Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia.
OBJECTIVES: To compare and evaluate the clinical and cost-effectiveness of transurethral vaporisation of the prostate (TUVP), a new electrosurgical modality, with the standard treatment, transurethral resection of the prostate (TURP). DESIGN: A multicentre randomised controlled trial of pragmatic design with associated economic evaluation using cost minimisation. SETTING: Patients were recruited from four centres in south-east England. PARTICIPANTS: Men requiring surgery for lower urinary tract symptoms deemed to be due to benign prostatic hypertrophy. INTERVENTIONS: TURP was performed and subsequent management conducted according to the usual practice of the clinical team. TUVP was performed with the most promising available equipment using a technique described in the literature. Postoperative management after TUVP was left to the ward team, who were not necessarily informed to which treatment arm the patient had been allocated. For the purpose of the study, patients were assessed clinically, by questionnaire and investigation at baseline, 2 months and 6 months after randomisation. A long-term follow-up postal questionnaire was sent to each patient at 2 years. For the economic evaluation, direct costs from the NHS viewpoint were collected. MAIN OUTCOME MEASURES: A reduction of at least 5 from the International Prostate Symptom Score (IPSS) was taken as a satisfactory outcome. The IPSS quality of life (QoL) question provided disease-specific information about QoL. Secondary outcome measures included urinary flow rate, post-void urinary volume, prostate volume and pressure-flow urodynamics. Questionnaires used included SF-36, EuroQol and a sexual function section based on the International Continence Society 'Benign Prostatic Hyperplasia' (ICS-BPH) questionnaire. Measurement of full blood count and urea and electrolytes was made at baseline and at 24 hours. Adverse events were recorded during the hospital stay and at follow-up visits. RESULTS: TURP and TUVP were both effective in producing a clinically important reduction in IPSS and positive change in the IPSS QoL question. The success rate for relief of symptoms was 85% for TURP and 74% for TUVP. Neither the success of the treatment nor the change in aggregated IPSS was significantly different between the groups. The improvement was sustained to 24 months after treatment with no significant difference between the groups. The effectiveness of both treatments was also equivalent when assessed through improvement in objective measures of urinary tract function, reduction in prostate size and the change in health questions of SF-36. The absolute incidence of adverse events was similar between the two groups. The incidence of severe or prolonged bleeding was less with TUVP, as evidenced by the need for blood transfusion and the drop in haemoglobin level 24 hours postoperatively. TURP and TUVP are broadly equivalent in direct NHS resource use. This study did not show any significant difference in inpatient stay or use of outpatient resources between the groups. The disposable electrodes used for TUVP are more expensive than reusable TURP electrodes. CONCLUSIONS: TURP and TUVP are equivalently effective in improving the symptoms of benign prostatic enlargement over at least 2 years. TUVP is associated with less morbidity due to haemorrhage than TURP. Replacement of TURP by TUVP would not produce a significant cost benefit to the NHS unless a reduction hospital inpatient stay of at least 1 day could be secured. Further research is necessary to determine why patients stay in hospital after transurethral surgery to the prostate and how a reduction in the length of stay can be achieved. A much larger observational study/audit is required to assess the incidence of infrequently occurring adverse events after TUVP. Longer term follow-up is also needed.