A search of the Medicines and Healthcare Products Regulatory Agency website revealed no manufacturer Field Safety Notices or Medical Device Alerts for this device. No reports of adverse events were identified from a search of the US Food and Drug Administration (FDA) database: Manufacturer and User Device Facility Experience (MAUDE).
A report by the National Patient Safety Agency (2009) detailed 3 deaths and 7 incidents of severe harm from suprapubic catheter (SPC) placement between September 2005 and June 2009 in England and Wales. Nine of these involved bowel perforation. A further 249 incidents related to lesser degrees of harm were also reported. The techniques used could not be established.
The literature search identified 6 relevant reports: 1 non‑comparative observational study (Jelski et al. 2013), 2 case series (Burki et al. 2011; Khan and Abrams 2008) including 1 with a cost analysis (Khan and Abrams 2008); 2 case reports (Jackson et al. 2010; Verwey et al. 2012); and 1 validation study with user survey (Vasdev et al. 2006). Burki et al. (2011) and Jelski et al. (2013) are only available as a conference abstract and poster respectively. Because of the limited amount of clinical data, all 6 studies meeting the selection criteria are included and summarised in this report. Details of these studies and their results are available in the appendix.
A non‑comparative observational study by Jelski et al. (2013) reported on a dedicated twice‑monthly SPC clinic in a UK hospital, in which the S‑Cath System has been used since July 2008 (table 2). Ultrasound use to locate the bowel began in 2011 (study end date not reported). The clinic was set up to place new SPCs and change difficult SPCs with 322 insertions reported. Insertion under local anaesthetic was not suitable in 2% of cases (whether these were patients or procedures was not stated). All patients were discharged at the end of the clinic session. The authors reported 4 complications; 3 bowel perforations (0.93%) and 1 persistent haematuria. Of the bowel perforations, 1 was confirmed at the time of the procedure and needed surgical repair, 1 was confirmed 3 years after the procedure, and 1 was suspected (at the first change of the SPC at 3 months). There were no bowel perforations after ultrasound scanning started to be used for the procedure. The authors concluded that there were low complication rates, and that a dedicated SPC clinic is safe and feasible and provides a good teaching opportunity.
The case series reported by Burki et al. (2011) included a retrospective analysis of 45 patients with spinal cord injuries (table 3). The patients had an SPC fitted using the S‑Cath System as a day case at a single UK centre. Ultrasound guidance was used in 12 patients with a history of abdominal surgery. The authors of this briefing note that the manufacturer states the use of S‑Cath is contraindicated in people who have had abdominal surgery. All procedures were successfully completed; but autonomic dysreflexia occurred in 2 patients. In 4 patients, a urethral catheter was also inserted for irrigation for 6 hours after the procedure. One patient had haematuria, needing a bladder washout in theatre, and 3 patients developed a urinary tract infection. SPCs were first changed in a catheter clinic at 6 weeks and subsequent changes were done in the community by district nurses. Eight of the SPCs (18%) could not be replaced by district nurses and temporary urethral catheters were used while the patients waited for a new SPC. The authors concluded that SPC insertion in this patient group is challenging and should be performed in theatre with anaesthetic support.
Khan and Abrams (2008) reported an audit exploring local and regional SPC insertion in the south-west region of England (table 4). The data was used to determine the proportion of patients whose SPCs might be managed in 1 outpatient department. Patients were subsequently followed in a prospective case series of people who had SPCs inserted as day cases. A weekly clinic was started, using the S‑Cath System to insert SPCs, to which 54 patients were referred between August 2006 and July 2007. Procedures were done by 1 trainee urologist who inserted the SPCs using local anaesthetic; ultrasound was used in patients whose bladders could not be distended adequately. Insertion was successful in 50 patients. Four people did not have an SPC inserted; difficulty in filling the bladder because of severe pain or urine leakage was the cause in 3 patients, and the procedure was stopped in the fourth patient because of a panic attack. Although there were no serious complications during the procedure in the 50 patients who had successful SPC insertion, 1 patient was admitted with haematuria after insertion and 1 patient had prophylactic antibiotics because of a suspected infection. In another patient, the SPC blocked within 1 week of insertion. It was changed and then stopped draining, necessitating reinsertion under general anaesthetic. The study also reported estimated cost savings, which are described in the cost and resources section of this briefing.
Jackson et al. (2010) presented a case report on a 66 year old man who had an SPC inserted using the S‑Cath System without cystoscopic guidance (table 5). The patient was admitted to hospital overnight because of pain at the catheter insertion site and pyrexia, assumed to be caused by urinary infection. These symptoms later settled. After 3 months, the SPC was changed in the community by an experienced nurse; the type of replacement catheter was not specified. The day after the SPC was changed, the patient presented with small bowel effluent draining from the SPC, although there was no pain or signs of peritonitis or sepsis. Cystoscopy found turbid urine and no sign of the SPC in the bladder. A CT scan showed that the catheter was within a loop of the small bowel. The SPC was removed without further complication. The authors concluded that although it has been suggested that this device may be safer that those used previously, there is still a risk of bowel injury.
The case report presented by Verwey et al. (2012) described an 82‑year old woman with a medical history of hysterectomy, cholecystectomy and bilateral hip replacement (table 6). Although a consultant urologist inserted the SPC using the S‑Cath System, there was some difficulty in passing the Seldinger needle into the bladder. The patient was readmitted 11 hours later after collapsing. Investigations suggested she was losing blood. An emergency laparotomy was done and an injury to the small bowel was found, which resulted in a small bowel resection. The patient was discharged to a community hospital after 26 days. The authors concluded that this case illustrates the risk of complications in patients with a history of pelvic or abdominal surgery, and supports the use of ultrasound in these cases. The manufacturer states the use of S‑Cath is contraindicated in people who have had abdominal surgery because of the risk of adhesions.
Vasdev et al. (2006; table 7) evaluated clinicians' experience of using the S‑Cath System. Six patients had SPCs inserted by 6 different clinicians, who were asked to complete a 5 domain questionnaire rating their confidence in doing the procedure compared with standard trocar placement. The 5 domains related to confidence in technique, dilator, use by junior staff, patient comfort, and safety of the device. In each of the domains the users preferred the S‑Cath System to standard techniques.
A briefing pack on the S‑Cath System, published by the former NHS Technology Adoption Centre (undated), listed several benefits of using the device. These include greater control and accuracy of placement, reduced risk of trauma and tissue damage, improved insertion and removal, and greater user confidence. The briefing suggested that the catheter rarely needs to be inserted under general anaesthetic, so reducing associated risks.
The manufacturer states that the S‑Cath System is used in about 80 NHS sites in England and Wales. No additional equipment or facilities beyond those for standard suprapubic catheterisation are needed to use this device, and no difficulties are anticipated in adopting this technology into current care pathways. If adopted in an outpatient setting, the related decrease in hospital stay could lead to a reduction in resource use.
The UK-based study carried out by Khan and Abrams (2008) described in the clinical evidence section and table 4, assessed the cost savings associated with moving SPC insertion from an inpatient to an outpatient setting. It is not clear which method of SPC insertion was used in the inpatient clinic. In the local inpatient audit, 43 patients had general anaesthetic and 23 had local anaesthetic; the numbers of patients treated with each anaesthetic in the regional audit is not clearly specified. In the day-case theatre, 50 of 54 patients had an SPC successfully inserted under local anaesthetic. The local mean cost of inpatient theatre insertion of an SPC was £2,400 compared with £462 for a day-case theatre insertion of the S‑Cath SPC. The costs included salaries, disposables, instruments and anaesthetics. Inpatient procedure costs also covered time in hospital (mean 4.1 days). Costs for emergency cases were based on elective inpatient costs and prolonged hospital stays were ignored because they may not have been directly related to SPC insertion. For the day-case scenario, costs for the proportion of patients eventually needing hospitalisation were included, as were the costs of additional procedures when outpatient SPC insertion failed. Based on the data collected, it was predicted that 90% of SPC insertion procedures in the south-west region of England could be carried out in an outpatient clinic. The authors estimated that the annual cost benefit of adopting an outpatient management strategy would be about £100,000 in the hospital involved, which, when extrapolated to the region would be £790,000 and to the UK as a whole would be £9.5 million.
A product review of the S‑Cath System (McMeekin et al. 2010) compared conventional SPC insertion with the S‑Cath System in 1 NHS hospital. The S‑Cath technique allowed the authors to move SPC insertion to an outpatient procedure, resulting in a reduction in hospital stay from 2.3 days to 28 minutes. No other details, including the number of patients studied, were specified.
The evidence identified was very limited in both quantity and quality, and no large scale or comparative studies were found. Most of the studies involved relatively small numbers of patients. Two case reports (Jackson et al. 2010; Verwey et al. 2012) included single patients and it can be assumed that the outcomes of these reports should not be generalised. In particular, Jackson et al. (2010) report on a patient who developed complications after SPC replacement. The S‑Cath System was used during the first SPC procedure, however the replacement catheter was not specified. Because the S‑Cath should only be used for initial insertion and not replacement of SPCs, it is unclear if the use of S‑Cath was related to these complications. The 2 case series (Burki et al. 2011; Khan and Abrams 2008) both included fewer than 55 patients, with Burki et al. (2011) analysing patients retrospectively, increasing the risk of bias. This study is only available as a conference abstract and so few details are available. It is unclear if the patients were consecutive, again raising concerns about bias.
Both Burki et al. (2011) and Verwey et al. (2012) used the S‑Cath System in patients with a history of abdominal surgery, which is contraindicated for SPC insertion. This may have contributed to the complications seen in these studies. Jelski et al. (2013) noted that there were no bowel perforations after ultrasound scanning was started; the instructions for using the S‑Cath System recommend the use of ultrasound.
Jelski et al. (2013) included a large number of patients, but because the study is only available as a poster presentation, few details are available and it is unclear if the data were collected prospectively. As conference presentations, Jelski et al. (2013) and Burki et al. (2011) are unlikely to have been peer reviewed.
Neither of the 2 case series (Burki et al. 2011; Khan and Abrams 2008) nor the observational study (Jelski et al. 2013) stated inclusion and exclusion criteria, and Khan and Abrams (2008) did not specify primary outcomes. However, all 3 of these studies seem to report adverse events relatively clearly and include relevant outcomes.
Khan and Abrams (2008) reported the cost savings associated with moving SPC insertion from an inpatient to a day-case setting using the S‑Cath System. It is unclear if S‑Cath was used in the inpatient setting. Although significant cost savings were found, these mostly resulted from changing SPC insertion from an inpatient to an outpatient procedure, and were not necessarily associated with using the S‑Cath System itself. Because the study does not detail why S‑Cath was chosen over other similar devices, it is unclear if using the S‑Cath System is a significant factor in this cost saving. The study also extrapolated local cost savings to the wider region and the UK. Local and national variations may mean that these estimated savings are inaccurate.
The Vasdev et al. (2006) validation study did not give any patient data but did include a user survey from a small number of clinicians. All the clinicians surveyed were urology staff, so may have been more experienced in SPC insertion than other S‑Cath System users. Less experienced users may have different viewpoints. Also, the questionnaire used in the study was not provided and it is unclear if it had been validated. The study may therefore have been open to bias.
Khan and Abrams (2008) and Vasdev et al. (2006) acknowledged the S‑Cath System manufacturer for permission to reproduce illustrations. No other conflicts of interest are declared by any authors.
All of the studies appear to be UK‑based, so the results are likely to be generalisable to the NHS setting.