Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial.

BACKGROUND: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. METHODS/DESIGN: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. DISCUSSION: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.

Adherence to European Association of Urology Guidelines on Prophylactic Antibiotics: An Important Step in Antimicrobial Stewardship.

BACKGROUND: The evolution of resistant pathogens is a worldwide health crisis and adherence to European Association of Urology (EAU) guidelines on antibiotic prophylaxis may be an important way to improve antibiotic stewardship and reduce patient harm and costs. OBJECTIVE: To evaluate the prevalence of antibiotic-resistant bacterial strains and health care costs during a period of adherence to EAU guidelines in a tertiary referral urologic institution. DESIGN, SETTING, AND PARTICIPANTS: A protocol for adherence to EAU guidelines for antibiotic prophylaxis for all urologic procedures was introduced in January 2011. Data for 3529 urologic procedures performed between January 2011 and December 2013 after protocol introduction were compared with data for 2619 procedures performed between January 2008 and December 2010 before protocol implementation. The prevalence of bacterial resistance and health care costs were compared between the two periods. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The outcome measures were the proportion of resistant uropathogens and costs related to antibiotic consumption and symptomatic postoperative infection. We used χ2 and Fisher's exact tests to test the significance of differences. RESULTS AND LIMITATIONS: The proportion of patients with symptomatic postoperative infection did not differ (180/3529 [5.1%] vs. 117/2619 [4.5%]; p=0.27). A total of 342 isolates from all patients with symptomatic postoperative infections were analysed. The rate of resistance of Escherichia coli to piperacillin/tazobactam (9.1% vs. 5.4%; p=0.03), gentamicin (18.3% vs. 11.2%; p=0.02), and ciprofloxacin (32.3% vs. 19.1%; p=0.03) decreased significantly after protocol introduction. The defined daily dose (DDD) use of ciprofloxacin fell from 4.2 to 0.2 DDD per 100 patient-days after implementation (p<0.001). Antibiotic drug costs (€76,980 vs. €36,700) and costs related to postoperative infections (€45,870 vs. €29,560) decreased following introduction of the protocol (p<0.001). CONCLUSIONS: Adherence to EAU guidelines on antibiotic prophylaxis reduced antibiotic usage without increasing post-operative infection rate and lowered the prevalence of resistant uropathogens. PATIENT SUMMARY: We analysed the impact of adherence to European Association of Urology guidelines on antibiotic prophylaxis for all surgical urologic procedures on the prevalence of infections and resistant bacterial strains and on costs. We found that adherence to the guidelines reduced the rate of bacterial resistance, in particular against piperacillin/tazobactam, gentamicin, and ciprofloxacin, and reduced costs without increasing the risk of postoperative infection after urologic procedures. We recommend adherence to the guidelines as an important part of antibiotic stewardship programmes.

Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre, placebo-controlled, randomised controlled trial and cost-effectiveness analysis of a calcium channel blocker (nifedipine) and an alpha-blocker (tamsulosin) (the SUSPEND trial).

BACKGROUND: Ureteric colic, the term used to describe the pain felt when a stone passes down the ureter from the kidney to the bladder, is a frequent reason for people to seek emergency health care. Treatment with the muscle-relaxant drugs tamsulosin hydrochloride (Petyme, TEVA UK Ltd) and nifedipine (Coracten(®), UCB Pharma Ltd) as medical expulsive therapy (MET) is increasingly being used to improve the likelihood of spontaneous stone passage and lessen the need for interventional procedures. However, there remains considerable uncertainty around the effectiveness of these drugs for routine use. OBJECTIVES: To determine whether or not treatment with either tamsulosin 400 µg or nifedipine 30 mg for up to 4 weeks increases the rate of spontaneous stone passage for people with ureteric colic compared with placebo, and whether or not it is cost-effective for the UK NHS. DESIGN: A pragmatic, randomised controlled trial comparing two active drugs, tamsulosin and nifedipine, against placebo. Participants, clinicians and trial staff were blinded to treatment allocation. A cost-utility analysis was performed using data gathered during trial participation. SETTING: Urology departments in 24 UK NHS hospitals. PARTICIPANTS: Adults aged between 18 and 65 years admitted as an emergency with a single ureteric stone measuring ≤ 10 mm, localised by computerised tomography, who were able to take trial medications and complete trial procedures. INTERVENTIONS: Eligible participants were randomised 1 : 1 : 1 to take tamsulosin 400 µg, nifedipine 30 mg or placebo once daily for up to 4 weeks to make the following comparisons: tamsulosin or nifedipine (MET) versus placebo and tamsulosin versus nifedipine. MAIN OUTCOME MEASURES: The primary effectiveness outcome was the proportion of participants who spontaneously passed their stone. This was defined as the lack of need for active intervention for ureteric stones at up to 4 weeks after randomisation. This was determined from 4- and 12-week case-report forms completed by research staff, and from the 4-week participant self-reported questionnaire. The primary economic outcome was the incremental cost per quality-adjusted life-year (QALY) gained over 12 weeks. We estimated costs from NHS sources and calculated QALYs from participant completion of the European Quality of Life-5 Dimensions health status questionnaire 3-level response (EQ-5D-3L™) at baseline, 4 weeks and 12 weeks. RESULTS: Primary outcome analysis included 97% of the 1167 participants randomised (378/391 tamsulosin, 379/387 nifedipine and 379/399 placebo participants). The proportion of participants who spontaneously passed their stone did not differ between MET and placebo [odds ratio (OR) 1.04, 95% confidence interval (CI) 0.77 to 1.43; absolute difference 0.8%, 95% CI -4.1% to 5.7%] or between tamsulosin and nifedipine [OR 1.06, 95% CI 0.74 to 1.53; absolute difference 1%, 95% CI -4.6% to 6.6%]. There was no evidence of a difference in QALYs gained or in cost between the trial groups, which means that the use of MET would be very unlikely to be considered cost-effective. These findings were unchanged by extensive sensitivity analyses around predictors of stone passage, including sex, stone size and stone location. CONCLUSIONS: Tamsulosin and nifedipine did not increase the likelihood of stone passage over 4 weeks for people with ureteric colic, and use of these drugs is very unlikely to be cost-effective for the NHS. Further work is required to investigate the phenomenon of large, high-quality trials showing smaller effect size than meta-analysis of several small, lower-quality studies. TRIAL REGISTRATION: Current Controlled Trials ISRCTN69423238. European Clinical Trials Database (EudraCT) number 2010-019469-26. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 63. See the NIHR Journals Library website for further project information.

Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial.

BACKGROUND: Meta-analyses of previous randomised controlled trials concluded that the smooth muscle relaxant drugs tamsulosin and nifedipine assisted stone passage for people managed expectantly for ureteric colic, but emphasised the need for high-quality trials with wide inclusion criteria. We aimed to fulfil this need by testing effectiveness of these drugs in a standard clinical care setting. METHODS: For this multicentre, randomised, placebo-controlled trial, we recruited adults (aged 18-65 years) undergoing expectant management for a single ureteric stone identified by CT at 24 UK hospitals. Participants were randomly assigned by a remote randomisation system to tamsulosin 400 µg, nifedipine 30 mg, or placebo taken daily for up to 4 weeks, using an algorithm with centre, stone size (≤5 mm or >5 mm), and stone location (upper, mid, or lower ureter) as minimisation covariates. Participants, clinicians, and trial personnel were masked to treatment assignment. The primary outcome was the proportion of participants who did not need further intervention for stone clearance within 4 weeks of randomisation, analysed in a modified intention-to-treat population defined as all eligible patients for whom we had primary outcome data. This trial is registered with the European Clinical Trials Database, EudraCT number 2010-019469-26, and as an International Standard Randomised Controlled Trial, number 69423238. FINDINGS: Between Jan 11, 2011, and Dec 20, 2013, we randomly assigned 1167 participants, 1136 (97%) of whom were included in the primary analysis (17 were excluded because of ineligibility and 14 participants were lost to follow-up). 303 (80%) of 379 participants in the placebo group did not need further intervention by 4 weeks, compared with 307 (81%) of 378 in the tamsulosin group (adjusted risk difference 1·3% [95% CI -5·7 to 8·3]; p=0·73) and 304 (80%) of 379 in the nifedipine group (0·5% [-5·6 to 6·5]; p=0·88). No difference was noted between active treatment and placebo (p=0·78), or between tamsulosin and nifedipine (p=0·77). Serious adverse events were reported in three participants in the nifedipine group (one had right loin pain, diarrhoea, and vomiting; one had malaise, headache, and chest pain; and one had severe chest pain, difficulty breathing, and left arm pain) and in one participant in the placebo group (headache, dizziness, lightheadedness, and chronic abdominal pain). INTERPRETATION: Tamsulosin 400 µg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Open urethroplasty versus endoscopic urethrotomy--clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial.

BACKGROUND: Urethral stricture is a common cause of difficulty passing urine in men with prevalence of 0.5 %; about 62,000 men in the UK. The stricture is usually sited in the bulbar part of the urethra causing symptoms such as reduced urine flow. Initial treatment is typically by endoscopic urethrotomy but recurrence occurs in about 60% of men within 2 years. The best treatment for men with recurrent bulbar stricture is uncertain. Repeat endoscopic urethrotomy opens the narrowing but it usually scars up again within 2 years requiring repeated procedures. The alternative of open urethroplasty involves surgically reconstructing the urethra, which may need an oral mucosal graft. It is a specialist procedure with a longer recovery period but may give lower risk of recurrence. In the absence of firm evidence as to which is best, individual men have to trade off the invasiveness and possible benefit of each option. Their preference will be influenced by individual social circumstances, availability of local expertise and clinician guidance. The open urethroplasty versus endoscopic urethrotomy (OPEN) trial aims to better guide the choice of treatment for men with recurrent urethral strictures by comparing benefit over 2 years in terms of symptom control and need for further treatment. METHODS/DESIGN: OPEN is a pragmatic, UK multicentre, randomised trial. Men with recurrent bulbar urethral strictures (at least one previous treatment) will be randomised to undergo endoscopic urethrotomy or open urethroplasty. Participants will be followed for 24 months after randomisation, measuring symptoms, flow rate, the need for re-intervention, health-related quality of life, and costs. The primary clinical outcome is the difference in symptom control over 24 months measured by the area under the curve (AUC) of a validated score. The trial has been powered at 90% with a type I error rate of 5% to detect a 0.1 difference in AUC measured on a 0-1 scale. The analysis will be based on all participants as randomised (intention-to-treat). The primary economic outcome is the incremental cost per quality-adjusted life year. A qualitative study will assess willingness to be randomised and hence ability to recruit to the trial. DISCUSSION: The OPEN Trial seeks to clarify relative benefit of the current options for surgical treatment of recurrent bulbar urethral stricture which differ in their invasiveness and resources required. Our feasibility study identified that participation would be limited by patient preference and differing recruitment styles of general and specialist urologists. We formulated and implemented effective strategies to address these issues in particular by inviting participation as close as possible to diagnosis. In addition re-calculation of sample size as recruitment progressed allowed more efficient design given the limited target population and funding constraints. Recruitment is now to target. TRIAL REGISTRATION: ISRCTN98009168 Date of registration: 29 November 2012.

Differences in urodynamic voiding variables recorded by conventional cystometry and ambulatory monitoring in symptomatic women

Objectives To determine whether there are differences in pressure and flow measurements between conventional cystometry (CONV) and ambulatory urodynamic monitoring (AMB) in women with overactive bladder syndrome and urinary incontinence. Materials and Methods Retrospective study which included female subjects who underwent both CONV (with saline filling medium) and AMB, separated by less than 24 months, not using medication active on the lower urinary tract and without history of prior pelvic surgery. Both tests were carried out in compliance with the International Continence Society standards. The paired Student’s t test was used to compare continuous variables. Bland-Altman statistics were used to assess the agreement of each variable between both studies. Results Thirty women with a median (range) age of 50 (14 - 73) years met the inclusion criteria. AMB was carried out at a mean (SD) of 11 (6) months after CONV. Measurements of pves and pabd at the end of filling, and Qmax were significantly higher from AMB recordings. There were no differences in pdet at the end of filling, pdetQmax or pdetmax during voiding, nor significant difference in Vvoid. Conclusions We provide previously undocumented comparative voiding data between CONV and AMB for patients who most commonly require both investigations. Our findings show higher values of Qmax but similar values of pdetQmax measured by AMB which may partly reflect an overall lower catheter caliber, physiological filling but perhaps also more ‘normal’ voiding conditions. .

Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial.

BACKGROUND: Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications.Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective α-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation.This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones. METHODS/DESIGN: The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo.Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The primary economic outcome is a reduction in the incremental cost per quality-adjusted life years, determined at 12 weeks. The analysis will be based on all participants as randomized (intention to treat). The trial has 90% power with a type I error rate of 5% to detect a 10% increase in primary outcome between the tamsulosin and nifedipine treatment groups. TRIAL REGISTRATION: ISRCTN69423238; EudraCT number: 2010-019469-26.

Comparative cost-effectiveness of robot-assisted and standard laparoscopic prostatectomy as alternatives to open radical prostatectomy for treatment of men with localised prostate cancer: a health technology assessment from the perspective of the UK National Health Service.

BACKGROUND: Robot-assisted laparoscopic prostatectomy is increasingly used compared with a standard laparoscopic technique, but it remains uncertain whether potential benefits offset higher costs. OBJECTIVE: To determine the cost-effectiveness of robotic prostatectomy. DESIGN, SETTING, AND PARTICIPANTS: We conducted a care pathway description and model-based cost-utility analysis. We studied men with localised prostate cancer able to undergo either robotic or laparoscopic prostatectomy for cure. We used data from a meta-analysis, other published literature, and costs from the UK National Health Service and commercial sources. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Care received by men for 10 yr following radical prostatectomy was modelled. Clinical events, their effect on quality of life, and associated costs were synthesised assuming 200 procedures were performed annually. RESULTS AND LIMITATIONS: Over 10 yr, robotic prostatectomy was on average (95% confidence interval [CI]) £1412 (€1595) (£1304 [€1473] to £1516 [€1713]) more costly than laparoscopic prostatectomy but more effective with mean (95% CI) gain in quality-adjusted life-years (QALYs) of 0.08 (0.01-0.15). The incremental cost-effectiveness ratio (ICER) was £18 329 (€20 708) with an 80% probability that robotic prostatectomy was cost effective at a threshold of £30 000 (€33 894)/QALY. The ICER was sensitive to the throughput of cases and the relative positive margin rate favouring robotic prostatectomy. CONCLUSIONS: Higher costs of robotic prostatectomy may be offset by modest health gain resulting from lower risk of early harms and positive margin, provided >150 cases are performed each year. Considerable uncertainty persists in the absence of directly comparative randomised data.

The clinical effectiveness of transurethral incision of the prostate: a systematic review of randomised controlled trials.

PURPOSE: Transurethral incision of the prostate gland (TUIP) is perceived as a less morbid surgical alternative to standard transurethral resection of the prostate gland (TURP) for treatment of symptomatic mild to moderate benign prostate enlargement (BPE). We aimed to evaluate comparative clinical effectiveness of the two procedures. METHODS: Systematic review and meta-analysis of short- and long-term data from randomised controlled trials comparing TUIP with TURP. RESULTS: This review considered data from 795 randomised participants across 10 RCTs of moderate to poor quality 8 of which stated an upper limit for prostate size. No difference in the degree of symptomatic improvement was seen between the two procedures. Improvement in peak urine flow rate was lower for TUIP compared to TURP whilst the rate of blood transfusion and TUR syndrome was higher after TURP. Urinary retention, urinary tract infection, strictures and incontinence did not differ between the two approaches, although clinically important differences could not be ruled-out. TUIP was associated with a shorter duration of operation and length of hospital stay but a higher re-operation rate. CONCLUSION: TUIP and TURP appear to offer equivalent symptomatic improvement for men with mild to moderate BPE. Choosing TUIP involves a trade-off between the lower risk of peri-operative morbidity and the higher risk of subsequent re-operation.

Surgical treatments for men with benign prostatic enlargement: cost effectiveness study.

OBJECTIVE: To determine which surgical treatment for lower urinary tract symptoms suggestive of benign prostate enlargement is cost effective. DESIGN: Care pathways describing credible treatment strategies were decided by consensus. Cost-utility analysis used Markov modelling and Monte Carlo simulation. DATA SOURCES: Clinical effectiveness data came from a systematic review and an individual level dataset. Utility values came from previous economic evaluations. Costs were calculated from National Health Service (NHS) and commercial sources. METHODS: The Markov model included parameters with associated measures of uncertainty describing health states between which individuals might move at three monthly intervals over 10 years. Successive annual cohorts of 25,000 men were entered into the model and the probability that treatment strategies were cost effective was assessed with Monte Carlo simulation with 10,000 iterations. RESULTS: A treatment strategy of initial diathermy vaporisation of the prostate followed by endoscopic holmium laser enucleation of the prostate in case of failure to benefit or subsequent relapse had an 85% probability of being cost effective at a willingness to pay value of pound20,000 (euro21,595, $28,686)/quality adjusted life year (QALY) gained. Other strategies with diathermy vaporisation as the initial treatment were generally cheaper and more effective than the current standard of transurethral resection repeated once if necessary. The use of potassium titanyl phosphate laser vaporisation incurred higher costs and was less effective than transurethral resection, and strategies involving initial minimally invasive treatment with microwave thermotherapy were not cost effective. Findings were unchanged by wide ranging sensitivity analyses. CONCLUSION: The outcome of this economic model should be interpreted cautiously because of the limitations of the data used. The finding that initial vaporisation followed by holmium laser enucleation for failure or relapse might be advantageous both to men with lower urinary tract symptoms and to healthcare providers requires confirmation in a good quality prospective clinical trial before any change in current practice. Potassium titanyl phosphate laser vaporisation was unlikely to be cost effective in our model, which argues against its unrestricted use until further evidence of effectiveness and cost reduction is obtained.

Alternative approaches to endoscopic ablation for benign enlargement of the prostate: systematic review of randomised controlled trials.

OBJECTIVE: To compare the effectiveness and risk profile of newer methods for endoscopic ablation of the prostate against the current standard of transurethral resection. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Electronic and paper records in subject area up to March 2006. REVIEW METHODS: We searched for randomised controlled trials of endoscopic ablative interventions that included transurethral resection of prostate as one of the treatment arms. Two reviewers independently extracted data and assessed quality. Meta-analyses of prespecified outcomes were done using fixed and random effects models and reported using relative risk or weighted mean difference. RESULTS: We identified 45 randomised controlled trials meeting the inclusion criteria and reporting on 3970 participants. The reports were of moderate to poor quality, with small sample sizes. None of the newer technologies resulted in significantly greater improvement in symptoms than transurethral resection at 12 months, although a trend suggested a better outcome with holmium laser enucleation (random effects weighted mean difference -0.82, 95% confidence interval 1.76 to 0.12) and worse outcome with laser vaporisation (1.49, -0.40 to 3.39). Improvements in secondary measures, such as peak urine flow rate, were consistent with change in symptoms. Blood transfusion rates were higher for transurethral resection than for the newer methods (4.8% v 0.7%) and men undergoing laser vaporisation or diathermy vaporisation were more likely to experience urinary retention (6.7% v 2.3% and 3.6% v 1.1%). Hospital stay was up to one day shorter for the newer technologies. CONCLUSIONS: Although men undergoing more modern methods of removing benign prostatic enlargement have similar outcomes to standard transurethral resection of prostate along with fewer requirements for blood transfusion and shorter hospital stay, the quality of current evidence is poor. The lack of any clearly more effective procedure suggests that transurethral resection should remain the standard approach.

Categorization of obstruction using noninvasive pressure flow measurements: sensitivity to change following prostatectomy.

PURPOSE: We determined whether categorizing men with lower urinary tract symptoms using a noninvasive pressure flow nomogram is sensitive to change following the removal of obstruction. MATERIALS AND METHODS: A prospective cohort of men undergoing transurethral prostate resection was recruited, of whom 143 (69%) underwent noninvasive pressure flow study using the penile cuff technique before and 4 months following surgery. Cuff pressure required to interrupt voiding, estimated isovolumetric bladder pressure and maximum flow rate were recorded during a single void. Values were plotted on a nomogram categorizing cases as obstructed (upper left quadrant), not obstructed (lower right quadrant) or diagnosis uncertain (upper right and lower left quadrants). Changes in maximum flow rate, cuff pressure required to interrupt voiding and nomogram position following transurethral prostate resection were then analyzed. RESULTS: Transurethral prostate resection resulted in an improved flow rate for all diagnostic groups, which was highest for obstructed cases with a mean +/- SD increase of 11 +/- 6 ml second(-1) (p <0.01). Men categorized with obstruction and those placed in the upper right quadrant showed significant decreases in cuff pressure required to interrupt voiding following transurethral prostate resection with a mean decrease of -45 +/- 35 and -48 +/- 32 cm H(2)O, respectively (p <0.01). The number of cases classified as not obstructed increased from 28 (19%) preoperatively to 114 (80%) after transurethral prostate resection. CONCLUSIONS: Sensitivity to change following the removal of obstruction further validates the usefulness of noninvasive measurement of bladder pressure by the penile cuff test and the categorization of obstruction by the noninvasive nomogram. Decreased isovolumetric bladder pressure following transurethral prostate resection may reflect a return to normal detrusor contraction strength.

Predicting the outcome of prostatectomy using noninvasive bladder pressure and urine flow measurements.

OBJECTIVES: To determine whether categorisation of bladder outlet obstruction (BOO) using measurements of bladder pressure and urine flow obtained by a novel noninvasive medical device (the penile cuff test) improves prediction of outcome from endoscopic prostatectomy (TURP). METHODS: A consecutive cohort of 208 men undergoing TURP following standard assessment in our institution was recruited, and 179 (86%) completed the protocol. Each subject underwent a penile cuff test prior to surgery; outcome was assessed by change in IPSS at 4 mo. The proportion of men with good outcome (>50% reduction in IPSS) was compared according to categorisation by noninvasive bladder pressure and urine flow measurements. RESULTS: The cuff test was completed by 93% of men with 2% experiencing an adverse event. Men categorised as having BOO by the test (37% of total) had an 87% chance of a good outcome from TURP (p<0.01), whilst of those deemed not obstructed (19% of total) 56% experienced good outcome (p<0.01). For the remaining men not categorised in these two groups, 77% had good outcome, which was identical to the result of the cohort as a whole (77%, p=NS). CONCLUSIONS: Urodynamic categorisation using measurements obtained by the noninvasive penile cuff test improves prediction of outcome for men with LUTS undergoing TURP. This finding together with the ease and acceptability of the test suggest its suitability for office-based clinical use to assist men and their physicians in the selection for surgical treatment for relief of LUTS.

Outcome of transurethral prostatectomy for the palliative management of lower urinary tract symptoms in men with prostate cancer.

OBJECTIVE: To investigate the efficacy of palliative transurethral prostatectomy (TURP) for lower urinary tract symptoms (LUTS) in men with prostate cancer. PATIENTS AND METHOD: The surgical outcome of TURP performed in 46 men with prostate cancer was studied. A poor outcome was defined as the development of urinary incontinence, repeat surgery and placement of a long-term catheter (LTC) within 1 year of surgery. A cohort of 47 men who underwent TURP for benign prostatic hyperplasia (BPH) was used as a control population. RESULTS: Initial catheter removal failed in a larger number of cancer patients compared to men with BPH (43% and 10%, respectively, P = 0.0001). Using objective endpoints, 37% (17/46) of cancer patients were defined as having a poor outcome because of repeat surgery, placement of a LTC or urinary incontinence following TURP. These events occurred in only 12% (6/47) of the control cohort (P = 0.004). In multiple regression analysis a good outcome was associated with presentation in acute urinary retention (AUR; P = 0.01) while a poor outcome was associated with surgery in the context of hormone refractory disease (P = 0.004). Requirement for a LTC despite surgery (12/46) was also associated with the absence of AUR at presentation (P = 0.01) and hormone refractory disease (P = 0.01). CONCLUSION: A significant number of men with prostate cancer and LUTS may not derive a good palliative benefit from TURP. Patients with hormone refractory disease in particular are more likely to have poorer outcomes.

A prospective randomized trial comparing transurethral prostatic resection and clean intermittent self-catheterization in men with chronic urinary retention.

OBJECTIVE: To determine whether a preliminary period of clean intermittent self-catheterization (CISC) before transurethral resection of the prostate (TURP) improves bladder contractility and surgical outcome in men with chronic urinary retention (CUR), and whether pressure-flow studies (PFS) before TURP predict the outcome. PATIENTS AND METHODS: The study was a two-centre, pragmatic and randomized trial. Included were 41 men scheduled for TURP with lower urinary tract symptoms (LUTS), an International Prostate Symptom Score (IPSS) of > 7, benign prostatic enlargement and a persistent postvoid residual urine volume (PVR) of > 300 mL. They had conventional PFS using unphysiological filling. The patients then gave consent and were randomized into two treatment groups; the first had TURP after stabilizing renal function by indwelling catheterization if indicated, and the second was taught CISC. Men in both groups were reviewed at 3 and 6 months after surgery or the start of CISC, by the IPSS, urine culture and assay of plasma creatinine, and upper tract imaging and repeat PFS at 6 months. The primary outcome variables were IPSS, maximum urinary flow rate, voiding and end-filling pressures, and mean PVR; secondary variables included treatment failure, complications and other urodynamic measures. RESULTS: Of the 41 patients, 17 (mean age 67 years, range 52-84) were randomized to immediate TURP and 24 (mean age 69 years, range 55-85) to CISC. There was a significant improvement in IPSS and quality of life at 6 months in both groups (P < 0.001). In the CISC group there was a significant improvement in voiding and end-filling pressures, indicating recovery of bladder function (P < 0.001 for each). Of the 41 men, nine (22%) with voiding pressures of < or = 45 cmH2O had no significant improvement in symptoms or urodynamic variables. Detrusor overactivity was found in 17 (41%) patients, of whom six had upper tract dilatation which resolved after treatment. CONCLUSION: The present results emphasize the usefulness of CISC in ensuring the recovery of bladder function in men with CUR. Measuring the voiding pressure before TURP can predict the surgical outcome. Both CISC and immediate TURP are effective for relieving LUTS and result in a better quality of life. A preliminary period of CISC before TURP for men with CUR and low voiding pressure may be valuable. The presence of upper tract dilatation is associated with high end-void and end-fill bladder pressures, and such men have a good outcome from surgery.