Health Technology Assessment 2005; Vol 9: number 4
Executive SummaryView/Download full monograph in Adobe Acrobat format (316 kbytes)
C Fowler,1* W McAllister,1 R Plail,2 O Karim3 and Q Yang4
1 Academic Urological Unit, Barts and The
London, Queen Marys School of Medicine and Dentistry, University of London,
2 Department of Urology, Conquest Hospital, Hastings, UK
3 Department of Urology, Wexham Park Hospital, Slough, UK
4 Bristol Urological Institute, Southmead Hospital, Bristol, UK
* Corresponding author
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).
A multicentre randomised controlled trial of pragmatic design with associated economic evaluation using cost minimisation.
Patients were recruited from four centres in south-east England.
Between March 1997 and August 1999, 235 men were recruited across the four participating centres. All patients had previously been assessed as requiring surgery for lower urinary tract symptoms deemed to be due to benign prostatic hypertrophy. Patients with clinical evidence of prostatic cancer, those unfit for surgery and those who had had previous prostatic surgery were excluded. Forty-five patients recruited were in urinary retention.
Randomisation was performed by a sealed envelope system provided by the data monitoring team at PROTO. Symptomatic and retention patients were randomised separately to ensure an even distribution in each arm. Patients were randomised as close as possible to the time of their operation.
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.
The International Prostate Symptom Score (IPSS) was used as the primary outcome measure. Patients in retention were allocated an IPSS related to the period immediately before retention occurred. A reduction of IPSS of ≥5 was taken as a satisfactory outcome. The IPSS quality of life (QoL) question provided disease-specific information about QoL.
The following were used as secondary outcome measures:
Blood was taken for measurement of full blood count and urea and electrolytes at baseline and at 24 hours. Adverse events were recorded on the Data Collection Form (DCF) during the hospital stay. At follow-up visits, any adverse event that had occurred since last contact with the study team was recorded, as were any visits to the district nurse, GP or any hospital.
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, defined as a >5 reduction in IPSS at 6 months 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.
There was no change from baseline for other domains of SF-36 or EuroQoL.
For the purposes of this study, an adverse event was defined as any undesirable experience that the patient had, whether considered procedure-related or not.
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. In particular, staff costs, theatre usage and capital equipment costs are the same. 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.
The studys primary conclusions were as follows:
The following areas of further research are recommended for consideration:
Fowler C, McAllister W, Plail R, Karim O, Yang Q. Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia. Health Technol Assess 2005;9(4).
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