Effect of home-based online training and activity feedback on oxygen uptake in patients after surgical cancer therapy: a randomized controlled trial.

BACKGROUND: Exercise training is beneficial in enhancing physical function and quality of life in cancer patients. Its comprehensive implementation remains challenging, and underlying cardiopulmonary adaptations are poorly investigated. This randomized controlled trial examines the implementation and effects of home-based online training on cardiopulmonary variables and physical activity. METHODS: Of screened post-surgical patients with breast, prostate, or colorectal cancer, 148 were randomly assigned (1:1) to an intervention (2 × 30 min/week of strength-endurance training using video presentations) and a control group. All patients received activity feedback during the 6-month intervention period. Primary endpoint was change in oxygen uptake after 6 months. Secondary endpoints included changes in cardiac output, rate pressure product, quality of life (EORTC QoL-C30), C-reactive protein, and activity behavior. RESULTS: One hundred twenty-two patients (62 intervention and 60 control group) completed the study period. Change in oxygen uptake between intervention and control patients was 1.8 vs. 0.66 ml/kg/min (estimated difference after 6 months: 1.24; 95% CI 0.23 to 2.55; p = 0.017). Rate pressure product was reduced in IG (estimated difference after 6 months: - 1079; 95% CI - 2157 to - 1; p = 0.05). Physical activity per week was not different in IG and CG. There were no significant interaction effects in body composition, cardiac output, C-reactive protein, or quality of life. CONCLUSIONS: Home-based online training among post-surgery cancer patients revealed an increase of oxygen uptake and a decrease of myocardial workload during exercise. The implementation of area-wide home-based training and activity feedback as an integral component in cancer care and studies investigating long-term effects are needed. TRIAL REGISTRATION: DRKS-ID: DRKS00020499 ; Registered 17 March 2020.

Robot-assisted pyeloplasty for ureteropelvic junction obstruction: initial experience with the novel avatera system.

PURPOSE: This pilot study was designed to interpret the technically specific features of the avatera robotic system and present our initial experience with this novel platform in robot-assisted pyeloplasty (RAP). METHODS: A single-center prospective study was conducted including all patients who underwent RAP with the avatera robotic system from June 2022 to October 2022 in our Department. Transperitoneal robot-assisted dismembered pyeloplasty was performed in all cases. The trocar placement and the surgical technique were similar in all patients. The successful completion of the procedures, operation time (including draping, docking and console time), decrease in hemoglobin postoperatively, and presence of any complications were the study's primary endpoints. RESULTS: In total, nine patients underwent RAP using the avatera system. All procedures were successfully completed. The draping of the robotic unit was completed in a median time of 10 min (range 7-15), while the median docking time was 17 min (range 10-24). The median console time was 88 min (range 78-116) and no complications were noticed. The median hemoglobin drop was calculated to 0.7 g/dL (range 0.4-1). During the mean follow-up of 9.33 ± 2.78 months, no late postoperative complications were noticed. CONCLUSION: The early outcomes of the use of the novel avatera system in RAP are presented. All operations were successfully completed with safety and efficacy, without complications or significant blood loss.

Systematic assessment of monogenic etiology in adult-onset kidney stone formers undergoing urological intervention-evidence for genetic pretest probability.

Kidney stone disease (KSD) is a prevalent condition associated with high morbidity, frequent recurrence, and progression to chronic kidney disease (CKD). The etiology is multifactorial, depending on environmental and genetic factors. Although monogenic KSD is frequent in children, unbiased prevalence data of heritable forms in adults is scarce. Within 2 years of recruitment, all patients hospitalized for urological kidney stone intervention at our center were consecutively enrolled for targeted next generation sequencing (tNGS). Additionally, clinical and metabolic assessments were performed for genotype-phenotype analyses. The cohort comprised 155 (66%) males and 81 (34%) females, with a mean age at first stone of 47 years (4-86). The diagnostic yield of tNGS was 6.8% (16/236), with cystinuria (SLC3A1, SLC7A9), distal renal tubular acidosis (SLC4A1), and renal phosphate wasting (SLC34A1, SLC9A3R1) as underlying hereditary disorders. While metabolic syndrome traits were associated with late-onset KSD, hereditary KSD was associated with increased disease severity in terms of early-onset, frequent recurrence, mildly impaired kidney function, and common bilateral affection. By employing systematic genetic analysis to a less biased cohort of common adult kidney stone formers, we demonstrate its diagnostic value for establishing the underlying disorder in a distinct proportion. Factors determining pretest probability include age at first stone (<40 years), frequent recurrence, mild CKD, and bilateral KSD.

Quality of life after robotic-assisted and laparoscopic radical prostatectomy: Results of a multicenter randomized controlled trial (LAP-01).

BACKGROUND: To explore cross-sectional and longitudinal differences in general health-related and prostate cancer-specific quality of life (QoL) after robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy and to analyze predictive variables for QoL outcomes. METHODS: In this multicenter, randomized controlled trial, prostate cancer patients were randomly assigned 3:1 to undergo either RARP or LRP. Patient-reported outcomes were prospectively collected before and 1, 3, 6, 12 months after radical prostatectomy and included QoL as a secondary outcome. Validated questionnaires were used to assess general health-related (EORTC QLQ-C30) and prostate cancer-specific (QLQ-PR25) QoL. Cross-sectional and longitudinal contrasts were analyzed through linear mixed models. Predictive variables for QoL outcomes were identified by general linear modeling. RESULTS: Of 782 randomized patients, QoL was evaluable in 681 patients. In terms of general QoL, the cross-sectional analysis showed only small differences between study arms, whereas longitudinal comparison indicated an advantage of RARP on recovery: RARP patients reported an earlier return to baseline in global health status (3 vs. 6 months) and social functioning (6 vs. 12 months). In role functioning, only the RARP arm regained baseline scores. Regarding prostate-specific QoL, LRP patients experienced more urinary symptoms and reported 3.2 points (95% confidence interval 0.4-6, p = 0.024) higher mean scores at 1-month follow-up and in mean 2.9 points (0.1-5, p = 0.042) higher urinary symptoms scores at 3-month follow-up than RARP patients. There were no other significant differences between treatment groups. Urinary symptoms, sexual activity, and sexual function remained significantly worse compared with baseline at all time points in both arms. CONCLUSIONS: Compared with LRP, the robotic approach led to an earlier return to baseline in several domains of general health-related QoL and better short-term recovery of urinary symptoms. Predictive variables such as the scale-specific baseline status and bilateral nerve-sparing were confirmed.

Bilateral Peritoneal Flaps Reduce Incidence and Complications of Lymphoceles after Robotic Radical Prostatectomy with Pelvic Lymph Node Dissection-Results of the Prospective Randomized Multicenter Trial ProLy.

PURPOSE: The purpose of this study was to investigate the effect of a surgically constructed bilateral peritoneal flap (PIF) as an adjunct to robot-assisted radical prostatectomy (RARP) and pelvic lymph node dissection (PLND) on the incidence of lymphoceles. MATERIALS AND METHODS: A total of 530 men with localized prostate cancer underwent a RARP with bilateral extended standardized PLND in a prospective randomized controlled trial. In group A, a PIF was created by suturing the margins of the bladder peritoneum to the ipsilateral endopelvic fascia at 2 points on each side. In group B, no PIF was created. The patients were followed 30 and 90 days after the surgery to assess the incidence, extent and treatment of lymphoceles. RESULTS: Lymphoceles occurred in 22% of group A patients and 33% of group B patients (p=0.008). Symptomatic lymphoceles were observed in 3.3% of group A patients and 8.1% of group B patients (p=0.027). Lymphoceles requiring intervention occurred significantly less frequently in group A patients (1.3%) than in group B patients (6.8%, p=0.002). The median lymphocele size was 4.3 cm in group A and 5.0 cm in group B (p=0.055). No statistically significant differences were observed in minor or major complications unrelated to lymphocele, blood loss, or surgical time between groups A and B. CONCLUSIONS: Bilateral PIFs in conjunction with RARP and PLND significantly reduce the total incidence of lymphoceles, the frequency of symptomatic lymphoceles and the rate of associated secondary interventions.

Age-stratified outcomes after radical prostatectomy in a randomized setting (LAP-01): do younger patients have more to lose?

OBJECTIVE: Age is known to have an impact on outcomes after radical prostatectomy (RP). However, age differences can be investigated from a cross-sectional as well as from a longitudinal perspective. This study combines both perspectives. MATERIALS AND METHODS: LAP-01 is the first multicenter randomized patient blinded trial comparing outcomes after robotic-assisted and laparoscopic RP. This study stratified the entire population that received nerve-sparing surgery and was potent at baseline by the following ages: ≤ 60 years, 61-65 years, and > 65 years. Potency was assessed using the IIEF-5. The EORTC QLQ-C30 was used for global health perception and the EORTC QLQ-PR25 for urinary symptoms. Continence was assessed by the number of pads used. Longitudinal change was assessed using either validated anchor-based criteria or the 1 or 0.5-standard-deviation criterion. Worsening of continence was measured by increasing numbers of pads. RESULTS: 310 patients were included into this study. Older patients had a significantly higher risk for worsening of continence at 3 and 6 months (OR 2.21, 95% CI [1.22, 4.02], p = 0.009 and OR 2.00, 95% CI [1.16, 3.46], p = 0.013, respectively); at 12 months, the odds of worsening did not differ significantly between age groups. Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups. In contrast, global health perception was better in older patients from a cross-sectional perspective and longitudinal decreases were significantly more common among the youngest patients, at 12 months (36.9% vs. 24.4%, p = 0.038). CONCLUSION: From a cross-sectional perspective, function scores were better in younger patients, but from a longitudinal perspective, age differences were found in continence only. In contrast, global health scores were better in older patients from a cross-sectional and longitudinal perspective. TRIAL REGISTRATION: The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.

Quality of life in urologic cancer patients: importance of and satisfaction with specific quality of life domains.

PURPOSE: Quality of life (QoL) has been the subject of increasing interest in oncology. Most examinations of QoL have focused on health-related QoL, while other factors often remain unconsidered. Moreover, QoL questionnaires implicitly assume that the subjective importance of the various QoL domains is identical from one patient to the next. The aim of this study was to analyze QoL in a broader sense, considering the subjective importance of the QoL components. METHODS: A sample of 173 male urologic patients was surveyed twice: once while hospitalized (t1) and once again 3 months later (t2). Patients completed the Questions on Life Satisfaction questionnaire (FLZ-M), which includes satisfaction and importance ratings for eight dimensions of QoL. A control group was taken from the general population (n = 477). RESULTS: Health was the most important QoL dimension for both the patient and the general population groups. While satisfaction with health was low in the patient group, the satisfaction ratings of the other seven domains were higher in the patient group than in the general population. The satisfaction with the domain partnership/sexuality showed a significant decline from t1 to t2. Multiple regression analyses showed that the domains health and income contributed most strongly to the global QoL score at t2 in the patient group. CONCLUSION: Health is not the only relevant category when assessing QoL in cancer patients; social relationships and finances are pertinent as well. Importance ratings contribute to a better understanding of the relevance of the QoL dimensions for the patients.

Predictors of psychiatric comorbidity in cancer patients at the time of their discharge from the hospital.

PURPOSE: A cancer diagnosis can have a substantial impact on one's mental health. The present study investigated the prevalence and predictors of psychiatric comorbidities in cancer patients at the time of their discharge from the hospital. METHODS: Psychiatric comorbidities were assessed shortly before hospital discharge and half a year after hospitalization using a structured clinical interview (SCID), based on the diagnostic and statistical manual of mental disorders (DSM-IV). Frequencies at both time points were estimated using percentages and corresponding 95% confidence intervals. Predictors of mental disorders were identified using binary logistic regression models. RESULTS: At time of hospital discharge, 39 out of 334 patients (12%) were diagnosed with a psychiatric comorbidity, and 15 (7%) were diagnosed half a year later. Among the diagnoses, adjustment disorders (3%) were most frequent at the time of hospital release, while major depression (3%) was the most frequent 6 months later. Having a mental disorder was associated with unemployment (odds ratio (OR) 3.4, confidence interval (CI) 1.1-10.9, p = 0.04). There was no evidence that school education (OR 2.0, CI 0.4-9.0, p = 0.38), higher education (OR 0.7, CI 0.2-2.4, p = 0.60), income (OR 1.0, CI 1.0-1.0, p = 0.06), tumor stage (OR 1.1, CI 0.4-3.2, p = 0.85), type of disease (OR 0.6, CI 0.2-2.1, p = 0.47), pain (OR 1.0, CI 1.0-1.0, p = 0.15), fatigue (OR 1.0, CI 1.0-1.0, p = 0.77), or physical functioning (OR 1.0, CI 1.0-1.0, p = 0.54) were related to the presence of a psychiatric comorbidity. CONCLUSIONS: Unemployment was associated with at least a threefold increased risk of mental disorder, which highlights the need for special attention to be given to this subgroup of cancer patients.

Extended Pelvic Lymph Node Dissection Does Not Affect Functional Outcomes during Bilateral Nerve-Sparing Radical Prostatectomy.

INTRODUCTION: A possible association between extended pelvic lymph node dissection (ePLND) in radical prostatectomy (RPE) and functional outcomes such as erectile function (EF) and continence recovery has been previously considered. This association stems from the direct proximity of ePLND to the pelvic plexus. In this paper, we aimed to critically examine an association of ePLND with functional outcomes in patients who underwent bilateral nerve-sparing RPE. METHODS: 272 out of 782 patients from a randomized, patient-blinded, multicenter trial were retrospectively classified into two groups based on the D'Amico criteria: 114 had no PLND and 158 had ePLND. Continence (no pad/safety pad) and EF (Index of Erectile Function-5 [IIEF-5] questionnaire ≥17; sufficient erection for sexual intercourse) were assessed at 3, 6, and 12 months as well as postsurgical complications (Clavien-Dindo Classification). RESULTS: After 12 months of follow-up, no significant difference for potency could be found between men without and subjected to ePLND: IIEF-5 ≥17 (23.2% vs. 27.2%; p = 0.55) and sufficient erection for intercourse (44.1% vs. 45.6%; p = 0.84). A multiple linear regression analysis demonstrated that while preoperative EF (p < 0.001), pathological tumor stage (p = 0.027), and robot-assisted bilateral nerve-sparing RPE (p < 0.001) were independent predictors of EF recovery, the same did not apply to ePLND. No association was detected for continence recovery (94.2% vs. 89.7%; p = 0.22) and complications of any grade after surgery (11.4% vs. 16.5%; p = 0.24). CONCLUSION: ePLND is not associated with increased risk of erectile dysfunction, incontinence or complications after bilateral nerve-sparing RPE.

[Beyond Content Alone: What Cancer Patients Consider as Important in Professional Psychosocial Support]. / Mehr als Inhalte: Was KrebspatientInnen bei professioneller psychosozialer Unterstützung wichtig ist.

OBJECTIVE: In this study we wanted to find out what cancer patients expect from professional psychosocial support. METHODS: Within a multicenter prospective study, patients were asked about their expectations from professional psychosocial support two years after diagnosis. Using qualitative methods, categories were built from the answers. The answers were assigned to the categories. RESULTS: 447 patients were contacted and 285 answers were obtained. Getting information as well as interaction with enough time for listening was considered as important. Support should result in enhancement of psychological strength. DISCUSSION: Apart from contents, aspects of how support is given such as attention and competence are important. There should be enough time for the consideration of individual needs. CONCLUSION: Both getting information and competence as well as listening and personal conversation are important.

Surgical Reintervention Rates after Invasive Treatment for Lower Urinary Tract Symptoms due to Benign Prostatic Syndrome: A Comparative Study of More than 43,000 Patients with Long-Term Followup.

PURPOSE: No large-scale comparison of the 4 most established surgical approaches for lower urinary tract symptoms due to benign prostate obstruction in terms of long-term efficacy is available. We compared photoselective vaporization, laser enucleation and open simple prostatectomy to transurethral resection with regard to 5-year surgical reintervention rates. MATERIALS AND METHODS: A total of 43,041 male patients with lower urinary tract symptoms who underwent transurethral resection (34,526), photoselective vaporization (3,050), laser enucleation (1,814) or open simple prostatectomy (3,651) between 2011 and 2013 were identified in pseudonymized claims and core data of the German local health care funds and followed for 5 years. Surgical reinterventions for lower urinary tract symptoms, urethral stricture or bladder neck contracture were evaluated. Surgical approach was related to reintervention risk using the Kaplan-Meier method and Cox proportional hazards models. RESULTS: A total of 5,050 first reinterventions were performed within 5 years of primary surgery (Kaplan-Meier survival without reintervention: 87.5%, 95% CI 87.2%-87.8%). Photoselective vaporization carried an increased hazard of reintervention (HR 1.31, 95% CI 1.17-1.46, p <0.001) relative to transurethral resection, open simple prostatectomy carried a lower hazard (HR 0.43, 95% CI 0.37-0.50, p <0.001) and laser enucleation of the prostate did not differ significantly (HR 0.84, 95% CI 0.66-1.08, p=0.2). This pattern was more pronounced regarding reintervention for lower urinary tract symptom recurrence (photoselective vaporization: HR 1.52, 95% CI 1.35-1.72, p <0.001; laser enucleation of the prostate: HR 0.84, 95% CI 0.63-1.14, p=0.3; open simply prostatectomy: HR 0.38, 95% CI 0.31-0.46, p <0.001 relative to transurethral resection). CONCLUSIONS: Five-year reintervention rates of transurethral resection and laser enucleation did not differ significantly, while photoselective vaporization had a substantially higher rate. Open simple prostatectomy remains superior to transurethral resection with respect to long-term efficacy.

Individualised positive end-expiratory pressure guided by electrical impedance tomography for robot-assisted laparoscopic radical prostatectomy: a prospective, randomised controlled clinical trial.

BACKGROUND: Robot-assisted laparoscopic radical prostatectomy requires general anaesthesia, extreme Trendelenburg positioning and capnoperitoneum. Together these promote impaired pulmonary gas exchange caused by atelectasis and may contribute to postoperative pulmonary complications. In morbidly obese patients, a recruitment manoeuvre (RM) followed by individualised PEEP improves intraoperative oxygenation and end-expiratory lung volume (EELV). We hypothesised that individualised PEEP with initial RM similarly improves intraoperative oxygenation and EELV in non-obese individuals undergoing robot-assisted prostatectomy. METHODS: Forty males (age, 49-76 yr; BMI <30 kg m-2) undergoing prostatectomy received volume-controlled ventilation (tidal volume 8 ml kg-1 predicted body weight). Participants were randomised to either (1) RM followed by individualised PEEP (RM/PEEPIND) optimised using electrical impedance tomography or (2) no RM with 5 cm H2O PEEP. The primary outcome was the ratio of arterial oxygen partial pressure to fractional inspired oxygen (Pao2/Fio2) before the last RM before extubation. Secondary outcomes included regional ventilation distribution and EELV which were measured before, during, and after anaesthesia. The cardiovascular effects of RM/PEEPIND were also assessed. RESULTS: In 20 males randomised to RM/PEEPIND, the median PEEPIND was 14 cm H2O [inter-quartile range, 8-20]. The Pao2/Fio2 was 10.0 kPa higher with RM/PEEPIND before extubation (95% confidence interval [CI], 2.6-17.3 kPa; P=0.001). RM/PEEPIND increased end-expiratory lung volume by 1.49 L (95% CI, 1.09-1.89 L; P<0.001). RM/PEEPIND also improved the regional ventilation of dependent lung regions. Vasopressor and fluid therapy was similar between groups, although 13 patients randomised to RM/PEEPIND required pharmacological therapy for bradycardia. CONCLUSION: In non-obese males, an individualised ventilation strategy improved intraoperative oxygenation, which was associated with higher end-expiratory lung volumes during robot-assisted laparoscopic prostatectomy. CLINICAL TRIAL REGISTRATION: DRKS00004199 (German clinical trials registry).

Mechanosensitivity Is a Characteristic Feature of Cultured Suburothelial Interstitial Cells of the Human Bladder.

Bladder dysfunction is characterized by urgency, frequency (pollakisuria, nocturia), and dysuria and may lead to urinary incontinence. Most of these symptoms can be attributed to disturbed bladder sensitivity. There is growing evidence that, besides the urothelium, suburothelial interstitial cells (suICs) are involved in bladder afferent signal processing. The massive expansion of the bladder during the filling phase implicates mechanical stress delivered to the whole bladder wall. Little is known about the reaction of suICs upon mechanical stress. Therefore, we investigated the effects of mechanical stimulation in cultured human suICs. We used fura-2 calcium imaging as a major physiological readout. We found spontaneous intracellular calcium activity in 75 % of the cultured suICs. Defined local pressure application via a glass micropipette led to local increased calcium activity in all stimulated suICs, spreading over the whole cell. A total of 51% of the neighboring cells in a radius of up to 100 µm from the stimulated cell showed an increased activity. Hypotonic ringer and shear stress also induced calcium transients. We found an 18-times increase in syncytial activity compared to unstimulated controls, resulting in an amplification of the primary calcium signal elicited in single cells by 50%. Our results speak in favor of a high sensitivity of suICs for mechanical stress and support the view of a functional syncytium between suICs, which can amplify and distribute local stimuli. Previous studies of connexin expression in the human bladder suggest that this mechanism could also be relevant in normal and pathological function of the bladder in vivo.

IC/BPS-associated alterations of M2 and M3 muscarinic acetylcholine receptor trafficking in human detrusor.

AIMS: To explore caveolae- and clathrin-mediated internalization of muscarinic M2 and M3 receptors, recycling and degradation in formalin-fixed paraffin-embedded detrusor sections; to study alterations possibly involved in the pathophysiology of the bladder functional disorder, interstitial cystitis/bladder pain syndrome (IC/BPS). MATERIALS AND METHODS: Samples of IC/BPS (n = 11) and cystectomy patients (n = 11) were analyzed. Proximity ligation assay (PLA) was used to detect interactions of M2 and M3 with endocytotic regulators (Cav-1, clathrin, Rab7, and Rab11) by Cy3 labeling. Analyses of three-dimensional (3D)-reconstructed z-stacks (63 × Oil 1.4) were done with Huygens software. We determined the object density for quantification and assessed membrane localization. RESULTS: Receptor/protein complexes were detected as well-demarcated 3D objects. Interactions of M2 with Cav-1, clathrin, Rab11, and Rab7 were significantly increased in IC/BPS. M3/clathrin and M3/Rab11 complexes were higher in IC/BPS, while M3/Cav-1 and M3/Rab7 were not. A significant shift of complexes from the membrane to cytoplasm was observed in conjunction with increased internalization via clathrin vesicles or caveolae in IC/BPS. CONCLUSIONS: High numbers of M3/clathrin and M3/Rab11 complexes reflect the well-documented clathrin-mediated desensitization of M3 and speak in favor with enhanced receptor protein expression in IC/BPS. Increased amounts of M2/Cav-1, M2/clathrin, and M2/Rab11 complexes represent altered M2 internalization and recycling leading to high abundance in IC/BPS. In this regard, caveolae-localized M2 could be possibly associated with the activation of nitric oxide (NO) synthase and NO production.

The association of socioeconomic status with quality of life in cancer patients over a 6-month period using individual growth models.

PURPOSE: Studies examining longitudinal associations between socioeconomic factors and quality of life (QoL) in cancer patients are rare. This study investigates changes in QoL over a 6-month period. METHODS: Four hundred forty-two cancer patients (mean age 64, SD = 11, 70% male) completed standardized questionnaires at the beginning (t1) and end (t2) of their hospital stay and 3 (t3) and 6 months (t4) thereafter. QoL was assessed with the EORTC QLQ-C30 core questionnaire. Mixed effect models were employed to analyze individual changes in QoL in relation to socioeconomic status (education, income, job status) over the four timepoints. Age, sex, cohabitation, disease and treatment factors, and comorbidity were included as covariates in the models. RESULTS: Income was a predictive factor for QoL. Patients with a low income had 8.8 percentage points (PP) lower physical, 4.9 PP lower emotional, and 11.4 PP lower role functioning. They also had 6.6 PP lower global QoL. Lower social functioning (6.2 PP) was found in patients with higher education or university degrees compared with those who were less educated or had not undergone an apprenticeship. Income also influenced trajectories of role functioning. There was no evidence that primary or secondary education and job type were related to QoL. CONCLUSIONS: The fact that income is negatively associated with many aspects of quality of life should be considered during and after treatment with a focus on patients with special needs.

Comparison of various continence definitions in a large group of patients undergoing radical prostatectomy: a multicentre, prospective study.

BACKGROUND: Due to the usage of various measurement methods and definitions, comparing continence rates after radical prostatectomy is a challenging task. This study compares continence rates based on different methods and aims to identify the definition for continence which agrees best with the patients' subjective assessment of continence. Additionally, continence was controlled for multiple influencing factors. METHODS: This prospective multicentre study was carried out in seven hospitals throughout Germany. Before and at 3, 6, and 12 months after surgery self-reporting questionnaires were completed and returned by 329 (84.4%) of 390 eligible patients. The questionnaires were independently evaluated and analysed by a third party. Association of continence with demographic, operative, and tumour factors in an ongoing comprehensive prostate cancer database was evaluated. RESULTS: The continence rate drops substantially for patients undergoing radical prostatectomy but increases again with time. Concrete numbers vary considerably depending on definition - 44% at 3 months and 68% at 12 months after surgery (0 pads) vs. 71 and 90% (0-1 pads). Significant confounding variables regarding continence rate are nerve-sparing procedure, categorized Gleason score, rehabilitative cure treatment, and pelvic floor training. The definition of 0 pads for continence coincides greater than 0-1 pads with the patients' self-assessment of being continent. CONCLUSION: A standardized definition for continence would be desirable, as it is one of the most important preconditions to guarantee sound comparison of continence rates. Since there are enough other factors that make comparison difficult, we suggest using the definition of "0 pads". It is easily measured objectively, leaves no room for interpretation, and agrees best with the patients' self-assessment.

In-bore biopsies of the prostate assisted by a remote-controlled manipulator at 1.5 T.

PURPOSE: To evaluate the technical and clinical utility of a fully MRI-compatible, pneumatically driven remote-controlled manipulator (RCM) for targeted biopsies of the prostate at 1.5 T. MATERIALS AND METHODS: The data of the first 22 patients that were biopsied under robotic assistance were analyzed. Interventional planning relied on T2-weighted (T2w) turbo spin-echo (TSE) images (axial and sagittal) with a high-b-value diffusion-weighted acquisition added in selected cases. Alignment of the needle guide was controlled with a short balanced SSFP sequence in two oblique planes along the MR-visible sheath. Signals were acquired with a combination of elements from a 30-channel body and a 32-channel spine coil. Biopsy samples were taken with a fully automatic 18-G biopsy gun with a length of 150 or 175 mm. RESULTS: Mean age was 66.6 years and average PSA level was 11.5 ng/ml. Fourteen out of 22 patients (63%) had received prior biopsies under transrectal ultrasound guidance. Diagnostic MRI reports (before biopsy) involved 17 cases with a single suspicious finding (four PI-RADS 3, one PI-RADS 3-4, eight PI-RADS 4 and nine PI-RADS 5 cases). The median effective procedure time was 33.9 (range 25.0-55.9) min for 16 cases with one CSR and 63.4 (52.7-81.8) min for 5 cases with two CSRs. The biopsy with three CSRs took 74.0 min. Histopathologic examination revealed prostate cancer in 14 of 22 cases. CONCLUSION: MR-targeted, transrectal biopsy of the prostate could be reliably performed with a robotic manipulator at a field strength of 1.5 T. Balanced SSFP imaging is considered a viable option for fast procedural control. Follow-up work needs to evaluate to what extent in-bore adjustments and workflow enhancements will contribute to shorter procedure times or higher patient comfort.

Response shift effects in the assessment of urologic cancer patients' quality of life.

OBJECTIVE: Urologic cancer patients often assess their quality of life (QoL) as being relatively good. Response shift (change in internal standards) may be one reason for that effect. The aim of this study was to test such response shift effects. METHODS: A sample of 197 male urologic cancer patients was tested while hospitalised (t1) and three months later (t2). The participants had to assess their current health state and the health state of two anchoring vignettes. They also completed the EORTC QLQ-C30 and PHQ-4 questionnaires, including a retrospective thentest. The control sample was comprised of members of the general population. RESULTS: The patients rated their general health as being worse than people from the general population did (effect size: d = 0.73, p < 0.001). Moreover, the patients assessed the vignette presenting physical problems as being significantly healthier than people from the general population did (d = 0.42, p < 0.001). Under the retrospective thentest condition, the patients rated their QoL and their mental burden as being significantly worse than in the pre-test condition. Both methods showed response shift effects. CONCLUSION: Urologic cancer patients' assessments of their QoL should be handled with caution because of possible shifts in their internal standards of judgement.

Prospective Multicenter Phase II Study on Focal Therapy (Hemiablation) of the Prostate with High Intensity Focused Ultrasound.

PURPOSE: We evaluated focal therapy with high intensity focused ultrasound hemiablation in a prospective trial. MATERIALS AND METHODS: We performed a prospective, multicenter, single arm study in patients with unilateral low/intermediate risk prostate cancer who were treated from April 2013 through March 2016 in Germany in AUO (Arbeitsgemeinschaft Urologische Onkologie) Study Protocol AP 68/11. Unilateral prostate cancer was assessed by transrectal ultrasound guided biopsy and multiparametric magnetic resonance imaging. Hemiablation was done using the Ablatherm® or the Focal One® device. The oncologic outcome was assessed by the salvage treatment rate, multiparametric magnetic resonance imaging and rebiopsy at 12 months. Functional outcome, quality of life, anxiety and depression were measured by validated questionnaires at baseline and every 3 months. RESULTS: Of the 54 recruited patients 51 completed 12-month or greater visits. Mean ± SD followup was 17.4 ± 4.5 months. Mean prostate specific antigen decreased from 6.2 ± 2.0 to 2.9 ± 1.9 ng/ml at 12 months (p <0.001). Biopsy at 12 months was positive for any prostate cancer and for clinically significant prostate cancer in 13 (26.5%) and 4 (8.2%) of the 49 patients, respectively. Posttreatment multiparametric magnetic resonance imaging had limited 25% sensitivity for clinically significant prostate cancer. Ten patients (19.6%) underwent salvage treatment. Potency was maintained in 21 of the 30 men who were potent preoperatively. There was no increase in incontinence. Quality of life, anxiety and depression did not change postoperatively. The study was limited by a short followup and the lack of a control arm. CONCLUSIONS: Focal therapy hemiablation is safe with little alteration of functional outcome. The oncologic outcome is acceptable on short-term followup. Followup multiparametric magnetic resonance imaging performed poorly and should not replace repeat biopsy. Focal therapy has no impact on posttreatment anxiety and depression.