
corresponding to his/her needs, handy, and easy to use.
The present review has some limitations, first of all, the
heterogeneity regarding the clinical outcomes and their
definitions in the included studies. The proposed
definitions of symptomatic UTI were: significant bacteriuria
(≥105 CFU/mL) plus at least one sign or symptom
suggestive of UTI , clinical definition of symptomatic UTI
(antibiotic treatment prescribed), and strict definition of
symptomatic UTI (antibiotic treatment prescribed,
bacteriuria, at least one of seven symptoms based on
consensus guidelines–fever, autonomic dysreflexia, increased
spasticity, discomfort or pain over the kidney or bladder
or during micturition, onset and/or increase in
incontinence episodes, cloudy urine with increased odour, malaise,
lethargy, or sense of unease; dipstick test positive for
leukocyte esterase) , clinical infection with symptoms
of UTI and for which treatment was prescribed ,
>104 CFU/mL , infection of the urinary tract that
requires the insertion of a Foley catheter , >105 CFU/mL
. With regard to haematuria, no precise definition was
given but the studies referred to microscopic haematuria
, gross haematuria , urethral bleeding [18, 31] and
haematuria in general [19, 32].
Secondly, nearly half of the trials presented attrition
biases that can greatly influence the strength of the
reported results. Moreover, dropouts occurred early and
were more frequent in the arm related to hydrophilic
catheters, thus resulting in an imbalance and a potential bias in
favour of the latter. This means that patients who didn’t
continue the study may have been less satisfied with
hydrophilic catheters than those who completed the study.
Thirdly, effectiveness data were derived from few
RCTs with less than 50 participants. Although systematic
reviews can be performed in practice with any number
of studies, when few studies are used, the heterogeneity
point estimate I2 should be interpreted cautiously, even
replaced with confidence intervals as reported by von
Another limitation of the current study is that UTIs
and episodes of haematuria are not the only
complications that can occur in users performing ICs, However,
the former are the most frequent complications in this
type of users, while the latter occur regularly in
onethird of them on a long-term basis .
In spite of the limitations of the current review and
meta-analyses, the results from two previously
published reviews [20, 23] in terms of UTI risk reduction
associated to the use of hydrophilic coated catheters
were verified. It should be noted that the
metaanalyses of this study were limited to randomised
clinical trials only to ensure high level of evidence
but this is a limitation per se since few high quality
trials exist and the available ones are compromised by
quality issues . On the other hand, the results
from this study also verify the results by several
observational studies that focused on the frequencies of
UTIs [38, 39], urethral trauma , urethral
complications , microscopic haematuria, and pain .
The management of UTIs with systemic symptoms
requiring medical intervention is associated with
significant costs. Findings can be summarised by a wide cost
span between €523 and €4167 [41–46] and it is likely
that more complicated UTIs are associated with higher
costs. A catheter that could lower UTI frequencies and
other types of complications is likely to limit the burden
for patients using IC, resulting in increased quality of
life. The combination of both economic and quality of
life aspects can be evaluated through a cost-effectiveness
analysis comparing hydrophilic catheters to
The meta-analyses results confirmed that hydrophilic
coated catheters are associated with a reduced risk of
UTI among patients using IC. On the other hand, a
risk reduction for haematuria associated to
hydrophilic coated catheters in general was not
demonstrated. The conclusions from the study are however
compromised by several limitations, such as the
heterogeneity of outcomes and definitions, the lack of
available high quality randomised controlled trials as
well as a higher dropout rate in the arms related to
hydrophilic catheters. In view of these limitations,
uncoated catheters may still maintain a place in the
Further studies are crucial to provide more direct
evidence of the comparison between hydrophilic versus
non-hydrophilic coated catheters and could be used to
integrate a cost-effectiveness model. In the meantime, it
is important also to consider the evidence from
observational data when assessing the effectiveness of
In conclusion, there is still further work to be
performed in order to assess incremental cost and
effectiveness of hydrophilic versus standard catheters to
optimise informed policy decisions.
(spinal OR SCI OR SCIs OR neurogenic OR bladder
OR urinary OR urethral OR dysfunction)
(hydrophilic OR LoFric OR coated OR POBE OR polyolefin
based elastomer OR polyolefin-based elastomer OR PVC
free OR PVC-free OR Speedicath OR Easicath)
(standard OR conventional OR plastic OR polyethylene
OR PVC OR polyvinyl OR nonhydrophilic OR non
hydrophilic OR non-hydrophilic OR non coated OR
(intermittent OR catheter*)
(urinary tract infection* OR UTI OR UTIs OR
infection* OR urethral trauma OR stricture* OR
hematuria OR haematuria)
Additional file 1: Figure S1. Risk of bias summary; Judgments
regarding risks of bias for each study included in the systematic review.
(PDF 211 kb)
Additional file 2: Figure S2. Risk of bias graph; Judgments regarding
risks of bias presented as percentages across all studies included in the
systematic review. (PDF 206 kb)
H: Hydrophilic coated catheters; IC: Intermittent catheterisation; NA: Not
available; NH: Non-hydrophilic coated catheters; PVC: Polyvinyl chloride;
RCT: Randomised controlled trial; RR: Relative risk; SCI: Spinal cord injury;
UTI: Urinary tract infection
The authors would like to thank Dr. Gabriella Fizzotti for medical advice for
the manuscript preparation.
The present study was funded by ASMB Srl through an unrestricted grant to
CERGAS, Bocconi University, Via Roentgen 1, 20136 Milan, Italy.
No interferences occurred in carrying out the research project and in writing
the manuscript that is the sole responsibility of the authors.
Availability of data and materials
The search query is available in Appendix. PRISMA statement is reported in Fig. 1.
CR study concept and design; acquisition, analysis and interpretation of data;
drafting of the manuscript. RT study concept and design; obtained funding;
study supervision. Both authors read and approved the final manuscript.
The authors declare that they have no competing interests.
Consent for publication
Ethics approval and consent to participate
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