Incremental value of transition zone and midline apical biopsy at baseline TRUS-guided biopsy for prostate cancer detection.

PURPOSE: To determine the diagnostic yield of transition zone (TZB) and midline apical biopsies (MAB) in baseline transrectal ultrasound (TRUS)-guided biopsies and to establish whether TZB and MAB for the diagnosis of prostate cancer (PCa) add clinical relevant information. METHODS: We performed baseline 9-core TRUS-guided biopsy in 412 consecutive subjects using sextant biopsies of the PZ (PZB), with an additional TZB on either side and a MAB at the prostatic apex. We determined the incremental diagnostic value of additional TZB an MAB to sextant PZB. RESULTS: Within a cohort of 412 patients with a median PSA of 7.5 ng/ml, 178 (43.2 %) patients were diagnosed with PCa upon baseline TRUS-guided biopsies. In 102 cases, at least one TZB was positive for PCa, with 6/412 (1.4 %) cases displaying PCa in the TZB only. MAB alone was positive for PCa in 4/412 (1.0 %) cases. One case (1/412; 0.2 %) had only a TZB and a MAB positive for PCa without positive PZB. Thus, 11/412 (2.7 %) of cases would not have been diagnosed with PCa at baseline TRUS-guided biopsy had only sextant PZ biopsy been performed. TZB detected a high-grade Gleason component (Gleason 4 and/or 5) not present in the PZB in 2.4 % of PCa cases. CONCLUSIONS: There is limited value for TZB and MAB in the context of sextant PZB at baseline TRUS-guided biopsies for PCa.

Quality of life after prostate cancer treatments in patients comparable at baseline.

BACKGROUND: Previous studies on the effects of different prostate cancer treatments on quality of life, were confounded because patients were not comparable. This study examined treatment effects in more comparable groups. METHODS: From 2008-2011, 240 patients with localised prostate cancer were selected to be eligible for both radical prostatectomy (RP) and external beam radiotherapy (EBRT). Brachytherapy (BT) was a third option for some. Health-related quality of life was measured by expanded prostate cancer index composite (EPIC) up to 12 months after treatment. RESULTS: In the sexual domain, RP led to worse summary scores (P<0.001) and more often to a clinically relevant deterioration from baseline than BT and EBRT (79%, 33%, 34%, respectively). In the urinary domain, RP also led to worse summary scores (P=0.014), and more deterioration from baseline (41%, 12%, 19%, respectively). Only on the irritative/obstructive urinary scale, more BT patients (40%) showed a relevant deterioration than RP (17%) and EBRT patients (11%). In the bowel domain, the treatment effects did not differ. CONCLUSION: This study provides a more unbiased comparison of treatment effects, as men were more comparable at baseline. Our results suggest that, for quality of life, radiotherapy is as least as good an option as RP for treating localised prostate cancer.

The predictive value of endorectal 3 Tesla multiparametric magnetic resonance imaging for extraprostatic extension in patients with low, intermediate and high risk prostate cancer.

PURPOSE: We determined the positive and negative predictive values of multiparametric magnetic resonance imaging for extraprostatic extension at radical prostatectomy for different prostate cancer risk groups. MATERIALS AND METHODS: We evaluated a cohort of 183 patients who underwent 3 Tesla multiparametric magnetic resonance imaging, including T2-weighted, diffusion weighted magnetic resonance imaging and dynamic contrast enhanced sequences, with an endorectal coil before radical prostatectomy. Pathological stage at radical prostatectomy was used as standard reference for extraprostatic extension. The cohort was classified into low, intermediate and high risk groups according to the D'Amico criteria. We recorded prevalence of extraprostatic extension at radical prostatectomy and determined sensitivity, specificity, positive predictive value and negative predictive value of multiparametric magnetic resonance imaging for extraprostatic extension in each group. Univariate and multivariate analyses were performed to identify predictors of extraprostatic extension at radical prostatectomy. RESULTS: The overall prevalence of extraprostatic extension at radical prostatectomy was 49.7% ranging from 24.7% to 77.1% between low and high risk categories. Overall staging accuracy of multiparametric magnetic resonance imaging for extraprostatic extension was 73.8%, with sensitivity, specificity, positive predictive value and negative predictive value of 58.2%, 89.1%, 84.1% and 68.3%, respectively. Positive predictive value of multiparametric magnetic resonance imaging for extraprostatic extension was best in the high risk cohort with 88.8%. Negative predictive value was highest in the low risk cohort with 87.7%. With an odds ratio of 10.3 multiparametric magnetic resonance imaging is by far the best preoperative predictor of extraprostatic extension at radical prostatectomy. CONCLUSIONS: For adequate patient counseling, knowledge of predictive values of multiparametric magnetic resonance imaging for extraprostatic extension is of utmost importance. High negative predictive value, important for decisions on nerve sparing strategies at radical prostatectomy, is only reached in low risk subjects.

Sexual functioning in patients with lower urinary tract dysfunction improves after percutaneous tibial nerve stimulation.

In this study, we evaluated the effect of lower urinary tract dysfunction and its neuromodulative therapy on sexual functioning. We studied 121 patients with an overactive bladder (OAB) (N = 83), chronic pelvic pain (N = 23) and nonobstructive retention (N = 15), which were treated with neuromodulation (i.e. percutaneous tibial nerve stimulation, PTNS). To obtain information on their sexual function, a self-administered standardized questionnaire was filled out before therapy as well as after 12 weeks of treatment. Before therapy, different aspects of sexual life were considered not normal in 25.3-45.6% of the cases. This improved significantly after treatment. Patients most likely to benefit were women, patients with an OAB and subjective responders. The aspects of sexual life which mostly improved were overall satisfaction, libido and the frequency of sexual activities. Sexual dysfunction is observed in a lot of patients with lower urinary tract disorders and may improve on successful therapy for the latter.

Sclerotherapy of the gallbladder in pigs. Development of a balloon catheter for a single-step procedure.

Gallbladder sclerotherapy after permanent cystic duct occlusion, to prevent gallstone recurrence in nonsurgical gallstone therapy, is at least a two-stage procedure. A balloon catheter was developed to perform gallbladder sclerotherapy with only temporary occlusion of the cystic duct, and the efficacy and safety of this method was subsequently investigated. Twenty pigs underwent cholecystostomy for positioning of a 7-Fr triple-lumen balloon catheter with proximal side holes. Sclerotherapy with 96% ethanol and 3% sodium tetradecyl sulfate for 20 minutes was performed. The animals were killed 24 hours, two, six, and 12 weeks after the procedure. The balloon catheter functioned well and seems suitable for procedures in which a temporary occlusion of the cystic duct is required. Although gallbladders after six and 12 weeks were shrunken and fibrotic, a single treatment of gallbladder sclerotherapy with subsequent catheter removal and no permanent cystic duct occlusion, as performed in this experiment, did not produce complete gallbladder ablation. In this study, sclerotherapy proved safe in the short term, but long-term effects remain to be assessed.

Biliary extracorporeal shockwave lithotripsy: short-term and long-term observations in an animal model.

The short- and long-term effects of biliary extracorporeal shockwave lithotripsy (ESWL) using an electromagnetic lithotriptor were investigated in 26 pigs. After implantation of single human gallstones into their gallbladders, all but 4 control pigs were subjected to 4,000 or 8,000 shock waves and killed one day (n = 9), one week (n = 7), or one year (n = 6) thereafter. Post-ESWL, no abnormalities of chest radiographs or laboratory tests were detected. Apart from focal injury of the gallbladder and liver, in 4 out of 9 pigs subpleural pulmonary hemorrhages were found one day post-ESWL. However, tissue damage was largely reversed within one week and after one year only small hepatic scars persisted as permanent damage. Stone fragmentation occurred in 19 (86%) out of 22 pigs, and was adequate (fragments < or = 5 mm) in 9 (41%) pigs. Tissue damage and stone fragmentation after 4,000 as compared with 8,000 shock waves were not significantly different. These data warrant further evaluation of this lithotriptor in human studies.

[Shock wave lithotripsy of gallbladder stones: the initial 54 patients treated in Rotterdam-Dijkzigt]. / Schokgolfvergruizing van stenen in de galblaas; de eerste 54 in Rotterdam-Dijkzigt behandelde patiënten.

From April 1988 till May 1990 54 patients with symptomatic gallbladder stones were treated in the University Hospital Rotterdam-Dijkzigt with extracorporeal shock wave lithotripsy (ESWL) followed by oral administration of bile acids (urso- and chenodeoxycholic acid). These patients on average underwent 2 sessions of ESWL with an electromagnetic lithotriptor (Lithostar and Lithostar Plus, Siemens AG, Erlangen, FRG). Ultimate disintegration of stones was achieved in 50/54 (93%) patients. The best results were achieved in patients with a solitary gallstone (56% of these patients were stone-free 12 months after ESWL). Four per cent of the patients with 2-10 stones were free of stones 12 months after ESWL). Thirty-seven per cent of the patients suffered from biliary colics after ESWL and three patients developed pancreatitis. The administration of oral bile acids were complicated by transient diarrhoea in 20% of the patients. ESWL followed by oral bile acid therapy is a relatively effective and safe therapy for a highly selected population of patients with gallbladder stones.

Prognostic factors for successful percutaneous tibial nerve stimulation.

OBJECTIVE: In sacral as well as tibial nerve stimulation test stimulation is the main prognostic factor for success. In our study we tried to identify prognostic patient characteristics to improve patient selection for neuromodulation therapy. METHODS: PTNS was applied to 132 patients in 8 study centers (51 men, 81 women, mean age of 53 years (range: 21-82)). 83 patients were treated for overactive bladder, 16 for non-obstructive urinary retention and 33 for chronic pelvic pain. All patients had to fill out micturition or pain diaries, as well as quality of life questionnaires before and after treatment. Patient characteristics were evaluated for their prognostic value for successful outcome of neuromodulation therapy with use of logistic regression. RESULTS: Objective success was seen in 32.6% of patients, subjective success in 51.5%. Most evaluated clinical parameters proved not to be of prognostic value. A history of sexual and/or physical abuse was found in 12 of 103 interviewed patients, but did not alter PTNS treatment outcome. However, a low total score at baseline in the SF-36 questionnaire proved to be predictive for not obtaining objective (OR 0.444 [95% CI: 0.198-0.996], p = 0.04) or subjective success (OR 0.424 [CI: 0.203-0.887], p = 0.02). Especially patients with a low SF-36 Mental Component Summary were prone to fail neuromodulation therapy: OR 0.123 (95% CI: 0.273-0.552), p = 0.006 for objective success. These patients also scored worse on disease-specific quality of life questionnaires, although they had no different disease severity compared to patients with good mental health. CONCLUSION: Bad mental health as measured with the SF-36 Mental Component Summary does not depend on symptom severity and is a negative predictive factor for success of percutaneous tibial nerve stimulation. It therefore might be used as a tool for better patient selection in neuromodulation therapy.

Dissolution of gallstones.

Gallstones represent a major health problem in western society. For symptomatic gallstones, cholecystectomy is the gold standard. A considerable number of patients, however, cannot tolerate or are unwilling to undergo surgery and anaesthesia. For these patients, dissolution therapy, administered either systemically ('oral dissolution') or directly into the gallbladder ('contact dissolution'), might be preferable. In this review, the possibilities and limitations of dissolution therapy are discussed. It is concluded that dissolution is a good alternative in selected symptomatic patients and that it is useful as adjuvant therapy after lithotripsy (ESWL) of gall-bladder stones.

In vivo assessment of shock-wave pressures. Implication for biliary lithotripsy.

During extracorporeal shock-wave lithotripsy, the pressure profile, which is generated by the lithotriptor, determines the risk of tissue damage. In the present study, the pressure distribution of a lithotriptor (Lithostar; Siemens A.G., Erlangen, Federal Republic of Germany) was investigated in 10 pigs, five of which had gallstones surgically implanted into the gallbladder. The in vivo values were compared with in vitro data. Measurements were carried out along the shock-wave transmission path at the focus within the gallbladder, the adjacent liver, the diaphragmatic surface of the right lung, and the shock-wave exit site from the skin. Interposition of ribs did not cause a significant decrease in focal positive pressure. However, a gallstone positioned in the focus caused a 30%-65% reduction in pressure, recorded immediately behind the stone. Pressures obtained in vivo were always 15%-25% lower than those measured in vitro. The spatial distributions of the positive pressure in vivo and in vitro were almost identical. There was a high correlation between the pressures in vitro and in vivo (r = 0.88; P less than or equal to 0.01). This justifies assessment of shock-wave energies generated during biliary lithotripsy by extrapolation of in vitro data. It is concluded that it is possible to characterize different lithotriptors by in vitro pressure profile measurements.

In vitro comparison of different gall stone dissolution solvents.

Extracorporeal shockwave lithotripsy (ESWL) of gall bladder stones leaves residual fragments that need to be dissolved by chemical solvents. In this study we compared the in vitro dissolving capacity of methyl tert-butyl ether (MTBE), mono-octanoin, limonene, and limonene/mono-octanoin (70%/30%). From nine sets of five human gall stones obtained at cholecystectomy, four stones were used for dissolution and the fifth was used for chemical analysis of cholesterol, calcium, and bilirubin contents. Eight sets were cholesterol stones with a mean (SD) cholesterol content of 89.9 (5.6)%. These stones dissolved completely in either solvent, often leaving sand-like debris, with the exception of one stone. MTBE dissolved cholesterol gall stones 100 times faster than mono-octanoin and 10 times faster than limonene or the limonene/mono-octanoin mixture (p less than 0.001). The combination of limonene and mono-octanoin was as effective as limonene alone. Of the four solvents, MTBE is the best one to evaluate for dissolution of residual fragments after ESWL treatment of gall bladder stones.

Electromagnetic shock wave lithotripsy of gallbladder stones: a wide range of inclusion criteria.

From April 1988 until November 1990, 83 patients with symptomatic gallbladder stones were treated in the University Hospital "Dijkzigt" Rotterdam with extracorporeal shock wave lithotripsy (ESWL) followed by oral administration of bile acids (urso- and chenodeoxycholic acid). According to our inclusion criteria, patients with up to 10 stones without any limit to the size of the stone(s) were accepted for treatment. On average, these patients underwent two sessions of ESWL with an electromagnetic lithotriptor (Lithostar and Lithostar Plus, Siemens AG, Erlangen, Germany). Fragmentation of stones was achieved in 70/83 (84% patients). The best results were achieved in patients with a solitary gallstone (50% of these patients were stone-free 12 months after ESWL). Four percent of the patients with two to three stones, and 12% of the patients with four to 10 stones were free of stones 12 months after ESWL. Twenty-eight (34%) patients suffered from biliary colics after ESWL, and three patients (3.5%) developed pancreatitis. The administration of oral bile acids was complicated by transient diarrhoea in 15 (18%) patients. ESWL followed by oral bile acid therapy is a relatively effective and safe therapy for a highly select population of patients with gallbladder stones, which can be performed on an outpatient basis. Although the results for multiple stones were poor, the usage of wide inclusion criteria (up to 10 stones of any size) did not affect the success rate of ESWL for multiple stones.

Extracorporeal shockwave lithotripsy of gallstones. Possibilities and limitations.

Recently extracorporeal shockwave lithotripsy (ESWL) has been introduced as a nonoperative treatment for gallstone disease. Except for lung damage, no significant adverse effects of ESWL of gallbladder stones have been observed in animals. In clinical use ESWL of gallbladder stones is now confined to 15% to 30% of symptomatic patients. To achieve complete stone clearance, ESWL of gallbladder stones must be supplemented by an adjuvant therapy. ESWL of bile duct stones is highly effective and can be considered in patients in whom primary endoscopic or surgical stone removal fails. Second generation lithotriptors allow anesthesia-free (outpatient) treatments, but the clinical experience with most of these ESWL devices is still limited. The likelihood of gallbladder stone recurrence is a major disadvantage of ESWL treatment, which raises the issue of cost-effectiveness. ESWL for cholelithiasis is a promising treatment modality with good short-term and unknown long-term results.

Electromagnetic shock wave lithotripsy of gallbladder stones in vitro: the role of different stone characteristics and treatment variables.

From 40 sets of five human gallstones obtained at cholecystectomy, four stones were subjected to either 125/250 (maximum generator output) or 250/500 (half maximum generator output) electromagnetic shock waves (treatments I/II and III/IV, respectively); the fifth stone was used for computed tomography (CT) and chemical analysis. Overall, 130 (81%) of 160 stones fragmented, including 72 (45%) adequately (fragments less than or equal to 5 mm). For the treatments I, II, III, and IV the overall fragmentation rates were 80%, 95%, 70%, and 80%, respectively. The corresponding percentages of adequate fragmentation ( less than or equal to 5 mm) were 38%, 70%, 30%, and 42%, respectively. The best results were thus obtained after application of 250 shock waves (maximum generator output; treatment II). Pure cholesterol stones (p less than 0.01), stones with a mean CT density less than or equal to 110 HU (p less than 0.001), and stones with a calcified rim (p < 0.05) fragmented significantly better, but adequate fragmentation ( less than or equal to 5 mm) was significantly determined by stone weight and diameter (p less than 0.001), bilirubin content (p less than 0.02), and calcium content (p less than 0.05). A weight greater than 500 mg and a diameter > 10 mm could be defined as stone characteristics with significant negative predictors of adequate fragmentation. However, because the experimental conditions in this in vitro study did not completely simulate clinical settings for various reasons, these observations must be interpreted accordingly.(ABSTRACT TRUNCATED AT 250 WORDS)

Methyl tert-butyl ether improves the efficacy of extracorporeal shock wave lithotripsy of human gallstones implanted in pigs.

OBJECTIVE: To investigate the contribution of contact dissolution with methyl tert-butyl ether (MTBE) to the success of extracorporeal shock wave lithotripsy (ESWL) of human gallstones implanted in pigs. DESIGN: Experimental study of matched pairs. SETTING: Laboratory for experimental surgery, The Netherlands. MATERIAL: 30 pigs. INTERVENTIONS: Couples of similar human gallstones were surgically implanted into the gallbladders of 30 pigs. All pigs underwent ESWL with an electromagnetic lithotriptor. Half the animals were given adjuvant treatment with MTBE for 2 hours immediately after the ESWL. All pigs were killed a week after treatment. RESULTS: Adjuvant MTBE dissolution led to superimposed damage of the gallbladder. One pig died of biliary leakage and peritonitis. For all kinds of stones, adjuvant MTBE treatment increased the median (range) percentage of stone dissolved by ESWL from 31 (0-58) to 60 (11-81) (p < 0.01), whereas for pure cholesterol stones the increase was from 23 (0-58) to 61 (11-81) (p < 0.01). CONCLUSIONS: These data warrant clinical evaluation of the applicability of combined ESWL and MTBE dissolution of symptomatic gallstones in selected patients.

Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction.

PURPOSE: Recently, intermittent percutaneous posterior tibial nerve stimulation was introduced as a treatment modality filling the gap between conservative and surgical therapies in patients with certain types of lower urinary tract dysfunction. MATERIALS AND METHODS: In a prospective multicenter trial posterior tibial nerve stimulation was evaluated in 37 patients who presented with symptoms of bladder overactivity, that is the urgency and frequency syndrome and/or urge incontinence, and 12 with nonobstructive urinary retention. Results were recorded in voiding diaries and on quality of life questionnaires before and after treatment. Patients were classified as responders, including those in whom therapy was successful and chose to continue treatment after the initial 12 weeks, and nonresponders, those who chose to stop treatment. RESULTS: Overall, a positive response was seen in 60% of all patients. In patients with bladder overactivity a statistically significant decrease was observed in leakage episodes, number of pads used, voiding frequency and nocturia, and an equal increase in mean and smallest volume voided. Improvements were also seen in nonobstructive urinary retention, including number of catheterizations, total and mean volume catheterized, and total and mean volume voided. Disease specific quality of life and some domains of general quality of life improved, especially of bladder overactivity. Only mild side effects were observed. CONCLUSIONS: Posterior tibial nerve stimulation is a minimally invasive and successful treatment option for patients with certain types of lower urinary tract dysfunction.