Also vaginal atrophy and declining oestrogen levels post-menopause, which results in loss of the protective vaginal flora, can increase the risk of infection. The prostate gland in men produces an antibacterial component which further reduces the risk of infection.
- Prescrizione off-label. Normative e applicazioni (Metodi) (Italian Edition).
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Symptoms are more difficult to diagnose in elderly patients, who may have pre-existing incontinence. In this group patients can present in the first instance with sepsis - an infection of the blood. Diagnoses of UTIs can be made based on either or both symptoms and urinalysis. Urinalysis identifies the presence of urinary nitrites and white blood cells leukocytes , where dipstick test kits can be used at home, without prescription; since bacteria can be found in healthy individuals, tests need to be read alongside symptoms.
Urine microscopy may also be used to identify bacteria. MRI, CT and ultrasound scans can also be used to observe any abnormality in the urinary system. Treatment usually involves antibiotics, either a short term course or in low doses as a preventative measure in those experiencing recurrences.
In more complicated cases, urine culture may also be used where urine samples are kept in conditions under which bacteria can grow to test positivity. The type of organism causing the infection can then be confirmed through microscopy or chemical tests and sensitivity testing used to identify the most suitable form of antibiotic. Urostomy bags are medical devices that are worn by urostomates and they can be used for the collection of waste from a surgically diverted urinary system of the individual.
They are used to collect waste that is output from a stoma created in the ostomate's skin and connected to the urinary system. Known urostomy bags comprise a collection pouch and in some cases the collection pouch is attached mechanically or with adhesive to a flange, commonly referred to as a mounting plate, wafer or a baseplate. The flange is fixed to the skin of an individual and the urostomy bag allows waste to drain from a stoma into the collection pouch, while protecting the surrounding skin from contamination by the waste.
Urostomy bags should be air- and water-tight and they should allow the urostomate to lead an active normal lifestyle that can include all forms of sports and recreation. Urostomates are more prone to UTIs than those who do not have an ostomy, mainly due to an abnormal urinary tract. Surgery in this patient group can lead to loss of valves normally present at the ends of the ureters, which would otherwise serve to prevent the backflow of urine.
Bacteria are therefore more likely to end up directly at the kidneys, resulting in a kidney infection.
This along with problematic fitting, use of urostomy bags without non-return valves with some patients and excess accumulation of urine in the urostomy bag can further increase the risk of infection. While the great majority of UTIs present as lower tract infections of the bladder and urethra, ostomates present with infections of the kidney.
The type of antibiotic usually prescribed is for lower urinary tract infections and is therefore not suitable for the ostomy patient. Progressive infection of the kidneys if not treated can be fatal. Without treatment temperatures can continue to rise resulting in unconsciousness and patients often have to be hospitalised for intravenous administration of antibiotics. Thus, there is a need to make early urinary tract infection easy to detect for the urostomate population.
Current methods of detection for UTIs utilise non-prescriptive home kit test strips. The limitation of this in the urostomate population is the incapacity to urinate on demand and having to deal with yet another device in addition to the bag and accessories, which renders monitoring difficult and may reduce uptake. Urostomy patients not only suffer from the complications surrounding stoma formation but are a population in which urinary tract infections UTIs are prevalent and in a large number of cases recurring.
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- Prevention of Urinary Tract Infections in the Outpatient and Inpatient Settings;
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- Bibliographic Information.
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- WO2017153320A1 - Diagnostic urostomy bag - Google Patents.
Accordingly, there is a need for development of an integrated diagnostic urostomy bag system that acts effectively. The present invention seeks to provide an alternative or improvement which preferably addresses one or more of the problems presented by prior art arrangements.
Imaging and Intervention in Urinary Tract Infections and Urosepsis
The present invention is directed to providing an ostomy bag having an integrated diagnostic device which allows early detection of urinary tract infection in urostomates. Remarkably, this allows production of an ostomy bag with technical advantages as will be detailed below. In accordance with a first aspect, the present invention provides an ostomy bag for an ostomate which comprises a flange adjoining at least one pouch wherein the pouch has an integrated diagnostic device for detection of urinary tract infection and an inlet leading to a waste collection space defined by two opposing surfaces of two walls, the opposing surfaces configured to separate on the introduction of waste through the inlet.
Preferably, the ostomy bag is a urostomy bag. Advantageously, the invention provides an easy-to-use and compliance-friendly approach to monitoring urine content. Preferably, the diagnostic device is provided in at least one wall of the pouch. Preferably, in use, it is provided in a wall facing away from the ostomate. Preferably, it is provided in the front side of the pouch facing away from the user. This provides the advantage that the ostomate can easily inspect the diagnostic device. Preferably, the flange adjoins a first wall of the pouch and the diagnostic device adjoins a second wall of the pouch.
Preferably, the diagnostic device is located substantially at or adjacent the bottom of the pouch in use. In this regard, preferably the pouch is drainable and the diagnostic device is positioned at or adjacent a drain outlet from the pouch where it is likely to come into complete contact with an ostomate's urine.
Androgens Enhance Male Urinary Tract Infection Severity in a New Model
This has the advantage of maximising contact with urine when urine is located in the pouch. In this regard, the detection cell of the diagnostic device is located so that a volume of about ml of urine in the pouch substantially wets the detection cell. Preferably, in use, the fluid level of a volume of about ml waste in the bag is above the level of the detection cell.
Preferably, the detection cell detects one or more substances in the waste and indicates information regarding one or more of a user's level of hydration, the presence of blood or other disease or condition, including type I diabetes. Preferably the indicator panel comprises a first indicator, which provides an optical signal when the detection cell comes into contact with moisture. Preferably, the optical signal is a change of colour. Preferably, the indicator comprises a web of material coated in an absorbent material and a chemical or reagent which changes colour on contact with moisture.
Advantageously, this provides the user with a clear indication of whether urine has contacted the detection cell. Preferably, the web of material is rectangular, has a width of at least about 5mm and a length of at least about 8mm, but it can be of any appropriate size and shape as long as it is of sufficient size to be seen clearly by the user.
Preferably, the indicator panel comprises at least one further indicator, preferably adjacent to the first indicator, which provides an optical signal, after contact with waste in the ostomy bag. Preferably, the optical signal is no change or a change of colour. Preferably, the indicator panel comprises at least three indicators. Preferably, they are arranged adjacent to each other. A first indicator provides an optical signal when the detection cell comes into contact with fluid; a second indicator is capable of detecting and indicating the presence in the waste of leukocytes or white blood cells; and a third indicator is capable of detecting and indicating the presence in the waste of a nitrite.
Preferably, the diagnostic device comprises a laminated structure having a number of layers. An inner layer of the diagnostic device preferably comprises a planar member preferably of plastics material. Preferably, the planar member has a width of about 2cm and a length of about 2cm. Preferably, the planar member defines an opening in its approximate centre, through which any urine in the pouch is able to pass.
In use, urine from a user collects in the pouch and enters the detection cell of the diagnostic device via the opening. Preferably, a sheet is attached to the side of the planar member facing outwardly from the pouch and a recess is provided over the opening in the planar member.
EVALUATION OF SINGLE-DOSE CEFTRIAXONE TREATMENT OF URIN : Critical Care Medicine
Preferably, the sheet is of plastics material. Preferably, it is transparent and more preferably it is colourless. The recess preferably contains a web of plastics material and on the web is provided the indicator panel of the detection cell. In an embodiment, the indicator panel comprises a nitrite detection indicator which comprises an acid which reacts with nitrite.
A further reaction involving an amine produces a colourful azo compound. In addition, in an embodiment, the indicator panel comprises a leukocyte esterase indicator which involves the use of an ester and the formation of azo compound from a diazonium salt. The indicator panel comprises indicators which preferably comprise pieces of absorbent material and which preferably provide an optical signal when a reagent on the absorbent material reacts with a specific analyte of interest.
For example, a colour change of one or more indicators can signify the presence of an infection. Preferably, urine from a user flows onto the indicator panel by the use of an absorbent material. Preferably an outer layer of the detection cell is provided by a colourless film, which is impermeable to urine and forms the outer wall of the pouch over the detection cell.
Preferably, the detection cell is incorporated into an ostomy bag during the production assembly line. In this regard, the detection cell is preferably welded to one or more of the ostomy bag liners. Preferably, the welding is around the periphery of the detection cell.