Plasmakinetic Enucleation of the Prostate Compared with Open Prostatectomy for Prostates Larger Than 100 Grams: A Randomized Noninferiority Controlled Trial with Long-term Results at 6 Years

Background

Studies have demonstrated that plasmakinetic enucleation of the prostate (PKEP) and open prostatectomy (OP) have equivalent short-term efficacy for large prostates, but no comparison concerning their long-term results was reported.

Objective

To demonstrate the noninferiority of PKEP to OP concerning maximum urinary flow rate (Q_max) at 1 yr postoperatively and to compare the long-term results of both procedures.

Design, setting, and participants

From 2004 to 2007, 160 patients with prostates >100 g were randomized to receive PKEP or OP. A total of 153 patients (95.6%) completed the noninferiority study, and 123 patients (76.9%) finished a 6-yr follow-up assessment.

Intervention

The PKEP procedures were performed with 27F Karl Storz continuous flow resectoscopy and the Gyrus PlasmaKinetic device. OP was performed by a suprapubic transvesical approach.

Outcome measurements and statistical analysis

The primary end point was Q_max at 1 yr postoperatively. Secondary end points included other perioperative parameters and postoperative micturition variables. The student t test, Mann-Whitney U test, chi-square test, or Fisher exact probability test was used as appropriate.

Results and limitations

PKEP was noninferior to OP regarding Q_max at 1 yr postoperatively. Compared with OP, PKEP was associated with less perioperative hemoglobin decrease, shorter catheterization time, and shorter postoperative hospital stay (1.0 vs 3.2 g/dl, 40 vs 148 h, and 3 vs 8 d, respectively; p < 0.001 for all), as well as fewer short-term complications (22.5% vs 42.5%, p = 0.031). On intention-to-treat analysis, both the PKEP and OP groups had equivalent Q_max (25.2 ± 7.0 ml/s vs 25.7 ± 7.6 ml/s, respectively; p = 0.688), International Prostate Symptom Score (3.5 [2–5] vs 3 [2–5], respectively p = 0.755), quality of life (2 [1–3] vs 2 [1–3], respectively; p = 0.950), and postvoid residual urine (20 [9–33.5] vs 16.5 [7–31] ml, respectively; p = 0.469) at 72 mo postoperatively. No patients required reoperation because of recurrence of BPH. The relatively small sample size is the limitation.

Conclusions

PKEP is a durable procedure with short- to long-term micturition improvement equivalent to OP and significantly lower perioperative morbidity.

Patient summary

We compared PKEP with OP for large prostates and found that PKEP is less invasive, with short- to long-term micturition improvement equivalent to OP.

Trial registration

Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates. ClinicalTrials.gov identifier NCT01952912. http://www.clinicaltrials.gov/ct2/show/NCT01952912?term=NCT016301952912&rank=1.     

Four-Year Outcome of a Prospective Randomised Trial Comparing Bipolar Plasmakinetic and Monopolar Transurethral Resection of the Prostate

Background

No data have been published on the midterm efficacy of bipolar transurethral resection of the prostate (TURP).

Objective

To evaluate 4-yr results from a prospective randomised trial comparing bipolar TURP with standard monopolar TURP.

Design, setting, and participants

Seventy patients with symptomatic benign prostatic hyperplasia were enrolled in this prospective randomised controlled trial in a tertiary-care institution. Inclusion criteria were age >50 yr, good performance status, urinary retention, International Prostate Symptom Score (IPSS) ≥18, and maximal flow rate (Q_max) ≤15 ml/s. Exclusion criteria were prostate volume <30 cm³, documented or suspected prostate cancer, neurogenic bladder, bladder stone or diverticula, urethral stricture, and maximal bladder capacity >500 ml.

Intervention

Patients underwent standard or bipolar plasmakinetic TURP performed by the same surgeon using the same surgical technique.

Measurements

Treatment efficacy was evaluated at 1, 2, 3, and 4 yr by comparing urinary flow rates, IPSS, and estimated postvoid residual (PVR) urine volume. Midterm complications were also recorded.

Results and limitations

The number of dropouts was not statistically significantly different in the two groups (p = 0.2). The significant improvements in both groups were maintained at 4 yr for the IPSS, quality of life score, Q_max, and PVR versus baseline values. The main outcome variables at 4 yr for bipolar and monopolar TURP were mean IPSS 6.9 and 6.4 (p = 0.58); mean Q_max 19.8 ml/s and 21.2 ml/s (p = 0.44), and mean PVR volume 42 ml and 45 ml (p = 0.3). Overall, 2 of 32 (6.2%) and 3 of 31 (9.6%) patients required reoperation because of late complications (p = 0.15). The major study limitation was the small sample size.

Conclusions

This study represents the secondary, midterm analysis of a previously published trial. Our 4-yr data confirm our initial positive findings for the efficacy and safety of bipolar plasmakinetic TURP. Larger well-designed studies are needed to corroborate these findings.     

Long-term Cancer-specific Outcomes of TaG1 Urothelial Carcinoma of the Bladder

Background

Few studies have investigated the natural history of TaG1 urothelial carcinoma of the bladder (UCB).

Objective

To assess the long-term outcomes of patients with TaG1 UCB and the impact of immediate postoperative instillation of chemotherapy (IPIC).

Design, setting, and participants

A retrospective analysis of 1447 patients with TaG1 UCB treated between 1996 and 2007 at eight centers. Median follow-up was 67.2 mo (interquartile range: 67.9). Patients were stratified into three European Association of Urology (EAU) guidelines risk categories; high-risk patients (n = 11) were excluded.

Intervention

Transurethral resection of the bladder with or without IPIC.

Outcome measurements and statistical analysis

Univariable and multivariable Cox regression models addressed factors associated with disease recurrence, disease progression, death of disease, and any-cause death.

Results and limitations

Of the 1436 patients, 601 (41.9%) and 835 (58.1%) were assigned to low- and intermediate-risk categories, respectively. The actuarial estimate of 5-yr recurrence-free survival was 56% (standard error: ±1). Advancing age (p = 0.04), tumor >3 cm (p = 0.001), multiple tumors (p < 0.001), and recurrent tumors (p < 0.001) were independently associated with increased risk of disease recurrence, whereas IPIC was associated with decreased risk (p = 0.001). The actuarial estimate of 5-yr progression-free survival was 95% ± 1. Advancing age (p < 0.001) and multiple tumors (p = 0.01) were independent risk factors for disease progression. Five-year cancer-specific survival was 98% ± 1. Advancing age (p = 0.001) and previous recurrence (p = 0.04) were associated with increased risk, whereas female gender (p = 0.02) was associated with decreased risk of cancer-specific mortality. Compared with low-risk patients, intermediate-risk patients were at significantly higher risk of disease recurrence, disease progression, and cancer-specific mortality (all p < 0.01). Limitations include the retrospective design of the study and the lack of a central pathology review.

Conclusions

TaG1 UCB patients experience heterogeneous risks of disease recurrence. We validated the EAU guidelines risk stratification in TaG1 UCB patients. IPIC was associated with a reduced risk of disease recurrence in patients with low- and intermediate-risk TaG1 UCB.     

GreenLight HPS 120-W Laser Vaporization Versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia: A Randomized Clinical Trial with Midterm Follow-up

Background

Photoselective vaporization (PVP) with the GreenLight HPS 120-W laser (GLL) was recently introduced for treatment of benign prostatic hyperplasia (BPH).

Objective

To compare results of GLL PVP and transurethral resection of the prostate (TURP) for treatment of BPH.

Design, setting, and participants

A total of 120 patients with BPH were randomly assigned to two equal groups: TURP or PVP.

Measurements

Both groups were compared regarding all relevant preoperative, operative, and postoperative parameters. Functional results in terms of improvement of International Prostate Symptom Score (IPSS), maximum flow rate (Q_max), and postvoid residual (PVR) urine were assessed at 1, 3, 6, 12, 24, and 36 mo. A total of 55 and 54 patients completed 36 mo of follow-up in the TURP and PVP groups, respectively.

Results and limitations

Baseline characteristics were comparable. Mean operative time was significantly shorter for TURP. Compared to preoperative values, there was significant reduction in hemoglobin and serum sodium levels at the end of TURP only. A significant difference in favor of PVP was achieved regarding the duration of catheterization and hospital stay. In the PVP, no major intraoperative complications were recorded and none of the patients required blood transfusion. Among TURP patients, 12 (20%) required transfusion, 3 (5%) developed TUR syndrome, and capsule perforation was observed in 10 patients. There was dramatic improvement in Q_max, IPSS, and PVP compared with preoperative values and the degree of improvement was comparable in both groups at all time points of follow-up. Storage bladder symptoms were significantly higher in PVP. By the end of 36 mo, five patients in TURP and six in PVP were lost to follow-up. A redo procedure was required in one TURP patient and six PVP patients (p < 0.05). Two TURP patients and four PVP patients developed bladder neck contracture (p > 0.05) treated by bladder neck incision; none in either group experienced urethral stricture or urinary incontinence.

Conclusions

Compared with TURP, 120-W GLL PVP is safe and effective in treatment of BPH.     

Athermal Division and Selective Suture Ligation of the Dorsal Vein Complex During Robot-Assisted Laparoscopic Radical Prostatectomy: Description of Technique and Outcomes

Background

Apical dissection and control of the dorsal vein complex (DVC) affects blood loss, apical positive margins, and urinary control during robot-assisted laparoscopic radical prostatectomy (RALP).

Objective

To describe technique and outcomes for athermal DVC division followed by selective suture ligation (DVC-SSL) compared with DVC suture ligation followed by athermal division (SL-DVC).

Design, settings, and participants

Retrospective study of prospectively collected data from February 2008 to July 2010 for 303 SL-DVC and 240 DVC-SSL procedures.

Surgical procedure

RALP with comparison of DVC-SSL prior to anastomosis versus early SL-DVC prior to bladder-neck dissection.

Measurements

Blood loss, transfusions, operative time, apical and overall positive margins, urine leaks, catheterization duration, and urinary control at 5 and 12 mo evaluated using 1) the Expanded Prostate Cancer Index (EPIC) urinary function scale and 2) continence defined as zero pads per day.

Results and limitations

Men who underwent DVC-SSL versus SL-DVC were older (mean: 59.9 vs 57.8 yr, p < 0.001), and relatively fewer white men underwent DVC-SSL versus SL-DVC (87.5% vs 96.7%, p < 0.001). Operative times were also shorter for DVC-SSL versus SL-DVC (mean: 132 vs 147 min, p < 0.001). Men undergoing DVC-SSL versus SL-DVC experienced greater blood loss (mean: 184.3 vs 175.6 ml, p = 0.033), and one DVC-SSL versus zero SL-DVC were transfused (p = 0.442). Overall (12.2% vs 12.0%, p = 1.0) and apical (1.3% vs 2.7%, p = 0.361) positive surgical margins were similar for DVC-SSL versus SL-DVC. Although 5-mo postoperative urinary function (mean: 72.9 vs 55.4, p < 0.001) and continence (61.4% vs 39.6%, p < 0.001) were better for DVC-SSL versus SL-DVC, 12-mo urinary outcomes were similar. In adjusted analyses, DVC-SSL versus SL-DVC was associated with shorter operative times (parameter estimate [PE] ± standard error [SE]: 16.84 ± 2.56, p < 0.001), and better 5-mo urinary function (PE ± SE: 19.93 ± 3.09, p < 0.001) and continence (odds ratio 3.39, 95% confidence interval 2.07–5.57, p < 0.001).

Conclusions

DVC-SSL versus SL-DVC improves early urinary control and shortens operative times due to fewer instrument changes with late versus early DVC control.     

Intérêt du mélange sérum salé hypertonique–hydroxyéthylamidon lors du choc hémorragique

Objective

Assessment of haemodynamic, respiratory and renal effects of hypertonic saline–hydroxyethyl starch (HyperHES^®) in critically ill-patients with hemorrhagic shock.

Patients and methods

Seventeen mechanically ventilated patients with hemorragic shock benefiting from a cardiovascular monitoring by PiCCO device and requiring rapid volume loading. Two hundred and fifty milliliters of HyperHES^® were given over 5 minutes. The efficacy of volume loading was assessed by the measure of the systolic arterial pressure (SAP), cardiac index (CI), stroke volume variation (SVV) and the indexed systemic vascular resistance (iSVR). Studied parameters were assessed at baseline, 5, 30, 60 and 180 minutes after the end of HyperHES^® infusion.

Results

SAP (105 ± 23 vs 77 ± 10; p < 0.001) and CI (4.8 ± 1.1 vs 3.5 ± 0.9; p < 0.001) were significantly increased whereas iSVR (1175 ± 310 vs 1501 ± 337; p < 0.01) and SVV (13 ± 7 vs 20 ± 5; p < 0.01) were significantly decreased 5 minutes after the HyperHES^® infusion. Sodium (145 ± 6 vs 136 ± 5; p < 0.001) and chloride (118 ± 7 vs 107 ± 6; p < 0.001) were increased 5 minutes after the infusion. The PaO₂/FiO₂ ratio as the extravascular lung water was not influenced by the infusion. The follow-up of renal parameters during the three first days (creatinemia, uremia and diuresis) did not revelead significant variations.

Conclusion

In patients with hemorrhagic shock, the infusion of hypertonic saline (7.5%) hydroxyethyl starch association was followed by an increase in SAP, CI serum sodium and chloride concentrations.

Study design

Prospective observational study.     

The primary determinants of radiation use during fixation of proximal femur fractures

Objectives

To establish the primary determinants of operative radiation use during fixation of proximal femur fractures.

Design

Retrospective cohort study.

Setting

Level I trauma centre.

Cohort

205 patients treated surgically for subtrochanteric and intertrochanteric femoral fractures.

Main outcome measures

Fluoroscopy time, dose-area-product (DAP).

Results

Longer fluoroscopy time was correlated with higher body mass index (p = 0.04), subtrochanteric fracture (p < 0.001), attending surgeon (p = 0.001), and implant type (p < 0.001). Increased DAP was associated with higher body mass index (p < 0.001), subtrochanteric fracture (p = 0.002), attending surgeon (p = 0.003), lateral body position (p < 0.001), and implant type (p = 0.05).

Conclusion

The strongest determinants of radiation use during surgical fixation of intertrochanteric and subtrochanteric femur fractures were location of fracture, patient body position, patient body mass index, and the use of cephalomedullary devices. Surgeon style, presumably as it relates to teaching efforts, seems to strongly influence radiation use.     

Bipolar versus Monopolar Transurethral Resection of the Prostate: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Context

Incorporation of bipolar technology in transurethral resection (TUR) of the prostate (TURP) potentially offers advantages over monopolar TURP (M-TURP).

Objective

To evaluate the evidence by a meta-analysis, based on randomized controlled trials (RCTs) comparing bipolar TURP (B-TURP) with M-TURP for benign prostatic obstruction. Primary end points included efficacy (maximum flow rate [Q_max], International Prostate Symptom Score) and safety (adverse events). Secondary end points included operation time and duration of irrigation, catheterization, and hospitalization.

Evidence acquisition

Based on a detailed, unrestricted strategy, the literature was searched up to February 19, 2009, using Medline, Embase, Science Citation Index, and the Cochrane Library to detect all relevant RCTs. Methodological quality assessment of the trials was based on the Dutch Cochrane Collaboration checklist. Meta-analysis was performed using Review Manager 5.0.

Evidence synthesis

Sixteen RCTs (1406 patients) were included. Overall trial quality was low (eg, allocation concealment and blinding of outcome assessors were poorly reported). No clinically relevant differences in short-term (12-mo) efficacy were detected (Q_max: weighted mean difference [WMD]: 0.72 ml/s; 95% confidence interval [CI], 0.08–1.35; p = 0.03). Data on follow-up of >12 mo are scarce for B-TURP, precluding long-term efficacy evaluation. Treating 50 patients (95% CI, 33–111) and 20 patients (95% CI, 10–100) with B-TURP results in one fewer case of TUR syndrome (risk difference [RD]: 2.0%; 95% CI, 0.9–3.0%; p = 0.01) and one fewer case of clot retention (RD: 5.0%; 95% CI, 1.0–10%; p = 0.03), respectively. Operation times, transfusion rates, retention rates after catheter removal, and urethral complications did not differ significantly. Irrigation and catheterization duration was significantly longer with M-TURP (WMD: 8.75 h; 95% CI, 6.8–10.7 and WMD: 21.77 h; 95% CI, 19.22–24.32; p < 0.00001, respectively). Inferences for hospitalization duration could not be made. PlasmaKinetic TURP showed an improved safety profile. Data on TUR in saline (TURis) are not yet mature to permit safe conclusions.

Conclusions

No clinically relevant differences in short-term efficacy exist between the two techniques, but B-TURP is preferable due to a more favorable safety profile (lower TUR syndrome and clot retention rates) and shorter irrigation and catheterization duration. Well-designed multicentric/international RCTs with long-term follow-up and cost analysis are still needed.     

Midterm Results from an International Multicentre Randomised Controlled Trial Comparing Bipolar with Monopolar Transurethral Resection of the Prostate

Background

Pooled data from randomised controlled trials (RCTs) with short-term follow-up have shown a safety advantage for bipolar transurethral resection of the prostate (B-TURP) compared with monopolar TURP (M-TURP). However, RCTs with follow-up >12 mo are scarce.

Objective

To compare the midterm safety/efficacy of B-TURP versus M-TURP.

Design, setting, and participants

From July 2006 to June 2009, TURP candidates with benign prostatic obstruction were consecutively recruited in four centres, randomised 1:1 into the M-TURP or the B-TURP arm and regularly followed up to 36 mo postoperatively. A total of 295 patients were enrolled.

Intervention

M-TURP or B-TURP using the AUTOCON II 400 electrosurgical unit.

Outcome measurements and statistical analysis

Safety was estimated by complication rates with a special emphasis on urethral strictures (US) and bladder neck contractures (BNCs) recorded during the short-term (up to 12 mo) and midterm (up to 36 mo) follow-up. Efficacy quantified by changes in maximum urine flow rate, postvoid residual urine volume, and International Prostate Symptom Score was compared with baseline, and reintervention rates in each arm were also evaluated.

Results and limitations

A total of 279 patients received treatment after allocation. Mean follow-up was 28.8 mo. A total of 186 of 279 patients (66.7%) completed the 36-mo follow-up. Posttreatment withdrawal rates did not differ significantly between arms. Safety was assessed in 230 patients (82.4%) at a mean follow-up of 33.4 mo. Ten US cases were seen in each arm (M-TURP vs B-TURP: 9.3% vs 8.2%; p = 0.959); two versus eight BNC cases (M-TURP vs B-TURP: 1.9% vs 6.6%; p = 0.108) were collectively detected at the midterm follow-up. Resection type was not a significant predictor of the risk of US/BNC formation. Efficacy was similar between arms and durable. A total of 10 of 230 patients (4.3%) experienced failure to cure and needed reintervention without significant differences between arms. High overall reintervention rates, withdrawal rates, and sample size determination not based on US/BNC rates represent potential limitations.

Conclusions

The midterm safety and efficacy of B-TURP and M-TURP are comparable.

Trial registration

Netherlands Trial Register, NTR703 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=703).     

HYAL-1 Hyaluronidase: A Potential Prognostic Indicator for Progression to Muscle Invasion and Recurrence in Bladder Cancer

Background

For bladder cancer (BCa) patients undergoing bladder-sparing treatments, molecular markers may aid in accurately predicting progression to muscle invasion and recurrence. Hyaluronic acid (HA) is a glycosaminoglycan that promotes tumor metastasis. Hyaluronoglucosaminidase 1 (HYAL-1)–type hyaluronidase (HAase) promotes tumor growth, invasion, and angiogenesis. Urinary HA and HAase levels are diagnostic markers for BCa.

Objective

We evaluated whether HA and HYAL-1 can predict progression to muscle invasion and recurrence among patients with non–muscle-invasive BCa.

Design, setting, and participants

: Based on tissue availability, tissue microarrays were prepared from a cohort of 178 BCa specimens (144 non–muscle invasive, 34 muscle invasive). Follow-up information was available on 111 patients with non–muscle-invasive BCa (mean follow-up: 69.5 mo); 58 patients recurred and 25 progressed to muscle invasion (mean time to progress: 22.3 mo).

Measurements

HA and HYAL-1 expression was evaluated by immunohistochemistry and graded for intensity and area of staining. Association of HA and HYAL-1 staining with BCa recurrence and muscle invasion was evaluated by univariate and multivariate models.

Results and limitations

HA and HYAL-1 expression correlated with tumor grade, stage, and multifocality (p < 0.05). In non–muscle-invasive BCa specimens, HYAL-1 staining was higher (234.3 ± 52.2; 200.6 ± 61.4) if patients experienced progression to muscle invasion or recurrence when compared with no progression or recurrence (164.1 ± 48.2; 172.1 ± 57; p < 0.001). HA staining correlated with muscle invasion (p < 0.001). In univariate analysis, age (p = 0.014), multifocality (p = 0.023), and HYAL-1 staining (p < 0.001) correlated with muscle invasion, whereas only HYAL-1 correlated with recurrence (p = 0.013). In multivariate analysis, HYAL-1 significantly associated with muscle invasion (p < 0.001; 76.8% accuracy) and recurrence (p = 0.01; 67.8% accuracy).

Conclusions

HYAL-1 is a potential prognostic marker for predicting progression to muscle invasion and recurrence.     

Renal Pelvic Anatomy Is Associated with Incidence,Grade, and Need for Intervention for Urine Leak Following Partial Nephrectomy

Background

Although the effect of tumor complexity on perioperative outcome measures is well established, the impact of renal pelvic anatomy on perioperative outcomes remains poorly defined.

Objective

To evaluate renal pelvic anatomy as an independent predictor of urine leak in moderate- and high-complexity tumors undergoing nephron-sparing surgery.

Design, setting, and participants

Patients undergoing open partial nephrectomy (PN) for localized RCC were stratified into intermediate- and high-complexity groups using a nephrometry score (7–9 and 10–12, respectively). A renal pelvic score (RPS) was defined by the percentage of renal pelvis contained inside the volume of the renal parenchyma. On this basis, patients were categorized as having an intraparenchymal (>50%) or extraparenchymal (<50%) renal pelvis.

Outcome measurements and statistical analysis

Characteristics of patients with and without an intraparenchymal renal pelvic anatomy were compared.

Results and limitations

Inclusion criteria were met by 255 patients undergoing PN for intermediate (73.6%) and complex (26.4%) localized renal tumors (mean size: 4.6 ± 2.9 cm). Twenty-four (9.6%) renal pelves were classified as completely intraparenchymal. Following stratification by RPS, groups differed with respect to Charlson comorbidity index, body mass index, and largest tumor size, while no differences were observed between hospital length of stay, nephrometry score, estimated blood loss, operative time, and age. Intrarenal pelvic anatomy was associated with a markedly increased risk of urine leak (75% vs 6.5%; p = 0.001), secondary intervention (37.5% vs 3.9%; p < 0.001), and prolonged duration of urine leak (93 ± 62 d vs 56 ± 29 d; p = 0.025).

Conclusions

Intraparenchymal renal pelvic anatomy is an uncommon anatomic variant associated with an increased rate of urine leak following PN. Elevated pressures within a small intraparenchymal renal pelvis might explain the increased risk. Preoperative imaging characteristics suggestive of increased risk for urine leak should be considered in perioperative management algorithms.     

Differences in patients with systemic sclerosis recruited from associations and tertiary care settings

Objective

To compare patients with systemic sclerosis (SSc) recruited from a patient association or a tertiary care setting.

Methods

We evaluated 248 SSc patients attending 4 annual meetings of a patient association between 2004 and 2007 (177) or during hospitalization (71). health-related quality of life (HRQoL) was assessed by the SF-36, global disability by the health assessment questionnaire (HAQ), hand disability by the Cochin Hand Function Scale (CHFS), mouth disability by the Mouth Handicap in Systemic Sclerosis (MHISS) scale, global hand and wrist mobility by the Kapandji index.

Results

As compared with hospitalized patients, those from the patient association were significantly older (mean age 58.73 ± 12.04 vs 53.818 ± 13.1; p = 0.001) and had a longer disease duration (10.98 ± 8.7 vs 7.13 ± 6.723 p = 0.0001). Association patients had significantly increased disability of the hand (CHFS 21.8 ± 19.8 vs 9.8 ± 14.1; p = 0.0001) and mouth (MHISS 20.65 ± 10.8 vs 13.25 ± 9.3; p = 0.0001) and impaired hand and wrist mobility (Kapandji score 38.05 ± 10.26 vs 43.90 ± 8.26, p = 0.001). The 2 groups did not differ in global disability or physical and mental scores of the SF36.

Conclusion

Patients recruited from a patient association have more severe SSc than do hospitalized patients. This finding must be taken into account in the design of surveys and clinical trials.     

Serum Isoform [−2]proPSA Derivatives Significantly Improve Prediction of Prostate Cancer at Initial Biopsy in a Total PSA Range of 2–10 ng/ml: A Multicentric European Study

Background

Strategies to reduce prostate-specific antigen (PSA)–driven prostate cancer (PCa) overdiagnosis and overtreatment seem to be necessary.

Objective

To test the accuracy of serum isoform [−2]proPSA (p2PSA) and its derivatives, percentage of p2PSA to free PSA (fPSA; %p2PSA) and the Prostate Health Index (PHI)—called index tests—in discriminating between patients with and without PCa.

Design, setting, and participants

This was an observational, prospective cohort study of patients from five European urologic centers with a total PSA (tPSA) range of 2–10 ng/ml who were subjected to initial prostate biopsy for suspected PCa.

Outcome measurements and statistical analysis

The primary end point was to evaluate the specificity, sensitivity, and diagnostic accuracy of index tests in determining the presence of PCa at prostate biopsy in comparison to tPSA, fPSA, and percentage of fPSA to tPSA (%fPSA) (standard tests) and the number of prostate biopsies that could be spared using these tests. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision curve analysis.

Results and limitations

Of >646 patients, PCa was diagnosed in 264 (40.1%). Median tPSA (5.7 vs 5.8 ng/ml; p = 0.942) and p2PSA (15.0 vs 14.7 pg/ml) did not differ between groups; conversely, median fPSA (0.7 vs 1 ng/ml; p < 0.001), %fPSA (0.14 vs 0.17; p < 0.001), %p2PSA (2.1 vs 1.6; p < 0.001), and PHI (48.2 vs 38; p < 0.001) did differ significantly between men with and without PCa. In multivariable logistic regression models, p2PSA, %p2PSA, and PHI significantly increased the accuracy of the base multivariable model by 6.4%, 5.6%, and 6.4%, respectively (all p < 0.001). At a PHI cut-off of 27.6, a total of 100 (15.5%) biopsies could have been avoided. The main limitation is that cases were selected on the basis of their initial tPSA values.

Conclusions

In patients with a tPSA range of 2–10 ng/ml, %p2PSA and PHI are the strongest predictors of PCa at initial biopsy and are significantly more accurate than tPSA and %fPSA.

Trial registration

The study is registered at http://www.controlled-trials.com, ref. ISRCTN04707454.     

GreenLight HPS 120-W laser vaporization versus transurethral resection of the prostate for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia: a randomized clinical trial with 2-year follow-up

Background

High-level evidence to support the use of photoselective vaporization of the prostate (PVP) is limited.

Objective

Assess the efficacy and safety of GreenLight HPS 120-W laser PVP compared with transurethral resection of the prostate (TURP).

Design, setting, and participants

A randomized clinical trial was performed with 50 patients having lower urinary tract symptoms due to benign prostatic hyperplasia in each treatment arm.

Intervention

Random allocation to PVP or TURP.

Measurements

International Prostate Symptom Score (IPSS), quality of life (QoL), and changes in maximum flow rate (Q_max) were the main end points. Patients were evaluated at a follow-up time of 2 yr. Five patients were lost to follow-up. A last observation carried forward analysis was done.

Results and limitations

Both laser PVP and TURP resulted in the same IPPS reduction at 2 yr (−15.7 and −14.9, respectively; p = 0.48) and in the same gain in Q_max (+14.5 ml/s and +13.1 ml/s, respectively; p = 0.65). QoL was equivalent for both treatment modalities. These results were independent of prostate size, American Society of Anesthesiologists risk category, and prior indwelling catheter. No statistically significant differences were detected between arms in terms of complication rates. In the laser PVP group, three patients were readmitted to the hospital and two developed a urethral stricture. In the TURP group, two patients were readmitted, six developed a urethral stricture, and two developed bladder neck sclerosis. In-hospital stay and time to catheter removal were significantly shorter with PVP. Limitations are the potential lack of power to detect differences in the complications between groups and the lack of blindness due to the nature of the intervention.

Conclusions

GreenLight HPS 120-W laser PVP is as effective as TURP for symptom reduction and improvement of QoL. No differences were seen in the response of storage and voiding symptoms. Laser PVP and TURP have the same complication rate. Length of stay is shorter for laser PVP group.     

Use of Potentially Curative Therapies for Muscle-invasive Bladder Cancer in the United States: Results from the National Cancer Data Base

Background

Despite its lethal potential, many patients with muscle-invasive bladder cancer (MIBC) do not receive aggressive, potentially curative therapy consistent with established practice standards.

Objective

To characterize the treatments received by patients with MIBC and analyze their use according to sociodemographic, clinical, pathologic, and facility measures.

Design, setting, and participants

Using the National Cancer Data Base, we analyzed 28 691 patients with MIBC (stages II–IV) treated between 2004 and 2008, excluding those with cT4b tumors or distant metastases. Treatments included radical or partial cystectomy with or without chemotherapy (CT), chemoradiotherapy (CRT), radiation therapy (RT), or CT alone and observation following biopsy. Aggressive therapy (AT) was defined as radical or partial cystectomy or definitive RT/CRT (total dose ≥50 Gy).

Outcome measurements and statistical analysis

AT use and correlating variables were assessed by multivariable, generalized estimating equation models adjusted for facility clustering.

Results and limitations

According to the database, 52.5% of patients received AT; 44.9% were treated surgically, 7.6% received definitive CRT or RT, and 25.9% of patients received observation only. AT use decreased with advancing age (odds ratio [OR]: 0.34 for age 81–90 yr vs ≤50 yr; p < 0.001). AT use was also lower in racial minorities (OR: 0.74 for black race; p < 0.001), the uninsured (OR: 0.73; p < 0.001), Medicaid-insured patients (OR: 0.81; p = 0.01), and at low-volume centers (OR: 0.64 vs high-volume centers; p < 0.001). Use of AT was higher with increasing tumor stage (OR: 2.23 for T3/T4a vs T2; p < 0.001) and nonurothelial histology (OR: 1.25 and 1.43 for squamous and adenocarcinoma, respectively; p < 0.001). Study limitations include retrospective design and lack of information about patient and provider motivations regarding therapy selection.

Conclusions

AT for MIBC appears underused, especially in the elderly and in groups with poor socioeconomic status. These data point to a significant unmet need to inform policy makers, payers, and physicians regarding appropriate therapies for MIBC.     

Œsophagectomie carcinologique : 16 ans d’évolution des pratiques anesthésiques ventilatoires,hémodynamiques et analgésiques

Objective

To describe the evolution of perioperative anesthesia practices in for esophageal cancer surgery.

Patients and methods

We conducted an observational retrospective study in a single center evaluating main perioperative practices during 16 years (1994–2009). Statistical analysis was done on 4 chronologic quartiles of same sample size.

Results

Two hundred and seven consecutive patients were included during the 4 periods 1994–1997 (n = 52), 1997–1999 (n = 52), 1999–2003 (n = 52) and 2004–2009 (n = 51). The main significant evolutions between the first and the fourth period were observed: (i) in ventilation: lower tidal volume (9.6[8.6–10.6] vs 7.6[7.0–8.3] mL/kg of ideal body weight (IBW), p < 0.01), increased use of Positive End Expiratory Pressure (0 vs 83 %, p < 0.001) and increased use of post-operative non-invasive ventilation (0 vs 51 %, p < 0.001); (ii) in hemodynamic management: lower fluid replacement (20.6 [16.0–24.6] vs 12.6 [9.7–16.2] mL/h/kg of IBW, p < 0.001); (iii) in analgesia: increased use of epidural thoracic anesthesia (31 vs 57 %, p < 0.001). Peroperative bleeding, type of fluid replacement, length of mechanical ventilation, length of stay in intensive care unit, ventilatory free days and mortality at day 28 didn’t change.

Conclusions

During these previous years, anesthesia practices in ventilation, hemodynamics and analgesia for esophageal cancer surgery have changed.     

Gender and Age Differences in the Perception of Bother and Health Care Seeking for Lower Urinary Tract Symptoms: Results from the Hospitalised and Outpatients’ Profile and Expectations Study

Background

Few comparisons have been made of health care seeking behaviour for lower urinary tract symptoms (LUTS) between men and women, as well as trends across age groups.

Objective

To investigate the bother from LUTS and effect on health care seeking in both men and women of different age groups and in comparison between the two genders.

Design, setting, and participants

A representative cross section of each of 13 clinics of a general academic hospital, with equal numbers of subjects recruited in each of six design cells that were defined by age (18–40, 41–60, 61–80 yr) and gender.

Intervention

A 2-h in-person interview, conducted by a trained psychologist/interviewer in a clinic office.

Measurements

Severity of LUTS was measured by the International Prostate Symptom Score (IPSS). Treatment seeking was measured by a single item. A bother question was modified to assess overall bother. Impact on quality of life (QoL) was measured by the IPSS QoL question.

Results and limitations

The final study sample comprised 415 patients. More women than men reported the presence of LUTS (85.5% vs 75.2%; p = 0.01). LUTS were more bothersome in women (25.4% of women vs 17.6% of men with bother “some” or “a lot”; p = 0.02). Severity of LUTS increased with age in both genders (men: p < 0.001; women: p = 0.03). Bother from LUTS increased as severity of symptoms increased in both genders (p < 0.001) but was associated with age only in men (p < 0.001). QoL showed similar results as bother. Although men and women had equal prevalence of treatment seeking (27.9% vs 23.7%; p = 0.40), men, but not women, were more likely to seek treatment as age (p < 0.01) and severity of LUTS (p < 0.001) increased. In multivariate logistic regressions, only bother from LUTS was associated with treatment seeking in women, compared with bother, age, and the presence of voiding symptoms in men.

Conclusions

In our hospital-based sample, differences in LUTS frequency, bother, and health care seeking profiles between men and women suggest a different perception and response to LUTS between the two genders.     

Plasma Vaporisation of the Prostate: Initial Clinical Results

Background

Laser vaporisation of the prostate has had a considerable impact in recent years. In an attempt to achieve tissue vaporisation with bipolar high-frequency generators, plasma vaporisation was recently introduced.

Objective

To provide the first clinical information on bipolar plasma vaporisation of the prostate for patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO).

Design, setting, and participants

Thirty patients were included in this prospective bicentre study.

Intervention

All patients underwent bipolar plasma vaporisation with a novel electrode (Olympus Winter & Ibe GmbH, Hamburg, Germany).

Measurements

International Prostate Symptom Score (IPSS), bother score, maximum flow rate (Q_max), and postvoid residual were evaluated at baseline and at the time of discharge as well as at 1, 3, and 6 mo after the intervention.

Results and limitations

Mean preoperative prostate volume was 59 ± 32 ml (range: 30–170), and mean operating time was 61 ± 26 min (range: 20–140). Besides one reoperation (conventional transurethral prostatectomy) due to persistent obstruction, no major complication occurred intra- or postoperatively and no blood transfusion was required. Catheterisation time averaged 41 ± 35 h (range: 18–192). Transient mild to moderate dysuria was noted in four patients (13%). At 1, 3, and 6 mo, Q_max increased from 6.6 ± 2.7 ml/s preoperative to 17.3 ± 4.7 ml/s (p < 0.01), 18.5 ± 4.6 ml/s (p < 0.01), and 18.1 ± 5.0 ml/s (p < 0.01), respectively. The IPSS decreased from 20.8 ± 3.6 to 10.4 ± 3.5 (p < 0.01), 8.2 ± 2.9 (p < 0.01), and 8.1 ± 3.1 (p < 0.01), respectively. These data represent a small nonrandomised study cohort with limited follow-up.

Conclusions

Our initial experience indicates that bipolar plasma vaporisation might be a safe and effective treatment option for patients with LUTS due to BOO. To define the potential role of this novel technique, randomised trials with longer follow-up are mandatory.     

Photographic assessment of burn wounds: A simple strategy in a resource-poor setting

Objective

To validate the use of photographic burn wound assessment in evaluation of burn size and wound characteristics.

Methods

Feasibility study of agreement between methods of measurement of burn size and characteristics, in patients admitted to the burn unit at Kamuzu Central Hospital (KCH), Malawi, over two months in 2011. Burn wounds were photographed and assessed clinically, concurrently, by an experienced clinician. Photographs reviewed by two blinded burn clinicians after 4–6 weeks. Correlation between clinical assessment and photographic evaluation was calculated using kappa score and Pearson's correlation coefficient.

Results

Thirty-nine patients were included in evaluation of TBSA, and fifty wounds assessed for their characteristics. Pearson's correlation coefficient for agreement of TBSA between clinical exam and photograph review by expert#1, and #2, was 0.96, 0.93 (p < 0.001), respectively. Pearson's correlation coefficients comparing expert#1 and #2 to the gold standard were: proportion of full-thickness burn (0.88 and 0.81, p < 0.001), and epithelialized superficial burn (0.89 and 0.55, p < 0.001). Kappa scores were significant for wound evolution (expert#1 0.57, expert#2 0.64, p < 0.001), and prognosis (expert#1 0.80, expert#2 0.80, p < 0.001).

Conclusions

Burn assessment with digital photography is a valid and affordable alternative to direct clinical exam, alleviating access issues to burn care in developing countries.     

Determinants of Laparoscopic Donor Nephrectomy Outcomes

Background

Pure laparoscopic donor nephrectomy (LDN) is a unique intervention because it carries known risks and complications, yet carries no direct benefit to the donor. Therefore, it is critical to continually examine and improve quality of care.

Objective

To identify factors affecting LDN outcomes and complications.

Design, setting, and participants

A retrospective analysis of prospectively collected data for 1204 consecutive LDNs performed from March 2000 through August 2012.

Intervention

LDN performed at an academic training center.

Outcome measurements and statistical analysis

Using multivariable regression, we assessed the effect of age, sex, body mass index (BMI), laterality, and vascular variation on operative time, estimated blood loss (EBL), complications, and length of stay.

Results and limitations

The following variables were associated with longer operative time (data given as parameter estimate plus or minus the standard error): female sex (9.09 ± 2.43; p < 0.001), higher BMI (1.03 ± 0.32; p = 0.001), two (7.87 ± 2.70; p = 0.004) and three or more (22.45 ± 7.13; p = 0.002) versus one renal artery, and early renal arterial branching (5.67 ± 2.82; p = 0.045), while early renal arterial branching (7.81 ± 3.85; p = 0.043) was associated with higher EBL. Overall, 8.2% of LDNs experienced complications, and by modified Clavien classification, 74 (5.9%) were grade 1, 13 (1.1%) were grade 2a, 10 (0.8%) were grade 2b, and 2 (0.2%) were grade 2c. There were no grade 3 or 4 complications. Three or more renal arteries (odds ratio [OR]: 2.74; 95% CI, 1.05–7.16; p = 0.04) and late renal vein confluence (OR: 2.42; 95% CI, 1.50–3.91; p = 0.0003) were associated with more complications. Finally, we did not find an association of the independent variables with length of stay. A limitation is that warm ischemia time was not assessed.

Conclusions

In our series, renal vascular variation prolonged operative time and was associated with more complications. While complicated donor anatomy is not a contraindication of LDN, surgical decision-making should take into consideration these results.