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C Ramsay, R Pickard,
C Robertson,
A Close,
L Vale,
N Armstrong,
DA Barocas,
Cg Eden,
C Fraser,
T Gurung, [......],
X Jia,
Tb Lam,
G Mowatt,
DE Neal,
Mc Robinson,
J Royle,
Sp Rushton,
P Sharma,
Mdf Shirley,
N Soomro
[show abstract]
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ABSTRACT: BACKGROUND: Complete surgical removal of the prostate, radical prostatectomy, is the most frequently used treatment option for men with localised prostate cancer. The use of laparoscopic (keyhole) and robot-assisted surgery has improved operative safety but the comparative effectiveness and cost-effectiveness of these options remains uncertain. OBJECTIVE: This study aimed to determine the relative clinical effectiveness and cost-effectiveness of robotic radical prostatectomy compared with laparoscopic radical prostatectomy in the treatment of localised prostate cancer within the UK NHS. DATA SOURCES: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, BIOSIS, Science Citation Index and Cochrane Central Register of Controlled Trials were searched from January 1995 until October 2010 for primary studies. Conference abstracts from meetings of the European, American and British Urological Associations were also searched. Costs were obtained from NHS sources and the manufacturer of the robotic system. Economic model parameters and distributions not obtained in the systematic review were derived from other literature sources and an advisory expert panel. REVIEW METHODS: Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies of men with clinically localised prostate cancer (cT1 or cT2); outcome measures included adverse events, cancer related, functional, patient driven and descriptors of care. Two reviewers abstracted data and assessed the risk of bias of the included studies. For meta-analyses, a Bayesian indirect mixed-treatment comparison was used. Cost-effectiveness was assessed using a discrete-event simulation model. RESULTS: The searches identified 2722 potentially relevant titles and abstracts, from which 914 reports were selected for full-text eligibility screening. Of these, data were included from 19,064 patients across one RCT and 57 non-randomised comparative studies, with very few studies considered at low risk of bias. The results of this study, although associated with some uncertainty, demonstrated that the outcomes were generally better for robotic than for laparoscopic surgery for major adverse events such as blood transfusion and organ injury rates and for rate of failure to remove the cancer (positive margin) (odds ratio 0.69; 95% credible interval 0.51 to 0.96; probability outcome favours robotic prostatectomy = 0.987). The predicted probability of a positive margin was 17.6% following robotic prostatectomy compared with 23.6% for laparoscopic prostatectomy. Restriction of the meta-analysis to studies at low risk of bias did not change the direction of effect but did decrease the precision of the effect size. There was no evidence of differences in cancer-related, patient-driven or dysfunction outcomes. The results of the economic evaluation suggested that when the difference in positive margins is equivalent to the estimates in the meta-analysis of all included studies, robotic radical prostatectomy was on average associated with an incremental cost per quality-adjusted life-year that is less than threshold values typically adopted by the NHS (£30,000) and becomes further reduced when the surgical capacity is high. LIMITATIONS: The main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction. CONCLUSIONS: This study demonstrated that robotic prostatectomy had lower perioperative morbidity and a reduced risk of a positive surgical margin compared with laparoscopic prostatectomy although there was considerable uncertainty. Robotic prostatectomy will always be more costly to the NHS because of the fixed capital and maintenance charges for the robotic system. Our modelling showed that this excess cost can be reduced if capital costs of equipment are minimised and by maintaining a high case volume for each robotic system of at least 100-150 procedures per year. This finding was primarily driven by a difference in positive margin rate. There is a need for further research to establish how positive margin rates impact on long-term outcomes. FUNDING: The National Institute for Health Research Health Technology Assessment programme.
Health technology assessment (Winchester, England). 11/2012; 16(41):1-313.
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R Pickard,
T Lam,
G Maclennan,
K Starr,
M Kilonzo,
G McPherson,
K Gillies,
A McDonald,
K Walton,
B Buckley,
C Glazener,
C Boachie,
J Burr,
J Norrie,
L Vale,
A Grant,
J N'dow
[show abstract]
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ABSTRACT: Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital and incurs significant costs for health-care providers such as the UK NHS. Many preventative strategies and measures have been introduced to minimise CAUTI risk, including the use of antimicrobial catheters. However, there is considerable uncertainty regarding their usefulness in terms of reducing symptomatic CAUTI, and whether or not they are cost-effective.
Do antimicrobial catheters reduce the rate of symptomatic urinary tract infection (UTI) during short-term hospital use and is their use cost-effective for the UK NHS?
A pragmatic multicentre UK randomised controlled trial comparing three catheters as they would be used in the UK NHS: antimicrobial-impregnated (nitrofurazone) and antiseptic-coated (silver alloy) catheters with the standard polytetrafluoroethylene (PTFE)-coated catheters. Economic evaluation used a decision model populated with data from the trial. Sensitivity analysis was used to explore uncertainty.
Relevant clinical departments in 24 NHS hospitals throughout the UK.
Adults requiring temporary urethral catheterisation for a period of between 1 and 14 days as part of their care, predominantly as a result of elective surgery.
Eligible participants were randomised 1 : 1 : 1 to one of three types of urethral catheter in order to make the following pragmatic comparisons: nitrofurazone-impregnated silicone catheter compared with standard PTFE-coated latex catheter; and silver alloy-coated hydrogel latex catheter compared with standard PTFE-coated latex catheter.
The primary outcome for clinical effectiveness was the incidence of UTI at any time up to 6 weeks post randomisation. This was defined as any symptom reported during catheterisation, up to 3 days or 1 or 2 weeks post catheter removal or 6 weeks post randomisation combined with a prescription of antibiotics, at any of these times, for presumed symptomatic UTI. The primary economic outcome was incremental cost per quality-adjusted life-year (QALY). Health-care costs were estimated from NHS sources with QALYs calculated from participant completion of the European Quality of Life-5 Dimensions (EQ-5D).
Outcome analyses encompassed 6394 (90%) of 7102 participants randomised. The rate of symptomatic UTI within 6 weeks of randomisation was 10.6% in the nitrofurazone group (n = 2153; -2.1% absolute risk difference), 12.5% in the silver alloy group (n = 2097; -0.1% absolute risk difference) and 12.6% in the PTFE group (n = 2144). The effect size {odds ratio (OR) [97.5% confidence interval (CI)]} was 0.82 (97.5% CI 0.66 to 1.01) for nitrofurazone (p = 0.037) and 0.99 (97.5% CI 0.81 to 1.22) for silver alloy (p = 0.92) catheters. The nitrofurazone catheters were more likely to cause discomfort during use and on removal. The primary economic analysis suggested that nitrofurazone-impregnated catheters would be, on average, the least costly (> £7 less than PTFE) and most effective option at current NHS prices. There was a 73% chance that nitrofurazone would be cost saving and an 84% chance that the incremental cost per QALY would be < £30,000. At the trial price (£6.46), silver alloy catheters were very unlikely to be cost-effective. These results were unchanged in sensitivity analyses, although when the length of stay cost was excluded the incremental cost per QALY for nitrofurazone against PTFE was £28,602.
The trial estimate of clinical effectiveness for nitrofurazone-impregnated catheters was less than the pre-specified minimum absolute risk difference that we considered important (-3.3%), and the surrounding CI included zero, indicating that any reduction in catheter-associated UTI was uncertain. Economic analysis, although associated with uncertainty, suggested that nitrofurazone-impregnated catheters may be cost-effective for the NHS. The trial ruled out the possibility that silver alloy-coated catheters might reach the pre-set degree of clinical effectiveness and that their use was unlikely to be cost-effective. These findings should be considered by patients, clinicians and health-care policy-makers to determine whether or not a change in practice is worthwhile. Future research should be aimed at determining the minimum clinically important difference in terms of CAUTI prevention in comparative trials, and to identify reliable methods which can detect the impact of the intervention on quality of life and other drivers of cost, when the intervention is a subsidiary part of overall treatment plans.
Current Controlled Trials ISRCTN75198618.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 47. See the HTA programme website for further project information.
Health technology assessment (Winchester, England). 11/2012; 16(47):1-197.
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M Imamura,
P Abrams,
C Bain,
B Buckley,
L Cardozo,
J Cody,
J Cook,
S Eustice,
C Glazener,
A Grant, [......],
D Jenkinson,
M Kilonzo,
G Nabi,
J N'Dow, R Pickard,
L Ternent,
S Wallace,
J Wardle,
S Zhu,
L Vale
[show abstract]
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ABSTRACT: To assess the clinical effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence (SUI) through systematic review and economic modelling.
The Cochrane Incontinence Group Specialised Register, electronic databases and the websites of relevant professional organisations and manufacturers, and the following databases: CINAHL, EMBASE, BIOSIS, Science Citation Index and Social Science Citation Index, Current Controlled Trials, ClinicalTrials.gov and the UKCRN Portfolio Database.
The study comprised three distinct elements. (1) A survey of 188 women with SUI to identify outcomes of importance to them (activities of daily living; sex, hygiene and lifestyle issues; emotional health; and the availability of services). (2) A systematic review and meta-analysis of non-surgical treatments for SUI to find out which are most effective by comparing results of trials (direct pairwise comparisons) and by modelling results (mixed-treatment comparisons - MTCs). A total of 88 randomised controlled trials (RCTs) and quasi-RCTs reporting data from 9721 women were identified, considering five generic interventions [pelvic floor muscle training (PFMT), electrical stimulation (ES), vaginal cones (VCs), bladder training (BT) and serotonin-noradrenaline reuptake inhibitor (SNRI) medications], in many variations and combinations. Data were available for 37 interventions and 68 treatment comparisons by direct pairwise assessment. Mixed-treatment comparison models compared 14 interventions, using data from 55 trials (6608 women). (3) Economic modelling, using a Markov model, to find out which combinations of treatments (treatment pathways) are most cost-effective for SUI.
Titles and abstracts identified were assessed by one reviewer and full-text copies of all potentially relevant reports independently assessed by two reviewers. Any disagreements were resolved by consensus or arbitration by a third person.
Direct pairwise comparison and MTC analysis showed that the treatments were more effective than no treatment. Delivering PFMT in a more intense fashion, either through extra sessions or with biofeedback (BF), appeared to be the most effective treatment [PFMT extra sessions vs no treatment (NT) odds ratio (OR) 10.7, 95% credible interval (CrI) 5.03 to 26.2; PFMT + BF vs NT OR 12.3, 95% CrI 5.35 to 32.7]. Only when success was measured in terms of improvement was there evidence that basic PFMT was better than no treatment (PFMT basic vs NT OR 4.47, 95% CrI 2.03 to 11.9). Analysis of cost-effectiveness showed that for cure rates, the strategy using lifestyle changes and PFMT with extra sessions followed by tension-free vaginal tape (TVT) (lifestyle advice-PFMT extra sessions-TVT) had a probability of greater than 70% of being considered cost-effective for all threshold values for willingness to pay for a QALY up to 50,000 pounds. For improvement rates, lifestyle advice-PFMT extra sessions-TVT had a probability of greater than 50% of being considered cost-effective when society's willingness to pay for an additional QALY was more than 10,000 pounds. The results were most sensitive to changes in the long-term performance of PFMT and also in the relative effectiveness of basic PFMT and PFMT with extra sessions.
Although a large number of studies were identified, few data were available for most comparisons and long-term data were sparse. Challenges for evidence synthesis were the lack of consensus on the most appropriate method for assessing incontinence and intervention protocols that were complex and varied considerably across studies.
More intensive forms of PFMT appear worthwhile, but further research is required to define an optimal form of more intensive therapy that is feasible and efficient for the NHS to provide, along with further definitive evidence from large, well-designed studies.
Health technology assessment (Winchester, England). 08/2010; 14(40):1-188, iii-iv.
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T Lourenco,
N Armstrong,
J N'Dow,
G Nabi,
M Deverill, R Pickard,
L Vale,
G MacLennan,
C Fraser,
S McClinton,
S Wong,
A Coutts,
G Mowatt,
A Grant
[show abstract]
[hide abstract]
ABSTRACT: To determine the clinical effectiveness and cost utility of procedures alternative to TURP (transurethral resection of the prostate) for benign prostatic enlargement (BPE) unresponsive to expectant, non-surgical treatments.
Electronic searches of 13 databases to identify relevant randomised controlled trials (RCTs).
Two reviewers independently assessed study quality and extracted data. The International Prostate Symptom Score/American Urological Association (IPSS/AUA) symptom score was the primary outcome; others included quality of life, peak urine flow rate and adverse effects. Cost-effectiveness was assessed using a Markov model reflecting likely care pathways.
156 reports describing 88 RCTs were included. Most had fewer than 100 participants (range 12-234). TURP provided consistent, high-level, long-term symptomatic improvement. Minimally invasive procedures resulted in less marked improvement. Ablative procedures gave improvements equivalent to TURP. Holmium laser enucleation of the prostate (HoLEP) additionally resulted in greater improvement in flow rate. HoLEP is unique amongst the newer technologies in offering an advantage in urodynamic outcomes over TURP, although long-term follow-up data are lacking. Severe blood loss was more common following TURP. Rates of incontinence were similar across all interventions other than transurethral needle ablation (TUNA) and laser coagulation, for which lower rates were reported. Acute retention and reoperation were commoner with newer technologies, especially minimally invasive interventions. The economic model suggested that minimally invasive procedures were unlikely to be cost-effective compared with TURP. Transurethral vaporisation of the prostate (TUVP) was both less costly and less effective than TURP. HoLEP was estimated to be more cost-effective than a single TURP but less effective than a strategy involving repeat TURP if necessary. The base-case analysis suggested an 80% chance that TUVP, followed by HoLEP if required, would be cost-effective at a threshold of 20,000 pounds per quality-adjusted life-year. At a 50,000 pounds threshold, TUVP, followed by TURP as required, would be cost-effective, although considerable uncertainty surrounds this finding. The main limitations are the quantity and quality of the data available, in the context of multiple comparisons.
In the absence of strong evidence in favour of newer methods, the standard--TURP--remains both clinically effective and cost-effective. There is a need for further research to establish (i) how many years of medical treatment are necessary to offset the cost of treatment with a minimally invasive or ablative intervention; (ii) more cost-effective alternatives to TURP; and (iii) strategies to improve outcomes after TURP.
Health technology assessment (Winchester, England) 12/2008; 12(35):iii, ix-x, 1-146, 169-515. · 4.26 Impact Factor
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[show abstract]
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ABSTRACT: Periurethral or transurethral injection of bulking agents is a surgical procedure most often used for the treatment of stress urinary incontinence a common, troublesome symptom amongst adult women.
To assess the effects of periurethral/transurethral injection therapy in the treatment of urinary incontinence in women.
We searched the Cochrane Incontinence Group Specialised Trials Register (28 February 2007), MEDLINE (January 1996 to March 2007, PREMEDLINE (7 February 2007) and the reference lists of relevant articles.
All randomised or quasi-randomised controlled trials of treatment for urinary incontinence, in which at least one management arm involved periurethral/transurethral injection therapy.
Two reviewers independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently using a standard form and clarification concerning possible unreported data sought directly from the investigators.
We identified twelve trials including 1318 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis. Injection of autologous fat was compared to placebo in a study of 68 women which was terminated early because of safety concerns. No differences in subjective or objective outcome were found in the two groups. No studies were found comparing injection therapy with conservative treatment. Two studies that compared injection with surgical management found significantly better objective outcome in the surgical group. Eight studies compared different agents - all results had wide confidence intervals. Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol and carbon spheres gave improvements equivalent to collagen. Porcine dermal implant gave improvements comparable to silicone at six months. A comparison of periurethral and transurethral methods of delivery of the bulking agent found similar outcome but a higher rate of early complications in the periurethral group.
Despite five additional trials, this updated review is still an unsatisfactory basis for practice. The trials were small and generally of moderate quality. The only evidence of benefit comes for within-group short-term changes following injection. The finding that placebo saline injection was followed by a similar symptomatic improvement questions the mechanism of any effects. There were no trials in comparison with pelvic floor muscle training -the obvious non-surgical comparator. Greater symptomatic improvement was observed after surgery, although these advantages need to be set against likely higher risks. No clear-cut conclusions could be drawn from trials comparing alternative agents; one small trial suggests that periurethral injection may carry more risks than transurethral injection. The single trial of autologous fat provides a reminder that periurethral injections can occasionally cause serious side-effects. Pending further evidence, injection therapy may represent a useful option for short-term symptomatic relief amongst selected women with co-morbidity that precludes anaesthesia - two or three injections are likely to be required to achieve a satisfactory result.
Cochrane database of systematic reviews (Online) 02/2007; · 5.72 Impact Factor
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[show abstract]
[hide abstract]
ABSTRACT: Adrenergic drugs have been used for the treatment of urinary incontinence. However, they have generally been considered to be ineffective or to have side effects which may limit their clinical use.
To determine the effectiveness of adrenergic agonists in the treatment of urinary incontinence in adults.
We searched the Cochrane Incontinence Group specialised trials register (searched 9 March 2005) and the reference lists of relevant articles.
Randomised or quasi-randomised controlled trials in adults with urinary incontinence which included an adrenergic agonist drug in at least one arm of the trial.
Two reviewers independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Reviewers' Handbook.
Twenty-two eligible randomised trials were identified, of which 11 were crossover trials. The trials included 1099 women with 673 receiving an adrenergic drug (phenylpropanolamine in 11 trials, midodrine in two, norepinephrine in three, clenbuterol in another three, terbutaline in one, eskornade in one and Ro-115-1240 in one). No trials included men. The limited evidence suggested that an adrenergic agonist drug is better than placebo in reducing the number of pad changes and incontinence episodes, as well as improving subjective symptoms. In two small trials, the drugs also appeared to be better than pelvic floor muscle training, possibly reflecting relative acceptability of the treatments to women but perhaps due to differential withdrawal of women from the trial groups. There was not enough evidence to evaluate the use of higher compared to lower doses of adrenergic agonists nor the relative merits of an adrenergic agonist drug compared with oestrogen, whether used alone or in combination. Over a quarter of women reported adverse effects. There were similar numbers of adverse effects with adrenergics, placebo or alternative drug treatment. However, when these were due to recognised adrenergic stimulation (insomnia, restlessness and vasomotor stimulation) they were only severe enough to stop treatment in 4% of women.
There was weak evidence to suggest that use of an adrenergic agonist was better than placebo treatment. There was not enough evidence to assess the effects of adrenergic agonists when compared to or combined with other treatments. Further larger trials are needed to identify when adrenergics may be useful. Patients using adrenergic agonists may suffer from minor side effects, which sometimes cause them to stop treatment. Rare but serious side effects, such as cardiac arrhythmias and hypertension, have been reported.
Cochrane database of systematic reviews (Online) 02/2005; · 5.72 Impact Factor
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[show abstract]
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ABSTRACT: Surgery performed to improve or replace the function of the diseased urinary bladder has been carried out for over a century. Main reasons for improving or replacing the function of the urinary bladder are bladder cancer, neurogenic bladder dysfunction, detrusor overactivity and chronic inflammatory diseases of the bladder (such as interstitial cystitis, tuberculosis and schistosomiasis). There is still much uncertainty about the best surgical approach. Options available at the present time include: (1) conduit diversion (the creation of various intestinal conduits to the skin) or continent diversion (which includes either a rectal reservoir or continent cutaneous diversion), (2) bladder reconstruction and (3) replacement of the bladder with various intestinal segments.
To determine the best way of improving or replacing the function of the lower urinary tract using intestinal segments when the bladder has to be removed or when it has been rendered useless or dangerous by disease.
We searched the Cochrane Incontinence Group's specialised register (3 May 2001), The Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2001), MEDLINE (1966 to May 2001), PREMEDLINE (4 June 2001), Dissertation Abstracts (18.6.2001) and the reference lists of relevant articles. Date of most recent search: June 2001.
All randomised or quasi-randomised controlled trials of surgery involving transposition of an intestinal segment into the urinary tract.
Trials were evaluated for appropriateness for inclusion and for methodological quality by the reviewers. Three reviewers were involved in the data extraction. The data collected was then analysed for statistical significance.
Two trials met the inclusion criteria with a total of 164 participants. These trials addressed only four of the 14 comparisons pre-specified in the protocol. There were no statistically significant differences found in the incidence of upper urinary tract infection, ureterointestinal stenosis and renal deterioration in the comparison of continent diversion with conduit diversion. There was no evidence of a difference in incidence of upper urinary tract infection and uretero-intestinal stenosis when conduit diversions were fashioned from either ileum or colon. No statistically significant difference was found in the incidence of renal scarring between anti-refluxing versus freely refluxing uretero-intestinal anastomotic techniques in conduit diversions. The confidence intervals were all wide, however, and did not rule out important differences. There was some limited evidence that use of the more complex nipple valve at the ureteroileal anastomosis was more likely to lead to upper tract deterioration than implantation into a non-detubularised, isoperistaltic ileal afferent limb.
The evidence from the included trials was very limited. Only two studies met the inclusion criteria; these were small, of moderate or poor methodological quality, and reported few of the pre-selected outcome measures. This review did not find any evidence that bladder replacement (orthotopic or continent diversion) was better than conduit diversion following cystectomy for cancer. There was no evidence to suggest that bladder reconstruction was better than conduit diversion for benign disease. The small amount of usable evidence for this review suggests that collaborative multicentre studies should be organised, using random allocation where possible.
Cochrane database of systematic reviews (Online) 02/2003; · 5.72 Impact Factor
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[show abstract]
[hide abstract]
ABSTRACT: Stress urinary incontinence is a common, troublesome symptom amongst adult women. Periurethral injection of bulking agents is a surgical procedure used for the treatment of urinary incontinence.
To assess the effects of periurethral injection therapy in the treatment of urinary incontinence in women.
We searched the Cochrane Incontinence Group trials register (February 2003), MEDLINE (January 1996 to January 2003), PREMEDLINE (7 February 2003) and the reference lists of relevant articles. Date of the most recent searches: February 2003.
All randomised or quasi-randomised controlled trials of treatment for urinary incontinence, in which at least one management arm involved periurethral injection therapy.
Two reviewers independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently using a standard form and clarification concerning possible unreported data sought directly from the investigators.
We identified seven trials that met the inclusion criteria. The limited data available prevented meta-analysis. Injection of autologous fat was compared to placebo in a study of 68 women which was terminated early because of safety concerns. No differences in subjective or objective outcome were found in the two groups. No studies were found comparing injection therapy with conservative treatment. The single study that compared injection with a variety of surgical management in 133 women found no significant difference in subjective outcome but did note significantly better objective outcome in the surgical group. The four studies that compared different agents found that silicone particles and carbon spheres gave improvement at 12 months equivalent to collagen. A comparison of paraurethral and transurethral methods of delivery of the bulking agent found similar outcome but a higher rate of early complications in the paraurethral group.
Data from the available randomised trials suggest, but do not prove, that periurethral injection of established manufactured bulking agents results in subjective and objective short term improvement of symptomatic female stress urinary incontinence in adults. Future recommendation as a first line treatment would require evidence of patient benefit and cost-effectiveness from randomised trials involving placebo and conservative treatment arms. Future studies should also record long-term outcome and monitor for delayed particle migration. Injection therapy is probably inferior to surgery but a long term comparative study against a single standard procedure (Burch colposuspension) is required to prove this. It is recommended that phase III studies of newer agents will not be worthwhile until the aforementioned trials have been performed and a rationale for the use of injection therapy decided. For women with extensive co-morbidity precluding anaesthesia, injection therapy may represent a useful option for relief of symptoms for a 12 month period although 2 or 3 injections are likely to be required to achieve a satisfactory result.
Cochrane database of systematic reviews (Online) 02/2003; · 5.72 Impact Factor
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Tania Lourenco,
Nigel Armstrong,
James Michael Olu N'Dow,
G Nabi,
M Deverill, R Pickard,
Luke David Vale,
Graeme Stewart MacLennan,
Cynthia Mary Fraser,
Sam McClinton,
S. Wong,
Alasdair George Coutts,
Graham Mowatt,
Adrian Grant,
BPE Study Group
[show abstract]
[hide abstract]
ABSTRACT: Objectives: To determine the clinical effectiveness and cost utility of procedures alternative to TURP (transurethral resection of the prostate) for benign prostatic enlargement (BPE) unresponsive to expectant, non-surgical treatments. Data sources: Electronic searches of 13 databases to identify relevant randomised controlled trials (RCTs). Review methods: Two reviewers independently assessed study quality and extracted data. The International Prostate Symptom Score/American Urological Association (IPSS/AUA) symptom score was the primary outcome; others included quality of life, peak urine flow rate and adverse effects. Costeffectiveness was assessed using a Markov model reflecting likely care pathways. Results: 156 reports describing 88 RCTs were included. Most had fewer than 100 participants (range 12–234). TURP provided consistent, high-level, longterm symptomatic improvement. Minimally invasive procedures resulted in less marked improvement. Ablative procedures gave improvements equivalent to TURP. Holmium laser enucleation of the prostate (HoLEP) additionally resulted in greater improvement in flow rate. HoLEP is unique amongst the newer technologies in offering an advantage in urodynamic outcomes over TURP, although long-term follow-up data are lacking. Severe blood loss was more common following TURP. Rates of incontinence were similar across all interventions other than transurethral needle ablation (TUNA) and laser coagulation, for which lower rates were reported. Acute retention and reoperation were commoner with newer technologies, especially minimally invasive interventions. The economic model suggested that minimally invasive procedures were unlikely to be cost-effective compared with TURP. Transurethral vaporisation of the prostate (TUVP) was both less costly and less effective than TURP. HoLEP was estimated to be more cost-effective than a single TURP but less effective than a strategy involving repeat TURP if necessary. The base-case analysis suggested an 80% chance that TUVP, followed by HoLEP if required, would be cost-effective at a threshold of £20,000 per quality-adjusted life-year. At a £50,000 threshold, TUVP, followed by TURP as required, would be cost-effective, although considerable uncertainty surrounds this finding. The main limitations are the quantity and quality of the data available, in the context of multiple comparisons. Conclusions: In the absence of strong evidence in favour of newer methods, the standard – TURP – remains both clinically effective and cost-effective. There is a need for further research to establish (i) how many years of medical treatment are necessary to offset the cost of treatment with a minimally invasive or ablative intervention; (ii) more cost-effective alternatives to TURP; and (iii) strategies to improve outcomes after TURP. Chief Scientist Office of the Scottish Government Health Directorate. Peer reviewed Publisher PDF
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Mari Imamura,
P Abrams,
Christine Bain,
B Buckley,
L Cardozo,
Dorothy June Cody,
Jonathan Alistair Cook,
S. Eustice,
Cathryn Margaret Anne Glazener,
Adrian Maxwell Grant, [......],
David James Jenkinson,
Mary Mueni Kilonzo,
G Nabi,
James Michael Olu N'Dow, R Pickard,
Laura Ternent,
Sheila Ann Wallace,
J. Wardle,
S Zhu,
Luke David Vale
