Chapter 1

Introduction

Urinary catheters are a crucial aspect of medical practice. The demand for noninvasive
diagnostic and percutaneous surgical treatment, which also enables the reduction of
operation trauma, is driving the development of catheter-based intervention for surgical
reasons. It is commonly used to provide temporary relief from anatomical or physiologic
constriction, to assist surgical repair of the urethra and enclosing structures, to maintain a
dry environment for the unconscious or diagnosed patient, and to allow accurate
measurement of urinary output in critically ill patients. Unfortunately, when administered
incorrectly or for an extended period of time, it may pose a risk to the same patients it is
intended to protect. It is the major cause of hospital-acquired urine infections and the
most prevalent risk factor for avoidable gram-negative sepsis. With the incredible
technological advancements of the present, we ought to be able to resolve the seemingly
straightforward but important challenge of emptying the urine bladder without causing
infection.

What is a catheter

A catheter is a small, flexible tube used in medicine that may perform a variety of tasks.
Medical devices called catheters can be implanted within the body to treat illnesses or
carry out surgery. Catheters can be made specifically for cardiovascular, urological,
gastrointestinal, neurovascular, and ophthalmic uses by changing the material or the
manner they are made. "Catheterization" refers to the act of inserting a catheter.

When it is used

People who have trouble spontaneously passing pee are typically treated with a urinary
catheter. Additionally, it can be used to aid with several tests and to drain the bladder
prior to or following surgery. Specifically, there are
  To allow urine to drain if the urethra, the tube that removes pee from the bladder,
is blocked for whatever reason, such as scar tissue or an enlarged prostate.
 To enable you to pass urine if you have nerve injury or bladder weakness that
interferes with your capacity to urinate.
 If you're having a baby, you may need an epidural anesthesia to drain your bladder
 To relieve bladder pressure prior to, during, or after certain types of surgery, such
as procedures on the womb, ovaries, or intestines
 When other forms of treatment have failed, for instance during chemotherapy for
bladder cancer, to inject medicine directly into the bladder as a treatment for urine
incontinence.

The catheter will be utilized up until its expiration date. This may be temporary and taken
off before leaving the hospital, or it may be required indefinitely.
 Chapter 2:
Literature Review

Background

For more than 3500 years, urinary catheters have been used to drain the bladder when it
fails to empty. For people with impaired bladder function and for whom the method is
feasible, clean intermittent self-catheterization is the optimal procedure. For those who
require an indwelling catheter, whether short- or long-term, the self-retaining Foley
catheter is invariably used, as it has been since its introduction nearly 80 years ago,
despite the fact that this catheter can cause bacterial colonization, recurrent and chronic
infections, bladder stones and septicemia, damage to the kidneys, the bladder and the
urethra, and contribute to the development of antibiotic resistance. In terms of medical,
social and economic resources, the burden of urinary retention and incontinence,
aggravated by the use of the Foley catheter, is huge. In the UK, the harm resulting from
the use of the Foley catheter costs the National Health Service between £1.0–2.5 billion
and accounts for

Table 1. Some important events in the history of the development of the urinary catheter

Date Devices and comments Reference

1500 Earliest record in an ancient Egyptian papyrus (the Ebers papyrus) of treatment of urinary retention by means of Hanafy et al.
BC transurethral bronze tubes, reeds, straws and curled-up palm leaves. [1]

400 References in Hippocratic writings to the use of malleable lead tubes. Milne [2]
BC

900s Malleable silver tube with numerous side holes which, according to Albucasis (Abu al-Qasim Khalaf ibn al-Abbas Al- Hanafy et al.
Zahrawi) (936-1013), apparently resulted in easier insertion. [4]

1100s Chinese records of the treatment of urinary retention by transurethral insertion of hollow leaves of onion (Allium Herman [5],
fistulosum). These were often hard to pass and rigid wood or metal tubes were alternatively used. Hume [6]
1500s First record by Fabricius of Acquapendente (1537-1619) of indwelling wax-impregnated cloth catheter moulded on Murphy [7]
silver sound, to reduce incidence of damage due to repeated catheterization

1600s Jan-Baptiste van Helmont (1578-1644) described a chamois skin catheter impregnated with white lead and linseed Murphy [7]
oil, inserted over a whalebone stylet. Later, wound silver wire was used to prevent collapse, with external grooves
filled with wax, tallow or bound with fine gut Putrefaction of the chamois skin was a major problem.

1700s Jean Louis Petit (1674-1750) devised a silver tube with double curve. This device was less satisfactory than its Petit [10]
immediate predecessors.

1750s Theden of Berlin and Bemard of Paris independently used a natural rubber gum coating of silk closely wound over Murphy [7],
a brass sound, finished with varnish to overcome stickiness. However, the varnish soon cracked, there was no Thomas [12]
method for reliable retention and they soon became blocked by encrustation.

1836 Louis Auguste Mercier (1811-1882) invented the coude (elbow) catheter Mattelaer and
Billiet [9]

1929 Development of the "modern" balloon-hased self-retaining catheter. In the device constructed by the CR Bard Foley [14]
Company to the design of Dr Frederic Foley, a rubber balloon was attached with fine silk and waterproof cement
close to the tip of a rubber catheter with a longitudinal groove which accommodated a fine tube to inflate the
balloon with water. Bard placed Foley's device on the market in 1933. Foley's original application of his now-
eponymous catheter was for post-prostatectomy haemostasis, but its wider application in the management of
urinary incontinence and retention soon became commonplace, although the latex frequently caused urethritis and
urethral strictures, and encrustration and infection were almost inevitable with longer-term catheterization

2001 Introduction of chemical impregnation and "antimicrobial" coating, particularly silver, aimed at inhibiting the Maki and
formation of surface biofilms and encrustation. These can reduce the risk of catheter- induced urinary tract Tambyah
infection, but only by 2-3 weeks. [16]

∼2100 deaths per year. Therefore, there is an urgent need for the development of an
alternative indwelling catheter system. The research agenda is for the new catheter to be
easy and safe to insert, either urethrally or suprapubically, to be retained reliably in the
bladder and to be withdrawn easily and safely when necessary, to mimic natural
physiology by filling at low pressure and emptying completely without damage to the
bladder, and to have control mechanisms appropriate for all users. [1]

Process of catheterization
A flexible tube called a catheter is used during the operation known as urinary
catheterization to empty the bladder and collect the urine. In hospitals or the community,
physicians or nurses often insert urinary catheters. They can either be implanted through
a tiny incision made in your lower belly or through the tube that exits the bladder to carry
urine. As long as the catheter is in the bladder, urine can pass through it and into a
drainage bag. The catheter may be withdrawn after a few minutes, hours, or days, or it
may be required for a long time, depending on the type of catheter you have and why it is
being used. Urinary catheterization may be used to empty a hypotonic neurogenic bladder
effectively or to treat bladder outlet blockage caused by benign prostatic hyperplasia,
strictures in the bladder neck, or urethra. Urine assessment and monitoring are made
possible by routine urinary drainage during surgical times or in critical care settings.
Often times, urinary catheterization may be done to collect sterile urine for culture,
remove blood or clots from the bladder, provide therapeutic medications to the bladder,
and assess the bladder using fluoroscopic or urodynamic tests. [2]

Structure of bladder & Natural defense

When the internal pressure caused by the expanding amount of urine exceeds a certain
threshold, the smooth-walled, distensible bladder contracts. A mix of voluntary and
involuntary relaxation of the external sphincter occurs simultaneously with this detrusor
action. The flow of urine then widens the normally closed urethral channel, enabling
almost bladder emptying. The bladder's primary mechanical defense against infection is
this cycle.

Types of catheter

Indwelling catheter

An IDC remains in situ, with one end held in the bladder by a small balloon inflated with
sterile water after insertion into the bladder; urine passes via a drainage tube either
urethrally (urethral catheter (UC)) or suprapubically through a surgically created site in
the abdomen (suprapubic catheter). The external end is attached either to tubing leading
to a urine collection bag or to a manual catheter valve. Collection bags allow continuous
drainage and storage of urine until a convenient time for the user to empty the bag into a
toilet or other receptacle. A catheter valve allows the user to keep urine stored in the
bladder until they wish to open the valve for drainage. Individual IDCs remain in situ for
varied periods from a few hours up to several weeks [3]

Img: Indwelling urinary catheters approx. 40 cm in length.

The indications for indwelling urethral catheters include

 Accurate monitoring of urine output in critically ill patients

 Increasing comfort in terminally or severely ill incontinent patients and managing
any skin damage caused by incontinence, when all other methods of managing
urinary incontinence have failed
 Maintaining a continuous outflow of urine in preoperative patients and patients
with voiding difficulties resulting from neurological disorders
 Providing immediate treatment of acute urinary retention

Intermittent catheters
This is a procedure that people can do at home, in which a tube (catheter) is inserted into
the urethra or a surgically created opening (stoma) in the abdomen to drain the bladder.
The catheter is immediately removed after the urine has drained. A person with complete
urinary retention typically self-catheterizes 4 to 6 times per day to empty the bladder.
Although hospitals and long-term care facilities use a new sterile catheter for every
catheterization, the reuse of intermittent catheters in the home setting is common in some
countries and remains controversial. Reasons for reuse are mainly related to costs and
environmental concerns, and reuse is less common in countries that reimburse people for
single-use catheters. [4]

Intermittent catheters approx. 10–40 cm in length.

Uses for intermittent catheterization include

 Obtaining urine samples

 Emptying the bladder
 Measuring residual volume
 Instilling medication
 Instilling contrast material into the bladder to study the bladder and urethra

Condom Catheter:
Originally constructed of latex, many condom catheters are now constructed from one of
several alternative substrates such as silicone. Single-use condom catheters (sometimes
referred to as Texas catheters) adhere to the penile shaft via an adhesive applied to the
interior surface of the device, or a double-sided adhesive strap that wraps around the
penis. In addition, condom catheter straps are available that wrap circumferentially
around the penile shaft; they are usually manufactured of foam or other materials with
variable elasticity in order to accommodate changes in penile shaft size with erectile
activity. A single-use condom catheter is available that adheres to the penile shaft via an
internal ring that is inflated with air to enable urinary containment. Most condom
catheters come in multiple sizes to accommodate variability in the circumference of the
penile shaft. Urinary drainage is accomplished by attaching the distal end (catheter tip) of
the device to a urinary drainage bag (leg bag or overnight bag). A device should be
chosen that has a non-kinking junction between the catheter tip and drainage bag.
Img: External collection devices on market

Correct application requires measuring the penile diameter at the base of the penile shaft,
gently cleansing and drying the penile skin, and clipping any hair growing on the shaft to
enhance adherence between the condom catheter or adhesive strap and skin. Some
clinicians use a liquid polymer acrylate (liquid skin barrier) to protect the underlying skin
and promote adherence; our literature review identified no studies supporting or refuting
the need for adding this step to the application process. Anticipated wear times for
condom catheters are 24 to 72 hours. [5]

Most used types

Approximately 4 million Americans undergo urinary catheterization annually, and more

than 500,000 of these catheterizations involve indwelling catheters left in place for some
period. Between 15% and 25% of patients may receive indwelling catheters during
hospitalization, and the prevalence of catheter use in residents of long-term care facilities
is estimated between 7.5% and 10%. One study found that of 4,010 individuals receiving
home care services, 4.5% used an indwelling catheter. Although the indications for
catheterization have been extensively outlined, reports of the inappropriate use of
catheters range from 21% to more than 50%. [6]

Advantage/ Disadvantage of intermittent Catheters

Intermittent catheterization is becoming the gold standard for the management of

bladder-emptying dysfunctions and following surgical interventions. Certain advantages
to intermittent catheterization, including the lower risks of catheter-associated urinary
tract infection (CAUTI) and complications, may make it a more desirable and safer
option than indwelling catheterization. Practicing intermittent catheterization, however,
may be difficult for patients with limited vision, dexterity, and mobility, although, in
these cases, family members and caregivers can be taught the procedure. [6]
Advantages and disadvantages of indwelling Catheters

An indwelling catheter can be used when

 When a blockage in the urinary tract—such as a bladder stone or, in males, an

enlarged prostate gland—cannot be removed right away, a urinary catheter may be
used long-term to treat urine retention (inability to empty the bladder when
necessary).
 if all other forms of therapy have failed, to treat urinary incontinence (leaking pee
or being unable to regulate urination)
 if nerve injury affects bladder control, to eliminate pee from the bladder (this is
called neuropathic bladder)
 in bedridden individuals who are too weak to use the restroom routinely

Disadvantages of indwelling catheterization include mechanical bladder perforation,

iatrogenic hypospadias, aberrant Foley's placement, urethral diverticula.

Advantages and disadvantages Condom catheter

Condom catheters are known to be discrete, reliable, comfortable and very easy to use
which makes them preferable to bladder catheter. Condom catheters are widely used in
the management of male urinary incontinence, bedridden patient and geriatric population.
They are considered to be safe, however, they are associated with complications in care
of an incorrect use. Complications and incidents of condom catheter use remain
underestimated. Users of CC should be aware of those complications and informed about
precautions to take to avoid them. Most of the condom catheter users face problems of
dislodgement and leaking due to unsuitable size or poor positioning. This problem seems
to be solved with the use of adhesive strips to avoid urinary leakage. There is also the
occurrence of cutaneous lesions and allergies and urinary tract infection due to long-term
use of condom catheter. [7]
Table 2: Advantages and disadvantages of various catheter modalities for bladder drainage[8]

Complications with indwelling catheter

With the indwelling catheter, the bladder's natural cycle of filling, expanding, and
emptying is changed to provide a continuous flow. Due to the retention balloon's
existence, the bladder cannot entirely empty since the pressure from it erodes the mucosal
surface. The lubricating periurethral glands are blocked, the urethra is swollen, and its
blood supply has been decreased by lateral pressure. A continually open channel allows
germs to enter the bladder upstream, and a disturbed periurethral surface provides a
second pathway for bacterial invasion around the catheter. To put it simply, a foreign
body changes a dynamic system into a static one. Antimicrobial treatment is useless in
the presence of the catheter. [9]

Complications with intermittent catheter

The most prevalent consequence in people undergoing IC is urinary tract infection. One
of the most crucial preventative strategies is to avoid overfilling the bladder and to
catheterize less frequently. Antibiotics are not necessary for the treatment of
asymptomatic bacteriuria. There is appear to be a danger of bacterial resistance
development with long-term antibacterial prevention. Chronic infection and urinary
sepsis are risks associated with prior indwelling catheter therapy. Prostatitis occurs more
frequently than is typically believed. Urethritis and epididymitis are uncommon.
Catheterization can cause trauma; however, the symptoms tend to fade quickly. With
prolonged usage of IC, however, urethral strictures and false passageways become more
common. The use of hydrophilic catheters may be able to reduce the risk of urethral
complications, although further evidence from comparison trials is required. [9]

Complications with condom catheter

Skin problems including dermatitis, erosion, and maceration are frequently observed. The
most common locations of skin damage in both men and women are the labial and vulvar
regions. A "too tight device" may be a contributing factor, increasing pressure and
perhaps occluding the penile shaft or pubic region. Skin irritation can be brought on by a
self-adhesive product's excessive or uneven adhesive. Some recommend protecting the
underlying skin with a liquid polymer acrylate (liquid skin barrier), which encourages
adhesion. Latex-based devices have been the main source of reported allergic responses,
however EUCD material has switched to more skin-friendly material (e.g., silicone). A
male patient who has used an external catheter for a long time has developed epidermal
sloughing of the whole penile shaft, which may have been brought on by latex
sensitization. Particularly with an ill-fitting device, urine can get trapped between the
catheter and skin, causing maceration, discomfort from self-adhesive external catheter
friction, and skin breakdown or erosion of the penile skin. Consider switching to a
reusable EUCD or glans-adherent male external catheter if penile shaft skin breakdown
occurs.

Significance of research
The involvement of the bladder and bowel is among the most significant quality-of-life
complications for many patients with neurological disorders. In addition to having a
positive impact on physical health, including the reduction of risk factors for UTIs and
decubitus ulcers, good management also has a positive effect on psychological,
environmental, and financial health, including increased self-esteem, social interaction,
and employment opportunities. Any increase in general well-being, self-esteem, and
social participation may enhance patients' experiences of pain, as it is a significant factor
for many neurological patients. [10]

Difficulty in catheterization

Urinary catheterization difficulties can result from both normal and pathological
anatomical abnormalities. The urologic history of a patient might reveal previous surgical
or radiological procedures that may have affected anatomic connections crucial to urine
catheterization. Additionally, previous instrumentation, trauma, and STDs might result in
anatomic alterations that could make urine catheterization difficult. Some of the factors
are listed below.

Figure 1 - Most common causes of difficult urethral catheterization [11]

With a greater grasp of patient-reported symptoms, a thorough genitourinary evaluation

of systems, and a physical examination, a challenging catheterization can be predicted
and appropriately handled. The success of catheterizations in challenging patients can be
improved by education on the methods, equipment, and supplies that are accessible.

Need for catheter in medical Wards

Indwelling urinary tract catheterization (IUTC) is a very common intervention frequently

required in hospitalized patients. It is estimated that 10-12% of hospital patients and four
per cent of patients in the community have urinary catheters in situ at any given time.
Nosocomial UTIs (urinary tract infections) develop in five per cent of catheterized
patients per day in the US, with associated bacteremia in four per cent and as many as
80% are a consequence of urinary catheters. Fever, pyelonephritis, urinary tract stones
and chronic renal inflammation are some of the other complications of this procedure.
IUTC also prolongs hospital stay and increases the cost of healthcare. Unfortunately,
inappropriate and excessive catheter use still persists. Research has shown that just
reminding physicians to remove unnecessary urinary catheters can significantly reduce
the duration of urinary catheterization and the catheter associated urinary tract infection
(CAUTI) rate in a hospital. [12]

Room for better research

Patients experience discomfort and anxiety as a result of difficult urinary catheterizations

and repeated attempts. The risk of post-instrumentation infection might rise with urethral
instrumentation and trauma. The urinary catheter runs the risk of creating a false urethral
route, undermining the bladder neck, or perforating the urethra or bladder if pressure is
applied even after resistance is met during urine catheterization. Hematuria can result
from trauma to the urethra, prostate, or bladder neck. Rectal leakage has also been
reported in cases of radiation or past surgery. Trauma from catheterization can cause
urethral infections, Fournier gangrene, or peri-urethral abscess in individuals with limited
mobility or patients with weak immune system. In the long run, instrumentation-induced
urethral trauma may cause urethral stricture illness.

Use of sensing technology

Pressure Sensors [13]

The development of a flexible strip with several pressure sensors that may be fastened to
a urethral catheter is under consideration. The instrumented urethral catheter can be used
for urodynamic testing in a clinic to assess the pressure in a human urethra. This might
aid in identifying the reasons of patients' urine incontinence. Surface micromachining
techniques are used to build capacitive pressure sensors on a flexible polyimide-copper
substrate, and the top and bottom sections of the sensor strip are aligned and assembled.
A pressure chamber is used in an in vitro test rig to experimentally assess the
manufactured sensor strip. It is demonstrated that the sensor strip has sufficient
sensitivity and reproducibility. Despite the fact that the calibration parameters for each
sensor on the strip are different from one another. The resolution of even the least
accurate sensor is higher than 0.1 psi.

Features of catheter with a pressure sensor

 Instead of the existing method of moving the device to measure pressure at one
spot at a time, the new catheter will offer simultaneous monitoring of pressure at
many points in the urethra.
 The suggested method allows for real-time pressure distribution measurement and
may be applied to urethral measurement while performing provocative actions like
coughing, pressing on the stomach, etc.
 The created sensing device will be very flexible for urethral insertion and
extremely small for mounting on a 2.6 (mm) diameter catheter.
 A cheap disposable sensor strip is used in the proposed sensor system. As long as
the slot size is uniform across all catheters, the sensor strip can be used with
catheters of different diameters.
 Capacitive sensors with tiny micron-sized air-gaps are used to achieve sufficient
sensitivity for monitoring of low urethral pressures. Parasitic fringe capacitance
 from human tissues is a substantial cause of inaccuracy for capacitive sensors. By
utilizing a reference sensor that only measures parasitic capacitance and is
insensitive to pressure, this inaccuracy will be eliminated.
 The sensors will make use of a single electrical interface at the catheter's distal end
and signal lines integrated on the sensor strip.
 A prefabricated flexible copper-on-PI substrate is used to create the sensor. Using
a channeled-PDMS dielectric, the top and bottom electrodes are first constructed
independently. For assembly, a specially created aligner is utilized.

This sensor has significant clinical uses for urodynamic assessment and may also be used
in other in vivo biomedical catheter applications. Capacitive force sensors make up the
sensors on the strip. They were created and micro-fabricated utilizing copper electrodes,
polyimide/PDMS substrates, surface micromachining, and a specially made alignment
machine. A bench-top pressure chamber was used for the experimental in vitro
assessment. The requisite sensitivity and range might be provided by the sensors on the
strip.

Applications of Silver in Urinary Catheter

UTI in a predetermined group of research participants. In a previous study done at our
hospital, we found that urethral meatus bacteria are the most common cause of catheter-
associated UTI episodes and that women are more likely than males to get infected via
the urethral route. Based on these findings, we hypothesized that an intervention that
stops germs from entering the urethral meatus and moving via the catheter-urethral
interface into the bladder would be especially beneficial for women. In accordance with
this hypothesis, women in the current study received superior UTI protection from the
silver catheter than did males in a study of a silver-containing catheter system. [14]

It has been suggested that silver-impregnated central venous catheters (CVCs) might be
used to reduce CVC colonisation and associated bloodstream infections (CRBSIs). The
improved bactericidal action of a newer generation of silver-impregnated CVCs
(LogiCath AgTive, MedeX Medical Inc., Naseby, Northants, UK) has been promoted.
The inner and outer surfaces of AgTive catheters, which are constructed of polyurethanes
loaded with silver nanoparticles, release noticeably more silver ions when they come into
contact with bodily fluids and intravenous solutions. These silver nanoparticle-
impregnated catheters significantly decreased CVC colonisation rates and catheter-
associated infection rates in a single-center, prospective experiment that had a mixed
sample of ICU and non-ICU patients. In order to evaluate the effectiveness of CVCs
impregnated with silver nanoparticles in a sizable population of critically sick patients in
ICUs, a multi-center, randomized, controlled study was conducted. The results are
reported in this publication. [15]

PH change Detection

Urinary catheter encrustation is known to be significantly influenced by the pH of urine.

The variety of variables that influence urine pH and, consequently, the validity and
reliability of urine pH testing, are less commonly recognized. It has been proposed that
meticulous urine pH monitoring, along with observation of obvious encrustation
symptoms and detailed documentation of the occurrence of catheter blockages, enables
the formulation of planned treatment strategies. However, there is substantial debate over
the accuracy of the measurement and how to monitor urine pH. Urine is often evaluated
by nurses after it has been passed, and they test what is known as the pH of the "voided."
The patient's catheter is used to collect the voiding urine, and the urine's pH is checked
right away. According to studies, individuals with urine pH levels below 6.8 had only
minimal quantities of encrustation whereas those with higher pH levels had noticeable
amounts. A study showed that the activity of calcium ions is possibly the most significant
aspect of the physiochemical process in urine, which plays a crucial role in encrustation.
It is well known that the pH of urine affects the percentage of total calcium that is ionized
in solution. The more Ca2+ that is still in solution, the lower the pH. The decrease in
urine Ca2+ correlated with rising pH is not linear, though. There is a threshold pH level
in urine over which calcium begins to precipitate, it has been demonstrated that the
critical pH is lower in people who form stones than it is in people who don't, suggesting
that a simple measurement of pH may not be a good indicator of a person's propensity to
produce encrustation.
 Fig: Blockage risk factor

In catheterized patients, pH can be a useful indicator of physicochemical activity, but it's

important to interpret the measurement of urine pH very carefully. [16]

Biofilm

Sessile polymicrobial communities known as biofilms are enclosed in a self-produced

extracellular polymeric matrix and cling to both biotic and abiotic surfaces. One of the
diseases' most potent virulence factors is biofilm; due to its delayed penetration, resistant
phenotype, and changed microenvironment, it not only helps the pathogen get past the
host's defenses but also increases antimicrobial resistance. Due to their increased
potential to result in device-related infections, which are not only challenging to cure but
also frequently persistent and recurring, biofilms constitute a severe concern.
Staphylococcus epidermidis, Enterococcus faecalis, Escherichia coli, Proteus mirabilis,
Pseudomonas aeruginosa, Klebsiella pneumoniae, and other gram-negative species are
the organisms that frequently infect urinary catheters and produce biofilm.
Staphylococcus epidermidis, Enterococcus faecalis, Escherichia coli, Proteus mirabilis,
Pseudomonas aeruginosa, Klebsiella pneumoniae, and other gram-negative species are
the organisms that frequently infect urinary catheters and produce biofilm.
Fig: Comparison of antibiotic resistance between biofilm producers and non-producers.

While 26.6% of the isolates were non-biofilm producers, biofilm was found in 73.4% of
them. The median number of catheterization days required to identify biofilm was 5.01
1.31 days. A silicone catheter was utilized in 30.4% of patients, compared to 69.5% of
patients who had a latex catheter. Escherichia coli was found to be the most prevalent
pathogen isolated (52.3%), whereas Enterobacter cloacae produced the greatest
percentage of biofilms (87.5%) among pathogens identified. The most ampicillin
resistance was recorded among biofilm producers (100%). Fosfomycin showed the least
amount of resistance (17.2%). Gender, catheterization time, and catheter type all showed
significant correlations with biofilm. [17]

A new Proteus mirabilis infection-responsive coating for urinary catheters that offers a
crystal-clear visual early signal of infection and ensuing obstruction. Patients having
long-term bladder catheterization may have major difficulties from the crystalline
biofilms of P. mirabilis. pH 6 is the pH of normal urine; however, bacterial urease raises
urine pH, causing precipitation of calcium and magnesium deposits, which forms thick
crystalline biofilms on the catheter surface and obstructs urine flow. The coating is a two-
layer system, with the self-quenching dye carboxyfluorescein present in the bottom poly
(vinyl alcohol) layer. A top layer made of the pH-responsive polymer poly (methyl
methacrylate-co-methacrylic acid) covers the whole structure. The Eudragit layer
dissolves when the urine pH is elevated (>pH 7), releasing the dye to provide a crystal-
clear visual alert before a blockage occurs. A clinically relevant in vitro bladder model
system was used to test prototype coatings, and the results showed that coatings can give
up to 12 hours' notice before a blockage occurs and can remain stable in the presence of
species that do not cause catheter blockage as well as in the absence of infection.

Above the retention balloon, prototype coatings were placed directly to the top 1 cm of
silicone catheters . Once the catheter is in place, this coated area floats in the bladder's
pool of leftover pee. This pool of urine works as a bacterial reservoir during infection and
generally has a high bacterial load. In the bladder model system, monitoring the urine
flow makes it simple to spot catheter blockages. First, it was established that coated
catheters did not affect P. mirabilis' capacity to build crystalline biofilms and obstruct
catheters in this system. This finding is important since modifications to catheter surfaces
may affect how quickly bacteria develop biofilms. [18]

Sensor to detect blockage due to crystalline biofilm formation on urinary catheters

The effectiveness and acceptance of an early warning sensor to foretell encrustation and
blockage of long-term indwelling urinary catheters are being tested in a research. When
changing the catheter, two sensors were connected in series between the catheter and the
urine bag. The sensor closest to the bag was replaced weekly along with the bag, while
the sensor closest to the catheter was left in place for the entire life of the catheter. Urine
samples were analyzed for bacteria and pH at each bag, sensor, and catheter change.
Every day, the sensors' color was recorded. Upon removal, each sensor and the catheter
were checked for encrustation and obstruction obvious signs. Participants were required
to complete a psychosocial impact of assistive technologies tool at the conclusion of the
trial and to keep a daily journal to note any changes in color and other pertinent
observations. A questionnaire on the sensor was given to participants, caregivers, and
healthcare workers who changed urine bags or catheters.

Table: participant evaluation summary

The modified sensor seems to be a reliable indicator of elevated pHv and the presence of
urease-producing bacteria, but it may take too long for the sensor to change color before
the catheter becomes blocked for it to be therapeutically effective. The relationship
between pH and the encrustation process may be too complex or unpredictable for pHv to
be a single proxy measure for impending blockage. It is unclear whether the sensor is
measuring pHv or the pH of the biofilm, but the time between sensor indication and
blockage would suggest as much. Numerous research has examined the connection
between pHv, the presence of urease-producing microorganisms, and catheter
encrustation tendency. The sensor is a helpful indication of the pH of the urine and of the
circumstances that might result in catheter obstruction. For those who have never used an
indwelling catheter, it could be very helpful. The data provides some compelling
evidence on the effectiveness and suitability of the sensor. [19]

Sensor to calculate urine output

Commercial monitoring equipment that can sense patients' physiological characteristics

and track the accomplishment of predetermined therapy goals is available in critical care
units. By doing so, this task is free of human mistake, and the workload of the medical
personnel is greatly reduced. Urine output, however, is still a highly important
physiological indicator that is physically recorded and monitored by the medical
personnel in critical care units. The majority of the patient's physiological characteristics
can be sensed by the commercial monitoring equipment that is now available in critical
care units. Just a few examples are heart rate, blood pressure, blood oxygen saturation
levels, respiratory rate, brain waves, and intracranial pressure. They provide doctors
access to an electronic record of physiological data that may be seen whenever they
choose. The majority of these monitoring systems enable doctors to set therapy objectives
for the metrics they record. The achievement of these therapeutic goals is automatically
monitored, and the devices produce audio alerts to inform the medical team whenever a
violation occurs. Overall, as a result of not having to continually monitor each patient's
physiological data in the critical care unit, the effort of the medical personnel is
significantly reduced. Additionally, mistakes might happen when monitoring the
temporal evolution of the patient's physiological data, just like they can with any tedious
and monotonous work. When these tasks are automated, many of these mistakes are
prevented.

A patient is considered to have oliguria if their Urine output(UO) is abnormally low. A

patient is considered to have anuria if no urine is ever produced by them. Pre-renal
azotemia, which can result from heart failure, infectious diseases, and gastrointestinal
conditions; intrinsic kidney damage, which can be brought on by acute tubular necrosis,
rhabdomyolysis, medication, and/or glomerulonephritis; and post-renal azotemia, which
is brought on by obstruction of the urine flow and can be brought on by an enlarged
prostate, compression of the urethra by a tumour, an expanded UO can occasionally be
excessively high; in these circumstances, the patient is referred to as having polyuria. The
most frequent cause of polyuria is diabetes, which is generally acknowledged.

Fig: Commercial urine meter used in critical care units.

A Foley catheter is inserted via the patient's urethra and into his or her bladder to measure
the patient's UO. The catheter's other end is attached to a plastic tube that is flexible and
connects to a graded container where the urine is collected. The nursing staff manually
logs the reading of each patient's container every hour and activates a valve that
discharges the patient's urine into a bigger container (see Figure 1). As a result, neither
the benefits of keeping a computerized record of this physiological parameter nor the
automated monitoring of its treatment objectives are enjoyed by the medical personnel.
The medical personnel could be freed up if there was a gadget that could automatically
measure the patients' UO and monitor the achievement of the set therapy targets. [20]

Chapter 3
Recommendation of smart catheter

The choice to use this device should be taken with the understanding that it carries
the risk of developing a serious disease that is frequently difficult to cure. Catheter
is the most prevalent source of infections in hospitals and other healthcare
institutions. Since then, scientific research has advanced, showing a better
knowledge of the bladder's infection-fighting defenses and how the Foley catheter
compromises them. Additionally, the problems brought on by the formation of
bacterial biofilms on catheters have been identified, and it is now evident how
these bacterial communities form on catheters. It is now clear that the catheter's
basic architecture, which hasn't evolved much since Dr. Fredric Foley first used it
in urology in 1937, has serious flaws. It is now clear that fundamental flaws in the
catheter's basic design—which hasn't altered much since Dr. Fredricc Foley first
used it in urology in 1937—induce vulnerability to infection. If we want to create a
tool fit for usage in the twenty-first century, these problems must be resolved
instantly.

Patients who use catheters are essentially more susceptible to infection because the
catheter compromises the defense mechanisms that typically keep the bladder free from
infection. An essential mechanical defense against infection is the regular filling and
evacuation of the bladder. It guarantees that any bacteria that manage to pollute the
bladder or urethra are removed. This defense system is compromised by the internal
Foley catheter.

The retention balloon assures that a sump of leftover urine builds below the drainage eyes
at the catheter tip so that the bladder does not fill upon constant drainage into a urine
collecting bag. Instead of flooding the urethra, urine trickles through the catheter and into
the drainage bag. This makes it easier for bacteria to pass through the urethra, and once
they enter the bladder, they are given access to a constantly replenishing pool of a
superior growth media. Urinary populations of bacteria multiply quickly and frequently
reach colony-forming units. The mucosal lining of the bladder may also be eroded by the
catheter's balloon and tip. The catheter's lateral pressure might obstruct the lubricating
periurethral glands and reduce blood flow to the urethral surface. The hydrophilic mucin
layer, which the urothelial cells secrete and which serves such crucial roles in preventing
bacterial adherence and infection of the bladder and urethral epithelia, is also disturbed
by the catheter.

Thus, the stressed mucosal surfaces offer desirable locations for bacterial colonization
and infection start-up. The absence of these essential defense mechanisms makes people
more susceptible to illness. These issues are not solved by efforts to avoid infections by
creating antimicrobial catheters or coatings for catheter surfaces that stop the growth of
germs.

Contemplation of smart urinary catheter

In a time when medical technology has advanced significantly, it is difficult to

understand why we still cannot undertake the seemingly simple procedure of
emptying the bladder without causing infection and a number of related problems.
In the twenty-first century, the morbidity and death rates brought on by current
technology, as well as the cost to the healthcare system in resolving the problems,
are intolerably high.

An efficient urine collection system should be emphasized as being of the utmost

significance in an ageing community since the management of bladder dysfunction
is a vital part of care for older and handicapped persons. The existing catheters,
with their thick walls, small internal diameters, uneven surfaces, and poorly
constructed eyelets, have lots of room for improvement. The production of an
instrument that does not compromise the body's inherent defenses against infection
represents the actual challenge facing the medical device industry. A catheter-
retention system, which enables the filling and thorough emptying of the bladder
so that a sump of leftover urine does not exist, is one of the criteria needed for such
an instrument.

Smart urinary catheter

It is an undeniable fact that catheters are of utmost importance in Medical industry thus
modern catheters should be able to eliminate or at least significantly reduce risks of
Urinary tract infection. Given the difficulty in diagnosing them, the development of
antibiotic resistance, and the development of defenses against hostile environments,
bacterial biofilms represent one of the most significant issues in modern medicine. These
factors necessitate the need for techniques that guarantee the low-cost, quick, or real-time
detection of biofilm development on medical equipment.

In order to provide a satisfactory result, it is essential to track the development of medical

biofilms in real-time. Likewise, the techniques used to execute such detection should be
affordable, small, biocompatible, and simple to produce for high-volume manufacture
(i.e., production of disposable sterile devices). By replacing the catheter or drainage in a
timely manner, these sensors should serve preventative epidemiological reasons,
preventing the host from being contaminated.
It would be possible to take rapid action, such as prompt antibiotic treatment or device
removal, when the early stages of bacterial attachment were recognized in the clinic by
monitoring the biofilm growth of pathogens like P. aeruginosa to biomedical devices in
real time. This would stop biofilm development and lessen side effects related to biofilms
and persistent infections. Early action can stop biofilms from moving on to the life cycle's
dispersion stage, where systemic infection may result. In addition to improving individual
health, this strategy would lower the price of medical care. Device-related infections are
now identified by patient complaints, and further study of the formed biofilm necessitates
removing the device for microscopic and microbiological inspection.

Definition

To address the issue of catheter-related urinary tract infections, a novel "smart catheter"
that detects the beginning of an infection and automatically delivers an anti-bacterial
chemical is under development.

Principle

One intriguing method for achieving these goals is to employ optical fiber sensors as a
device for monitoring biofilm development. In microbiology nowadays, optical
instruments are frequently used to count the amount of bacteria, but not to identify
biofilms. However, several investigations employing optical fiber biosensors are already
being made to look at biofilms (OFBs). Recent research suggests that optical sensors can
identify the development of biofilm accumulation on their surface. Observing variations
in the refractive index (RI) of the environment around the sensing element is the
fundamental aspect of how OFBs work.

Fiber-optic biosensors may be made to detect biomolecules and are based on

measurements of absorbance, RI, fluorescence, chemiluminescence, etc. As a result of
recent developments in nanotechnology, it is now possible to detect bacteria, cells, in
vivo bio-sensing, and other tiny bio-species using optical fibers with micro- or nano-sized
dimensions. The transduction signals in fiber-optic biosensors are based on minute
variations in the RI brought on by biomolecule immobilization or binding interactions.
Because of the optical nature of the stimulation and the many detection modalities, these
devices have significant advantages for in situ monitoring. Strong magnetic fields,
electromagnetic interference, and distant sensing are not present.

Infection-fighting catheters are currently on the market and function by dispensing

antibiotic compounds. However, because these "unintelligent catheters" repeatedly
release the drugs, they quickly run out of the drugs and lose their antibacterial action. The
new smart catheter's antibiotic ingredient, is held in reserve until it detects the first signs
of an infection.

These biosensors can either function in various conditions including, “surface RI”
condition, which involves the immobilization of components with much smaller
dimensions and skin depth than the wavelength elements (for example, proteins), or in
the so-called "volume RI" condition, which involves the sensing element being placed in
a homogeneous medium with varying RI. These conditions depend of the Type of
Sensors used.

By detecting changes in the pH, or acid-base environment, or biofilm formation smart

catheter functions. When a sticky film of bacteria has developed on the catheter and their
population has grown to the point that a health-threatening infection starts, several
alterations mark the crucial moment. The catheter "turns on" at that moment and releases
antibiotic, which breaks up the bacterial films and prevents infection. It subsequently
"turns off," protecting its antibacterial-producing material stockpiles.

Advantage of using fibre optic sensors

Fibre optic biosensors provide benefits such as high sensitivity, resilience, dependability,
quick detection, high sensitivity, and real-time monitoring. A biosensor's sensitivity is a
key need for diagnostic use, and the method used to immobilise the receptor is essential
for the system's stability and sensitivity. They are also immune to electromagnetic
interference and do not need electrical currents at the sensing location. These
characteristics help fibre optic biosensors work well; in fact, because they can
simultaneously and discretely direct light of several wavelengths, they may be employed
for multiple analyte detection employing numerous DNA probes. They can be carried out
label-free or label-based and have the ability to be integrated on a single chip.

Comparison between various optical biosensors

References

[1] Urinary catheters: history, current status, adverse events and research agenda

[2] https://www.ncbi.nlm.nih.gov/books/NBK564404/

[3] Innovating urinary catheter design: An introduction to the engineering challenge

[4] Intermittent Catheters for Chronic Urinary Retention: A Health Technology

Assessment

[5] External Collection Devices as an Alternative to the Indwelling Urinary Catheter

[6] Best Practices in Urinary Catheter Care

[7] Condom catheter induced penile skin erosion

[8] European and Asian guidelines on management and prevention of

catheter-associated urinary tract infections

[9] Complications of intermittent catheterization: their prevention and treatment

[10] Improving quality of life for clean intermittent catheter users

[11] The Approach to the Difficult Urethral Catheterization among Urology Residents in the United
States

[12] Appropriate use of indwelling urethra catheters in hospitalized patients: results of a

multicentre prevalence study

[13] Distributed Pressure Sensors for a Urethral Catheter

[14] Prevention of Catheter-Associated Urinary Tract Infection with a

Silver Oxide-Coated Urinary Catheter: Clinical and Microbiologic Correlates

[15] Comparison of triple-lumen central venous catheters impregnated with silver

nanoparticles vs conventional catheters in intensive care unit patients

[16] In catheterized patients, pH can be a useful indicator of physicochemical activity,

but it's important to interpret the measurement of urine pH very carefully.

[17] Bacterial biofilm-based catheter-associated urinary tract infections: Causative

pathogens and antibiotic resistance

[18] An in-situ infection detection sensor coating for urinary catheters

[19] A clinical evaluation of a sensor to detect blockage due to crystalline biofilm

formation on indwelling urinary catheters

[20] A Device for Automatically Measuring and Supervising the Critical Care Patient’S
Urine Output