Application of Urethral Contrast Computed Tomography Three-Dimensional Imaging in the Postoperative Assessment of Prostate Hyperplasia.

This study assesses the morphological effectiveness of benign prostatic hyperplasia (BPH) surgery using multislice spiral computed tomography three-dimensional imaging (CT3D) with urethral contrast. Twenty-five male patients with BPH and bladder outlet obstruction (BOO) who underwent bipolar transurethral resection of the prostate were selected. Preoperative and postoperative CT3D indicators of retrograde and voiding cystourethrography, including bladder neck diameter, length of the posterior urethra, and degree of prostate protrusion into the bladder and upper and lower diameter of the prostate were used to assess bladder neck and posterior urethra morphology and BOO severity. In addition, preoperative and postoperative International Prostate Symptom Scores and maximum urine flow rates were compared. Postoperative CT3D was used to evaluate changes following obstruction relief postsurgery. Preoperative CT3D indicated significant BOO, whereas postoperative imaging showed improved patency but with irregular posterior urethral lumens and varying degrees of residual glandular tissue. Comparative analysis of preoperative and postoperative bladder outlet metrics revealed significant changes (p < .05). Urethral contrast CT3D effectively visualizes the prostate, bladder neck, and prostatic urethra. It quantifies changes in the urethral lumen postsurgery, correlating the extent of posterior urethral lumen spaciousness with urinary flow rates.

Antegrade ejaculation preservation in surgical treatment for benign prostatic hyperplasia: quest for balance between voiding and sexual function.

PURPOSE OF REVIEW: Surgical treatment of benign prostatic hyperplasia (BPH) carries a significant risk of ejaculation dysfunction. Preservation of antegrade ejaculation while providing effective, well tolerated, and durable treatment of BPH is a paramount component of physical and sexual well being for significant number of men. We reviewed available literature with an aim of providing status on antegrade ejaculation preserving BPH surgical therapies. RECENT FINDINGS: Minimally invasive surgical therapies for BPH have been developed over the last decade, with significant marketing emphasis on their potential for preservation of antegrade ejaculation. However, the question about durability of relief of bladder outlet obstruction remains. Parallel to this technological development, the understanding of anatomical structures involved in ejaculation have resulted in technical modifications of well established surgical treatments modalities like transurethral resection of prostate, endoscopic enucleation of prostate and simple prostatectomy, thereby providing safe and durable relief of bladder outlet obstruction secondary to BPH with a satisfactory preservation of antegrade ejaculation. SUMMARY: Preservation of antegrade ejaculation is an important goal for significant number of men needing BPH surgery. Novel minimally invasive surgical technologies have been developed for this purpose; but understanding of the anatomical structures essential for antegrade ejaculation have allowed technical modification of existing surgical techniques with excellent preservation of antegrade ejaculation.

Outcomes of bladder neck botulinum toxin injection for female primary bladder neck obstruction-does subjective improvement correlate with an objective assessment?

INTRODUCTION AND HYPOTHESIS: Common options for management of primary bladder neck obstruction (PBNO) in women include medications and surgical treatment. Less invasive treatment such as bladder neck botulinum toxin injection can be an alternate therapy in patients with failed conservative management. In this study, we describe the subjective and objective outcomes, patient satisfaction, and willingness for repeat treatment with bladder neck botulinum toxin injection in females with PBNO. METHODS: A retrospective analysis of ten female PBNO patients managed with bladder neck botulinum toxin injection was performed. Subjective parameters were quantified with symptom assessment, International Prostate Symptom Score (IPSS), and Quality of life (QoL) score. Objective parameters were assessed with maximum flow rate (Qmax) in uroflowmetry and postvoid residual (PVR). RESULTS: The mean pre-treatment IPSS, QoL score, Qmax, PVR was 24.2 ± 5.0, 4.8 ± 0.63, 5.73 ± 3.18 ml/s, and 210 ± 66 ml, respectively. Seven of the ten patients subjectively improved (IPSS 12.9 ± 9.6, QoL2.9 ± 1.6, p < 0.05). Three patients improved objectively (mean Qmax 17.3 ± 2.7 ml/s, PVR 42.7 ± 7.5 ml, p < 0.05). Three patients accepted repeat botulinum toxin injection. Three patients who showed no improvement underwent bladder neck incision with resolution of symptoms. CONCLUSION: Botulinum toxin can be an intermediary therapy in female patients with PBNO who want a minimally invasive procedure.

Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT.

BACKGROUND: Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery. OBJECTIVES: The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome. DESIGN: This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research. SETTING: Urology departments of 26 NHS hospitals in England. PARTICIPANTS: Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised. INTERVENTIONS: Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm). MAIN OUTCOME MEASURES: The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness. RESULTS: A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (-0.33, 95% CI -1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43-44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS. LIMITATIONS: The trial met its predefined recruitment target, but surgery rates were lower than anticipated. CONCLUSIONS: Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS. FUTURE WORK: Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56164274. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 42. See the NIHR Journals Library website for further project information.

After hospital referral, men with bothersome lower urinary tract symptoms (LUTS) are assessed with standard tests. These include measurement of urine flow rate, bladder diaries and questionnaires, including the International Prostate Symptom Score (IPSS). UPSTREAM (Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods) researched whether or not including an extra test, urodynamics (UDS), helps when considering treatment options. UDS is a more invasive test and measures pressure in the bladder to check whether or not the prostate is causing obstruction. It was presumed that, if there is no obstruction, surgery would not be offered, so that using UDS would reduce the number of prostate operations. Each man participating (820 in total) was assessed with the standard tests. Around half of them had no extra tests (the 'routine care' arm of the trial); the rest had the UDS tests (the 'UDS' arm). Men then went on to have treatment, which they chose having discussed their test results with a urologist. IPSS and other symptom scores were examined for each man 18 months after joining the trial. At 18 months, surgery outcomes were known for 792 men and IPSS was known for 669 men. We investigated if the two trial arms showed similar changes in the IPSS and if there were fewer operations done in the UDS arm. We identified similar reductions in the IPSS in both arms. However, UDS tests did not reduce the number of operations. Analysing all the costs, it was found that a pathway including UDS costs more than routine care. Interviews were conducted that showed that men found UDS acceptable, and that the additional information helped both the men and their doctors consider which treatment would be most appropriate. These results do not support the routine use of UDS in the assessment of every man considering prostate surgery for LUTS. Further exploration of the data may identify circumstances in which UDS could be helpful.

Clinical Safety and Cost-Effectiveness of Follow-up Virtual Clinic for Bladder Outflow Obstruction Surgery.

Introduction: Bladder outflow obstruction (BOO) surgery is among the most commonly performed urologic procedures. Postoperative assessment consists of physical measurement of uroflowmetry and post-void residual volume, but health systems worldwide have experienced pressures in demand, leading to exploration of greater efficiency in organizing clinic protocols. International Prostate Symptom Score (IPSS) questionnaire measurement has been identified as a tool to predict change in postoperative management. Our institution established a nurse-led follow-up virtual clinic (VC) for patients undergoing BOO surgery based on IPSS measurement. We present the clinical and economic outcomes of this new service. Materials and Methods: Patients with a successful postoperative trial without catheter were contacted by telephone via VC and discharged by a Urology Clinical Nurse Specialist (UCNS) if IPSS was <8. Data were analyzed for IPSS, arrangement of subsequent clinic visits, and numbers discharged. Primary outcome was the proportion of patients discharged after VC consultation. Secondary outcomes were overall discharge rate following subsequent face-to-face (FTF) appointment; and the proportion of patients re-referred from Primary Care within 3 months of discharge from VC. Cost savings were calculated based on tariffs of £135 for first attendance with UCNS, £199 for uroflowmetry, and £47.84 for VC appointment. Results: The first 50 patients to be recipients of the new VC were included. The median IPSS and quality-of-life score were 13 (interquartile range [IQR] 5) and 3 (IQR 1), respectively. Thirty-nine (78%) patients were discharged from VC; 36 (72%) had IPSS <8. Overall discharge rate following subsequent FTF appointment was 88%. Two patients discharged from VC (5.1%) were subsequently re-referred, neither of whom required additional treatment. Total cost savings with VC amounted to £10,634. Conclusion: Telephone follow-up for BOO surgery based on IPSS is clinically safe and cost-effective, providing greater efficiency for clinic protocols.

Holmium laser prostatectomy in a tertiary Italian center: A prospective cost analysis in comparison with bipolar TURP and open prostatectomy.

OBJECTIVE: To assess the economic impact of Holmium laser enucleation of prostate (HoLEP) in comparison with transurethral resection of prostate (TURP) and open prostatectomy (OP). METHODS: Between January 2017 and January 2018, we prospectively enrolled 151 men who underwent HoLEP, TURP or OP at tertiary Italian center, due to bladder outflow obstruction symptoms. Patients with prostate volume ≤ 70 cc and those with prostate volume > 70 cc were scheduled for TURP or HoLEP and OP or HoLEP, respectively. Intraoperative and early post-operative functional outcomes were recorded up to 6 months follow up. Cost analysis was carried out considering direct costs (operating room [OR] utilization costs, nurse, surgeons and anesthesiologists' costs, OR disposable products costs and OR products sterilization costs), indirect costs (hospital stay costs and diagnostics costs) and global costs as sum of both direct and indirect plus general costs related to hospitalization. Cost analysis was performed comparing patients referred to TURP and HoLEP with prostate volume ≤ 70 cc and men underwent OP and HoLEP with prostate volume > 70 cc respectively. RESULTS: Overall, 53 (35.1%), 51 (33.7%) and 47 (31.1%) were scheduled to HoLEP, TURP and OP, respectively. Both TURP, HoLEP and OP proved to effectively improve urinary symptoms related to BPE. Considering patients with prostate volume ≤ 70 cc, median global cost of HoLEP was similar to median global cost of TURP (2151.69 € vs. 2185.61 €, respectively; p = 0.61). Considering patients with prostate volume > 70 cc, median global cost of HoLEP was found to be significantly lower than median global cost of OP (2174.15 € vs. 4064.97 €, respectively; p ≤ 0.001). CONCLUSIONS: Global costs of HoLEP are comparable to those of TURP, offering a cost saving of only 11.4 € in favor of HoLEP. Conversely, HoLEP proved to be a strong competitor of OP because of significant global cost sparing amounting to 1890.82 € in favor of HoLEP.

Is diabetes mellitus associated with clinical outcomes in aging males treated with transurethral resection of prostate for bladder outlet obstruction: implications from Taiwan Nationwide Population-Based Cohort Study.

PURPOSE: We assessed the lower urinary tract symptoms (LUTSs) and clinical outcomes between diabetes mellitus (DM) patients and non-diabetic (non-DM) patients receiving transurethral resection of prostate (TUR-P). METHODS: This analysis was a retrospective cohort study using 13 years (2000-2012) of claims data from Taiwan's National Health Insurance Research Database (NHIRD). A total of 4,887 patients who had persistent LUTSs and underwent TUR-P for prostate enlargement (benign prostate enlargement [BPE]) were enrolled and divided into two groups: DM and non-DM groups. The patients' characteristics, postoperative clinical outcomes, and the medication records after TUR-P were compared. Chi-square test was used for categorical variables and independent samples t-test for continuous variables. Multivariable logistic regression analysis was used to compare the risk of postoperative outcomes. Finally, we estimated the medication-free survival rate after TUR-P using Kaplan-Meier method and compared it between study groups using log-rank test. RESULTS: DM group patients had a higher prevalence of comorbidities. Postoperatively, the DM group had lower rates of urinary tract infection (UTI; odds ratio [OR], 0.78; P=0.009) and higher rates of urinary retention requiring catheterization (OR, 1.35; P=0.01) within 1 month after TUR-P. A higher proportion of patients with DM took anti-muscarinics (OR, 1.23; P=0.032) within the first 3 months and α-blockers (OR, 1.18; P=0.049) during 3-12 months after receiving TUR-P. Overall, the DM group patients had a worse postoperative medication-free survival compared to that of non-DM group patients (95% confidence interval [95% CI], 1.14; P=0.005). CONCLUSION: DM patients require higher rates of continuing medication after TUR-P, especially anti-muscarinics in 3 months postoperatively and alpha-blocker after 3 months postoperatively. DM patients also had higher incidence of urine retention after surgery. DM patients had relatively poor treatment outcomes compared to DM-free patients.

Prospective assessment of perioperative course in 2648 patients after surgical treatment of benign prostatic obstruction.

PURPOSE: TUR-prostate (TUR-P) is considered the reference method for surgical treatment of benign prostatic obstruction (BPO); Greenlight laser photoselective vaporization (PVP) and thulium laser vapoenucleation (ThuVEP) have also been established as treatments of BPO. Objective of this prospective observation was to compare a large numbers of patients treated in everyday routine. METHODS: This prospective multicentre data collection assesses morbidity and perioperative course of consecutive men treated with BPO-related transurethral surgery between 2011 and 2014 in a German metropolis area with TUR-P, PVP or ThuVEP. RESULTS: Two thousand six hundred and forty-eight patients have been treated in the time period. All treatment options achieved immediate improvement of voiding parameters. Multivariate analyses proved shorter hospital stay after laser treatments as compared to resection (p < 0.001). In terms of hospital stay, the advantage of ThuVEP compared to TUR-P increased with prostate volume (p < 0.001). Patients with ongoing anticoagulation or bridging had prolonged hospital stay (p < 0.001). Overall adverse events were least frequent in PVP (p 0.016), as were Clavien 3b events (p < 0.001). CONCLUSIONS: Surgical treatment of BPO is effective and safe independent of the surgical procedure. Volume reduction is most effective in ThuVEP; PVP has the lowest rate of severe complications. Laser treatment is associated with shorter hospital stay. Surgery under ongoing anticoagulation prolonged the post-operative hospital stay.

Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial.

BACKGROUND: Lower urinary tract symptoms (LUTS) comprise storage symptoms, voiding symptoms and post-voiding symptoms. Prevalence and severity of LUTS increase with age and the progressive increase in the aged population group has emphasised the importance to our society of appropriate and effective management of male LUTS. Identification of causal mechanisms is needed to optimise treatment and uroflowmetry is the simplest non-invasive test of voiding function. Invasive urodynamics can evaluate storage function and voiding function; however, there is currently insufficient evidence to support urodynamics becoming part of routine practice in the clinical evaluation of male LUTS. DESIGN: A 2-arm trial, set in urology departments of at least 26 National Health Service (NHS) hospitals in the United Kingdom (UK), randomising men with bothersome LUTS for whom surgeons would consider offering surgery, between a care pathway based on urodynamic tests with invasive multichannel cystometry and a care pathway based on non-invasive routine tests. The aim of the trial is to determine whether a care pathway not including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is included, at 18 months after randomisation. This primary clinical outcome will be measured with the International Prostate Symptom Score (IPSS). We will also establish whether inclusion of invasive urodynamics reduces rates of bladder outlet surgery as a main secondary outcome. DISCUSSION: The general population has an increased life-expectancy and, as men get older, their prostates enlarge and potentially cause benign prostatic obstruction (BPO) which often requires surgery. Furthermore, voiding symptoms become increasingly prevalent, some of which may not be due to BPO. Therefore, as the population ages, more operations will be considered to relieve BPO, some of which may not actually be appropriate. Hence, there is sustained interest in the diagnostic pathway and this trial could improve the chances of an accurate diagnosis and reduce overall numbers of surgical interventions for BPO in the NHS. The morbidity, and therapy costs, of testing must be weighed against the cost saving of surgery reduction. TRIAL REGISTRATION: Controlled-trials.com - ISRCTN56164274 (confirmed registration: 8 April 2014).

Establishment and value assessment of efficacy prediction model about transurethral prostatectomy.

OBJECTIVES: To establish and to evaluate discriminant models to predict the outcomes of transurethral prostatectomy. METHODS: Clinical data of patients treated with transurethral prostatectomy between January and December 2013 were collected, including medical history, symptoms, biochemical tests, ultrasonography and urodynamics. Surgical efficacy was evaluated at 6-month follow up. Predictive models were constructed by logistic regression. Receiver operating characteristic curve and diagnostic tests were used to test the accuracy of models before the predictive value between models was compared. RESULTS: A total of 182 patients were included, with 73.6% having an effective outcome. History of recurrent urinary tract infection (OR 1.33), score of storage phase (OR 2.58), maximum flow rate (OR 2.11) and detrusor overactivity (OR 3.13) were found to be risk factors. International Prostate Symptom Score (OR 0.13), transitional zone index (OR 0.58), resistive index of prostatic artery (OR 0.46), bladder wall thickness (OR 0.78), ultrasonic estimation of bladder weight (OR 0.28), bladder outlet obstruction index (OR 0.20) and bladder contractility index (OR 0.83) were found to be protective factors. The areas under the curve of models using factors from ultrasonography and urodynamics were 0.792 and 0.829 respectively, with no significant difference being found between them (P = 0.348). CONCLUSIONS: Surgical efficacy of transurethral prostatectomy is positively correlated to severe voiding phase symptoms, outlet obstruction and better detrusor contractility, and negative correlated with urinary infection, severe storage phase symptoms and excessive detrusor contractibility. Ultrasonography might replace urodynamics in selecting patients for whom transurethral prostatectomy is more likely to be beneficial.

Evaluation of the cost effectiveness of vesico-amniotic shunting in the management of congenital lower urinary tract obstruction (based on data from the PLUTO Trial).

OBJECTIVE: To determine the cost-effectiveness of in-utero percutaneous Vesico Amniotic Shunt (VAS) in the management of fetal lower urinary tract obstruction (LUTO). DESIGN: Model based economic analysis using data from the randomised controlled arm of the PLUTO (percutaneous vesico-amniotic shunting for lower urinary tract obstruction) trial. SETTING: Fetal medicine departments in United Kingdom, Ireland and Netherlands. POPULATION OR SAMPLE: Pregnant women with a male, singleton fetus with LUTO. METHODS: Costs and outcomes were prospectively collected in the trial; three separate base case analyses were performed using the intention to treat (ITT), per protocol and uniform prior methods. Deterministic and probabilistic sensitivity analyses were performed to explore data uncertainty. MAIN OUTCOME MEASURES: Survival at 28 days, 1 year and disease free survival at 1 year. RESULTS: VAS was more expensive but appeared to result in higher rates of survival compared with conservative management in patients with LUTO. Using ITT analysis the incremental cost effectiveness ratios based on outcomes of survival at 28 days, 1 year, or 1 morbidity-free year on the VAS arm were £ 15,506, £ 15,545, and £ 43,932, respectively. CONCLUSIONS: VAS is a more expensive option compared to the conservative approach in the management of individuals with LUTO. Data from the RCT suggest that VAS improves neonatal survival but does not result in significant improvements in morbidity. Our analysis concludes that VAS is not likely to be cost effective in the management of these patients given the NICE (National Institute of Health and Clinical Excellence) cost threshold of £ 20,000 per QALY.

The Percutaneous shunting in Lower Urinary Tract Obstruction (PLUTO) study and randomised controlled trial: evaluation of the effectiveness, cost-effectiveness and acceptability of percutaneous vesicoamniotic shunting for lower urinary tract obstruction.

BACKGROUND: Congenital lower urinary tract obstruction (LUTO) is a disease associated with high perinatal mortality and childhood morbidity. Fetal vesicoamniotic shunting (VAS) bypasses the obstruction with the potential to improve outcome. OBJECTIVE: To determine the effectiveness, cost-effectiveness and patient acceptability of VAS for fetal LUTO. DESIGN: A multicentre, randomised controlled trial incorporating a prospective registry, decision-analytic health economic model and preplanned Bayesian analysis using elicited opinions. Patient acceptability was evaluated by interview in a qualitative study. SETTING: Fetal medicine departments in the UK, Ireland and the Netherlands. PARTICIPANTS: Pregnant women with a male singleton fetus with LUTO. INTERVENTIONS: In utero percutaneous VAS compared with conservative care. MAIN OUTCOME MEASURES: The primary outcome was survival to 28 days. Secondary outcome measures were survival and renal function at 1 year of age, cost of care and cost per additional life-year and per disability-free survival at the end of 1 year. RESULTS: The trial stopped early with 31 women randomised because of difficulties in recruitment. Of those randomised to VAS and conservative management, 3/16 (19%) and 2/15 (13%), respectively, did not receive their allocated intervention. Based on intention-to-treat analysis, survival at 28 days was higher if allocated VAS (50%) than conservative management (27%) [relative risk (RR) 1.88, 95% confidence interval (CI) 0.71 to 4.96, p = 0.27]. At 12 months survival was 44% in the VAS arm and 20% in the conservative arm (RR 2.19, 95% CI 0.69 to 6.94, p = 0.25). Neither difference was statistically significant. Of survivors at 1 year, two in the VAS arm had no evidence of renal impairment and four in the VAS arm and two in the conservative arm required medical management. One baby in the conservative arm had end-stage renal failure at 1 year. VAS was more expensive because of additional surgery and intensive care. VAS cost £15,500 per survivor at 1 year and £43,900 per disability-free year. Elicited expert opinions showed uncertainty in the effect of VAS at 28 days. In a Bayesian analysis combining elicited opinion with the results, uncertainty of the benefit of VAS remained (RR 1.31, 95% credible interval 0.84 to 2.18). The acceptability study identified visualisation of the fetus during ultrasound scanning, perceiving a personal benefit, and altruism as positive influences on recruitment. Fear of the VAS procedure and the perceived severity of LUTO influenced non-participation. The need for more detailed information about the condition and its implications during pregnancy and following delivery was a further important finding of this research. Recruitment was hampered by logistical and regulatory difficulties, a lower incidence of LUTO and lower antenatal diagnosis rate [estimated to be 3.34 (95% CI 2.95 to 3.72) per 10,000 total births and 47%, respectively, in an associated epidemiological study] and high termination of pregnancy rates. In the registry women also demonstrated a clear preference for conservative management. CONCLUSIONS: Survival to 28 days and 1 year appears to be higher with VAS than with conservative management, but it is not possible to prove benefit beyond reasonable doubt. Notably, prognosis in both arms for survival and renal function is poor. VAS was substantially more costly and unlikely to be regarded as cost-effective based on the 1-year data. Parents should be counselled about the risks of pregnancy loss with or without VAS insertion. The National Institute for Health and Care Excellence interventional procedures guidance (IPG 202) should be updated to reflect this new evidence. Babies in the PLUTO trial should be followed up long term for the different outcomes. TRIAL REGISTRATION: ISRCTN53328556. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 17, No. 59. See the NIHR Journals Library website for further project information.

Conventional monopolar resection or bipolar resection in saline for the management of large (>60 g) benign prostatic hyperplasia: an evaluation of morbidity.

The objective of this study was to compare the efficacy and safety of bipolar transurethral resection in saline (TURIS) and conventional monopolar transurethral resection (TURP) in men with voiding difficulties due to high volume (>60g) benign prostatic hyperplasia. Between May 2005 and January 2009, 66 men with bladder outlet obstruction due to large benign hyperplasia (BPH) (>60 g) underwent transurethral resection, either by Olympus monopolar or Olympus bipolar TURIS technique. Perioperative and outcome data were recorded and compared. There was no significant difference in patient age, prostate size, PSA, uroflow rate, post voiding residual urine, operation time, catheterization time, and hospital stay. In the monopolar TURP group, an important drop in serum sodium was observed (3.12 mmol/L), statistically significantly different (p = 0.012) from the 1.30 mmol/L drop in the bipolar TURIS group. One case of clinical TUR syndrome was observed in the conventional monopolar TURP group. Early and late complications such as clot retention, urinary retention, bladder neck stenosis, and urethral stricture were identical in both groups. The bipolar TURIS device is a valid treatment option for patients with BPH-related voiding disorders due to high volume BPH. Obviating the risk of TUR syndrome, this minimally invasive procedure may be a good surgical option in the urologist's armamentarium.

A randomized trial of photoselective vaporization of the prostate using the 80-W potassium-titanyl-phosphate laser vs transurethral prostatectomy, with a 1-year follow-up.

OBJECTIVE: To compare the potassium-titanyl-phosphate Greenlight(TM) 80-W laser ablation system for photovaporization of the prostate (PVP; Laserscope, San Jose, CA, USA) with transurethral resection of the prostate (TURP), as many technologies have been proposed as equivalent or superior to TURP without gaining widespread acceptance, due to lack of data from randomized trials. PATIENTS AND METHODS: In all, 120 patients were randomized to undergo either TURP or PVP after a full urological evaluation, which was repeated at 1, 3, 6 and 12 months after surgery. Irrigation use, duration of catheterization (DOC), length of hospital stay (LOS), blood loss, cost and operative time were also assessed. RESULTS: Both groups showed a significant increase in mean (sd) maximum urinary flow rate from baseline (P < 0.05); in the TURP group from 8.9 (3.0) to 19.4 (8.7) mL/s (154%), and in the PVP group from 8.8 (2.5) to 18.6 (8.2) mL/s (136%). The International Prostate Symptom Score (IPSS) decreased from 25.4 (5.7) to 10.9 (9.4) in the TURP group (53%), and from 25.3 (5.9) to 8.9 (7.6) in the PVP group (61%). The trends were similar for the bother and Quality of Life scores. There was no difference in sexual function as measured by Baseline Sexual Function Questionnaires. The DOC was significantly less in the PVP than the TURP group (P < 0.001), with a mean (range) of 13 (0-24) h vs 44.7 (6-192) h. The situation was similar for LOS (P < 0.001), with a mean (range) of 1.09 (1-2) and 3.6 (3-9) days in the PVP and TURP groups, respectively. Adverse events and complications were less frequent in the PVP group. Costs were also 22% less in the PVP group. CONCLUSIONS: This trial shows that PVP is an effective technique when compared to TURP, producing equivalent improvements in flow rates and IPSS with the advantages of markedly reduced LOS, DOC and adverse events. A long-term follow-up is being undertaken to ensure durability of these results.

In-utero stenting: development of a low-cost high-fidelity task trainer.

OBJECTIVE: To develop an in-utero stent placement training model. METHODS: The in-utero stent task trainer was constructed using a formalin-preserved gravid pig uterus. Altering the size of the uterine segment, changing the fluid level in the uterus and addition of a large Ziploc freezer bag variably filled with differing amounts of ultrasound gel can vary the procedural skill required. RESULTS: Thoracoamniotic and vesicoamniotic shunts can be simulated using this life-like model. The cost of eight to 10 learning stations is approximately US $ 60. Fetal position, maternal size and amniotic fluid status can be altered rapidly to increase the complexity of the procedure. CONCLUSIONS: This low-cost and realistic task trainer can provide the opportunity to practice in-utero shunt procedures in a non-clinical environment. This model should enhance learning and reinforce acquired skills.

Greenlight laser in benign prostatic hyperplasia: turning green into gold.

PURPOSE OF REVIEW: The purpose of this review is to present recent clinical data published upon the photoselective vaporization of the prostate procedure and introduce new ideas about the future influence of this new technology upon the treatment of benign prostatic hyperplasia. RECENT FINDINGS: Published studies have provided significant evidence that the photoselective vaporization of the prostate laser procedure is efficient, safe, easy to learn and early results show that it can compete with transurethral resection of the prostate. The major advantages of this technique are that it is a bloodless procedure, the patient goes home after a few hours and it can be applied to all patient categories. The cost of the photoselective vaporization of the prostate procedure is being investigated and a few studies addressing this issue seem to conclude that this surgical option is a cost effective decision. Lately, thoughts about early surgical intervention with the photoselective vaporization of the prostate laser are being expressed but properly designed studies are needed. SUMMARY: The photoselective vaporization of the prostate laser procedure is getting worldwide fast recognition and it is the first time that transurethral resection of the prostate and open prostatectomy are being threatened. The cost of this procedure is being examined but it is difficult to draw solid conclusions since reimbursement strategies differ between various countries.

Holmium laser enucleation versus open prostatectomy for benign prostatic hyperplasia: an inpatient cost analysis.

OBJECTIVES: To compare the cost of open transvesical prostatectomy (OP) with that of holmium laser enucleation (HoLEP) in the treatment of bladder outlet obstruction (BOO) attributed to benign prostatic hyperplasia. METHODS: From February to May 2004, 63 consecutive patients with symptomatic benign prostatic hyperplasia in a large prostate (70 to 220 g) and documented BOO were randomized to surgical treatment with OP (29 in group 1) or HoLEP (34 in group 2). All costs associated with the procedures during the hospital stay were recorded prospectively, and a cost-effectiveness analysis of the critical perioperative (ie, intraoperative and postoperative to hospital discharge) data was performed. RESULTS: The cost analysis showed a mean perioperative cost of 2868.9 euros (3556.3 dollars) for group 1 and 2356.5 euros (2919.4 dollars) for group 2. A direct comparison analysis showed that the most significant cost factors were the operative time (average 16.1% and 25.1% to the cost of OP and HoLEP, respectively), operating room surgical setup/disposables, including laser fiber and resectoscope loop in group 2 (average 13.3% and 29.3% to the cost of OP and HoLEP, respectively), and length of postoperative hospital stay (average 53.3% and 32.0% to the cost of OP and HoLEP, respectively). Overall, the hospitalization cost of HoLEP was 9.6% less than that for OP. CONCLUSIONS: Our data have demonstrated that HoLEP is associated with a significant hospital net cost savings compared with OP in patients undergoing surgery for symptomatic benign prostatic hyperplasia in large glands.

Assessment of voiding outcome, sexual function and quality of life two years following KTP/YAG hybrid laser prostatectomy.

OBJECTIVE: To assess the long-term outcome of patients undergoing KTP/YAG hybrid laser treatment for bladder outlet obstruction due to benign prostatic enlargement, in terms of symptomatic relief, complications, sexual function, patient satisfaction and acceptance of procedure. PATIENTS AND METHODS: The study recruited 148 patients prospectively. The hybrid laser treatment involved performing an initial bladder neck incision using KTP laser at 34 W followed by 4/6 point coagulation using NdYAG laser at 60 W. Patients were followed up till 2 years and assessed using uroflowmetry, International Prostate Symptom Score (IPSS), Patient Satisfaction Score (PSS), BPH impact index (BII) and the Danish Prostate Symptom Score (DAN-PSS) sexual function questionnaire. RESULTS: 137 patients were followed up for 2 years. There was a significant improvement in the maximum flow rate, IPSS and Quality of Life Scale (QLS). The mean BII (2.9) and the mean PSS (1.9) were low suggesting overall satisfaction with the procedure. The complications included urethral stricture (0.73%), bladder neck obstruction (2.15%) and retreatment (3.6%). 79.4% had a significant decrease in the ejaculate and 32.8% had a significant change in the strength of erections. On comparing the two groups (sexual function affected vs. not affected), the age, BII, IPSS and PSS were significantly higher (p < 0.05) in the group of patients that were affected. CONCLUSIONS: Following KTP/YAG hybrid laser prostatectomy the outcome for voiding is good and durable for up to 2 years. The patient satisfaction level following the procedure is high and the procedure well accepted. However, significant interference with sexual function occurs, which appears to be occurring in tandem with a poor voiding outcome.

Complications after radical retropubic prostatectomy in the medicare population.

OBJECTIVES: Radical prostatectomy is the standard of care for the treatment of clinically localized prostate cancer in the appropriate patient. However, the morbidity associated with this procedure remains controversial, since complications from centers of excellence are low but nationwide surveys have reported a much higher risk of complications. This study reports the complication rates after radical retropubic prostatectomy (RRP) for men in the Medicare population. METHODS: All men in the Medicare population who underwent RRP in 1991 were identified. All inpatient, outpatient, and physician (Part B) Medicare claims for these men for 1991 to 1993 were then analyzed to determine outcomes. Procedures performed for complications resulting from RRP were recorded, as were the diagnosis codes that may have heralded a complication after RRP. RESULTS: In 1991, 25,651 men in the Medicare population underwent RRP. The mean age of these men was 70.5 years. Procedures for the relief of bladder outlet obstruction or urethral strictures after RRP occurred in 19.5% of these men. A penile prosthesis was implanted in 718 men (2.8%) after prostatectomy, and 593 men (2.3%) had an artificial urinary sphincter placed after prostatectomy. A diagnosis of urinary incontinence was reported in 5573 men (21.7%) after radical prostatectomy, but only 2025 of these men (7.9%) continued to carry this diagnosis more than 1 year after prostatectomy. A diagnosis of erectile dysfunction was reported in 5510 men (21.5%) after radical prostatectomy, but only 3276 of these men (12.8%) continued to carry this diagnosis more than 1 year after surgery. CONCLUSIONS: A review of a large, nationwide, heterogenous cohort of men revealed a morbidity rate that is slightly higher than that reported by major centers that perform large numbers of radical retropubic prostatectomies but is lower than complication rates obtained by patient surveys. The limitations of claim information in determining patient outcomes, however, must be considered when evaluating these data.

Transurethral needle ablation (TUNA) of the prostate: a clinical and urodynamic evaluation.

OBJECTIVES: This prospective study evaluated the clinical and urodynamic changes in patients with obstruction due to benign prostatic hyperplasia (BPH) treated with transurethral needle ablation (TUNA). METHODS: One hundred twenty patients with obstructive uropathy due to BPH were treated with the TUNA procedure between January 1994 and December 1995. All patients were selected according to the criteria established by the guidelines proposed by the International Consensus Committee (World Health Organization, Paris, 1993). The TUNA procedure was performed in an outpatient setting using topical intraurethral anesthesia (2% lidocaine gel). RESULTS: Patients showed a decrease in irritative symptoms as measured by the international Prostate Symptom Score (IPSS) and postprocedure urodynamic parameters. The mean (+/- SD) pretreatment IPSS was 20.8 +/- 4.5. At 3 months, the IPSS decreased to 9.7 +/- 3.0 (108 patients) (P < 0.001). At 6 months it decreased to 6.8 +/- 3.1 (86 patients) and remained at 6.2 +/- 2.9 (72 patients) and 6.7 +/- 3.8 (42 patients) at 12 and 18 months, respectively (P < 0.001). At 1 year after treatment, the peak flow rate (Qmax) increased from 8.2 +/- 3.4 mL/s to 15.9 +/- 2.1 mL/s and was 14.1 +/- 2.5 mL/s at 18 months of follow-up (P < 0.01). Urodynamic re-evaluation performed in 72 patients 12 months after TUNA demonstrated the absence of obstruction in 30 (41.7%). An additional 30 patients (41.7%) had equivocal results, whereas the remaining 12 (16.6%) still had obstruction, according to the Abrams-Griffith nomogram. Mean detrusor pressure at Qmax decreased from 85.3 +/- 18.5 cm H2O to 63.7 +/- 24.9 cm H2O at 12 months of follow-up. CONCLUSIONS: Our results confirm that the TUNA procedure is safe and effective when performed as an outpatient procedure. In addition, TUNA produced better results in patients presenting with moderate to severe irritative symptoms and minimal obstruction as determined by pressure/flow studies.