S-Cath System for suprapubic catheterisation

Regulatory bodies

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.

Clinical evidence

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.

Recent and ongoing studies

No ongoing or in-development trials on the S‑Cath System for suprapubic catheterisation were identified in the preparation of this briefing.