Use of nebulized antimicrobial agents in burned and mechanically ventilated patients with persistent Acinetobacter baumannii, Pseudomonas aeruginosa, or Enterobacteriacea

Background

Nebulized antibiotics are used to locally treat colonizations of multi-resistant organisms. Prior systemic nephrotoxic antibiotic use with serum creatinine rises warranted an alternative therapy in 69 ventilator-dependent patients with persisting sputum cultures and need for ventilatory support.

Materials and methods

Following IRB approval, retrospective patient data were reviewed. Analysis included comparison of these 69 patients (71 treatments) to 142 Gram-negative infected burn patients matched for age and burn size.

Results

Mean pooled age and burn wound percent for the 71 triplicates (n = 211 patients) were 55.6 ± 18.3 years and 27.4 ± 22.3% burns. Fifty-seven of 69 (83%) patients had inhalation injuries and 54 of 69 (78%) patients survived. Nebulizations averaged 6.8 ± 3.3 days (range 3–12 days). Serum creatinine rose in 2 patients receiving colistimethate nebulizations, known to cause nephrotoxicity following nebulization. Triplicate comparisons via ANOVA noted prolonged ventilatory support (F = 13.39; p ? 0.05) and length of stay (F = 6.11; p ? 0.5). Variance was attributed to the sicker nebulized patients. Twenty-four inhalation injury-only triplicates further confirmed that nebulized patient subgroup was more ill.

Conclusion

Short duration antibiotic nebulization may allow higher intra-tracheal antibiotic concentrations and may facilitate weaning from the ventilator by reducing bacterial bioburden.     

Comparisons of the Perioperative,Functional, and Oncologic Outcomes After Robot-Assisted Versus Pure Extraperitoneal Laparoscopic Radical Prostatectomy

Background

In spite of the increasing use of robot-assisted radical prostatectomy (RALP) worldwide, no level 1 evidence-based benefit favouring RALP versus pure laparoscopic approaches has been demonstrated in extraperitoneal laparoscopic procedures.

Objective

To compare the operative, functional, and oncologic outcomes between pure laparoscopic radical prostatectomy (LRP) and RALP.

Design, setting, and participants

From 2001 to 2011, 2386 extraperitoneal LRPs were performed consecutively in cases of localised prostate cancers.

Intervention

A total of 1377 LRPs and 1009 RALPs were performed using an extraperitoneal approach.

Outcome measurements and statistical analysis

Patient demographics, surgical parameters, pathologic features, and functional outcomes were collected into a prospective database and compared between LRP and RALP. Biochemical recurrence–free survival was tested using the Kaplan-Meier method. Mean follow-up was 39 and 15.4 mo in the LRP and RALP groups, respectively.

Results and limitations

Shorter durations of operative time and of hospital stay were reported in the RALP group compared with the LRP group (p < 0.001) even beyond the 100 first cases. Mean blood loss was significantly lower in the RALP group (p < 0.001). The overall rate and the severity of the complications did not differ between the two groups. In pT2 disease, lower rates of positive margins were reported in the RALP group (p = 0.030; odds ratio [OR]: 0.396) in multivariable analyses. The surgical approach did not affect the continence recovery. Robot assistance was independently predictive for potency recovery (p = 0.045; OR: 5.9). Survival analyses showed an equal oncologic control between the two groups. Limitations were the lack of randomisation and the short-term follow-up.

Conclusions

Robotic assistance using an extraperitoneal approach offers better results than pure laparoscopy in terms of operative time, blood loss, and hospital stay. The robotic approach independently improves the potency recovery but not the continence recovery. When strict indications of nerve-sparing techniques are respected, RALP gives better results than LRP in terms of surgical margins in pathologically organ-confined disease. Longer follow-up is justified to reach conclusions on oncologic outcomes.     

Clinical outcomes following bowel resection versus reduction of intussusception

Background

Intussusception is most commonly managed with air-contrast reduction. However, when this fails, emergent operation with resection or manual reduction is indicated. It is not known if there are advantages to resection compared with manual reduction.

Methods

A retrospective review of all patients receiving operative care for intussusception from February 2000 to December 2011. Patients undergoing intestinal resection were compared with those treated with manual reduction alone.

Results

Of 111 patients, 49 underwent resection and 62 underwent manual reduction. Mean (±SD) time to oral intake favored manual reduction (2.1 ± 1.2 versus 2.6 ± 1.2 d, respectively, P = 0.05). Manual reduction was associated with a greater need for repeat imaging (47% versus 18%, P = 0.002) and the only recurrences were with manual reduction (8% versus 0%, P = 0.1). Mean duration of stay was no different (P = 0.36), nor was the need for reoperation (P = 0.9).

Conclusions

Patients undergoing manual reduction have an increased number of radiographic imaging procedures. The surgeon should have a low threshold for resection for intussusceptions requiring operative management.     

Contemporary Management of Postchemotherapy Testis Cancer

Context

Some controversy still exists regarding the management of testis cancer following chemotherapy for disseminated disease.

Objective

To review the available literature concerning the management of postchemotherapy testis cancer.

Evidence acquisition

A Medline search was conducted to identify original and review articles, as well as guidelines addressing the management of testis cancer following first-line chemotherapy. Keywords included germ cell tumor, testis cancer, retroperitoneal lymph node dissection, and chemotherapy. The most relevant articles were critically reviewed with the consensus of all the collaborative authors, who have expertise in the management of germ cell tumors (GCTs).

Evidence synthesis

Approximately one-third of patients who undergo chemotherapy for metastatic GCTs have residual retroperitoneal disease. All patients with residual masses ≥1 cm after chemotherapy for nonseminomatous GCTs should undergo postchemotherapy retroperitoneal lymph node dissection (PC-RPLND) because of the risk of mature teratoma in 40–45% of cases and of viable GCT in 10–15% of cases. Patients who obtain a complete serologic remission and radiographic residual <1 cm after chemotherapy have a 6–9% risk of relapse. Patients with a completely resected teratoma in only the PC-RPLND specimen have a >90% chance of cure, while patients with viable GCTs should be considered for additional therapy, depending on the percentage of viable tumor. In patients with disseminated seminoma, postchemotherapy masses <3 cm may be safely observed, while patients with masses >3 cm should be evaluated with positron emission tomography (PET)/computed tomography 2 mo after completion of chemotherapy, with very selective administration of PC-RPLND. Late relapse occurring >2 yr after chemotherapy is rare, and surgery remains the mainstay of therapy in cases of resectable masses independent of tumor markers. There is still controversy on whether high-dose chemotherapy confers a survival benefit compared with conventional-dose chemotherapy in the salvage setting. Surgery should always be considered for resectable masses following salvage therapies or in chemoresistant disease to maximize chance of cure.

Conclusions

Patients with advanced GCTs can achieve long-term disease-free survival when chemotherapy is combined with expert and judicious resection of residual disease. PC-RPLND is recommended for residual masses >1 cm identified on postchemotherapy imaging in nonseminomatous GCT and possibly for PET-positive residual disease ≥3 cm in treated seminomas.     

Randomised Controlled Trial Comparing Laparoscopic and Robot-assisted Radical Prostatectomy

Background

The advantages of robot-assisted radical prostatectomy (RARP) over laparoscopic radical prostatectomy (LRP) have rarely been investigated in randomised controlled trials.

Objective

To compare RARP and LRP in terms of the functional, perioperative, and oncologic outcomes. The main end point of the study was changes in continence 3 mo after surgery.

Design, setting, and participants

From January 2010 to January 2011, 120 patients with organ-confined prostate cancer were enrolled and randomly assigned (using a randomisation plan) to one of two groups based on surgical approach: the RARP group and the LRP group.

Intervention

All RARP and LRP interventions were performed with the same technique by the same single surgeon.

Outcome measurements and statistical analysis

The demographic, perioperative, and pathologic results, such as the complications and prostate-specific antigen (PSA) measurements, were recorded and compared. Continence was evaluated at the time of catheter removal and 48 h later, and continence and potency were evaluated after 1, 3, 6, and 12 mo. The student t test, Mann-Whitney test, χ² test, Pearson χ² test, and multiple regression analysis were used for statistics.

Results and limitations

The two groups (RARP: n = 60; LRP: n = 60) were comparable in terms of demographic data. No differences were recorded in terms of perioperative and pathologic results, complication rate, or PSA measurements. The continence rate was higher in the RARP group at every time point: Continence after 3 mo was 80% in the RARP group and 61.6% in the LRP group (p = 0.044), and after 1 yr, the continence rate was 95.0% and 83.3%, respectively (p = 0.042). Among preoperative potent patients treated with nerve-sparing techniques, the rate of erection recovery was 80.0% and 54.2%, respectively (p = 0.020). The limitations included the small number of patients.

Conclusions

RARP provided better functional results in terms of the recovery of continence and potency. Further studies are needed to confirm our results.     

Retroperitoneal Lymph Node Dissection with No Adjuvant Chemotherapy in Clinical Stage I Nonseminomatous Germ Cell Tumours: Long-Term Outcome and Analysis of Risk Factors of Recurrence

Background

The best management for patients with clinical stage I (CS1) nonseminomatous germ cell tumours (NSGCT) is still under debate.

Objective

We evaluated the long-term oncologic outcome of retroperitoneal lymph node dissection (RPLND) in patients with CS1 NSGCTs and reevaluated the traditional predictors of recurrence in a set of patients not undergoing adjuvant treatment.

Design, setting, and participants

Between 1985 and 1995, 322 consecutive CS1 NSGCT patients underwent primary RPLND not followed by adjuvant chemotherapy in a single referral centre. Patients were followed until relapse for a median time of 17 yr.

Measurements

We estimated the crude cumulative incidence of any recurrence. Categories pN and pT, vascular invasion (VI), percentage of embryonal carcinoma, and presence of teratoma were evaluated as 2-yr recurrence predictors of event in a binary logistic model.

Results and limitations

Fifty patients had a recurrence (46 in ≤2 yr and only 4 [1.2%] in >2 yr). The 10-yr recurrence incidence was 15.2%. Significant predictors of recurrence at multivariable analysis were pN+, pT >1, and the presence of VI. However, the discriminative ability of the model was modest (Harrell C = 0.74); only 9% and 3% of patients had a predicted recurrence probability >30% and >50%, respectively.

Conclusions

RPLND alone could prevent recurrence in 85% of patients and minimise late relapses to 1.2%. Most patients could avoid the immediate and late toxicity of chemotherapy. Prognostic parameters combined into the multivariable model appeared of limited use in identifying a subset of patients at high risk of recurrence.     

A Randomized,Double-Blind,Dose-Finding,Multicenter, Phase 2 Study of Radium Chloride (Ra 223) in Patients with Bone Metastases and Castration-Resistant Prostate Cancer

Background

Patients with castration-resistant prostate cancer (CRPC) and bone metastases have an unmet clinical need for effective treatments that improve quality of life and survival with a favorable safety profile.

Objective

To prospectively evaluate the efficacy and safety of three different doses of radium chloride (Ra 223) in patients with CRPC and bone metastases.

Design, setting, and participants

In this phase 2 double-blind multicenter study, 122 patients were randomized to receive three injections of Ra 223 at 6-wk intervals, at doses of 25 kBq/kg (n = 41), 50 kBq/kg (n = 39), or 80 kBq/kg (n = 42). The study compared the proportion of patients in each dose group who had a confirmed decrease of ≥50% in baseline prostate-specific antigen (PSA) levels.

Outcome measurements and statistical analysis

Efficacy was evaluated using blood samples to measure PSA and other tumor markers, recorded skeletal-related events, and pain assessments. Safety was evaluated using adverse events (AEs), physical examination, and clinical laboratory tests. The Jonckheere-Terpstra test assessed trends between groups.

Results and limitations

The study met its primary end point with a statistically significant dose–response relationship in confirmed ≥50% PSA declines for no patients (0%) in the 25-kBq/kg dose group, two patients (6%) in the 50-kBq/kg dose group, and five patients (13%) in the 80-kBq/kg dose group (p = 0.0297). A ≥50% decrease in bone alkaline phosphatase levels was identified in six patients (16%), 24 patients (67%), and 25 patients (66%) in the 25-, 50-, and 80-kBq/kg dose groups, respectively (p < 0.0001). The most common treatment-related AEs (≥10%) occurring up to week 24 across all dose groups were diarrhea (21%), nausea (16%), and anemia (14%). No difference in incidence of hematologic events was seen among dose groups. Potential limitations include small patient numbers and differences among dose groups at baseline.

Conclusions

Ra 223 had a dose-dependent effect on serum markers of CRPC activity, suggesting that control of bone disease with Ra 223 may affect cancer-related outcomes. Ra 223 was well tolerated at all doses.

Trial registration

ClinicalTrials.gov: NCT00337155.     

Effects of Tadalafil Treatment on Erectile Function Recovery Following Bilateral Nerve-sparing Radical Prostatectomy: A Randomised Placebo-controlled Study (REACTT)

Background

The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors (PDE5-Is) on penile function after nerve-sparing radical prostatectomy (NSRP) remains unclear.

Objective

The primary objective was to compare the efficacy of tadalafil 5 mg once daily and tadalafil 20 mg on demand versus placebo taken over 9 mo in improving unassisted erectile function (EF) following NSRP, as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain (IIEF-EF) score ≥22 after 6-wk drug-free washout (DFW). Secondary measures included IIEF-EF, Sexual Encounter Profile question 3 (SEP-3), and penile length.

Design, setting, and participants

Randomised, double-blind, double-dummy, placebo-controlled trial in men ≤68 yr of age with adenocarcinoma of the prostate (Gleason ≤7) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada.

Interventions

1:1:1 randomisation to 9 mo of treatment with tadalafil 5 mg once daily, tadalafil 20 mg on demand, or placebo followed by a 6-wk DFW and 3-mo open-label tadalafil once daily (all patients).

Outcome measurements and statistical analysis

Logistic regression, mixed-effects model for repeated measures, and analysis of covariance, adjusting for treatment, age, and country, were applied to IIEF-EF scores ≥22, SEP-3, and penile length.

Results and limitations

Four hundred twenty-three patients were randomised to tadalafil once daily (n = 139), on demand (n = 143), and placebo (n = 141). The mean age was 57.9 yr of age (standard deviation: 5.58 yr); 20.9%, 16.9%, and 19.1% of patients in the tadalafil once daily, on demand, and placebo groups, respectively, achieved IIEF EF scores ≥22 after DFW; odds ratios for tadalafil once daily and on demand versus placebo were 1.1 (95% confidence interval [CI], 0.6–2.1; p = 0.675) and 0.9 (95% CI, 0.5–1.7; p = 0.704). At the end of double-blind treatment (EDT), least squares (LS) mean IIEF-EF score improvement significantly exceeded the minimally clinically important difference (MCID: ΔIIEF-EF ≥4) in both tadalafil groups; for SEP-3 (MCID ≥ 23%), this was the case for tadalafil once daily only. Treatment effects versus placebo were significant for tadalafil once daily only (IIEF-EF: p = 0.016; SEP-3: p = 0.019). In all groups, IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment. At month 9 (EDT), penile length loss was significantly reduced versus placebo in the tadalafil once daily group only (LS mean difference 4.1 mm; 95% CI, 0.4–7.8; p = 0.032).

Conclusions

Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP, and data suggest a potential role for tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes. Unassisted EF was not improved after cessation of active therapy for 9 mo.

Trial registration

ClinicalTrials.gov identifier NCT01026818.     

Beyond the Learning Curve of the Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy: Oncologic and Functional Results of the First 200 Patients with ≥1 Year of Follow-up

Background

Robot-assisted laparoscopic radical prostatectomy (RARP) has become the main surgical option for localized prostate cancer. We recently developed a new approach for RARP, passing through the pouch of Douglas and avoiding all the Retzius structures involved in continence and potency preservation.

Objective

To report the functional and oncologic results of our first 200 patients operated on using this new approach.

Design, setting, and participants

This was a prospective, noncontrolled case series including the first 200 consecutive patients undergoing this kind of surgery (January the 1st, 2010 to December the 31st, 2011).

Surgical procedure

Retzius-sparing RARP.

Outcome measurements and statistical analysis

All perioperative, oncologic, and functional data were prospectively recorded. Potency was defined as an International Index of Erectile Function-5 questionnaire score >17; continence was defined as use of no pad or of one safety liner. Oncologic results were reported as positive surgical margins (PSM) and 1-yr biochemical disease-free survival (1y-bDFS). Recurrence was defined as a repeated prostate-specific antigen >0.2 ng/ml. Complications were graded according to the Clavien-Dindo system. The first 100 patients (group 1) were compared with the second 100 (group 2) to evaluate the learning curve effects.

Results and limitations

The median patient age was 65 yr. Comparing the two groups, transfusions were needed in 8% versus 4% of cases in groups 1 and 2, respectively (p = 0.02). There was one Clavien-Dindo grade 3b in group 1 versus one grade 3a complication in group 2. In patients with pT2 disease, PSMs were recorded in 22.4% of those in group 1 versus 10.1% in group 2 (p = 0.045). 1y-bDFS was 89% in group 1 versus 92% in group 2. For groups 1 and 2, respectively, immediate continence was reached in 92% versus 90% of patients, and the 1-yr continence rate was 96% versus 96%. Considering the 77 potent patients aged <65 yr who underwent bilateral intrafascial nerve-sparing surgery, 40.4% of those in group 1 versus 40% of those in group 2 reached their first intercourse within 1 mo; at 1 yr of follow-up, these figures had increased to 81% versus 71%, respectively (p = 0.162). The main limitation of this study is its noncontrolled nature.

Conclusions

We demonstrated Retzius-sparing RARP to be oncologically safe and to result in high early continence and potency rates. Long-term, prospective, comparative, and possibly randomized studies are needed.     

Gonadotropin-releasing Hormone Agonists and Acute Kidney Injury in Patients with Prostate Cancer

Background

Androgen deprivation therapy (ADT) might increase the risk of acute kidney injury (AKI) in patients with prostate cancer (PCa).

Objective

To examine the impact of ADT on AKI in a large contemporary cohort of patients with nonmetastatic PCa representing the US population.

Design, setting, and participants

Overall, 69 292 patients diagnosed with nonmetastatic PCa between 1995 and 2009 were abstracted from the Surveillance Epidemiology and End Results–Medicare database.

Outcomes measurements and statistical analyses

Patient in both treatment arms (ADT vs no ADT) were matched using propensity-score methodology. Ten-year AKI rates were estimated. Competing-risks regression analyses tested the association between ADT and AKI, after adjusting for the risk of death during follow-up.

Results and limitations

Overall, the 10-yr AKI rates were 24.9% versus 30.7% for ADT-naive patients versus those treated with ADT, respectively (p < 0.001). When patients were stratified according to the type of ADT, the 10-yr AKI rates were 31.1% versus 26.0% for men treated with gonadotropin-releasing hormone (GnRH) agonists and bilateral orchiectomy, respectively (p < 0.001). In multivariable analyses, the administration of GnRH agonists (hazard ratio [HR]: 1.24; 95% confidence interval [CI], 1.18–1.31; p < 0.001), but not bilateral orchiectomy (HR: 1.11; 95% CI, 0.96–1.29; p = 0.1), was associated with the risk of experiencing AKI. Our study is limited by its retrospective design.

Conclusions

ADT is associated with an increased risk of AKI in patients with nonmetastatic PCa. In particular, the administration of GnRH agonists, but not surgical castration, may substantially increase the risk of experiencing AKI. These observations should help provide physicians with better patient selection to reduce the risk of AKI.

Patient summary

The administration of gonadotropin-releasing hormone agonists, but not bilateral orchiectomy, increases the risk of acute kidney injury (AKI) in patients with prostate cancer (PCa). These observations should help provide physicians with better patient selection to reduce the risk of AKI in PCa patients.     

Robot-Assisted Partial Nephrectomy: An International Experience

Background

Robot-assisted partial nephrectomy (RAPN) is emerging as a viable approach for nephron-sparing surgery (NSS), though many reports to date have been limited by evaluation of a relatively small number of patients.

Objective

We present the largest multicenter RAPN experience to date, culling data from four high-volume centers, with focus upon functional and oncologic outcomes.

Design, setting, and participants

A retrospective chart review was performed for 183 patients who underwent RAPN at four centers between 2006 and 2008.

Surgical procedure

RAPN was performed using methods outlined in the supplemental video material. Though operative technique was similar across all institutions, there were minor variations in trocar placement and hilar control.

Measurements

Perioperative parameters, including operative time, warm ischemic time, blood loss, and perioperative complications were recorded. In addition, we reviewed functional and oncologic outcomes.

Results and limitations

Mean age at treatment was 59.3 yr. Mean tumor size was 2.87 cm. Mean total operative time was 210 min while mean ischemic time was 23.9 min. Calyceal repair was required in 52.1% of procedures. Mean estimated blood loss was 131.5 ml. Sixty-nine percent of excised tumors were malignant, of which 2.7% exhibited positive surgical margins. The incidence of major complications was 8.2%. At up to 26 mo follow-up, there have been no documented recurrences and no significant change in serum creatinine (1.03 vs 1.04 mg/dl, p = 0.84) or estimated glomerular filtration rate (eGFR) from baseline (82.2 vs 79.4 mg/ml per square meter, p = 0.74). The study is limited by its retrospective nature, and the outcomes are likely influenced by the robust prior laparoscopic renal experience of each of the surgeons included in this study.

Conclusions

RAPN is a safe and efficacious approach for NSS, offering short ischemic times, as well as perioperative morbidity equivalent to other standard approaches. Moreover, RAPN is capable of providing patients with excellent functional and oncologic outcomes.     

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.     

Current Technique of Open Intrafascial Nerve-Sparing Retropubic Prostatectomy

Background

Open nerve-sparing retropubic prostatectomy (nsRP) is still the most common surgical approach for the treatment of localised prostate cancer. Even though the principles of the technique and its oncological efficacy have often been published, ongoing refinements allow further improvements in functional outcome and morbidity.

Objective

To describe our current technique of open nsRP with data addressing urinary continence, potency, cancer control rates, and perioperative morbidity.

Design, setting, and participants

Our analyses relied on 1150 patients who were treated with nsRP in the Martini-Clinic by two high-volume surgeons from April 2005 to December 2007.

Surgical procedure

Key elements are a selective ligation of the dorsal vein complex and early release of the neurovascular bundles using a high anterior tension- and energy-free intrafascial technique. During dissection of the urethra, its posterior insertion at Denonvilliers’ fascia (DF) is preserved. DF is left in situ, and it is selectively opened above the seminal vesicles (SV). The SV are completely removed inside DF, and five muscle-sparing interrupted sutures are used for anastomosis.

Measurements

Functional and oncological outcome data were prospectively assessed using validated questionnaires. Moreover, intra- and perioperative morbidity were evaluated.

Results and limitations

Age and extent of nerve-sparing approach influenced urinary continence and potency. Complete urinary continence 1 yr after nsRP was found in 97.4% (men <60 yr) to 84.1% (men >70 yr) of patients. In preoperative potent men, erections sufficient for intercourse were reported between 84–92% and 58.3–70% of patients following bilateral and unilateral nerve sparing, respectively. Median blood loss was 580 ml (range: 130–1800 ml), and the transfusion rate was 4.3%. Median operative time was 165 min (range: 85–210 min). In organ-confined cancers, recurrence-free survival and cancer-specific-survival 10 yr after retropubic prostatectomy were 87% and 98.3%, respectively.

Conclusions

Open intrafascial nsRP combines excellent long-term cancer control rates with superior functional outcome and a low morbidity.     

The Effect of Tumor Location on Prognosis in Patients Treated with Radical Nephroureterectomy at Memorial Sloan-Kettering Cancer Center

Background

The prognostic impact of primary tumor location on outcomes for patients with upper-tract urothelial carcinoma (UTUC) is still contentious.

Objective

To test the association between tumor location and disease recurrence and cancer-specific survival (CSS) in patients treated with radical nephroureterectomy (RNU) for UTUC.

Design, setting, and participants

Prospectively collected data were retrospectively reviewed from 324 consecutive patients treated with RNU between 1995 and 2008 at a single tertiary referral center. Patients who had previous radical cystectomy, preoperative chemotherapy, previous contralateral UTUC, or metastatic disease at presentation were excluded. This left 253 patients for analysis. Tumor location was categorized as renal pelvis or ureter based on the location of the dominant tumor. Recurrences in the bladder only, in nonbladder sites, and in any site were analyzed.

Intervention

All patients were treated with RNU.

Measurements

Recurrence-free survival and CSS probabilities were estimated using Kaplan-Meier and Cox regression analyses.

Results and limitations

Median follow-up for survivors was 48 mo. The 5-yr recurrence-free probability (including bladder recurrence) and CSS estimates were 32% and 78%, respectively. On multivariable analysis, pathologic stage was the only predictor for disease recurrence (p = 0.01). Tumor location was not an independent predictor for recurrence (hazard ratio: 1.19; p = 0.3), and there was no difference in the probability of disease recurrence between ureteral and renal pelvic tumors (p = 0.18). On survival analysis, we also found no differences between ureteral and renal pelvic tumors on probability of CSS (p = 0.2). On multivariate analysis, pathologic stage (p < 0.0001) and nodal status (p = 0.01) were associated with worse CSS. This study is limited by its retrospective nature.

Conclusions

Our study did not show any differences in recurrence and CSS rates between patients with ureteral and renal pelvic tumors treated with RNU.     

The Clinical Effectiveness of Retropubic (IVS-02) and Transobturator (IVS-04) Midurethral Slings: Randomized Trial

Background

Few series comparing the clinical efficacy of retropubic slings versus transobturator slings for the treatment of female stress urinary incontinence (SUI) are available.

Objective

To compare clinical efficacy of retropubic tape operations and transobturator suburethral tape operations for the surgical treatment of female SUI.

Design, setting, and participants

From January 2003 to December 2005, 611 patients underwent clinical and urodynamic evaluation before surgical treatment for SUI. Patients with advanced urogenital prolapse (pelvic organ prolapse-quantification scale [POP-Q] scale grade >1) were excluded, and 537 patients were included in this study. After 18 mo, 398 women were available for follow-up efficacy evaluation at a tertiary academic center.

Intervention

All patients underwent either a retropubic sling procedure or a transobturator sling procedure. Patients were randomly allocated into two study groups at a ratio of 1:1.

Measurements

After 18 mo all enrolled patients were clinically checked for clinical efficacy of both procedures.

Results and limitations

Demographic and urodynamic parameters of patients were similar in both groups. No bladder injury occurred in the transobturator sling group (IVS-04), whereas 13 intraoperational bladder perforations (6.5%) occurred in the retropubic sling group (IVS-02) (p < 0.001). The tape erosion rate was <2.5% in both groups (p = 0.7). After 18 mo, 398 patients (201 in the IVS-02 group and 197 in the IVS-04 group) were evaluated in terms of clinical efficacy of the procedures. We found out that there was no statistically significant difference in clinical efficacy between these two procedures (χ² = 1.88, p = 0.39). In the IVS-02 group, 75.1% of patients (n = 151) remained dry (cured), 16.9% of patients (n = 34) reported significant improvement, and 8.0% of patients (n = 16) were considered as failures. In the IVS-04 group, 74.1% of patients (n = 146) remained dry, 14.2% of patients (n = 28) reported significant improvement, and 11.7% (n = 23) were considered as failures.

Conclusions

Based on an 18-mo follow-up, the efficacies of both techniques are comparable; however, the retropubic route appears to be more efficient in the intrinsic sphincter deficiency (ISD) group.     

OnabotulinumtoxinA 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients with Overactive Bladder and Urinary Incontinence: A Randomised,Double-Blind,Placebo-Controlled Trial

Background

Overactive bladder (OAB) syndrome with urinary incontinence (UI) is prevalent in the population and impairs health-related quality of life (HRQOL).

Objective

To assess the impact on efficacy, safety, and HRQOL of onabotulinumtoxinA (BOTOX^®, Allergan, Inc.) treatment in patients with OAB with UI.

Design, setting, and participants

This pivotal, multicentre, double-blind, randomised, placebo-controlled, phase 3 study enrolled patients with idiopathic OAB with ≥3 urgency UI episodes over 3 d and ≥8 micturitions per day who were inadequately managed by anticholinergics.

Intervention

OnabotulinumtoxinA at a 100 U dose (n = 277) or placebo (n = 271), administered as 20 intradetrusor injections of 0.5 ml.

Outcome measurements and statistical analysis

Co–primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale (TBS) at week 12. Additional end points included other OAB symptoms (episodes of urinary urgency incontinence, micturition, urgency, and nocturia) and HRQOL (Incontinence Quality of Life [I-QOL], King's Health Questionnaire [KHQ]). Safety assessments included adverse events (AEs), postvoid residual (PVR) urine volume, and initiation of clean intermittent catheterisation (CIC).

Results and limitations

OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 (−2.95 for onabotulinumtoxinA versus −1.03 for placebo; p < 0.001). Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo (p ≤ 0.01). Patients perceived a significant improvement in their condition, as measured by patients with a positive treatment response on the TBS (62.8% for onabotulinumtoxinA versus 26.8% for placebo; p < 0.001). Clinically meaningful improvements from baseline in all I-QOL and KHQ multi-item domains (p < 0.001 versus placebo) indicated positive impact on HRQOL. AEs were mainly localised to the urinary tract. Mean PVR was higher in the onabotulinumtoxinA group (46.9 ml versus 10.1 ml at week 2; p < 0.001); 6.9% of onabotulinumtoxinA patients versus 0.7% of placebo patients initiated CIC.

Conclusions

OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinically relevant improvements in all OAB symptoms, patient-reported benefit, and HRQOL in patients inadequately managed by anticholinergics.

Trial registration

ClinicalTrials.gov: NCT00910520.     

The development and preliminary validation of the Taiwanese Manual Ability Measure for Burns

Objective

To develop and validate the Taiwanese Manual Ability Measure for Burns (T-MAM for Burns), a task-oriented functional evaluation tool to assess self-reported manual ability in burn patients.

Design

A longitudinal study.

Participants

A sample of 45 burn patients from burn rehabilitation centers with varying degrees of hand involvement.

Methods

The preliminary testing version was formed by adding burn specific items to the Taiwanese version of the Manual Ability Measure. A field test was then conducted for item reduction and psychometric properties testing.

Results

Out of 55 initial items, 20 were selected into the final version of the T-MAM for Burns. Psychometric analyses indicated that it was reliable (test–retest ICC = .99), with adequate concurrent validity with various other hand function tests (r = −.79 with the short form Disabilities of the Arm, Shoulder, and Hand, or, the QuickDASH) and discriminative validity (significant difference (t = 2.99, P = .005) between groups with unilateral vs. bilateral hand burns), and responsive (ES = .24 and .44 at one- and 3-month evaluations).

Conclusion

This study shows that the T-MAM for Burns has great potential to be a functional outcome measure for burn rehabilitation. Additional research with a larger sample should be conducted to further confirm its validity and reliability.     

Impact of Adjuvant Radiation Therapy on Urinary Continence Recovery After Radical Prostatectomy

Background

Little is known about the impact of adjuvant radiation therapy (aRT) after radical prostatectomy (RP) on urinary continence (UC).

Objective

To evaluate the impact of aRT on UC recovery in patients with unfavourable pathologic characteristics.

Design, setting, and participants

The study included 361 patients with either pT2 with positive surgical margin(s) or pT3a/pT3b node-negative disease treated with RP at a tertiary care referral centre.

Intervention

Patients were stratified according to the administration of aRT into two groups: group 1 (no aRT; n = 208; 57.8%) and group 2 (aRT; n = 153; 42.2%).

Outcome measurements and statistical analysis

Continence was defined as no use of protective pads. Log-rank test was used to compare the rate of UC recovery according to aRT status. The association between aRT and UC was also tested in Cox regression models after accounting for age, Cancer of the Prostate Risk Assessment (CAPRA) score, nerve-sparing (NS) status, Charlson Comorbidity Index, body mass index, and year of surgery.

Results and limitations

At a mean follow-up of 30 mo, 254 patients (70.4%) recovered complete UC. The 1- and 3-yr UC recovery was 51% and 59% for patients submitted to aRT versus 81% and 87% for patients not receiving aRT, respectively (p < 0.001). At univariable analysis, older age (p < 0.001), presence of non–organ-confined disease (p < 0.001), non-NS procedure (p < 0.001), and delivery of aRT (p < 0.001) were significantly associated with lower UC. At multivariable analysis, the delivery of aRT remained an independent predictor of worse UC recovery (hazard ratio: 0.57; p = 0.001). Patients treated with aRT had a 1.6-fold higher risk of incontinence. Younger age (p = 0.02), lower CAPRA score (p = 0.03), and NS approach (p < 0.001) also represented independent predictors of UC recovery. The main limitations of the study are related to the lack of validated questionnaires in the evaluation of UC and in the lack of information regarding UC status at aRT.

Conclusions

The delivery of aRT has a detrimental effect on UC. The oncologic benefits must be balanced with an impaired UC recovery. Patients should be informed of such impairment before adjuvant treatments are planned.