A Prospective,Randomised Trial Comparing Plasmakinetic Enucleation to Standard Transurethral Resection of the Prostate for Symptomatic Benign Prostatic Hyperplasia: Three-year Follow-up Results

Background

Plasmakinetic enucleation of the prostate (PKEP) has recently been proved a safe and technically feasible procedure for benign prostatic hyperplasia (BPH). However, its long-term safety, efficacy, and durability in comparison with the gold-standard transurethral resection of the prostate (TURP) have not yet been reported.

Objective

To report the 3-yr follow-up results of a prospective, randomised clinical trial comparing PKEP with standard TURP for symptomatic BPH.

Design, setting, and participants

A total of 204 patients with bladder outflow obstruction (BOO) secondary to BPH were prospectively randomised 1:1 into either the PKEP group or the TURP group.

Intervention

The patients in each group underwent the procedure accordingly.

Measurements

All patients were assessed perioperatively and followed at 1, 3, 6, 12, 18, 24, and 36 mo postoperatively. The preoperative and postoperative parameters included International Prostate Symptom Score (IPSS), quality of life (QoL) scores, the International Index of Erectile Function (IIEF) questionnaire, maximum urinary flow rates (Q_max), transrectal ultrasound (TRUS)–assessed prostate volume, postvoid residual urine (PVRU) volume, and serum prostate-specific antigen (PSA) level. Patient baseline characteristics, perioperative data, and postoperative outcomes were compared. All complications were recorded.

Results and limitations

PKEP was significantly superior to TURP in terms of the drop in haemoglobin (0.74 ± 0.33 g/dl vs 1.88 ± 1.06 g/dl; p < 0.001), intraoperative irrigation volume (11.7 ± 4.5 l vs 15.4 ± 6.2 l; p < 0.001), postoperative irrigation volume and time (18.5 ± 7.6 l vs. 30.0 ± 11.4 l and 16.6 ± 5.2 h vs 25.3 ± 8.5 h; all p < 0.001), recovery room stay (67.3 ± 11.1 min vs 82.0 ± 16.4 min; p < 0.001), catheterisation time (51.7 ± 26.3 h vs 80.5 ± 31.6 h; p < 0.001), hospital stay (98.4 ± 20.4 h vs 134.2 ± 31.5 h; p < 0.001), and resected tissue (56.4 ± 12.8 g vs 43.8 ± 15.5 g; p < 0.001). There were no statistical differences in operation time and sexual function between the two groups. At 36 mo postoperatively, the PKEP group had a maintained and statistically significant improvement in IPSS (2.4 ± 2.2 vs 4.3 ± 2.9; p < 0.001), QoL (0.6 ± 0.5 vs 1.6 ± 1.4; p < 0.001), Q_max (28.8 ± 10.1 ml/s vs 25.1 ± 8.0 ml/s; p = 0.017), and TRUS volume (21.0 ± 7.3 ml vs 26.4 ± 6.8 ml; p < 0.001), with urodynamically proven deobstruction (Schäfer grade 0.2 ± 0.02 vs 0.8 ± 0.1; p < 0.001). More extensive clinical trials are required to validate these results.

Conclusions

PKEP is a safe and highly effective technique for relieving BOO. At 3-yr follow-up, the clinical efficacy of PKEP is durable and compares favourably with TURP.     

Transvesical Robotic Simple Prostatectomy: Initial Clinical Experience

Background

Despite significant developments in transurethral surgery for benign prostatic hyperplasia (BPH), simple prostatectomy remains an excellent option for patients with large glands.

Objective

To describe our technique of transvesical robotic simple prostatectomy (RSP).

Design, setting, and participants

From May 2011 to April 2013, 25 patients underwent RSP.

Surgical procedure

We performed RSP using our technique.

Outcome measurements and statistical analysis

Baseline demographics, pathology data, perioperative complications, 90-d complications, and functional outcomes were assessed.

Results and limitations

Mean patient age was 72.9 yr (range: 54–88), baseline International Prostate Symptom Score (IPSS) was 23.9 (range: 9–35), prostate volume was 149.6 ml (range: 91–260), postvoid residual (PVR) was 208.1 ml (range: 72–800), maximum flow rate (Q_max) was 11.3 ml/s, and preoperative prostate-specific antigen was 9.4 ng/ml (range: 1.9–56.3). Eight patients were catheter dependent before surgery. Mean operative time was 214 min (range: 165–345), estimated blood loss was 143 ml (range: 50–350), and the hospital stay was 4 d (range: 2–8). There were no intraoperative complications and no conversions to open surgery. Five patients had a concomitant robotic procedure performed. Early functional outcomes demonstrated significant improvement from baseline with an 85% reduction in mean IPSS (p < 0.0001), an 82.2% reduction in mean PVR (p = 0.014), and a 77% increase in mean Q_max (p = 0.20). This study is limited by small sample size and short follow-up period. One patient had a urinary tract infection; two had recurrent hematuria, one requiring transfusion; one patient had clot retention and extravasation, requiring reoperation.

Conclusions

Our technique of RSP is safe and effective. Good functional outcomes suggest it is a viable option for BPH and larger glands and can be used for patients requiring concomitant procedures.

Patient summary

We describe the technique and report the initial results of a series of cases of transvesical robotic simple prostatectomy. The procedure is both feasible and safe and a good option for benign prostatic hyperplasia with larger glands.     

A Randomized Double-blind Placebo-controlled Phase 2 Dose-ranging Study of OnabotulinumtoxinA in Men with Benign Prostatic Hyperplasia

Background

Botulinum toxin treatment has been investigated as a minimally invasive alternative to oral medications in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (LUTS/BPH).

Objective

To explore the efficacy of onabotulinumtoxinA 100 U, 200 U, and 300 U versus placebo in men with LUTS/BPH in a phase 2 dose-ranging study.

Design, setting, and participants

A multicenter double-blind randomized, placebo-controlled 72-wk study enrolled men ≥50 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥12, total prostate volume (TPV) 30–100 ml, and maximum flow rate (Q_max) 5–15 ml/s.

Intervention

Single transperineal (n = 63) or transrectal (n = 311) administration of placebo (n = 94) or onabotulinumtoxinA 100 U (n = 95), 200 U (n = 94), or 300 U (n = 97) into the prostate transition zone.

Outcome measurements and statistical analysis

The primary efficacy end point was a change from baseline in IPSS at week 12. Secondary end points were Q_max, TPV, and transition zone volume (TZV). Analysis of covariance and the Cochran-Mantel-Haenszel method assessed the efficacy and proportion of IPSS responders. Adverse events (AEs) were assessed.

Results and limitations

Significant improvements from baseline in IPSS, Q_max, TPV, and TZV were observed for all groups, including placebo, at week 12 (p < 0.001), with no significant differences between onabotulinumtoxinA and placebo. However, in an exploratory post hoc analysis, a significant reduction in IPSS versus placebo was observed with onabotulinumtoxinA 200 U in prior α-blocker users (n = 180) at week 12. AEs were comparable across all groups.

Conclusions

Reductions in LUTS/BPH symptoms were seen in all groups, including placebo, with no significant between-group differences owing to a large placebo effect from the injectable therapy. The findings from the post hoc analysis in men previously treated with α-blockers will be further explored in an appropriately designed study.

Trial registration

http://www.Clinical Trials.gov; NCT00284518.     

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.     

180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study

Background

The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned.

Objective

The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Q_max) at 6 mo and the proportion of patients who were complication free.

Design, setting, and participants

Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO.

Intervention

180-W GL XPS system or TURP.

Outcome measurements and statistical analysis

Measurements used were IPSS, Q_max, prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level.

Results and limitations

The study demonstrated the noninferiority of XPS to TURP for IPSS, Q_max, and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS (p < 0.001). Early reintervention rate within 30 d was three times higher after TURP (p = 0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up.

Conclusions

XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Q_max, and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo.

Trial registration

ClinicalTrials.gov, identifier NCT01218672.     

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.     

Eraser Laser Enucleation of the Prostate: Technique and Results

Background

Eraser, a 1318-nm diode laser, has been used for 15 yr for resection of lung metastases. It was recently introduced in urology for small kidney tumors and for the treatment of benign prostatic obstruction.

Objective

To demonstrate on video our technique of Eraser laser enucleation of the prostate (ELEP) and report our experience.

Design, setting, and participants

From June 2010 to October 2011, 43 consecutive patients were prospectively evaluated. All of them had lower urinary tract symptoms suggestive of benign prostatic obstruction and a mean prostate size of 59.9 ml (range: 34–89 ml) on transrectal ultrasound. Their mean prostate-specific antigen value was 3.4 ng/ml (range: 0.8–5.0 ng/ml); mean maximum flow rate (Q_max), 6.9 ml/s (range: 2–11 ml/s); mean International Prostate Symptom Score (IPSS), 25.9 (range: 18–32); and mean postvoid residual (PVR), 170.5 ml (range: 60–330 ml).

Surgical procedure

The details of the technique are shown on video.

Outcome measurements and statistical analysis

Success was defined as patients being able to void with improved IPSS, Q_max, PVR volume, and ameliorated quality of life.

Results and limitations

The mean operating time was 67.0 ± 11.43 min. Mean serum hemoglobin was 15.1 ± 0.87 g/l before, and 14.39 ± 0.94 g/l after surgery. Mean blood loss was 115.90 ± 98.12 ml. No blood transfusions were required. All patients had their catheters removed within 2 d and were able to void spontaneously after this time. Significant improvements were noted in Q_max, quality of life, IPSS, and PVR volume from baseline to each follow-up time point.Based on the validated Clavien-Dindo system, we observed one grade 1d complication, one grade 2 complication, and one grade 3b complication.

Conclusions

ELEP is a safe and reproducible method for relieving bladder outflow obstruction and lower urinary tract symptoms. Its advantages include minimal blood loss, short catheterization time, and a brief hospital stay.     

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.     

Solifenacin Plus Tamsulosin Combination Treatment in Men With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction: A Randomized Controlled Trial

Background

Alpha blockers are prescribed to manage lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Antimuscarinics are prescribed to treat overactive bladder (OAB).

Objective

To investigate the safety of a combination of solifenacin (SOLI) and tamsulosin oral controlled absorption system (TOCAS) in men with LUTS and bladder outlet obstruction (BOO).

Design, setting, and participants

Randomized, double-blind, parallel-group, placebo-controlled study in men aged >45 yr with LUTS and BOO for ≥3 mo, total International Prostate Symptom Score (IPSS) ≥8, BOO index ≥20, maximum urinary flow rate (Q_max) ≤12 ml/s, and voided volume ≥120 ml.

Interventions

Once-daily coadministration of TOCAS 0.4 mg plus SOLI 6 mg, TOCAS 0.4 mg plus SOLI 9 mg, or placebo for 12 wk.

Outcome measurements and statistical analysis

Primary (safety) measurements: Q_max and detrusor pressure at Q_max (P_detQ_max). Other safety assessments included postvoid residual (PVR) volume. Secondary end points included bladder contractile index (BCI) score and percent bladder voiding efficiency (BVE). An analysis of covariance model compared each TOCAS plus SOLI combination with placebo.

Results and limitations

Both active treatment groups were noninferior to placebo at end of treatment (EOT) for P_detQ_max and Q_max. Mean change from baseline PVR was significantly higher at all time points for TOCAS 0.4 mg plus SOLI 6 mg, and at weeks 2, 12, and EOT for TOCAS 0.4 mg plus SOLI 9 mg versus placebo. Both treatment groups were similar to placebo for BCI and BVE. Urinary retention was seen in only one patient receiving TOCAS 0.4 mg plus SOLI 6 mg. Limitations of the study were that prostate size and prostate-specific antigen level were not measured.

Conclusions

TOCAS 0.4 mg plus SOLI 6 mg or 9 mg was noninferior to placebo at EOT for P_detQ_max and Q_max in men with LUTS and BOO, and there was no clinical or statistical evidence of increased risk of urinary retention.     

Endoscopic Vaporesection of the Prostate Using the Continuous-Wave 2-μm Thulium Laser: Outcome and Demonstration of the Surgical Technique

Background

The potential of a new continuous-wave (CW) 70-W, 2.013-μm thulium-doped yttrium aluminium garnet (Tm:YAG) laser for the endoscopic treatment of benign prostatic hyperplasia (BPH) is investigated.

Objective

The simultaneous combination of vaporisation and resection of prostatic tissue in a retrograde fashion is the main characteristic of this new laser technique. We provide a DVD that shows the main steps of this procedure.

Design, setting, and participants

We retrospectively evaluated 56 nonconsecutive patients who were treated by thulium laser vaporesection of the prostate in our institution between 2005 and 2007.

Surgical procedure

Vaporesection of the prostate is performed by moving the fibre semicircumferentially from the verumontanum towards the bladder neck, thereby undermining tissue and cutting chips.

Measurements

Blood loss, postvoiding residual urine (PVRU), maximum flow rate (Q_max), and the International Prostate Symptom Score (IPSS) were measured as well as prostate volume and prostate-specific antigen (PSA). The duration of the procedure, need for postoperative irrigation, duration of catheterisation, and hospital stay were recorded.

Results and limitations

The median procedure time was 60 min, postoperative irrigation was necessary in 19 out of 56 patients, and the median duration of catheterisation was 23 hr. At the day of discharge, the mean haemoglobin value decreased by 0.2 mg/dl (p = 0.13), the average Q_max improved from 8.1 to 19.3 ml/s (p < 0.001), and the PVRU decreased from 152 ml to 57 ml (p < 0.05). The blood transfusion rate was 3.6%, and two patients needed a recatheterisation postoperatively (3.6%). After a median follow-up of 9 mo, the IPSS improved from 19.8 at baseline to 8.6 (p < 0.001). Four patients had a repeat transurethral resection of the prostate (TURP) during the learning curve, but this was not necessary in any of the later patients. One patient developed a urethral stricture, and another developed a bladder neck contracture.

Conclusions

The thulium laser seems to be a suitable tool for the endoscopic treatment of BPH.     

Obesity Is Associated with Increased Prostate Growth and Attenuated Prostate Volume Reduction by Dutasteride

Background

Although obesity has been associated with larger prostate volumes (PV), few studies have actually investigated whether obesity enhances PV growth, especially among men using 5α-reductase inhibitors.

Objective

To examine whether obesity is associated with enhanced PV growth measured by serial transrectal ultrasound (TRUS) measurements.

Design, setting, and participants

We conducted a secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial, which was originally aimed at cancer risk reduction among high-risk men with a single negative prestudy biopsy.

Intervention

Per-protocol randomization to placebo or dutasteride and mandatory TRUS-guided biopsies at 2 yr and 4 yr.

Outcome measurements and statistical analysis

Percentage change in PV at 2 yr and 4 yr from baseline. We tested its association with baseline body mass index (BMI) groups of <25, 25–29.9, and ≥30 kg/m² using multivariable linear regression. Secondarily, we tested whether BMI was associated with the likelihood of having no PV reduction among men randomized to dutasteride using multivariable logistic regression.

Results and limitations

Of 8122 participants, we analyzed 71.8% and 54.5% with complete 2-yr and 4-yr PV data, respectively. In multivariable analysis, men on placebo with BMI ≥30 versus <25 kg/m² had enhanced PV growth from baseline (at 2 yr: 17.0% vs 10.7%, p < 0.001; at 4 yr: 29.4% vs 20.1%; p = 0.001). Men on dutasteride with BMI ≥30 versus <25 kg/m² had attenuated PV reduction from baseline (at 2 yr: −14.3% vs −18.5%; p = 0.002; at 4 yr: −13.2% vs −19.3%; p = 0.001) and higher likelihood of having no PV reduction (at 2 yr: odds ratio [OR]: 1.44; 95% confidence interval [CI], 1.08–1.93; p = 0.014; at 4 yr: OR: 1.62; 95% CI, 1.18–2.22; p = 0.003). We found no significant interactions between BMI and dutasteride on PV change at 2 yr and 4 yr (p interaction ≥0.36). No clinical outcomes or effects of weight change were assessed.

Conclusions

Obesity enhanced PV growth and attenuated PV reduction by dutasteride. The null interaction between obesity and dutasteride for PV change implies that the effect of obesity on dutasteride-treated men is likely a combination of dutasteride-driven PV reduction with obesity-driven PV growth rather than decreased dutasteride efficacy.

ClinicalTrials.gov identifier

NCT00056407.     

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.     

Could Interferon Still Play a Role in Metastatic Renal Cell Carcinoma? A Randomized Study of Two Schedules of Sorafenib Plus Interferon-Alpha 2a (RAPSODY)

Background

Sorafenib has proven efficacy in metastatic renal cell carcinoma (mRCC). Interferon (IFN) has antiangiogenic activity that is thought to be both dose- and administration-schedule dependent.

Objective

To compare two different schedules of IFN combined with sorafenib.

Design, setting, and participants

Single-stage, prospective, noncomparative, randomized, open-label, multicenter, phase 2 study on previously untreated patients with mRCC and Eastern Cooperative Oncology Group performance status 0–2.

Intervention

Sorafenib 400 mg twice daily plus subcutaneous IFN, 9 million units (MU) three times a week (Arm A) or 3 MU five times a week (Arm B).

Outcome measurements and statistical analysis

Primary end points were progression-free survival (PFS) for each arm and safety. Data were evaluated according to an intent-to-treat analysis.

Results and limitations

A total of 101 patients were evaluated. Median PFS was 7.9 mo in Arm A and 8.6 mo in Arm B (p = 0.049) and the median duration of response was 8.5 and 19.2 mo, respectively (p = 0.0013). Nine partial responses were observed in Arm A, and three complete and 14 partial responses were observed in Arm B (17.6% vs 34.0%; p = 0.058); 24 and 21 patients (47% and 42%), respectively, achieved stable disease. The most common grade 3–4 toxicities were fatigue plus asthenia (28% vs 16%; p = 0.32) and hand-foot skin reactions (20% vs 18%).

Conclusions

Sorafenib plus frequent low-dose IFN showed good efficacy and tolerability. Further investigations should be warranted to identify a possible positioning of this intriguing regimen (6% complete response rate) in the treatment scenario of mRCC.     

Appréciation de la place de l’anesthésie locorégionale pour la prise en charge des plaies de la face aux urgences

Objective

Defining the place of regional anaesthesia (RA) for facial wounds in an emergency department.

Study Design

Prospective observational study conducted in the emergency department of a regional hospital.

Patients and methods

Two hundred and forty-six successive patients with one or more facial wounds were included from 1st august 2004 to 31st december 2004. Data on patient, operator, wound (measured by the number of stitches), anaesthetic method (RA, local anaesthesia [LA], or no anaesthesia), method of repairing skin, duration of intervention, operator comfort (verbal numeric scale [VNS] from 0 to 10) and pain feeled by the patient (visual analogic scale [VAS] from 0 to 10) in the different stages of care were collected.

Results

Compared to the LA, the RA of the face decreased the number of punctures (1.36 vs 4.38 punctures, p < 0.001) and the quantity of local anaesthetic injected (2.8 ml vs 5.3 ml, p < 0.01) for wounds requiring more than 10 stitches. It has improved operator comfort (VNS = 10 [8–10] vs 8 [6.75–10] (p < 0.01)). Its effectiveness during skin repair was equivalent to that of the LA by infiltration (VAS 0 [0–1] vs 0 [0–1]).

Conclusion

When practicable, the RA of the face is a better technique than the LA for facial wounds treatment.     

Tolterodine Treatment Improves Storage Symptoms Suggestive of Overactive Bladder in Men Treated With α-Blockers

Background

Some men receiving α-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder (OAB).

Objective

To evaluate the efficacy of tolterodine extended release (ER) in men on α-blocker therapy.

Design, setting, and participants

This double-blind trial included men aged ≥40 yr with frequency, urgency, and at least moderate problems reported on the Patient Perception of Bladder Condition (PPBC), despite being on a stable dose of α-blocker for ≥1 mo.

Interventions

Subjects were randomized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed α-blocker therapy.

Measurements

At baseline and week 12, subjects completed the PPBC, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), and 5-d bladder diaries using the five-point Urinary Sensation Scale (USS). Frequency–urgency sum was defined as the sum of USS ratings for all micturitions.

Results and limitations

PPBC improvement from baseline to week 12 was reported by 63.6% and 61.6% of subjects receiving tolterodine ER plus α-blocker and placebo plus α-blocker, respectively; this treatment difference, which was the primary end point, was not statistically significant (p > 0.6699). At week 12, subjects receiving tolterodine ER plus α-blocker had significantly greater improvements versus placebo plus α-blocker in 24-h micturitions (−1.8 vs −1.2; p = 0.0079) and daytime micturitions (−1.3 vs −0.8; p = 0.0123); 24-h urgency episodes (−2.9 vs −1.8; p = 0.0010), daytime urgency episodes (−2.2 vs −1.4; p = 0.0017), and nocturnal urgency episodes (−0.5 vs −0.3; p = 0.0378); frequency–urgency sum (−7.8 vs −5.1; p = 0.0065); IPSS storage subscale (−2.6 vs −2.1; p = 0.0370); and OAB-q symptom bother scale (−17.9 vs −14.4; p = 0.0086) and coping domain (15.4 vs 12.4; p = 0.0491). Acute urinary retention requiring catheterization occurred in <1% of either group. There were no clinically meaningful changes in postvoid residual volume or maximum urinary flow rate.

Conclusions

Men with bothersome OAB symptoms despite continued α-blocker therapy showed significantly greater improvements in diary variables, IPSS Storage scores, and symptom bother when receiving additional tolterodine ER versus placebo plus α-blocker.     

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.     

Robotic Partial Nephrectomy with Superselective Versus Main Artery Clamping: A Retrospective Comparison

Background

Concerns have been raised regarding partial nephrectomy (PN) techniques that do not occlude the main renal artery.

Objective

Compare the perioperative outcomes of superselective versus main renal artery control during robotic PN.

Design, setting, and participants

A retrospective analysis of 121 consecutive patients undergoing robotic PN using superselective control (group 1, n = 58) or main artery clamping (group 2, n = 63).

Intervention

Group 1 underwent tumor-specific devascularization, maintaining ongoing arterial perfusion to the renal remnant at all times. Group 2 underwent main renal artery clamping, creating global renal ischemia.

Outcome measurements and statistical analysis

Perioperative and functional data were evaluated. The Pearson chi-square or Fisher exact and Wilcoxon rank sum tests were used.

Results and limitations

All robotic procedures were successful, all surgical margins were negative, and no kidneys were lost. Compared with group 2 tumors, group 1 tumors were larger (3.4 vs 2.6 cm, p = 0.004), more commonly hilar (24% vs 6%, p = 0.009), and more complex (PADUA 10 vs 8, p = 0.009). Group 1 patients had longer median operative time (p < 0.001) and transfusion rates (24% vs 6%, p < 0.01) but similar estimated blood loss (200 vs 150 ml), perioperative complications (15% vs 13%), and hospital stay. Group 1 patients had less decrease in estimated glomerular filtration rate at discharge (0% vs 11%, p = 0.01) and at last follow-up (11% vs 17%, p = 0.03). On computed tomography volumetrics, group 1 patients trended toward greater parenchymal preservation (95% vs 90%, p = 0.07) despite larger tumor size and volume (19 vs 8 ml, p = 0.002). Main limitations are the retrospective study design, small cohort, and short follow-up.

Conclusions

Robotic PN with superselective vascular control enables tumor excision without any global renal ischemia. Blood loss, complications, and positive margin rates were low and similar to main artery clamping. In this initial developmental phase, limitations included more perioperative transfusions and longer operative time. The advantage of superselective clamping for better renal function preservation requires validation by prospective randomized studies.

Patient summary

Preserving global blood flow to the kidney during robotic partial nephrectomy (PN) does not lead to a higher complication rate and may lead to better postoperative renal function compared with clamped PN techniques.     

Circulational heat dissipation of upper airway: Canine model of inhalational thermal injury

Background

The upper airway has powerful heat-absorbing ability, in which the blood circulation may play an important role.

Objective

This study aimed to explore the circulational heat-dissipating ability, and to investigate the contribution of blood circulation to the heat-absorbing ability of upper airway.

Methods

18 adult, male Beagle dogs were divided into three groups to inhale thermal dry air of 70–80 °C, 150–160 °C or 310–320 °C for 20 min. Blood temperatures and blood flow rates of bilateral common jugular veins (CJVs) were measured. Dogs’ breathing rates and air temperatures in middle trachea were also measured. According to the formula “Q = c·m·ΔT”, the heat dissipated by blood (Q_-blood) and the heat release by air (Q_-air) were calculated out. The contribution of circulational heat dissipation to the heat-absorbing ability of upper airway was defined as “C_-blood”.

Results

The blood temperature rise of CJV was 2.24 ± 0.60 °C. The blood flow rate of CJV was 44.5 ± 5.9 ml/min. The air temperature in middle trachea was 63.5 ± 18.9 °C. The mean breathing rate was 51.8 ± 7.5/min. The calculated “Q_-blood” and “Q_-air” were 13197.3 ± 4408.6 J and 33540.2 ± 24578.7 J, and the “C_-blood” was 55.2 ± 25.0% (21.7–88.8%).

Conclusion

Circulational heat dissipation plays an important role in the heat-absorbing process of upper airway when inhaled air is less than 160 °C. However, for air higher than 160 °C, some other mechanism might be dominant in the upper airway's heat-absorbing ability.     

Cologne burn centre experience with assault burn injuries

Objective

To evaluate demographic and socioeconomic factors associated with assault burn injuries.

Background

Assault by burning demonstrates a rare but severe public health issue and accounts for unique injury characteristics in the burn intensive care unit (BICU).

Methods

We conducted a retrospective cohort study involving patients with thermal injuries admitted to the BICU of a university hospital. The patient cohort was divided into two groups (ABI group: patients with assault burns, n = 41; Control group: population of all other burned patients admitted to the BICU, n = 1202). Bivariate and multivariate analyses including demographic and socioeconomic data were used to identify factors associated with assault burns.

Results

Forty-one assault-related burn victims were identified in the study period. This represents 3.3% of all significant burns admitted. Comparing battery victims with the control population, assault patients were more likely to be young (mean age 36.2 years vs. 42.2 years) and immigrants (41.5% vs. 15.1%). Furthermore, marital status (65.9% vs. 40.8% singles), employment status (36.6% vs. 9.7% unemployed) and insurance status (41.5% vs. 12.3% social insurance) were significantly different in the bivariate analysis. Logistic regression evaluation identified three variables that were independently associated with assault burns: younger age (≤25 years) (odds ratio, 2.54 [95% confidence interval, 1.29–5.02]; p = 0.007), ethnic minority (odds ratio, 3.71 [95% confidence interval, 1.91–7.20]; p < 0.001) and unemployment (odds ratio, 4.02 [95% confidence interval, 2.03–7.97]; p < 0.001).

Conclusions

The high incidence of youngsters, unemployment and the great proportion of immigrants in victims of assault might provide several opportunities for community-based psychosocial and occupational programs. A multidisciplinary approach targeting issues specific to the violent nature of the injury and the socioeconomic background of the victims may be of benefit to improve their perspectives for rehabilitation.