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Appendix

Appendix

Contents

Data tables

Table 2: Overview of the Jelski et al. (2013) observational study

Table 3: Overview of the Burki et al. (2011) case series

Table 4: Overview of the Khan and Abrams (2008) case series

Table 5: Overview of the Jackson et al. (2010) case report

Table 6: Overview of Verwey et al. (2012) case report

Table 7: Overview of Vasdev et al. (2006) validation study

Table 2 Overview of the Jelski et al. (2013) observational study

Study component

Description

Objectives/
hypotheses

To show that a dedicated SPC clinic is safe and feasible.

Study design

Single-arm, observational study.

Setting

Dedicated SPC clinic in a UK hospital.

Intervention

Mediplus S‑Cath System using the Seldinger technique.

Primary outcomes

Feasibility and safety of SPC insertions.

Patients included

322 SPC insertions (number of patients not reported).

Background

A dedicated, twice‑monthly SPC clinic, led by a trained specialist nurse, was set up in a procedure room in July 2008. Ultrasound scanning started in 2011. Two aspects:

  • clinic: GP referrals – discussions on SPC suitability and problematic catheters

  • procedural: insertion of new SPC, change of difficult catheters.

Results/
outcomes

SPC insertion under local anaesthetic was not suitable for 2% (whether this was patients or procedures was not stated). All patients were discharged by the end of the clinic session.

Adverse events

  • 1 persistent haematuria

  • 3 bowel perforations (0.93% risk, but none since ultrasound scanning started): 2 confirmed (1 at the time of the procedure, which needed surgery, and 1 after 3 years); 1 suspected when the SPC was changed after 3 months.

Conclusions

'A dedicated SPC clinic can be safe and feasible if guidelines are followed.

Low complication rates.

Provides invaluable teaching opportunities (controlled environment, high concentration of patients, high turnover).

May be of value in future to increase use of SPC in acute and chronic setting' (extract from the poster, no further details given).

Abbreviation: SPC, suprapubic catheter.

Table 3 Overview of the Burki et al. (2011) case series

Study component

Description

Objectives/
hypotheses

Selected patients with a SCI, who had a neuropathic bladder, had SPC insertion as a day case, with the first change of SPC in a catheter clinic at 6 weeks and subsequent changes done in the community by district nurses. Experience with this technique over a 1‑year period is presented.

Study design

Retrospective case series.

Setting

A single UK hospital and community setting. Patients treated between June 2009 and June 2010.

Intervention

Mediplus S‑Cath System.

Primary outcomes

Problems encountered during the procedure and post-operative complications.

Patients included

n=45

Mean age was 54 years (range 15–88 years)

Male to female ratio was 2.75:1

Spinal cord injury was described as: cervical=28; thoracic=9; lumbar=4; multiple sclerosis=2; post-sacrectomy=1; cauda equina=1.

Background

The procedure was done as a day case under appropriate anaesthesia and ultrasound guidance was used when there was a history of abdominal surgery.

Results

All procedures were successfully completed. Ultrasound scan was used in 12 people. Filling the bladder was difficult in most of the people because of small contracted bladders. Urinary leakage around the urethral orifice was a problem, especially in women. Importantly, positioning the patient for insertion of the cystoscope and SPC was challenging. In 4 people, a urethral catheter was inserted to perform irrigation for 6 hours after SPC insertion.

Adverse events

One patient with haematuria needed bladder washout in theatre. Three patients developed UTIs. Autonomic dysreflexia occurred in 2 patients during the procedure. All patients had a successful first change of SPC in a catheter clinic after 6 weeks, but 18% (8/45) of the SPCs could not subsequently be replaced by district nurses. These 8 patients had temporary urethral catheters and were booked for reinsertion of SPC.

Conclusions

SPC insertion in patients with a SCI is a challenging procedure and should be done under controlled conditions in theatre with an anaesthetist present and using ultrasound when appropriate. There is a high reinsertion rate, but this may be related to changing the SPC in the community.

Abbreviations: SCI, spinal cord injury; SPC, suprapubic catheterisation; UTI, urinary tract infection.

Table 4 Overview of the Khan and Abrams (2008) case series

Study component

Description

Objectives/
hypotheses

To explore, by an audit, the regional practice of inserting an SPC, and to prospectively determine the proportion of SPCs that can be successfully managed on an outpatient basis in 1 department.

Study design

Retrospective audit and clinician survey that gathered data on all patients who had an SPC inserted between April 2005 and March 2006. Prospective case series that gathered data on patients scheduled for SPC insertion using the S‑Cath System from August 2006 and July 2007.

Setting

Retrospective audit: urology departments in 12 UK hospitals in the south-west of England.

Prospective audit: SPC clinic in 1 UK hospital in south-west England.

Intervention

Mediplus S‑Cath System.

Primary outcomes

Not applicable.

Patients included

Retrospective audit

Locally:

  • 66 patients (mean age 70 years, range 26–93)

  • 49 patients had an elective procedure (7 were day cases), 17 were emergency admissions

  • 43 patients had a GA and 23 patients had LA

  • median (range) hospital stay was 3.5 (1–85) days.

Regionally:

  • 480 SPCs were inserted in theatre, of which 52% (249) were as elective inpatients, 11% (52) were day cases, and 37% (179) were emergency admissions

  • a nurse-led outpatient service was available in 2 hospitals, where 89% of clinic patients had successful insertion under LA, and 11% were referred for insertion under GA.

Prospective case series

An SPC was successfully inserted in 50 of 54 patients in the new SPC clinic.

Background

Local practice was determined by a retrospective analysis of the hospital database between April 2005 and March 2006. Regional practice was identified by contacting regional hospitals. A questionnaire was also e-mailed to each of the 11 urology departments. This aimed to determine the departmental practice of SPC insertion regarding method, type of anaesthesia, preferred method of filling the bladder, and whether ultrasound guidance was used. Participants were also asked about factors influencing their decision to insert the SPC in the operating theatre, and whether outpatient-based SPC insertion was attempted first.

As a result of the audit, a new once‑weekly SPC clinic was set up.

All SPCs were inserted by 1 trainee urologist using the S‑Cath System under LA. Patients stayed under observation for 1–2 hours after the procedure. The first catheter change was done in a nurse-led clinic 4 weeks later, after which patients were discharged to primary care.

Locally, mean costs were calculated for outpatient, inpatient and day-case procedures. The cost differential to the trust of adopting outpatient SPC insertion was estimated and this was extrapolated to the region and to the UK as a whole.

Results/
outcomes

Outpatient SPC insertion was successful in 50 patients and unsuccessful in 4 patients. Difficulty in filling the bladder because of severe pain or urine leakage was the reason for 3 of the unsuccessful procedures (all had small-capacity bladders due to multiple sclerosis). In the fourth patient, the procedure was stopped because of a panic attack.

Adverse events

Of the 50 successful procedures, 1 patient was given prophylactic antibiotics because of a suspected infection. There were no serious complications during the procedure. One patient was admitted with haematuria after insertion. In 1 patient, the SPC stopped draining after it had been changed due to a blockage within the first week of insertion, and needed reinsertion under GA.

Conclusions

SPC is safe and feasible as an outpatient procedure for most patients, and its widespread use would produce considerable cost savings.

Abbreviations: GA, general anaesthetic; LA, local anaesthetic; SPC, suprapubic catheter.

Table 5 Overview of the Jackson et al. (2010) case report

Study component

Description

Objectives/
hypotheses

To present a case of small intestine injury after suprapubic catheterisation.

Study design

Retrospective descriptive case report.

Setting

UK-hospital setting.

Intervention

Mediplus S‑Cath System.

Primary outcomes

Not applicable.

Patients included

n=1

66 year old man with chronic retention and obstructive uropathy.

Background

Urethral catheterisation was done and the patient's renal function stabilised. A trial without a catheter after 3 months was unsuccessful. An SPC was inserted under local anaesthetic, without cystoscopic guidance. Overnight admission and IV antibiotics were needed because of pain at insertion site and low-grade pyrexia, assumed to be caused by a urinary infection. These symptoms settled, and the patient was discharged home with a short course of ciprofloxacin.

Adverse events

After 3 months, an experienced nurse in the community changed the SPC. The patient presented to the admissions unit the next day, with a greenish fluid, identified as small bowel effluent, draining from the SPC. He remained pain-free and systemically well, with no evidence of sepsis or peritonitis. Flexible cystoscopy showed turbid urine in the bladder, and no sign of the SPC. The bladder was catheterised urethrally. A CT scan was done with contrast instilled through the SPC, which showed that the catheter lay within a loop of small bowel. The injury was managed conservatively as a controlled entero-cutaneous fistula.

Results/
outcomes

The SPC was removed after 2 weeks and a dry dressing applied. The patient recovered without further complication.

Conclusions

This case shows that the risk of bowel injury can still occur despite using the S‑Cath System.

Abbreviations: IV, intravenous; SPC, suprapubic catheter.

Table 6 Overview of the Verwey et al. (2012) case report

Study component

Description

Objectives/
hypotheses

Not applicable.

Study design

Retrospective descriptive case report.

Setting

UK-hospital setting.

Intervention

Mediplus S‑Cath System.

Primary outcomes

Not applicable.

Patient included

An 82‑year old woman with a medical history of hysterectomy, atrial fibrillation, hypertension, bilateral hip replacement and open cholecystectomy.

Background

A consultant urologist inserted an SPC using the S‑Cath System. The bladder was filled using a flexible cystoscope before locating it with the Seldinger needle. There was some difficulty in passing the Seldinger needle into the bladder, but thereafter, it was a straight forward insertion. The patient felt well after the procedure and was discharged later that day.

Results/
outcomes

Post-operatively the patient needed intensive care in the form of fluid balance and inotropic support in ITU. Post-operative recovery was complicated by confusion, generalised weakness and sepsis of unknown source. The patient gradually improved and was discharged after 26 days to a community hospital for 15 days of further rehabilitation.

Adverse events

The patient began feeling unwell and collapsed twice. There were no cardiac symptoms or history of a fall. Two further episodes of dizziness were followed by unresponsiveness lasting 30 seconds. Respiratory examination found crackles in the left lung base. Investigations showed raised WBC count (14.9×109/litre), haemoglobin of 11.4 g/dl, and an INR of 3.1. BP was 180/92 mmHg. There was abdominal tenderness, particularly in the epigastric area. The SPC was draining clear urine but there was a small amount of blood leaking from around the insertion site. Fluid resuscitation corrected 2 hypotensive episodes.

A CT scan showed that the SPC was in place and high-density fluid was present in the abdomen and pelvis, in keeping with haemorrhage. An emergency laparotomy showed a small bowel injury, a large haematoma in the mesentery, and about 2,400 ml of blood with clots in the peritoneal cavity. A small bowel resection with end-to-end anastomosis was done.

Conclusions

This case shows that the risk of complications during SPC insertion is increased in patients with previous abdominal or pelvic surgery, and offers strong support for using ultrasound guidance when carrying out the procedure in these patients.

Abbreviations: BP, blood pressure: dl, decilitre (100 ml); INR, international normalised ratio; ITU, intensive therapy unit; SPC, suprapubic catheter; WBC, white blood cell.

Table 7 Overview of the Vasdev et al. (2006) validation study

Study component

Description

Objectives/
hypotheses

To present an evaluation of a new Seldinger technique for SPC describing the technique and post-procedure results.

Study design

Validation study (user experience survey).

Setting

A single UK hospital.

Intervention

Mediplus S‑Cath System.

Primary outcomes

To evaluate patient safety and the clinician's perception of a new Seldinger technique for SPC.

Patients included

Six patients who had SPCs inserted by 6 members of the urology department (specialist registrars and consultants).

Background

All clinicians completed a questionnaire after doing the procedure, rating their confidence in the new device compared with the standard technique across 5 domains, each using a simple scale. The rating scale for the questionnaire ranged from −100% to +100%.

Results/
outcomes

Confidence (mean [range]):

  • technique +38% (range 0% to +95%)

  • dilator +47% (range −40% to +95%)

  • patient comfort +17% (range 0% to +50%)

  • use by junior staff +39% (range −50% to +80%)

  • safety +37% (range −50% to +80%).

Adverse events

Not reported.

Conclusions

Overall, users expressed greater confidence in application, patient comfort, and safety compared with standard trochar placement. Given the current drive to minimise risk, these devices appear to represent a significant advance over standard methods and merit consideration for routine use.

Abbreviation: SPC, suprapubic catheter.