S-Cath System for suprapubic catheterisation

CE marking

Mediplus was awarded a Class IIb CE mark for the S‑Cath System in July 2005, and the most recent date of renewal was December 2015. The CE-mark certification covers all components of the S‑Cath suprapubic Foley catheter with introducer set.

Description

The S‑Cath System is designed for placing suprapubic catheters using the Seldinger technique. This technique uses a guidewire to place the catheter in the bladder with the aim of reducing the risk of bladder or bowel injury. The S‑Cath System uses a 3‑stage guidewire in place of a traditional guidewire. Traditional guidewires can kink, preventing the catheter from being inserted into the bladder, and can also injure the surrounding tissues.

The S‑Cath System consists of:

The guidewire is made up of 3 parts; a 'floppy' tip, a more rigid central section and a third, solid section with 2 reference marks printed on it. The floppy tip helps prevent injuries to the posterior wall of the bladder, and the central section gives resistance, which allows the user to work out its location. The reference marks on the solid section help with device placement and allow the trocar (a hollow tube with a pointed end) to be safely inserted.

Patients are prepared in the same manner used for conventional suprapubic catherisation using the trochar puncture method. Ultrasound is recommended to confirm that the bowel is not trapped between the abdomen and bladder. The needle is inserted into the bladder, and once this is in position, the guidewire is inserted through the needle, floppy end first, until the first black mark on the guidewire is reached. The needle can then be withdrawn. The trocar with its sheath is then fed over the guidewire and into the bladder. When it is correctly positioned, the guidewire and trocar can be removed, leaving the sheath in place. The catheter is then inserted and the sheath removed.

S-Cath catheters are removed in the conventional manner, with normal local procedures followed for re‑catheterisation. The S‑Cath System is indicated for initial SPC insertion only and cannot be used for re-catheterisation, which is outside the scope of this briefing.

The S‑Cath catheter has an integrated balloon, unlike most Foley catheters in which the balloon is mounted on the outside of the catheter shaft. Traditional Foley catheters have a tendency to 'cuff', an effect in which the catheter balloon creases or forms ridges when deflated. This can make it more likely that the patient feels pain or discomfort as the catheter is removed. The integrated balloon in the S‑Cath System is less likely to 'cuff' and so removal may be more comfortable for the patient.

S-Cath catheters are available in a range of diameters from 8 Fr to 18 Fr, measured using the 'French' scale system (referred to as Fr) with 1 Fr equal to 0.33 mm in diameter. The 8 Fr and 12 Fr versions of the S‑Cath System are suitable for children. The catheter is 42 cm in length, and is available in open and closed tip formats. Open tip catheters allow an additional, non-proprietary guidewire to be used to change the catheter. The guidewire is passed through the lumen of the catheter into the bladder and, after deflating the balloon, the catheter can be withdrawn. The new catheter can then be slid into place over the guidewire. Open tip catheters are shorter, which reduces the risk of the tip of the catheter irritating the bladder wall.

Setting and intended use

The S‑Cath System is indicated for bladder irrigation or drainage through a needle puncture or incision. It is suitable for children, young people and adults of both sexes who need an SPC. There is no age limit on its use but its suitability in young children should be based on clinical judgement. The instructions for use state that the catheter can remain in place for up to 12 weeks before being replaced.

SPC insertion is carried out by urologists or other trained and supervised clinical staff in hospital inpatient and outpatient settings. The British Association of Urological Surgeons' practice guidelines on suprapubic catheterisation (Harrison et al. 2010) recommend that ultrasound be used as an adjunct to SPC insertion to find out whether the bladder is distended. They also recommend that ultrasound should only be used to look for interposing bowel loops along the planned catheter track by clinicians who have specific training and experience in this task.

Although its use in pregnancy is not specifically contraindicated, suprapubic catheterisation is absolutely contraindicated in the absence of an easily palpable or ultrasonographically localised distended bladder (National Patient Safety Agency 2009). Other contraindications to using suprapubic catheters are bladder cancer, anticoagulant and antiplatelet treatment, abdominal wall sepsis, a subcutaneous vascular graft in the suprapubic region (for example a femoro-femoral crossover graft; Harrison et al. 2010), uncontrolled blood clotting leading to prolonged or excessive bleeding, pelvic cancer (with or without radiation), and previous abdominal or pelvic surgery (because of the risk of adhesions; National Patient Safety Agency 2009).

Current NHS options

Several options are available for people who are unable to pass urine normally. This includes permanent urinary diversion (British Association of Urological Surgeons 2016), which surgically reroutes urine flow. This may be used in people who have had their bladder removed. People with an intact bladder who have difficulty passing urine normally will more often be fitted with a urinary catheter.

There are 2 main types of urinary catheters: intermittent catheters that are inserted to empty the bladder and are immediately removed, and indwelling or permanent catheters that stay in place for several days or weeks (NHS Choices 2015a). Indwelling catheters may be more suitable for some people who need long‑term catheterisation because repeated insertions are avoided.

Indwelling catheters may be inserted through the urethra (the tube which carries urine out of the body) or through a tube inserted above the pubic area (an SPC). SPCs have some advantages over urethral indwelling catheters because they can improve patient comfort and dignity, they are easier to keep clean and are less likely to be pulled out of position. SPCs do not inhibit sexual activity and also reduce the risk of genital damage (NHS Choices 2015b).

The blind technique of SPC insertion (that is, using a trochar or guidewire but without ultrasound guidance) relies on adequate filling of the bladder to move the bowel away from the site of the needle puncture (Jacob et al. 2012). Ultrasound examination may be used to identify loops of bowel along the planned catheter track, but it is not considered necessary in people with a readily palpable bladder and no history of lower abdominal surgery (Harrison et al. 2010). The National Patient Safety Agency (2009) Rapid Response Report on minimising risks of SPC insertion states that using ultrasound is a safer method especially in people in whom the procedure could be difficult, such as those with a large build or abdominal adhesions, or who are uncooperative. Conventional trochar puncture SPCs may be inserted under general, local or epidural anaesthetic and the procedure is usually carried out in an operating theatre.

NICE has issued a quality statement on urinary catheters in its quality standard on infection prevention and control, and guidance on the long-term use of urinary catheters in its clinical guideline on healthcare-associated infections.

NICE is aware of the following CE‑marked devices that appear to fulfil a similar function to the S‑Cath System:

Table 1 NHS Tariffs for relevant outpatient attendance

The price of similar products may vary depending on the size and type of catheter. Examples from the NHS Supply Chain website have been included for reference purposes: