A prospective trial comparing consecutive series of open retropubic and robot-assisted laparoscopic radical prostatectomy in a centre with a limited caseload

Background

Robot-assisted radical prostatectomy (RALP) is performed worldwide, even in institutions with limited caseloads. However, although the results of large RALP series are available, oncologic and functional outcomes as well as complications from low-caseload centres are lacking.

Objective

To compare perioperative, oncologic, and functional outcomes from two consecutive series of patients with localised prostate cancer treated by retropubic radical prostatectomy (RRP) or recently established RALP in our hospital, which has a limited caseload.

Design, setting, and participants

One hundred fifty consecutive patients were enrolled. Their data and outcomes were collected and extensively evaluated.

Intervention

Seventy-five consecutive patients underwent RRP, and 75 consecutive patients underwent RALP, including all patients of the learning curve.

Measurements

Patient baseline characteristics, perioperative and postoperative outcomes, and complications were evaluated. End points were oncologic data (positive margins, prostate-specific antigen [PSA]), perioperative complications, urinary continence, and erectile function at 3- and 12-mo follow-up.

Results and limitations

The preoperative parameters from the two groups were comparable. The positive surgical margin (PSM) rates were 32% for RRP and 16% for RALP (p = 0.002). For RRP and RALP, the PSA value was <0.2 ng/ml in 91% and 88% of patients 3 mo postoperatively (p = 0.708) and in 87% and 89% of patients 12 mo postoperatively (p = 0.36), respectively. Continence rates for RRP and RALP were 83% and 95% at 3-mo follow-up (p = 0.003) and 80% and 89% after 12-mo follow-up (p = 0.092), respectively. Among patients who were potent without phosphodiesterase type 5 inhibitors (PDE5-I) before RRP and RALP, recovery of erectile function with and without PDE5-Is was achieved in 25% (12 of 49 patients) and 68% (25 of 37 patients) 3 mo postoperatively (p = 0.009) and in 26% (12 of 47 patients) and 55% (12 of 22 patients) 12 mo postoperatively (p = 0.009), respectively. Minimal follow-up for RRP was 12 mo; median follow-up for the RALP group was 12 mo (range: 3–12). According to the modified Clavien system, major complication rates for RRP and RALP were 28% and 7% (p = 0.025), respectively; minor complication rates were 24% and 35% (p = 0.744), respectively.

Conclusions

Despite a limited caseload and including the learning curve, RALP offers slightly better results than RRP in terms of PSM, major complications, urinary continence, and erectile function.     

The impact of prostate size, median lobe, and prior benign prostatic hyperplasia intervention on robot-assisted laparoscopic prostatectomy: technique and outcomes

Background

Large prostate size, median lobes, and prior benign prostatic hyperplasia (BPH) surgery may pose technical challenges during robot-assisted laparoscopic prostatectomy (RALP).

Objective

To describe technical modifications to overcome BPH sequelae and associated outcomes.

Design, settings, and participants

A retrospective study of prospective data on 951 RALP procedures performed from September 2005 to November 2010 was conducted. Outcomes were analyzed by prostate weight, prior BPH surgical intervention (n = 59), and median lobes >1 cm (n = 42).

Surgical procedure

RALP.

Measurements

Estimated blood loss (EBL), blood transfusions, operative time, positive surgical margin (PSM), and urinary and sexual function were measured.

Results and limitations

In unadjusted analysis, men with larger prostates and median lobes experienced higher EBL (213.5 vs 176.5 ml; p < 0.001 and 236.4 vs 193.3 ml; p = 0.002), and larger prostates were associated with more transfusions (4 vs 1; p = 0.037). Operative times were longer for men with larger prostates (164.2 vs 149.1 min; p = 0.002), median lobes (185.8 vs 155.0 min; p = 0.004), and prior BPH surgical interventions (170.2 vs 155.4 min; p = 0.004). Men with prior BPH interventions experienced more prostate base PSM (5.1% vs 1.2%; p = 0.018) but similar overall PSM. In adjusted analyses, the presence of median lobes increased both EBL (p = 0.006) and operative times (p < 0.001), while prior BPH interventions also prolonged operative times (p = 0.014). However, prostate size did not affect EBL, PSM, or recovery of urinary or sexual function.

Conclusions

Although BPH characteristics prolonged RALP procedure times and increased EBL, prostate size did not affect PSM or urinary and sexual function.     

Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial

Background

Urinary tract infection (UTI) is a prevalent condition in women during their lifetime with a high rate of recurrence within 3–6 mo.

Objectives

Our aim was to investigate the efficacy and tolerability of the intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS) in female patients with a history of recurrent UTI.

Design, setting, and participants

We conducted a prospective, randomised, double-blind, placebo-controlled study comparing the intravesical instillation of HA-CS with placebo in women with recurrent UTI.

Intervention

Participants were randomised to receive 50 ml of sterile sodium HA 1.6% and CS 2.0% solution (IALURIL^®) weekly for 4 wk and then monthly for 5 mo.

Measurements

The primary end point of the study was defined as the mean number of UTI per patient per year. Participants were evaluated addressing UTI status/urinary symptoms and with a general health-related quality-of-life (QoL) questionnaire at baseline and after 3, 6, 9, and 12 mo.

Results and limitations

In the intention-to-treat analysis, 57 women were randomly allocated to HA-CS (n = 28) or placebo (n = 29). The UTI rate per patient per year at the end of the study (12 mo) (mean ± SD: −86.6% ± 47.6 vs −9.6% ± 24.6; mean difference: 77%; 95% confidence interval, 72.3–80.8; p = 0.0002) and the mean time to UTI recurrence (52.7 ± 33.4 vs 185.2 ± 78.7 d; p < 0.001) were significantly reduced after treatment with HA-CS compared with placebo. Overall urinary symptoms and QoL measured by questionnaires significantly improved compared with placebo (Pelvic Pain and Urgency/Frequency questionnaire symptom score: 14.53 ± 4.32 vs 9.88 ± 6.77; p = 0.004; SF-36 QoL score: 78.6 ± 6.44 vs 53.1 ± 4.72; p < 0.001). No serious adverse event was reported.

Conclusions

Compared with placebo, HA-CS intravesical instillations significantly reduced UTI rate without severe side effects while improving symptoms and QoL over a 12-mo period in patients with recurrent UTI.

Trial registration

ISRCTN 76354426.     

Periurethral Suspension Stitch During Robot-Assisted Laparoscopic Radical Prostatectomy: Description of the Technique and Continence Outcomes

Background

Several studies have shown that robot-assisted laparoscopic radical prostatectomy (RALP) is feasible, with favorable complication rates and short hospital times. However, the early recovery of urinary continence remains a challenge to be overcome.

Objective

We describe our technique of periurethral retropubic suspension stitch during RALP and report its impact on early recovery of urinary continence.

Design, setting, and participants

We analyze prospectively 331 consecutive patients who underwent RALP, 94 without the placement of suspension stitch (group 1) and 237 with the application of the suspension stitch (group 2).

Surgical procedure

The only difference between the groups was the placement of the puboperiurethral stitch after the ligation of the dorsal venous complex (DVC). The periurethral retropubic stitch was placed using a 12-in monofilament polyglytone suture on a CT-1 needle. The stitch was passed from right to left between the urethra and DVC, and then through the periostium on the pubic bone. The stitch was passed again through the DVC, and then through the pubic bone in a figure eight, and then tied.

Measurements

Continence rates were assessed with a self-administered validated questionnaire (Expanded Prostate Cancer Index Composite [EPIC]) at 1, 3, 6, and 12 mo after the procedure. Continence was defined as the use of no absorbent pads or no leakage of urine.

Results and limitations

In group 1, the continence rate at 1, 3, 6, and 12 mo postoperatively was 33%, 83%, 94.7%, and 95.7%, respectively; in group 2, the continence rate was 40%, 92.8%, 97.9%, and 97.9%, respectively. The suspension technique resulted in significantly greater continence rates at 3 mo after RALP (p = 0.013). The median/mean interval to recovery of continence was also statistically significantly shorter in the suspension group (median: 6 wk; mean: 7.338 wk; 95% confidence interval [CI]: 6.387–8.288) compared to the nonsuspension group (median: 7 wk; mean: 9.585 wk; 95% CI: 7.558–11.612; log rank test, p = 0.02).

Conclusions

The suspension stitch during RALP resulted in a statistically significantly shorter interval to recovery of continence and higher continence rates at 3 mo after the procedure.     

Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebo-controlled trial

Background

Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP).

Objective

To establish the superiority of duloxetine over placebo in SUI after RP.

Design, setting, and participants

We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80 mg of duloxetine daily or matching placebo for 3 mo.

Measurements

The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events.

Results and limitations

Thirty-one patients were randomised to either the treatment (n = 16) or control group (n = 15). Reduction in IEF was significant with duloxetine compared to placebo (mean ± standard deviation [SD] variation: −52.2% ± 38.6 [range: −100 to +46] vs +19.0% ± 43.5 [range: −53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0–101.4; p < 0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p = 0.006, p = 0.02, p = 0.0004, and p = 0.003, respectively). Both treatments were well tolerated throughout the study period.

Conclusions

Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.     

Influence of the analgesic strategy on the respiratory function after thoracic surgery for lobectomy

Objective

To compare the influence of thoracic epidural analgesia (TEA) with intravenous patient-controlled analgesia with morphine (PCA) on the early postoperative respiratory function after lobectomy.

Study design

Prospective and comparative observational study.

Patients and methods

Fourty-four patients scheduled for lobectomy (n = 22 per group) were studied on the evolution of the postoperative respiratory function assessed by the forced vital capacity (FVC) and the forced expired volume (FEV₁) during the first two postoperative days and the analysis of noctural arterial desaturation during the three first postoperative nights.

Results

The use of TEA resulted in fewer decrease both in FEV₁ (1.01 ± 0.34 versus 1.31 ± 0.51 l/s for Day 1, P = 0.03; 1.13 ± 0.37 versus 1.53 ± 0.59 l/s for Day 2, P = 0.01) and in FVC (1.23 [1.05-1.51] versus 1.57 [1.38–2.53] l for day 1, P = 0.008; 1.33 ± 0.43 versus 2.24 ± 0.87 l for day 2, P < 0.001). Moreover, the duration of arterial desaturation < 90% were longer in the PCA group during the first (8.6 [0.8–28.2] versus 1.3 [0–2.6] min, P = 0.02) and the second postoperative night (13.5 [3.5–54] versus 0.4 [0–2.6] min, P = 0.025).

Conclusion

The results of this study suggest that the use of TEA is associated with a better preservation of respiratory function assessed by spirometric data and noctural arterial desaturation recording after thoracic surgery for lobectomy.     

Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial

Background

Tadalafil improved lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH; LUTS/BPH) in clinical studies but has not been evaluated together with an active control in an international clinical study.

Objective

Assess tadalafil or tamsulosin versus placebo for LUTS/BPH.

Design, setting, and participants

A randomised, double-blind, international, placebo-controlled, parallel-group study assessed men ≥45 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥13, and maximum urinary flow rate (Q_max) ≥4 to ≤15 ml/s. Following screening and washout, if needed, subjects completed a 4-wk placebo run-in before randomisation to placebo (n = 172), tadalafil 5 mg (n = 171), or tamsulosin 0.4 mg (n = 168) once daily for 12 wk.

Measurements

Outcomes were assessed using analysis of covariance (ANCOVA) or ranked analysis of variance (ANOVA) (continuous variables) and Cochran-Mantel-Haenszel test or Fisher exact test (categorical variables).

Results and limitations

IPSS significantly improved versus placebo through 12 wk with tadalafil (−2.1; p = 0.001; primary efficacy outcome) and tamsulosin (−1.5; p = 0.023) and as early as 1 wk (tadalafil and tamsulosin both −1.5; p < 0.01). BPH Impact Index significantly improved versus placebo at first assessment (week 4) with tadalafil (−0.8; p < 0.001) and tamsulosin (−0.9; p < 0.001) and through 12 wk (tadalafil −0.8, p = 0.003; tamsulosin −0.6, p = 0.026). The IPSS Quality-of-Life Index and the Treatment Satisfaction Scale–BPH improved significantly versus placebo with tadalafil (both p < 0.05) but not with tamsulosin (both p > 0.1). The International Index of Erectile Function–Erectile Function domain improved versus placebo with tadalafil (4.0; p < 0.001) but not tamsulosin (−0.4; p = 0.699). Q_max increased significantly versus placebo with both tadalafil (2.4 ml/s; p = 0.009) and tamsulosin (2.2 ml/s; p = 0.014). Adverse event profiles were consistent with previous reports. This study was limited in not being powered to directly compare tadalafil versus tamsulosin.

Conclusions

Monotherapy with tadalafil or tamsulosin resulted in significant and numerically similar improvements versus placebo in LUTS/BPH and Q_max. However, only tadalafil improved erectile dysfunction.

Trial registration

Clinicaltrials.gov ID NCT00970632     

Cerebral salt wasting syndrome: experimental study in rats

Introduction

The cerebral salt wasting syndrome (CSWS) is characterized by hyponatraemia secondary to excessive natriuesis with osmotic duiresis. This syndrome, frequently, occurs after subarachnoid haemorrhage (SAH), but may occur after any acute cerebral aggression.

Objectives

The aim of the study was to assess the frequency of the CSWS in animal models with, SAH, cerebral ischemia (CI), and cranial trauma (CT), and its correlation with the secretion of brain natriuretic peptide (BNP).

Method

Four groups of rats were selected: group SAH (n = 7) consisted of SAH induced by perforation of the carotid artery in its intracerebral part; group CI (n = 7) consisted of CI induced by ligature of the carotid artery; group CT (n = 7) consisted of induced CT; and a control group Sham (n = 7). Weight, serum sodium, BNP, and urinary sodium, were measured at baseline and 24 hours after.

Results

Rats with SAH had significant natriuresis and diuresis with negative sodium balance (–95.9 ± 447.4 μmol) with a significant difference (P < 0.05) compared to the rats of the CI and the Sham groups. There was no difference in the 24 hours level of BNP between the four different groups.

Conclusion

We conclude that SAH, in animal models, induced high diuresis with negative sodium balance in the first 24 hours. These findings were absents in the others groups. This was independent of the BNP secretion and may correspond to the early occurrence of a CSWS.     

Interest of entropy monitoring during low-grade cerebral aneurysm embolisation

Objective

Evaluate the supply of entropy monitoring on anaesthetic drugs consumption, haemodynamic stability, and recovery time in patients undergoing embolisation of cerebral artery aneurysm (asymptomatic or low Hunt and Hess grades).

Methods

Two groups, G1 without entropy monitoring (Datex-Ohmeda S/5™), G2 with entropy monitoring (16 patients in each group). Each group had similar anaesthetic protocol (propofol target control infusion and continuous intravenous infusion remifentanil). For G2, the state entropy (SE) values were kept between 35 and 45. We studied anaesthetic drug consumption, arterial pressure parameters, extubation delay and feasibility. Statistical analysis used Mann and Whitney test, Fisher test. Significativity was p < 0.05.

Results

No intraoperative incident. Propofol consumption was lower in G2 (7.49 ± 2.28 mg/kg per hour versus 9.46 ± 2.50 mg/kg per hour; p < 0.05). A tendency to reduction was observed for remifentanil consumption (6.65 ± 2.04 μg/kg per hour versus 7.94 ± 2.92 μg/kg per hour; p = 0.056), and extubation delay (14.1 ± 8.6 min versus 26.5 ± 22.0 min; p = 0.056), in G2. The entropy monitoring had no repercussion on haemodynamic stability, but the arterial pressure values were significantly higher in G2 (73.60 ± 8.49 mmHg versus 67.10 ± 5.58 mmHg). Entropy captor does not disrupt embolisation procedure. Coils liberation alter temporarily RE and SE values.     

Does Varicocele Repair Improve Male Infertility? An Evidence-Based Perspective From a Randomized,Controlled Trial

Background

Randomized controlled trials (RCTs) addressing varicocele treatment are scarce and have conflicting outcomes.

Objective

To determine whether varicocele treatment is superior or inferior to no treatment in male infertility from an evidence-based perspective.

Design, setting, and participants

A prospective, nonmasked, parallel-group RCT with a one-to-one concealed-to-random allocation was conducted at the authors’ institution from February 2006 to October 2009. Married men 20–39 yr of age who had experience infertility ≥1 yr, had palpable varicoceles, and with at least one impaired semen parameter (sperm concentration <20 million/ml, progressive motility <50%, or normal morphology <30%) were eligible. Exclusions included subclinical or recurrent varicoceles, normal semen parameters, and azoospermia. Sample size analysis suggested 68 participants per arm.

Intervention

Participants were randomly allocated to observation (the control arm [CA]) or subinguinal microsurgical varicocelectomy (the treatment arm [TA]). Semen analyses were obtained at baseline (three analyses) and at follow-up months 3, 6, 9, and 12. The mean of each sperm parameter at baseline and follow-ups was determined.

Measurements

We measured the spontaneous pregnancy rate (the primary outcome), changes from baseline in mean semen parameters, and the occurrence of adverse events (AE—the secondary outcomes) during 12-mo follow-up; p < 0.05 was considered significant.

Results and limitations

Analysis included 145 participants (CA: n = 72; TA: n = 73), with a mean age plus or minus standard deviation of 29.3 ± 5.7 in the CA and 28.4 ± 5.7 in the TA (p = 0.34). Baseline characteristics in both arms were comparable. Spontaneous pregnancy was achieved in 13.9% (CA) versus 32.9% (TA), with an odds ratio (OR) of 3.04 (95% confidence interval [CI], 1.33–6.95) and a number needed to treat (NNT) of 5.27 patients (95% CI, 1.55–8.99). In CA within-arm analysis, none of semen parameters revealed significant changes from baseline (sperm concentration [p = 0.18], progressive motility [p = 0.29], and normal morphology [p = 0.05]). Conversely, in TA within-arm analysis, the mean of all semen parameters improved significantly in follow-up versus baseline (p < 0.0001). In between-arm analysis, all semen parameters improved significantly in the TA versus CA (p < 0.0001). No AEs were reported.

Conclusions

Our RCT provided level 1b evidence of the superiority of varicocelectomy over observation in infertile men with palpable varicoceles and impaired semen quality, with increased odds of spontaneous pregnancy and improvements in semen characteristics within 1-yr of follow-up.     

Renal damage caused by warm ischaemia during laparoscopic and robot-assisted partial nephrectomy: an assessment using Tc 99m-DTPA glomerular filtration rate

Background

Few studies assessing the functional change of each kidney following warm ischaemia after partial nephrectomy are available.

Objectives

Our aim was to identify the effects of the warm ischaemic time (WIT) on renal function after partial nephrectomy under the pneumoperitoneum.

Design, setting, and participants

Forty-four consecutive patients who underwent laparoscopic partial nephrectomy (LPN) or robot-assisted partial nephrectomy (RAPN) from June 2008 to May 2009 for a single cT1 renal tumour were included in this prospective protocol.

Measurements

Technetium Tc 99m-diethylenetriaminepentaacetic acid (Tc 99m-DTPA) renal scintigraphy was used to determine the glomerular filtration rate (GFR) of both kidneys and each kidney individually. Tc 99m-DTPA GFR was performed preoperatively and 3 mo postoperatively. In addition, we analysed Tc 99m-DTPA scintigraphy GFR regionally in the healthy areas of the affected kidney.

Results and limitations

Patients with WIT >28 min had a significantly greater decrease in the GFR of the affected kidney (p = 0.031). The GFR of the affected kidney showed a significant decrease perioperatively (46.4 ± 14.3 to 37.9 ± 11.9 ml/min per 1.73 m²; p = 0.003). The functional change of the nonaffected kidney showed an increasing trend (47.5 ± 13.8 to 51.4 ± 14.3 ml/min per 1.73 m²), although it was not statistically significant (p = 0.103). Regional Tc 99m-DTPA GFR of both affected kidney and nonaffected kidney showed no significant differences perioperatively (6.3 ± 1.8 to 6.1 ± 1.9 ml/min per 1.73 m²; p = 0.641; 6.6 ± 1.9 to 7.1 ± 2.0 ml/min per 1.73 m²; p = 0.200). On multivariate analysis, preoperative GFR, resected volume of marginal healthy tissue, and WIT were independent predictors for functional reduction of the affected kidney (p < 0.05). The study was limited by small numbers and short follow-up periods.

Conclusions

Stationary overall renal function after LPN or RAPN is masked possibly by functional compensation of the contralateral healthy kidney. The damage of the affected kidney estimated by scintigraphy occurs when WIT exceeds 28 min during partial nephrectomy under the pneumoperitoneum.     

Propensity-score-matched comparison of perioperative outcomes between open and laparoscopic nephroureterectomy: a national series

Background

Nephroureterectomy (NU) represents the primary management for patients with nonmetastatic upper tract urothelial carcinoma (UTUC). Either an open NU (ONU) or a laparoscopic NU (LNU) may be considered. Despite the presence of several reports comparing perioperative and cancer-control outcomes between the two approaches, no reports relied on a population-based cohort.

Objectives

Examine intraoperative and postoperative morbidity of ONU and LNU in a population-based cohort.

Design, setting, and participants

We relied on the US Nationwide Inpatient Sample (NIS) to identify patients with nonmetastatic UTUC treated with ONU or LNU between 1998 and 2009. Overall, 7401 (90.8%) and 754 (9.2%) patients underwent ONU and LNU, respectively. To adjust for potential baseline differences between the two groups, propensity-score-based matching was performed. This resulted in 3016 (80%) ONU patients matched to 754 (20%) LNU patients.

Intervention

All patients underwent NU.

Measurements

The rates of intra- and postoperative complications, blood transfusions, prolonged length of stay (pLOS), and in-hospital mortality were assessed for both procedures. Multivariable logistic regression analyses were performed within the cohort after propensity-score matching.

Results and limitations

For ONU versus LNU respectively, the following rates were recorded: blood transfusions, 15% versus 10% (p < 0.001); intraoperative complications, 4.7% versus 2.1% (p = 0.002); postoperative complications, 17% versus 15% (p = 0.24); pLOS (≥5 d), 47% versus 28% (p < 0.001); in-hospital mortality, 1.3% versus 0.7% (p = 0.12). In multivariable logistic regression analyses, LNU patients were less likely to receive a blood transfusion (odds ratio [OR]: 0.6; p < 0.001), to experience any intraoperative complications (OR: 0.4; p = 0.002), and to have a pLOS (OR: 0.4; p < 0.001). Overall, postoperative complications were equivalent. However, LNU patients had fewer respiratory complications (OR: 0.4; p = 0.007). This study is limited by its retrospective nature.

Conclusions

After adjustment for potential selection biases, LNU is associated with fewer adverse intra- and perioperative outcomes than ONU.     

Endoluminal isoproterenol irrigation decreases renal pelvic pressure during flexible ureterorenoscopy: a clinical randomized, controlled study

Objectives

Irrigation during ureterorenoscopic procedures causes increased pelvic pressure (PP), which may lead to intrarenal backflow with potential harmful consequences. This study aims to investigate PP response to intraluminal administration of isoproterenol (β-agonist; ISO) during flexible ureterorenoscopy.

Methods

Twelve patients admitted for retrograde intrarenal stone surgery (RIRS) were included. Patients were randomized to (1) irrigation with saline (n = 6) or (2) irrigation with ISO 0.1 μg/mL (n = 6). Irrigation rate was standardized to 8 mL/min. A ureteral catheter was retrogradely placed in the renal pelvis for PP measurements. PP, heart rate (HR), and mean arterial pressure (MAP) were also measured.

Results

Baseline PP was 12.1 ± 4 mm Hg in the saline group and 10.3 ± 4 mm Hg in the ISO group (p = 0.44).In the saline group, PP increased to a mean 33 ± 12 mm Hg during ureterorenoscopy. In the ISO group, PP was a mean 19 ± 3 mm Hg (p = 0.029).During endoscopy, PP peaks as high as 328 mm Hg were noted during saline irrigation. The number of pressure peaks above 50 mm Hg was minimized dramatically during ISO irrigation (p = 0.035). No systemic side effects to ISO irrigation were observed.

Conclusion

For the first time, a randomized, controlled human study demonstrates that pharmacologic modulation of the ureter is possible during upper urinary tract endoscopy. The ability to relax ureteral tone during endoscopy may have clinical advantages.     

Radiofrequency ablation versus partial nephrectomy in patients with solitary clinical T1a renal cell carcinoma: comparable oncologic outcomes at a minimum of 5 years of follow-up

Background

Long-term comparative outcomes for radiofrequency ablation (RFA) versus partial nephrectomy (PN) for the primary treatment of clinical T1a renal cell carcinoma (RCC) have not previously been reported.

Objective

Report comparative 5-yr oncologic outcomes for RFA versus PN in patients with clinical T1a RCC.

Design, setting, and participants

Observational single-institution cohort study, involving consecutive patients with a solitary histologically confirmed T1a RCC treated by RFA or PN and followed for a minimum of 5 yr. Those presenting with synchronous multiple, metachronous, bilateral, and/or metastatic disease, a history of hereditary RCC syndromes, a family history of RCC, and with post-treatment follow-up <5 yr were excluded from analysis.

Measurements

The Kaplan-Meier method was used to determine 5-yr overall survival (OS), cancer-specific survival (CSS), local recurrence-free survival (local RFS), overall disease-free survival (DFS), and metastasis-free survival (MFS) for RFA versus PN. Survival curves were compared using the log-rank test. A p value ≤0.05 was considered statistically significant.

Results and limitations

A total of 37 patients in each group met the selection criteria. The RFA cohort was significantly older and had more advanced comorbidities, but other patient characteristics were similar. For RFA versus PN, median follow-up was 6.5 yr (interquartile range [IQR]: 5.8–7.1) versus 6.1 yr (IQR: 5.4–7.3) (p = 0.68), respectively. The 5-yr OS was 97.2% versus 100% (p = 0.31), CSS was 97.2% versus 100% (p = 0.31), DFS was 89.2% versus 89.2% (p = 0.78), local RFS was 91.7% versus 94.6% (p = 0.96), and MFS was 97.2% versus 91.8% (p = 0.35), respectively. Study limitations are retrospective data analysis, loss to follow-up, limited statistical power, and limited generalizability of our data.

Conclusions

In appropriately selected patients, RFA is an effective minimally invasive therapy for the treatment of cT1a RCC, yielding comparable long-term oncologic outcomes to nephron-sparing surgery.     

30 microg intrathecal clonidine prolongs labour analgesia, but increases the incidence of hypotension and abnormal foetal heart rate patterns

Objective

To assess the efficacy of spinal clonidine combined with bupivacaine and sufentanil and its effects on maternal and foetal outcome.

Study design

Prospective double-blind randomized study.

Patients and methods

One hundred and five patients requesting labour analgesia had combined spinal epidural analgesia with intrathecal bupivacaine 2.5 mg and were randomly assigned to receive in addition either sufentanil 5 μg (S5), sufentanil 5 μg and clonidine 30 μg (C30), or sufentanil 10 μg (S10). Onset time, duration of analgesia, visual analogue scores, blood pressure, ephedrine requirements, heart rate, nausea, pruritus, sedation, motor block, foetal heart rate abnormalities, mode of delivery and Apgar scores were recorded.

Results

Mean duration of spinal analgesia was significantly longer in patients receiving spinal clonidine compared to patients in S5 group (144 ± 61 min versus 95 ± 37 min). The onset time of analgesia was significantly shorter in S10 group (3 ± 1 min) versus C30 group (4 ± 1 min) and S5 group (4 ± 1 min) (P = 0.002). Hypotension was significantly more frequent in C30 group (29 versus 3% and 3% in S5 and S10 groups) (p = 0,001). Foetal heart rate abnormalities and sedation were also significantly more frequent in C30 group. Mode of delivery (spontaneous, instrumental or caesarean delivery) and Apgar scores were unaffected by clonidine treatment.

Conclusion

Intrathecal clonidine 30 μg prolongs analgesia. However, it increases the incidence of hypotension, and abnormal foetal heart rate patterns. Thus, this study confirms that the use of 30 μg intrathecal clonidine for labour analgesia is not recommended.     

Effects of the gonadotropin-releasing hormone antagonist ganirelix on normal micturition and prostaglandin E(2)-induced detrusor overactivity in conscious female rats

Background

Gonadotropin-releasing hormone (GnRH) antagonists have been reported to have beneficial effects on lower urinary tract symptoms in patients with benign prostatic hyperplasia.

Objective

Our aim was to investigate the effects of ganirelix, a GnRH receptor antagonist, on bladder function and detrusor overactivity (DO) in female rats.

Design, setting, and participants

Female Sprague-Dawley rats received 2 wk of daily systemic (0.1 mg/kg) or acute intravesical administration (IVES; 0.14 mg/l or 1.4 mg/l) ganirelix or vehicle (controls).

Measurements

Assessments were obtained using cystometry in awake rats, organ bath studies, enzyme-linked immunosorbent assay, and western blot (WB).

Results and limitations

Luteinising hormone levels were lower in rats treated systemically with ganirelix than in controls. No differences were observed in body or bladder weights. Micturition interval (MI), micturition volume (MV), residual volume, and bladder capacity (BC) were similar in both groups at baseline. No differences in urodynamic pressure parameters were observed between groups at baseline. Intravesical prostaglandin E₂ reduced MI, MV, and BC, and it increased basal pressure (BP), threshold pressure (TP), flow pressure (FP), and maximum pressure (MP) in all rats. MI, MV, and BC were reduced by 43% ± 4%, 50% ± 4%, and 43% ± 4% (controls) versus 22% ± 3%, 23% ± 3%, and 21% ± 3% (ganirelix-treated rats; p < 0.001). TP and FP increased by 38% ± 8% and 30% ± 4% (controls) versus 16% ± 7% and 16% ± 5% (ganirelix; p < 0.05). The maximal force of contractions for carbachol was larger in detrusor from ganirelix-treated rats (231% vs 177% of 60 mM K+-induced contractions). At 0.14 mg/l, but not 0.14 mg/l, IVES ganirelix increased MI, MV, and BC and decreased BP, TP, FP, and MP. In vitro, ganirelix had no effect on detrusor function. The gonadotropin-releasing hormone receptor was expressed (by WB) in the bladder mucosa.

Conclusions

Systemic treatment with ganirelix counteracted experimental DO in female rats. Because bladder preparations from these rats exhibited larger contractions to carbachol and because intravesical ganirelix affected both micturition intervals and urodynamic pressure profiles, a peripheral site of action of ganirelix in the urinary bladder cannot be excluded.     

Vardenafil decreases bladder afferent nerve activity in unanesthetized, decerebrate, spinal cord-injured rats

Background

Phosphodiesterase type 5 inhibitors (PDE5-Is) improve storage symptoms in benign prostatic hyperplasia patients, despite a lack of effect on peak urinary flow rate. Moreover, vardenafil improves urodynamic parameters in spinal cord-injured (SCI) patients with neurogenic detrusor overactivity (NDO). SCI rats also display NDO characterized by nonvoiding contractions (NVCs) during bladder filling, resulting in an increased bladder afferent nerve firing (BANF).

Objective

We postulated that vardenafil could improve urodynamic parameters by reducing BANF. The effect of vardenafil has been investigated on intravesical pressure by cystometry experiments while recording BANF in response to bladder filling.

Design, setting, and participants

Complete T7–T8 spinalization was performed in 15 female adult Sprague-Dawley rats (250–275 g).

Measurements

At 21–29 d postspinalization, fine filaments were dissected from the L6 dorsal roots and placed across a bipolar electrode. Bladder afferent nerve fibers were identified by electrical stimulation of the pelvic nerve and bladder distension. SCI rats were decerebrated before cystometry experiments. Bladders were filled to determine the maximal bladder filling volume (BFV) for each rat. Then, after bladder stabilization at 75% of maximal BFV, saline (n = 7) or vardenafil 1 mg/kg (n = 8) was delivered intravenously. NVCs and BANF were recorded for 45 min.

Results and limitations

In all SCI rats, BANF was already present and regular at resting conditions (26.2 ± 4.1 spikes per second). During bladder filling, intravesical pressure (IVP) slowly increased with transient NVCs superimposed. Concomitantly, BANF progressively increased up to 2.4-fold at maximal BFV (2.08 ± 0.24 ml). After stabilization at submaximal BFV, BANF was increased by 186 ± 37%. Vardenafil injection induced an immediate decrease in NVCs compared to saline (p < 0.001) and BANF (52% decrease vs 28% in saline after 45 min; p < 0.001).

Conclusions

Systemic vardenafil reduced both NVCs and BANF in unanesthetized, decerebrate, SCI rats. These findings provide new insights into the mechanism of action by which PDE5-Is improve storage symptoms in SCI patients.     

Amino-Terminal Pro-C-Type Natriuretic Peptide is Associated with the Presence, Severity, and Duration of Vasculogenic Erectile Dysfunction

Background

Endothelial dysfunction is a key event in the pathophysiology of erectile dysfunction (ED) and generalized vascular disease. C-type natriuretic peptide (CNP) is a paracrine molecule that effects endothelial integrity and vascular tone.

Objective

To determine the role of CNP in men with vasculogenic ED.

Design, setting, and participants

Fifty-two consecutive men (age: 57 ± 10 yr) with nonpsychogenic and nonhormonal ED for >6 mo and free of cardiovascular disease who were referred to the Cardiovascular Diseases and Sexual Health Unit of our Department for evaluation of ED were compared with 31 subjects with normal erectile function matched for age, body mass index, and traditional risk factors.

Measurements

Vasculogenic ED was diagnosed according to comprehensive history, physical examination, Sexual Health Inventory for Men (SHIM-5) scoring, hormonal testing, and penile color-Doppler ultrasound. Amino-terminal proCNP (NT-proCNP) was measured in plasma with enzyme-linked immunosorbent assay (ELISA).

Results and limitations

Compared to controls, ED patients had significantly lower NT-proCNP levels (0.21 ± 0.08 pmol/l in ED patients vs 0.34 ± 0.07 pmol/l in control subjects; p < 0.001). NT-proCNP levels were associated with erectile performance as expressed by SHIM-5 score (r = 0.57; p < 0.001), even after adjusting for confounders. There was also an inverse linear relationship between ED duration and NT-proCNP levels (p < 0.05). In patients with arteriogenic ED, there was a positive correlation of NT-proCNP levels with peak systolic velocity (PSV) (r = 0.51; p = 0.01).

Conclusions

CNP levels are associated with the presence, severity, and duration of ED. These findings provide further insight into the role of CNP in the pathophysiology of ED.     

Randomized Controlled Trial of Barbed Polyglyconate Versus Polyglactin Suture for Robot-Assisted Laparoscopic Prostatectomy Anastomosis: Technique and Outcomes

Background

Transperitoneal robot-assisted laparoscopic prostatectomy (RALP) urethrovesical anastomosis is a critical step. Although the prevalence of urine leaks ranges from 4.5% to 7.5% at high-volume RALP centers, urine leaks prolong catheterization and may lead to ileus, peritonitis, and require intervention. Barbed polyglyconate sutures maintain running suture line tension and may be advantageous in RALP anastomosis for reducing this complication.

Objective

To compare barbed polyglyconate and polyglactin 910 (Vicryl, Ethicon, Somerville, NJ, USA) running sutures for RALP anastomosis.

Design, setting, and participants

This was a prospective, randomized, controlled, single-surgeon study comparing RALP anastomosis using either barbed polyglyconate (n = 45) or polyglactin 910 (n = 36) sutures.

Surgical procedure

RALP anastomosis using either barbed polyglyconate or polyglactin 910 sutures was studied.

Measurements

Operative time, cost differential, perioperative complications, and cystogram contrast extravasation by anastomosis suture type were measured.

Results and limitations

Although baseline characteristics and overall operative times were similar, barbed polyglyconate sutures were associated with shorter mean anastomosis times of 9.7 min versus 9.8 min (p = 0.014). In addition, anastomosis with barbed polyglyconate rather than polyglactin 910 sutures was associated with more frequent cystogram extravasation 8 d postoperatively (20.0% vs 2.8%; p = 0.019), longer mean catheterization times (11.1 d vs 8.3 d; p = 0.048), and greater suture costs per case ($51.52 vs $8.44; p < 0.001). After 8 of 29 (27.6%) barbed polyglyconate anastomosis sites demonstrated postoperative day 8 cystogram extravasation, we modified our technique to avoid overtightening, reducing cystogram extravasation to 1 (6.3%) of 16 subsequent barbed polyglyconate anastomosis sites. Potential limitations include small sample size and the single-surgeon study design.

Conclusions

Compared to traditional sutures, barbed polyglyconate is more costly and requires technical modification to avoid overtightening, delayed healing, and longer catheterization time following RALP.