Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study).

OBJECTIVES: To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP). PATIENTS AND METHODS: As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK-ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post-procedure, and complication data post-PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non-inferiority analysis on propensity-score-matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire-based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK-ROPE study database. RESULTS: The results showed that PAE was clinically effective, producing a median 10-point IPSS improvement from baseline at 12 months post-procedure. PAE did not appear to be as effective as TURP, which produced a median 15-point IPSS score improvement at 12 months post-procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality-of-life (QoL) improvement, there was no evidence of PAE being non-inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post-procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non-target embolization that presented as self-limiting penile ulcers. Additional patient-reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy-one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights. CONCLUSION: Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone-beam computed tomography is encouraged to improve operator confidence and minimize non-target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients' symptoms, requirements and anatomical variation.

The TURis System for Transurethral Resection of the Prostate: A NICE Medical Technology Guidance.

The transurethral resection in saline (TURis) system was notified by the company Olympus Medical to the National Institute of Health and Care Excellence's (NICE's) Medical Technologies Evaluation Programme. Following selection for medical technologies guidance, the company developed a submission of clinical and economic evidence for evaluation. TURis is a bipolar surgical system for treating men with lower urinary tract symptoms due to benign prostatic enlargement. The comparator is any monopolar transurethral resection of the prostate (mTURP) system. Cedar, a collaboration between Cardiff and Vale University Health Board, Cardiff University and Swansea University in the UK, acted as an External Assessment Centre (EAC) for NICE to independently critique the company's submission of evidence. Eight randomised trials provided evidence for TURis, demonstrating efficacy equivalent to that of mTURP for improvement of symptoms. The company presented meta-analyses of key outcome measures, and the EAC made methodological modifications in response to the heterogeneity of the trial data. The EAC analysis found that TURis substantially reduced the relative risks of transurethral resection syndrome (relative risk 0.18 [95 % confidence interval 0.05-0.62]) and blood transfusion (relative risk 0.35 [95 % confidence interval 0.19-0.65]). The company provided a de novo economic model comparing TURis with mTURP. The EAC critiqued the model methodology and made modifications. This found TURis to be cost saving at £70.55 per case for existing Olympus customers and cost incurring at £19.80 per case for non-Olympus customers. When an additional scenario based on the only available data on readmission (due to any cause) from a single trial was modelled, the estimated cost saving per case was £375.02 for existing users of Olympus electrosurgery equipment and £284.66 per case when new Olympus equipment would need to be purchased. Meta-analysis of eight randomised trials showed that TURis is associated with a statistically significantly reduced risk of transurethral resection syndrome and a reduced need for blood transfusion-two factors that may drive cost saving for the National Health Service. The clinical data are equivocal as to whether TURis shortens the hospital stay. Limited data from a single study suggest that TURis may reduce the rate of readmission after surgery. The NICE guidance supports adoption of the TURis technology for performing transurethral resection of the prostate in men with lower urinary tract symptoms due to benign prostatic enlargement.

Feasibility of resectoscopic operative hysteroscopy in a UK outpatient clinic using local anesthetic and traditional reusable equipment, with patient experiences and comparative cost analysis.

STUDY OBJECTIVE: To assess procedural success, patient acceptability, and cost-saving potential of operative hysteroscopy using conventional equipment and local anesthetic in an outpatient clinic. DESIGN: Feasibility study/service evaluation (Canadian Task Force classification II-3). SETTING: Outpatient (office) clinic in a large UK teaching hospital. PATIENTS: One hundred eighteen women with diagnosed or suspected intrauterine myomas or polyps. INTERVENTIONS: Operative hysteroscopy (122 monopolar resection procedures using 8- or 10-mm diameter rigid resectoscopes with glycine solution for uterine irrigation) with the patient under local anesthesia in an outpatient (office) clinic. MEASUREMENTS AND MAIN RESULTS: Procedural success, duration of procedure, pathologic measurements, glycine irrigant deficit, patient pain scores and satisfaction, and comparative costs were recorded. Success of outpatient procedures was 90% (110 of 122 attempted), with a significantly reduced median procedure duration compared with a surgical setting using local (-7 minutes; p = .009) or general (-12.5 minutes; p < .001) anesthetic. Glycine irrigant absorption was low (median deficit, 0 mL), and no deficit was observed in 81% of patients. Mean (SD) estimated disease volume was comparable to that of hysteroscopic resection procedures in a surgical setting (3.38 [5.09] cm(3)), and weight was 1.8 (1.84) g. Patients tolerated the procedure well and reported low pain scores (highest median periprocedure pain measurement was 1.25 of 10), and 7-day follow-up satisfaction responses were positive. Retrospective cost analysis demonstrated that operative resection in an outpatient clinic was less expensive than in a surgical setting using general anesthetic (-$1003) or local anaesthetic (-$234). Reduced staff costs were the primary reason for this saving. CONCLUSIONS: Operative hysteroscopic resection of myomas and polyps is feasible and well tolerated by patients in an outpatient/office setting using local anaesthetic and conventional equipment. The outpatient procedure is less expensive and its duration is shorter than in a surgical setting.

Cost-effective non-surgical treatment of chronic pressure ulcers in the community.

The Salisbury Pressure Ulcer Outreach Service successfully treats patients with chronic pressure ulcers that have not healed during routine community treatment. These patients have grade 4 pressure ulcers, involving extensive destruction, or damage to muscle and bone. A combination of scientific, seating and tissue viability expertise with a holistic approach results in non-surgical healing for 70% of patients. For those who still require surgery, outcomes are more successful with this approach, resulting in low recurrence rates. Prior to creation of the outreach service, patients were referred directly for surgical closure, resulting in high recurrence levels and long waiting lists. The authors compared costs of the Pressure Ulcer Outreach Service with the previous system of surgical closure. The model base case found that the Pressure Ulcer Outreach Service saved £8588 per patient, and that cost savings could be even greater if the outreach service was extended into preventative work.