Age-adjusted high-dose chemotherapy followed by autologous stem cell transplantation or conventional chemotherapy with R-MP as first-line treatment in elderly primary CNS lymphoma patients - the randomized phase III PRIMA-CNS trial.

BACKGROUND: Older primary central nervous system lymphoma (PCNSL) patients have an inferior prognosis compared to younger patients because available evidence on best treatment is scarce and treatment delivery is challenging due to comorbidities and reduced performance status. High-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT) after high-dose methotrexate (MTX)-based immuno-chemotherapy has become an increasingly used treatment approach in eligible elderly PCNSL patients with promising feasibility and efficacy, but has not been compared with conventional chemotherapy approaches. In addition, eligibility for HCT-ASCT in elderly PCNSL is not well defined. Geriatric assessment (GA) may be helpful in selecting patients for the best individual treatment choice, but no standardized GA exists to date. A randomized controlled trial, incorporating a GA and comparing age-adapted HCT-ASCT treatment with conventional chemotherapy is needed. METHODS: This open-label, multicenter, randomized phase III trial with two parallel arms will recruit 310 patients with newly diagnosed PCNSL > 65 years of age in 40 centers in Germany and Austria. The primary objective is to demonstrate that intensified chemotherapy followed by consolidating HCT-ASCT is superior to conventional chemotherapy with rituximab, MTX, procarbazine (R-MP) followed by maintenance with procarbazine in terms of progression free survival (PFS). Secondary endpoints include overall survival (OS), event free survival (EFS), (neuro-)toxicity and quality of life (QoL). GA will be conducted at specific time points during the course of the study. All patients will be treated with a pre-phase rituximab-MTX (R-MTX) cycle followed by re-assessment of transplant eligibility. Patients judged transplant eligible will be randomized (1:1). Patients in arm A will be treated with 3 cycles of R-MP followed by maintenance therapy with procarbazine for 6 months. Patients in arm B will be treated with 2 cycles of MARTA (R-MTX/AraC) followed by busulfan- and thiotepa-based HCT-ASCT. DISCUSSION: The best treatment strategy for elderly PCNSL patients remains unknown. Treatments range from palliative to curative but more toxic therapies, and there is no standardized measure to select patients for the right treatment. This randomized controlled trial will create evidence for the best treatment strategy with the focus on developing a standardized GA to help define eligibility for an intensive treatment approach. TRIAL REGISTRATION: German clinical trials registry DRKS00024085 registered March 29, 2023.

High/low-volume center experience predicts outcome of AMS 800 in male stress incontinence: Results of a large middle European multicenter case series.

AIM: To analyze the influence of implantation volume of artificial sphincters (AMS 800) on outcome in a large central European multicenter cohort study. METHODS: As part of the DOMINO (Debates on Male Incontinence) project, the surgical procedures and outcomes were retrospectively analyzed in a total of 473 patients who received an artificial sphincter (AMS 800) between 2010 and 2012. Clinics that implanted at least 10 AMS 800 per year were defined as high-volume centers. RESULTS: Sixteen centers had a mean rate of 9.54 AMS 800/y of which five clinics were identified as high-volume centers. They implanted significantly more double cuffs (55% vs 12.1%; P < .001), used the perineal approach significantly more often (78% vs 67.7%; P = .003) and chose larger mean cuff sizes (4.63 cm vs 4.42 cm; P = .002). With a mean follow-up of 18 months, the revision rate was significantly higher at low-volume centers (38.5% vs 26.7%; P = .037), urethral erosion being the main reason for revision. Social continence (0-1 pads/24 h) was achieved significantly more often in high-volume centers (45.5% vs 24.2%; P = .002). CONCLUSIONS: Our study showed significantly better continence results and lower revision rates at high-volume centers, confirming earlier results that are still true in this decade. We, therefore, recommend surgery for male incontinence at qualified centers.

An overview of the ATOMS generations: port types, functionality and risk factors.

BACKGROUND: We report the multicentre comparison of the different port types of the adjustable transobturator male incontinence system (ATOMS, A.M.I., Austria). METHODS: Between 10/09 and 10/16, 383 patients received an ATOMS. Of these, 63% received the inguinal port (IP, 2009-2013), 23% the intraoperative manually connectable scrotal port (SP, 2013-2015), and 14% the pre-connected fully silicone-covered scrotal port (SSP, 2014-2016). During the follow-up period, continence parameters, pain and quality of life ratings and postoperative port-associated complications were evaluated and compared. Statistical analysis was performed with GraphPad Prism 7®, p < 0.05 considered as significant. RESULTS: Regarding preoperative parameters (BMI, ASA score, previous radiotherapy/incontinence surgery, and preoperative 24-h pad count/24-h pad test), no significant differences were found. Regarding perioperative parameters, the mean operative time was significantly shorter for the SP and SSP (IP vs. SP p < 0.0001, IP vs. SSP p = 0.0048, SP vs. SSP p = 0.697). Comparison of the postoperative 24-h pad count, 24-h pad test and uroflowmetry data revealed no significant differences. However, the postoperative ICIQ-SF score was significantly better for the SSP (p = 0.0232) than the SP. A significant difference was also observed in postoperative port-associated complications. According to the Clavien-Dindo classification, we identified one grade I and 29 grade IIIb complications for the IP, 1 grade I and 6 grade IIIb complications for the SP, but only 2 grade IIIb complications for the SSP (IP vs. SP p = 0.0231, IP vs. SSP p = 0.0189 and SP vs. SSP p = 0.0453). CONCLUSION: The SSP shows fewer complications while retaining comparable efficacy.

Bladder cancer in nonagenarians: a multicentre study of 123 patients.

OBJECTIVE: To investigate the oncological outcome of nonagenarians with bladder cancer, as a substantial rise in bladder cancer in the old-old age group in the upcoming decades is expected, due to demographic changes and the peak incidence around the age of 85 years. The paucity of data of nonagenarians prompted us to investigate the outcomes of such patients. PATIENTS AND METHODS: A retrospective, multicentre study was designed to assess patient demographics, tumour patterns, treatment strategies and outcome in patients aged ≥90 years treated at participating centres. Patients entered either as de novo or as recurrent cancer. The study period ranged from 01.01.2006 to 31.12.2016. RESULTS: A total of 123 patients with a mean (range) age of 91 (90-99) years were recruited. The American Society of Anesthesiologists Physical Status Classification (ASA-score) distribution was as follows: II, 38%; III, 50%; IV, 12%; and the male to female ratio 2.4:1. The median (range) follow-up was 8 (1-132) months. In all, 60% of patients had a de novo cancer diagnosis. Histological findings revealed: pTa 39% (n = 48), pT1 28.5% (n = 35), and ≥pT2 33% (n = 40). Overall, 67.5% patients had no recurrence, 25.2% one and 7.5% two or more. pTa tumours (n = 48) recurred in 20 patients (42%), pT1 tumours (n = 35) in 12 (34%), and ≥pT2 tumours (n = 40) in six (15%). The median overall survival (OS) was 30.0 months for patients with pTa tumours, 14.0 months for pT1 tumours, and 6.0 months for ≥pT2 tumours. The overall mortality rate of patients with pTa tumours was 40%, with pT1 tumours at 60%, and ≥pT2 tumours 75%. The ASA-score also had a strong influence on median OS after stratification by ASA-score (II, 30 months; III, 12 months; IV, 4 months). CONCLUSIONS: In nonagenarians with bladder tumours, pTa/pT1/≥pT2 stages are almost evenly distributed and two-thirds of patients had no recurrence after transurethral resection of the bladder. The mean OS was 1.3 years, and 6 months for ≥pT2 tumours. Further case-series of patients in this specific age-group are required to identify the best management of this increasing proportion of patients with bladder tumours.

The AdVance and AdVanceXP male sling in urinary incontinence: is there a difference?

PURPOSE: To compare the efficacy and perioperative complications of the AdVanceXP with the original AdVance male sling. METHODS: We retrospectively enrolled 109 patients with an AdVance and 185 patients with an AdVanceXP male sling. The baseline characteristics and complication rates were analyzed retrospectively. Functional outcome and quality of life were evaluated prospectively by standardized, validated questionnaires. The Chi2-test for categorical and Mann-Whitney U test for continuous variables were performed to identify heterogeneity between the groups. RESULTS: Regarding operation time, there was no significant difference between the slings (p = 0.146). The complication rates were comparable in both groups except for postoperative urinary retention. This occurred significantly more often in patients with the AdVanceXP (p = 0.042). During follow-up, no differences could be identified regarding ICIQ-SF, PGI or I-QoL or number of pad usage. CONCLUSIONS: The AdVance and AdVanceXP are safe and effective treatment options for male stress urinary incontinence. However, the innovations of the AdVanceXP sling did not demonstrate a superiority over the original AdVance sling regarding functional outcome.

The TiLOOP® Male Sling: Did We Forejudge.

INTRODUCTION: To evaluate the safety and efficacy of the TiLOOP® male sling (pfm medical, Cologne, Germany) used in the treatment for male stress urinary incontinence (SUI). MATERIAL AND METHODS: We retrospectively evaluated a total of 34 patients with a TiLOOP® male sling. Perioperative complication rates were assessed and validated questionnaires were prospectively evaluated to assess quality of life and satisfaction rate. Outcome and complication rates were analysed by using descriptive statistics. Correlation of continence outcome and risk factors was performed with the chi-square test. A p value below 0.05 was considered statistically significant. RESULTS: The majority of patients (70.6%) were diagnosed with mild or moderate male SUI. During surgery, one instance (2.9%) of intraoperative urethral injury was observed. There were no immediate postoperative complications. The mean follow-up time was 44.6 months. An improvement of male SUI was reported by 61.9% of the patients and 38.1% reported no change according the Patient Global Impression of Improvement. The mean perineal pain score was 0.5 according to the international index of pain. CONCLUSIONS: The TiLOOP® is a safe treatment option for male SUI in our cohort with a low complication rate. However, the functional outcome of the TiLOOP® was inferior when compared to the outcome of the AdVance® male sling.

Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

OBJECTIVE: To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS® , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. PATIENTS AND METHODS: In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (<10 mL/day and 0-1 pad/day), device durability, treatment failure, and device complications were recorded. Nonparametric tests were used for statistical analyses. RESULTS: After a median (interquartile range [IQR]) follow-up of 31 (10-54) months and a median (IQR) of 3 (2-4) adjustments, the overall success rate was 90% (258 men) and the dry rate was 64% (184). Daily pad test and pad use decreased from a median of 400 mL/day and 4 pads/day to a median of 18 mL/day and 1 pad/day (both P < 0.001), concomitantly QoL ratings significantly improved and changed to a high level of satisfaction (PGI-I 4 to 2, ICIQ-SF 17 to 5; both P < 0.001). The UI results at 12 months were comparable to those at final follow-up. Chronic pain and intraoperative complications did not occur. Most of the postoperative complications were Clavien-Dindo grade I-III (no grade IV or V). At present, 231 (80%) of all the ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P < 0.001) were prognostic factors for beneficial treatment outcome. CONCLUSION: The ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy.

Five-year experience with the adjustable transobturator male system for the treatment of male stress urinary incontinence: a single-center evaluation.

BACKGROUND: We report on our 5-year experience with the adjustable transobturator male system (ATOMS®, A.M.I., Feldkirch, Austria). METHODS: Between 10-2009 and 10-2014, 54 patients received an ATOMS. The mean follow-up of this retrospective observational trial was 27.5 ± 18.4 (2.3-59) months. Within each follow-up, the following were evaluated: micturition protocol, 24-h pad count, uroflowmetry and residual volume. Statistical analysis was performed with SigmaPlot® 11.0, p < 0.05 considered as significant. RESULTS: Stress urinary incontinence (SUI) I°, II° and III° was seen in 1 (1.9 %), 16 (29.6 %) and 37 patients (68.5 %), respectively. In summary, 48.1 % of the patients became "dry" (0-"safty pad"/day), while 29.6 % achieved at least an "improvement" of about more than 50 % (1-2 pads/day), which corresponds to an overall success rate of 77.7 %. The mean number of pads/day decreased from 7.7 to 1.6. Regarding the initial degree of SUI, patients with mild or moderate incontinence had a significantly better outcome (p = 0.002, 95 % CI 0.9066 to 2.760). Postoperative complications were scaled according to the Clavien classification, in which we have seen 4 grade I-, 1 grade IIIa- and 9 grade IIIb-complications (overall 25.9 %). The evaluation of quality of life by ICIQ-SF showed a significant improvement (p = 0.0001, 95 % CI -14.56 to -11.75). CONCLUSION: The treatment of male SUI using the ATOMS incontinence system achieved the best results in patients with mild and moderate incontinence. For severe incontinent patients, the system represents an efficient alternative.

Risk Factors for Failure of Male Slings and Artificial Urinary Sphincters: Results from a Large Middle European Cohort Study.

INTRODUCTION: We analysed the impact of predefined risk factors: age, diabetes, history of pelvic irradiation, prior surgery for stress urinary incontinence (SUI), prior urethral stricture, additional procedure during SUI surgery, duration of incontinence, ASA-classification and cause for incontinence on failure and complications in male SUI surgery. MATERIALS AND METHODS: We retrospectively identified 506 patients with an artificial urinary sphincter (AUS) and 513 patients with a male sling (MS) in a multicenter cohort study. Complication rates were correlated to the risk factors in univariate analysis. Subsequently, a multivariate logistic regression adjusted to the risk factors was performed. A p value <0.05 was considered statistically significant. RESULTS: A history of pelvic irradiation was an independent risk factor for explantation in AUS (p < 0.001) and MS (p = 0.018). Moreover, prior urethral stricture (p = 0.036) and higher ASA-classification (p = 0.039) were positively correlated with explantation in univariate analysis for AUS. Urethral erosion was correlated with prior urethral stricture (p < 0.001) and a history of pelvic irradiation (p < 0.001) in AUS. Furthermore, infection was correlated with additional procedures during SUI surgery in univariate analysis (p = 0.037) in MS. CONCLUSIONS: We first identified the correlation of higher ASA-classification and explantation in AUS. Nevertheless, only a few novel risk factors had a significant influence on the failure of MS or AUS.

Efficacy and safety of the ZSI375 artificial urinary sphincter for male stress urinary incontinence: lessons learned.

PURPOSE: To analyze efficacy and safety for the ZSI375 artificial urinary sphincter in a multicenter case series. METHODS: Thirteen male patients with stress urinary incontinence underwent implantation of a ZSI375 artificial urinary sphincter device between 2010 and 2012 in three international continence reference centers. Perioperative characteristics and postoperative complications were analyzed using the Clavien-Dindo scale. Re-hospitalization and explantation rates, and functional outcome were assessed. Inner-group and between-group differences were analyzed using Wilcoxon, Mann-Whitney U, and Fisher's exact test whenever indicated. Kaplan-Meier analysis was performed to assess device survival. A p value below 0.05 was considered statistically significant. RESULTS: There were no intraoperative complications. Median follow-up was 13.5 months. In this period, four device defects (30.8 %) could be observed, being the main cause for device explantation, followed by device infection (15.4 %), non-resolvable pain (7.7 %), and urethral erosion (7.7 %). There were no Clavien IV or Clavien V complications. Overall explantation rate was 61.5 %. Mean time-to-explantation was 279 ± 308 days. There was no significant influence of previous irradiation and previous invasive incontinence therapy (p = 0.587 and p = 0.685, respectively). Mean daily pad usage decreased from 5.8 ± 1.5 to 2.4 ± 2.1 (p = 0.066). One patient (7.7 %) did not use any pads. Social continence (0-1 pads) was achieved in 15.4 % of the patients. CONCLUSION: This is the most current study that is investigating the outcome after ZSI375 implantation in a multicenter case series. Based on our results, explantation rates after ZSI375 implantation are high and efficacy rates seem lower than previously described. Addressing this high failure rate, the system has undergone a two-step modification in the meantime.

Complications and Short-Term Explantation Rate Following Artificial Urinary Sphincter Implantation: Results from a Large Middle European Multi-Institutional Case Series.

UNLABELLED: Background/Aims/Objectives: To analyze perioperative complication and short-term explantation rates after perineal or penoscrotal single-cuff and double-cuff artificial urinary sphincter (AUS) implantation in a large middle European multi-institutional patient cohort. METHODS: 467 male patients with stress urinary incontinence underwent implantation of a perineal single-cuff (n = 152), penoscrotal single-cuff (n = 99), or perineal double-cuff (n = 216) AUS between 2010 and 2012. Postoperative complications and 6-month explantation rates were assessed. For statistical analysis, Fisher's exact test and Kruskal-Wallis rank sum test, and a multiple logistic regression model were used (p < 0.05). RESULTS: Compared to perineal single-cuff AUS, penoscrotal single-cuff implantation led to significantly increased short-term explantation rates (8.6% (perineal) vs. 19.2% (penoscrotal), p = 0.019). The postoperative infection rate was significantly higher after double-cuff compared to single-cuff implantation (6.0% (single-cuff) vs. 13.9% (double-cuff), p = 0.019). The short-term explantation rate after primary double-cuff placement was 6.5% (p = 0.543 vs. perineal single-cuff). In multivariate analysis, the penoscrotal approach (p = 0.004), intraoperative complications (p = 0.005), postoperative bleeding (p = 0.011), and perioperative infection (p < 0.001) were independent risk factors for short-term explantation. CONCLUSIONS: Providing data from a large contemporary multi-institutional patient cohort from high-volume and low-volume institutions, our results reflect the current standard of care in middle Europe. We indicate that the penoscrotal approach is an independent risk factor for increased short-term explantation rates.

Sexuality and erectile function after implantation of an Adjustable Transobturator Male System (ATOMS) for urinary stress incontinence. A multi-institutional prospective study.

OBJECTIVES: To investigate erectile function and sexuality before/after implantation of the ATOMS device including continence outcome, pain perception and co-morbidities. MATERIALS AND METHODS: We collected data from 34 patients (2010-2014) who were provided with an ATOMS implant due to mild or moderate stress urinary incontinence (SUI) after radical prostatectomy (RPE), transurethral resection (TURP) or radiotherapy. Previous failed implants were no contraindication. Sexuality was evaluated with the International Index of Erectile Function (IIEF-5). The Visual Analog Scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) were used to analyse pain perception. Results regarding continence, influence of co-morbidities and drug intake were interpreted. RESULTS: IIEF-5 score increased 6 months after ATOMS implantation with a mean difference of 2.18 (Cl: 1.22, 3.14), p < 0,001). Non-sexually active patients had the greatest benefit. However, 50% of patients achieved a mean IIEF-5 of 10.1 and 38% of patients reported a new onset of sexual activity at follow up (mean IIEF-5 score of 12.9). This is in accordance with reduced SUI and absence of persistent pain syndrome. Overall success rate regarding 24h pad-use was 88% (no pad rate 38%). Previous failed implants did not influence results but diabetes, obesity and drug intake (beta-blockers, antidepressants) led to poorer outcomes. CONCLUSION: Sexuality and erectile function improves significantly 6 months after ATOMS implantation. We postulate that reduced SUI (also during sexual activity) and absence of chronic pain are the improving factors. ATOMS should be offered to men with mild to moderate SUI who are interested in regaining their erectile function and sexual activity.

Use of Calcium Channel Blockers is Associated with Mortality in Patients with Chronic Kidney Disease.

BACKGROUND/AIMS: The use of antihypertensive medicines has been shown to reduce proteinuria, morbidity, and mortality in patients with chronic kidney disease (CKD). A specific recommendation for a class of antihypertensive drugs is not available in this population, despite the pharmacodynamic differences. We have therefore analysed the association between antihypertensive medicines and survival of patients with chronic kidney disease. METHODS: Out of 2687 consecutive patients undergoing kidney biopsy a cohort of 606 subjects with retrievable medical therapy was included into the analysis. Kidney function was assessed by glomerular filtration rate (GFR) estimation at the time point of kidney biopsy. Main outcome variable was death. RESULTS: Overall 114 (18.7%) patients died. In univariate regression analysis the use of alpha-blockers and calcium channel antagonists, progression of disease, diabetes mellitus (DM) type 1 and 2, arterial hypertension, coronary heart disease, peripheral vascular disease, male sex and age were associated with mortality (all p<0.05). In a multivariate Cox regression model the use of calcium channel blockers (HR 1.89), age (HR 1.04), DM type 1 (HR 8.43) and DM type 2 (HR 2.17) and chronic obstructive pulmonary disease (HR 1.66) were associated with mortality (all p < 0.05). CONCLUSION: The use of calcium channel blockers but not of other antihypertensive medicines is associated with mortality in primarily GN patients with CKD.

Is the Standard Artificial Urinary Sphincter AMS 800 Still a Treatment Option for the Irradiated Male Patient Presenting with a Devastated Bladder Outlet?

BACKGROUND: Circular urethral compression with an artificial sphincter allows control of voiding, even in patients with severe stress urinary incontinence, but it heightens the risk of urethral atrophy and erosion. This study of one of the largest populations of patients treated with radiotherapy investigates the additive effect of the post-radiogenic stricture of the membranous urethra/bladder neck on AMS 800 artificial urinary sphincter outcomes. METHODS: In a retrospective multicenter cohort study, we analyzed patients fitted with an AMS 800, comparing those who had received radiotherapy with patients presenting a devastated bladder outlet (stricture of the membranous urethra/bladder neck). We determined the correlation between these groups of patients using both univariate and stepwise adjusted multivariate regression. The revision-free interval was estimated by a Kaplan-Meier plot and compared by applying the log-rank test. A p value below 0.05 was considered statistically significant. RESULTS: Of the 123 irradiated patients we identified, 62 (50.4%) had undergone at least one prior desobstruction for bladder-neck/urethra stenosis. After a mean follow-up of 21 months, the latter tended to achieve social continence less frequently (25.7% vs. 35%; p = 0.08). Revision was required significantly more often for this group (43.1% vs. 26.3%; p = 0.05) due to urethral erosion in 18 of 25 cases. A stenosis recurred in five cases; desobstruction was performed in two cases, leading to erosion in both. Multivariate analysis revealed a significantly higher risk of revision when recurrent stenosis necessitated at least two prior desobstructions (HR 2.8; p = 0.003). CONCLUSIONS: A devastated bladder outlet is associated with a lower proportion of men with social continence and a significantly higher need for revision compared with irradiated patients without a history of urethral stenosis. Alternative surgical procedures should be discussed beforehand, especially in cases of recurrent urethral stenosis.

No association of angiotensin-converting enzyme inhibitor or angiotensin 2 receptor blocker intake with acute kidney injury in patients undergoing kidney biopsy.

BACKGROUND: Treatment with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin 2 receptor blockers (ARBs) is associated with an increased risk for acute kidney injury after cardiovascular interventions. However, for patients undergoing kidney biopsy, no data is available. METHODS: Four hundred and sixty-six patients undergoing kidney biopsy were retrospectively analyzed of whether or not concomitant intake of ACEIs or ARBs impairs kidney function. RESULTS: Three hundred and twenty-three patients received ACEIs or ARBs or both before kidney biopsy. ACEI/ARB intake had no effect on kidney function compared to patients without this medication (all p > 0.05). CONCLUSION: Treatment with ACEIs or ARBs is not associated with risk of acute kidney injury in subjects undergoing kidney biopsy.

Kidney biopsy in patients with glomerulonephritis: is the earlier the better?

BACKGROUND: Interventional diagnostic procedures are established for several diseases in medicine. Despite the KDOQI guideline recommendation for histological diagnosis of kidney disease to enable risk stratification, its optimal time point has not been evaluated. We have therefore analyzed whether histological diagnosis of glomerulonephritis (GN) at an early stage of chronic kidney disease (CKD) is associated with different outcome compared to diagnosis at a more advanced stage. METHODS: A cohort of 424 consecutive patients with histological diagnosis of GN were included in a retrospective data analysis. Kidney function was assessed by glomerular filtration rate (GFR) estimation at the time point of kidney biopsy and after consecutive immunosuppressive therapy. Censored events were death, initiation of dialysis or kidney transplantation, or progression of disease, defined as deterioration of CKD stage ≥ 1 from kidney biopsy to last available kidney function measurement. RESULTS: Occurrence of death, dialysis/transplantation or progression of disease were associated with GFR and CKD stage at the time of kidney biopsy (p < 0.001 for all). Patients with CKD stage 1 and 2 at kidney biopsy had fewer endpoints compared to patients with a GFR of <60 ml/min (p < 0.001). CONCLUSION: Kidney function at the time point of histological GN diagnosis is associated with clinical outcome, likely due to early initiation of specific drug treatment. This suggests that selection of therapy yields greatest benefit before renal function is impaired in GN.

Predictive Effect of Inflammatory Response and Foot Ulcer Localization on Outcome in Younger and Older Individuals with Infected Diabetic Foot Syndrome.

The diabetic foot syndrome (DFS) is the most important cause for non-traumatic major amputation in adult individuals and actually one of the most frightening events in diabetics' life. Despite the often protracted treatment of infected DFS at the end patients are often confronted with amputation. We investigated 352 individuals with infected DFS in two age separated-groups. Older individuals presented with significant worse renal function and lower HbA1c on day of admittance. Most detected ulcers involved the plantar sides of the metatarsal heads (MTH) and the toes. We saw an age-dependent translocation of foot ulcers from plantar and hindfoot to the forefoot and toes. In average every third wound provoked amputation, in the majority (94%) minor amputations, only 1.9% major amputations occurred. Lesions of the 5th toe or its MTH and interdigital or interphalangeal joint ulcers led to amputation in more than 60%. Worse renal function and WBC above 11 tsd/µl were linked with higher amputation risk. But in particular current scoring systems like SINBAD or Wagner-Armstrong scale and thus finally clinician's assessment of the wound situation gave a substantial hint for subsequent amputation - regardless of age.

Fixed or adjustable sling in the treatment of male stress urinary incontinence: results from a large cohort study.

BACKGROUND: Fixed and adjustable male slings for the treatment of male urinary stress incontinence became increasingly popular during the last decade. Although fixed slings are recommended for the treatment of mild to moderate stress urinary incontinence, there is still a lack of evidence regarding the precise indication for an adjustable male sling. Furthermore, there is still no evidence that one type of male sling is superior to another. However, both, adjustable and fixed slings, are commonly utilized in daily clinical practice. This current investigation aims to evaluate the differences between fixed and adjustable male slings regarding indications, complication rates and functional outcome in the treatment of male stress urinary incontinence in current clinical practice. METHODS: A total of 294 patients with a fixed and 176 patients with an adjustable male sling were evaluated in a multicenter single arm cohort trial. Data collection was performed retrospectively according the medical record. Functional outcome was prospectively analyzed by standardized, validated questionnaires. Descriptive statistics was performed to present patient characteristics, complication rates and functional outcome. A chi2-test for categorical and independent t-test for continuous variables was performed to identify heterogeneity between the groups and to correlate preoperative characteristics with the outcome. A P value <0.05 was considered statistically significant. RESULTS: Patients with higher degree of urinary incontinence (P<0.001) and risk factors such as history of pelvic irradiation (P<0.001) or prior surgery for urethral stricture (P=0.032) were more likely to receive an adjustable MS. Complication rates were comparable except for infection (P=0.009, 0 vs. 2.3%) and pain (P=0.001, 1.7% vs. 11.3%) which occurred more frequently in adjustable slings. Functional outcome according validated questionnaires demonstrated no differences between fixed and adjustable male slings. CONCLUSIONS: Adjustable male slings are more frequently utilized in patients with higher degree of incontinence and risk factors compared to fixed slings. No differences could be identified between functional outcome which may imply an advantage for adjustability. However, pain and infection rates were significantly higher in adjustable MS and should be considered in the decision process for sling type.

Artificial Urinary Sphincter Cuff Size Predicts Outcome in Male Patients Treated for Stress Incontinence: Results of a Large Central European Multicenter Cohort Study.

PURPOSE: The aim was to study the correlation between cuff size and outcome after implantation of an AMS 800 artificial urinary sphincter. METHODS: A total of 473 male patients with an AMS 800 sphincter implanted between 2012 and 2014 were analyzed in a retrospective multicenter cohort study performed as part of the Central European Debates on Male Incontinence (DOMINO) Project. RESULTS: Single cuffs were implanted in 54.5% and double cuffs in 45.5% of the patients. The cuffs used had a median circumference of 4.5 cm. Within a median follow of 18 months, urethral erosion occurred in 12.8% of the cases and was associated significantly more often with small cuff sizes (P<0.001). Multivariate analysis showed that, apart from cuff size (P=0.03), prior irradiation (P<0.001) and the penoscrotal approach (P=0.036) were associated with an increased erosion rate. Continence rate tended to be highest with median cuff sizes (4-5.5 cm). CONCLUSION: Apart from irradiation and the penoscrotal approach, small cuff size is a risk factor for urethral erosion. Results are best with cuff sizes of 4.5-5.5 cm.

Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer.

INTRODUCTION: The high diagnostic potential of 64Cu-PSMA PET-CT imaging was clinically investigated in prostate cancer patients with recurrent disease and in the primary staging of selected patients with advanced local disease. The aim of our study is to assess the uptake behavior in the clinical setting of 64Copper Prostate-Specific Membrane Antigen (64Cu PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) in prostate cancer. METHODS: A retrospective study was performed in 23 patients with intermediate, high risk and progressive disease at primary staging of prostate cancer. All patients underwent 64Cu-PSMA PET. Overall, 250 MBq (4 MBq per kg bodyweight, range 230-290 MBq) of 64Cu-NODAGA PSMA was intravenously applied. PET images were performed 30 min (pelvis and abdomen) and 1-2 h post-injection (skull base to mid-thigh). Maximum standardized uptake values (SUVmax) were measured in the organs with high physiological uptake such as liver and kidney, and, additionally, background activity was measured in the gluteal area and in suspected tumor lesions using a HERMES workstation. RESULTS: PSMA uptake was detected in prostate bed in nine patients, in six patients in distant metastases (bone, lung and liver) and in nine patients in lymph nodes. Of 23 patients, 5 (20.8%) did not show any focal pathological uptake in the whole body. The number of sites (prostate bed, lymph nodes, distant metastases) with positive PSMA uptake was significantly associated with PSA values before imaging (P = 0.0032). The 64Cu PSMA uptake increased significantly from 30 min to 1-3 h post-injection (Wilcoxon signed rank test, P = 0.002). CONCLUSIONS: 64Cu NODAGA-PSMA PET is a promising imaging tool in the detection of residual disease in patients with recurrent or primary progressive prostate cancer. Furthermore, the increased tracer uptake over time indicates in vivo stability of the diagnostic radiopharmaceutical.