bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction.

OBJECTIVE: To present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD). STUDY DESIGN AND RESULTS: bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham-controlled, double-blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self-Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS. CONCLUSIONS: A total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow-up assessments at the study end.

Resilience in patients with complex regional pain syndrome 1-a cross-sectional analysis of patients participating in a cross-sectional cohort study.

OBJECTIVE: To assess the degree of resilience in patients with complex regional pain syndrome (CRPS) 1, to explore the relationship between resilience and patient-related outcome measurements and to describe a pattern of clinical manifestations associated with low resilience. METHODS: This study presents a cross-sectional analysis of baseline information collected from patients enrolled in a single center study between February 2019 and June 2021. Participants were recruited from the outpatient clinic of the Department of Physical Medicine & Rheumatology of the Balgrist University Hospital, Zurich, Switzerland. We used linear regression analysis to explore association of resilience with patient reported outcomes at baseline. Furthermore, we explored the impact of significant variables on the low degree resilience using logistic regression analysis. RESULTS: Seventy-one patients (females 90.1%, mean age 51.2 ± 12.9 years) were enrolled. There was no association between CRPS severity and the level of resilience. Quality of Life was positively correlated with resilience, as was pain self-efficacy. Pain catastrophizing was inversely correlated with the level of resilience. We observed a significant inverse association between anxiety, depression and fatigue and the level of resilience. The proportion of patients with a low resilience increased with higher level of anxiety, depression and fatigue on the PROMIS-29, without reaching statistical significance. CONCLUSION: Resilience seems to be an independent factor in CRPS 1 and is associated with relevant parameters of the condition. Therefore, caretakers may screen the current resilience status of CRPS 1 patients to offer a supplementary treatment approach. Whether specific resilience training modifies CRPS 1 course, requires further investigations.

Distribution of preoperative angle alpha and angle kappa values in patients undergoing multifocal refractive lens surgery based on a positive contact lens test.

PURPOSE: To assess the preoperative objective angle alpha and angle kappa measurements of patients deciding to undergo multifocal refractive lens surgery based on a subjective positive multifocal contact lens test (MCLT). METHODS: Retrospective, consecutive case series. Alpha and kappa angles were measured using the iTrace aberrometer. All patients also performed a 1-week MCLT. Only patients with a positive MCLT underwent surgery. Visual outcome (UCVA) was obtained in the 1-year follow-up. We assessed the preoperative distribution of angle values within MCLT positive and negative patient groups. RESULTS: Two hundred seventeen eyes (111 patients) were included. Mean age was 56.4 years (SD 5.6) and 46.9% were female. In 71 eyes (38 patients), MCLT was positive. Of them, 12 eyes (17%) had an angle alpha and angle kappa ≥ 0.5mm. Of 146 eyes (73 patients) who refrained from surgery due to a negative MCLT, 71 eyes (48.6%) had both angles small (<0.5mm). In the 1-year follow-up, UCVA improved by 0.68 logMAR (SD 0.51; p<0.001) from baseline. Eyes with both small angle alpha and kappa sizes improved by 0.78 logMAR (SD 0.56), as did eyes with high (≥0.5mm) angle sizes (0.82 logMAR (SD 0.53). UCVA of eyes (n=24) with high alpha but low kappa sizes improved less (-0.31 logMAR (SD 0.13; p=0.019)). CONCLUSION: Four out of five patients with a positive MCLT also had correspondingly small angle values. One-half of patients with low preoperative angle values refrained from surgery due to a negative MCLT result. One-year visual acuity improvement was substantial and independent from angle sizes.

Telemedicine Service for Keratoconus Monitoring: Patient Satisfaction and Prospects for Further Expansion.

Introduction: During the COVID-19 pandemic, keratoconus patient care moved from in-person clinics to virtual care. We surveyed patient satisfaction with the new virtual clinic model. Methods: We assessed the views of keratoconus patients enrolled in the novel virtual service between June 1 and July 31, 2020, in individual structured telephone interviews using Likert questions. Results: Of the 88 patients enrolled, the opinions of 69 patients could be evaluated (78.4%). Compared with previous in-person visits, mean waiting times for diagnostic examinations dropped from 43 (±32) min to 4 (±3) min (p < 0.001). The majority of patients (68; 99%) were satisfied or very satisfied with the overall service irrespective of the communication channel (telephone or video). A majority also indicated a desire to continue attending the virtual keratoconus clinic after the pandemic and supported the idea of decentralized sites for future diagnostic measurements. Discussion: A novel virtual service to monitor keratoconus progression was well received and was associated with shorter waiting times. There was a strong interest on the part of patients to further develop the virtual keratoconus clinic. Conclusions: This study demonstrates that keratoconus patients managed very well the conversion from in-person to virtual care. A solid majority of keratoconus patients also supported further expansion of the virtual consultations to a completely decentralized telemedicine model.

Frequency of Eye Diseases in Residents of Nursing Homes - 1-Year Results of a Novel Telemedicine Service in Switzerland.

PURPOSE: For the elderly in nursery homes, a visit to the ophthalmologist is a burden, which might lead to undertreatment. We have recently started offering a novel ophthalmological service combining onsite examination and telemedical interpretation for patients with limited access to ophthalmological care. This study summarises the frequency of findings of treatable eye diseases after the first year of operation in participants who dropped out from regular ophthalmological control. METHODS: Participants' clinical characteristics, frequency of service utilisation, and findings were extracted from the system and analysed. RESULTS: Of 1946 residents approached, 540 (27.7%; 1080 eyes) signed up for the service. A complete examination was possible in 412 persons (813 eyes) and partially possible in the remaining 128. The mean age of the examined participants mean age was 83.9 years (SD 9.7), and they were predominantly female (69.8%). The majority had a diagnosis of dementia (54.5%) and 20.2% had diabetes mellitus requiring treatment. The median care level (ranging from 0 - 12) was 7 (interquartile range 6 - 9), corresponding to a care need of 121 - 140 min/d. The mean best-corrected decimal visual acuity was 0.55 (SD 0.24). For 164 eyes (15.2%), the current spectacle correction was insufficient. An untreated cataract was present in 145 eyes (13.4%), 89 eyes (8.2%) were receiving glaucoma treatment, and 7 eyes had a decompensated glaucoma. Dry age-related macular degeneration (AMD) appeared in 276 eyes (25.6%), 12 eyes (1.1%) had wet AMD, and 24 eyes (11.0%) among patients with diabetes showed signs of diabetic retinopathy. Other pathologies were uncommon. CONCLUSION: Residents of nursery homes, who are unable to attend regular ophthalmological control, show various treatable ophthalmological conditions, including cataracts, glaucoma, and retinal pathologies. Screening with a novel telemedicine service allows for the identification of treatable conditions and careful planning and referral of patients to appropriate clinics having the necessary infrastructure for this particular population.

Neuro-psychiatric manifestations in patients with systemic lupus erythematosus: A systematic review and results from the Swiss lupus cohort study.

OBJECTIVES: Systemic lupus erythematosus (SLE) is a systemic autoimmune disease associated with neuro-psychiatric (NP) manifestations. Frequency and patterns of neuro-psychiatric systemic lupus erythematosus (NPSLE) vary substantially between patients. We conducted a systematic review (SR) of the literature and examined prevalence and characteristics of NPSLE in the Swiss SLE cohort study (SSCS). METHODS: The SR search was performed between January 1999 and January 2020. We included prospective/cross-sectional studies focusing on NPSLE. We secured study characteristics, cohort compositions and frequencies of NP manifestations, assessed heterogeneity across reports and investigated sources of variation using meta-regression models. Regarding the SSCS, we reviewed all patients included and classified NP manifestations. RESULTS: The SR searches identified 530 studies. We included 22 studies in our meta-analysis, the mean frequency of NPSLE ranged from 10.6% to 96.4%. The frequency of NPSLE in the SSCS was 28.1%. Severe events including cerebrovascular insults, seizures and psychosis appeared in 7.1%, 5.3% and 6.5% respectively. There was a linear relationship between duration of SLE and cumulative incidence of NPSLE. CONCLUSIONS: The spectrum of NPSLE is very broad. The diagnostic work-up and rates of reported manifestations varied substantially across studies. We call for concerted efforts and consensus regarding definitions of NPSLE that will facilitate accurate diagnosis and attribution to SLE, particularly with a view to timely intervention and patient outcomes.

Occurrence of motility disorders in patients undergoing tube surgery-consecutive, retrospective follow-up case series analysis.

BACKGROUND: The two glaucoma drainage devices (GDD) Ahmed and Baerveldt tubes are most commonly used for the treatment of refractory glaucoma. We noticed a significant number of patients with postoperative motility disorders resulting in diplopia. We investigated the occurrence and patterns of postoperative motility disorders overall and between the two GDD tubes using the Hess Screen Test. METHODS: Retrospective single-center matched case series of 20 patients undergoing Ahmed and 20 patients undergoing Baerveldt tube implantation with a follow-up of at least 1 year. In order to investigate the dynamic of GDD-induced motility disorder over time, from 25 patients, a follow-up examination from two different time periods (3 to 6 months and 12 to 24 months postoperatively) was available. From these 25 patients, 12 had received an Ahmed and 13 a Baerveldt GDD. To compare the different Hess Screen Tests, we developed nine categories of possible emerging motility disorder in the operated eye as a primary endpoint: Motility restriction in up-gaze, in down-gaze, in abduction, in adduction; combined motility disorders in up-gaze and adduction, up-gaze and abduction, down-gaze and adduction, down-gaze and abduction. If there was no motility disorder, this was also separately classified. RESULTS: Regardless of the used device, Ahmed or Baerveldt, most patients experienced motility disorders to some extent; mainly down-gaze and adduction were affected. However not every motility disorder resulted in diplopia. Although over time a decrease in ocular misalignment was seen, the incidence of diplopia was stable. Nevertheless, only few required therapy. We noted no difference between Ahmed and Baerveldt tube implant devices. CONCLUSION: Ocular misalignment and restriction of motility is a common finding after GDD. Although not every motility disorder results in diplopia, it is frequent. Therefore, it needs to be taken into consideration in informed consent.

Optimizing clinical trial design using prospective cohort study data: a case study in neuro-urology.

STUDY DESIGN: Simulations using data from a prospective cohort study. OBJECTIVES: To illustrate how prospective cohort data can be employed in randomized controlled trial (RCT) planning to assess feasibility and operational challenges, using TASCI (Transcutaneous tibial nerve stimulation in patients with Acute Spinal Cord Injury to prevent neurogenic detrusor overactivity: a nationwide randomized, sham-controlled, double-blind clinical trial) as a case study. SETTING: Spinal cord injury (SCI) rehabilitation centers in Switzerland. METHODS: TASCI is nested in the multicenter Swiss Spinal Cord Injury Cohort Study (SwiSCI), which prospectively includes patients with acute SCI. In simulations, data from 640 patients, collected by SwiSCI, were used to investigate different scenarios of patient eligibility and study consent, as well as the performance of the randomization list. Descriptive analysis was used to describe the population of interest and the simulation results; multivariable logistic regression analysis was performed to identify predictors of discharge within the TASCI intervention time period. RESULTS: The recruitment target of 114 patients is obtainable within the originally envisioned 3-year time period under the most favorable recruitment scenario examined. The distribution of the primary prognostic factor produced imbalance in the randomization lists and informed further discussion of the cut-off values used in stratification. Influxes of patients resulted in overlapping intervention periods for multiple participants, which guided resource allocation. Early discharge was related to the primary prognostic factor and study center, but is only anticipated in about 8% of participants. CONCLUSIONS: Prospective cohort data are a very valuable resource for planning RCTs.

Mismatch of corneal specialists' expectations and keratoconus knowledge in general ophthalmologists - a prospective observational study in Switzerland.

BACKGROUND: To assess whether Swiss general ophthalmologists have the minimal keratoconus knowledge that corneal specialists would expect them to have. METHODS: Corneal specialists defined "minimal keratoconus knowledge" (MKK) with respect to definition, risk factors, symptoms and possible treatment options of keratoconus. A telephone interview survey was conducted among one hundred ophthalmologists (mean age 51.9 years (SD 9.5), 60 % male) from the German-speaking part of Switzerland. For each participant, years of work experience, number of keratoconus patients seen per year and access to a topography device were obtained. We calculated the proportion of MKK and examined in multivariate analyses whether ophthalmologists with access to topography and with greater work experience performed better than other groups. RESULTS: No single ophthalmologist had MKK. The mean MKK was 52.0 %, and the range was 28.6-81.0 %. Per 10 years of working in private practice, the MKK decreased by 8.1 % points (95 % CI: -14.2, -2.00; p = 0.01). Only 24 % of participants correctly recalled the definition of keratoconus, 9 % all risk factors, 5 % all symptoms and 20 % all treatment modalities. The MKK values were not associated with the number of keratoconus patients seen per year and the availability of topography to diagnose keratoconus. CONCLUSIONS: There is a substantial mismatch between corneal specialist' expectations and general ophthalmologists' knowledge about keratoconus. The low recall of symptoms and risk factors may explain why ophthalmologists diagnose relatively few cases of keratoconus, resulting in inefficient care delivery and delayed intervention.

Improved Diagnostics Help to Identify Clinical Features and Biomarkers That Predict Mycoplasma pneumoniae Community-acquired Pneumonia in Children.

BACKGROUND: There are no reliable signs or symptoms that differentiate Mycoplasma pneumoniae (Mp) infection in community-acquired pneumonia (CAP) from other etiologies. Additionally, current diagnostic tests do not reliably distinguish between Mp infection and carriage. We previously determined that the measurement of Mp-specific immunoglobulin M antibody-secreting cells (ASCs) by enzyme-linked immunospot assay allowed for differentiation between infection and carriage. Using this new diagnostic test, we aimed to identify clinical and laboratory features associated with Mp infection. METHODS: This is a prospective cohort study of children, 3-18 years of age, with CAP from 2016 to 2017. Clinical features and biomarkers were compared between Mp-positive and -negative groups by Mann-Whitney U test or Fisher exact test, as appropriate. Area under the receiver operating characteristic curve (AUC) differences and optimal thresholds were determined by using the DeLong test and Youden J statistic, respectively. RESULTS: Of 63 CAP patients, 29 were Mp-positive (46%). Mp positivity was statistically associated with older age (median, 8.6 vs 4.7 years), no underlying disease, family with respiratory symptoms, prior antibiotic treatment, prolonged prodromal respiratory symptoms and fever, and extrapulmonary (skin) manifestations. Lower levels of C-reactive protein, white blood cell count, absolute neutrophil count, and procalcitonin (PCT), specifically PCT <0.25 µg/L, were statistically associated with Mp infection. A combination of age >5 years (AUC = 0.77), prodromal fever and respiratory symptoms >6 days (AUC = 0.79), and PCT <0.25 µg/L (AUC = 0.81) improved diagnostic performance (AUC = 0.90) (P = .05). CONCLUSIONS: A combination of clinical features and biomarkers may aid physicians in identifying patients at high risk for Mp CAP.

The Challenge of Asymptomatic Bacteriuria and Symptomatic Urinary Tract Infections in Patients with Neurogenic Lower Urinary Tract Dysfunction.

PURPOSE: We investigated the prevalence of asymptomatic bacteriuria and the incidence of symptomatic urinary tract infections in patients with neurogenic lower urinary tract dysfunction undergoing urodynamics. We also assessed predictors of symptomatic urinary tract infections. MATERIALS AND METHODS: We evaluated a prospective consecutive series of 317 patients, including 106 women and 211 men, with neurogenic lower urinary tract dysfunction. Of the patients 111 (35%) voided spontaneously, 141 (44%) relied on intermittent self-catheterization and 65 (21%) relied on an indwelling catheter. Before urodynamics the urine samples were collected by sterile catheterization for dipstick testing and urine culture. We assessed the association of patient characteristics with symptomatic urinary tract infections after urodynamics in patients with asymptomatic bacteriuria and developed a prediction model based on the most important risk factors. RESULTS: Before urodynamics urine cultures were negative in 123 patients (39%) and positive in 194 (61%). Escherichia coli and Klebsiella pneumoniae were the most frequent bacteria, found in 32% and 18% of patients, respectively. Of 194 patients with a positive culture 35 (18%) had at least 1 symptomatic urinary tract infection. In patients with a history of previous urinary tract infections the overall estimated probability of a symptomatic urinary tract infection was 45% regardless of the underlying neurological disorder. CONCLUSIONS: A symptomatic urinary tract infection will develop in the followup year in about 1 of 5 patients with asymptomatic bacteriuria. This rather low overall probability precludes routine antibiotic prophylaxis or treatment in patients with neurogenic lower urinary tract dysfunction who have asymptomatic bacteriuria since 4 of 5 would be overtreated. However, in patients with a history of previous symptomatic urinary tract infections antibiotic prescription might be justified.

Quantitative electrical pain threshold assessment in the lower urinary tract.

AIMS: Assessing the reliability of electrical pain threshold (PT) and evaluating the impact of stimulation frequency at different locations in the healthy lower urinary tract (LUT). METHODS: Ninety subjects (age: 18.3-35.8 years, 40 females, 50 males) were randomly allocated to one stimulation site (bladder dome [BD], trigone, proximal, membranous (only males), or distal urethra). Using 0.5 Hz/1.1 Hz/1.6 Hz electrical stimulation (square wave, pulse width:1 ms), current perception thresholds (CPTs), PTs and tolerance thresholds were assessed at two visits. Analyses were performed using linear mixed models, intraclass correlation coefficients (ICC) and Bland-Altman method. RESULTS: PTs vary in relation to stimulation frequency, location and between genders. PT decreased with higher stimulation frequency. The highest PTs were measured at the BD and membranous urethra with males reporting higher PTs than females. Reliability of PT assessments according to ICC was good to excellent across all frequencies, locations, and genders (ICC = 0.61-0.97), except for BD and distal urethra in females showing poor to fair reliability (BD: all frequencies, distal urethra: 0.5 Hz). CONCLUSIONS: PTs can be safely and reliably assessed from bladder and urethral locations. Semi-objective PT assessment may provide additional information on functionality and sensitivity of the LUT slow fiber afferents and complement findings from urodynamic investigations and CPT assessments. In conclusion, the developed methodology may open new opportunities for using electrical stimulation paradigms for LUT PT assessments and diagnostics. All this allows a more precise, location-specific characterization of pain origin and pain reaction towards therapy.

New technique to reduce systemic side effects of timolol eye drops: The tissue press method-Cross-over clinical trial.

IMPORTANCE: Nasolacrimal occlusion (NLO) is effective in reducing systemic absorption of eye drop medication but it is difficult and often performed poorly. We propose an alternative easier and equally effective technique. BACKGROUND: To test the effectiveness of systemic absorption, we evaluated plasma concentration and ocular effects after topically administered timolol and compared to NLO. DESIGN: Cross-over trial carried out in Capital Eye Specialist, Wellington. PARTICIPANTS: A total of 21 subjects over 18 years without contraindications for topical beta-blocker medication and not using systemic beta-blockers. METHODS: During three clinic visits separated by at least one week, alternative approaches to reduce systemic eye drop absorption were tested. These were: (a) nasolacrimal (punctal) occlusion for 5 min, (b) tissue press method or (c) no intervention. Timolol plasma levels were measured 1 h after drop application. At each visit, baseline measurement of blood pressure, heart rate and intraocular pressure (IOP) were performed, and repeated 1 h after timolol 0.5% eye drop application. MAIN OUTCOME MEASURES: Comparison of timolol plasma concentration after each intervention. Secondary outcome measurements included effects on blood pressure, heart rate and IOP. RESULTS: Plasma timolol concentrations after tissue press method and NLO were significantly lower than those without intervention. Comparing tissue press method to NLO, there were no significant differences in plasma levels of timolol, blood pressure, heart rate or IOP. CONCLUSION AND RELEVANCE: The tissue press method is equally effective as NLO in reducing systemic absorption of timolol. It is also easier and faster to administer.

Desmopressin for treating nocturia in patients with multiple sclerosis: A systematic review: A report from the Neuro-Urology Promotion Committee of the International Continence Society (ICS).

AIMS: To systematically assess all available evidence on efficacy and safety of desmopressin for treating nocturia in patients with multiple sclerosis (MS). METHODS: This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies were identified by electronic search of Cochrane register, Embase, Medline, Scopus (last search March 3, 2018) and by screening of reference lists and reviews. RESULTS: After screening of 7015 abstracts, 8 prospective, and 1 retrospective studies were included enrolling a total of 178 patients. The mean patient age ranged between 43 and 51 years. A significant decrease in the number of micturitions per night was reported in 5 studies. An increase in the maximum hours of uninterrupted sleep was only found in two studies. A significant reduction of the volume of nocturnal incontinence was described in one study. The patient satisfaction rates ranged from 56% to 82%. The rate of adverse events was between 0% and 57.9%. The rate of hyponatremia ranged from 0% to 23.5% and other commonly reported adverse events were headache, nausea, fluid retention, rhinitis/epistaxis, malaise, and swollen ankles. Risk of bias and confounding was relevant in all studies. CONCLUSIONS: Preliminary data suggest that desmopressin might be effective for treating nocturia in patients with MS. However, adverse events are relatively common, the overall quality of evidence is low and the number of studied patients is very limited. Further studies with newer formulations of desmopressin are highly warranted.

Alpha-blockers for treating neurogenic lower urinary tract dysfunction in patients with multiple sclerosis: A systematic review and meta-analysis. A report from the Neuro-Urology Promotion Committee of the International Continence Society (ICS).

AIM: We aimed to systematically assess the evidence on the efficacy and safety of alpha-blockers in patients with multiple sclerosis (MS) suffering from neurogenic lower urinary tract dysfunction (NLUTD). METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used to perform this systematic review. An electronic search of Cochrane register, Embase, Medline, Scopus (last search 3 March 2018) and screening of reference lists as well as reviews were used to identify the studies. Articles were included if they reported on efficacy/safety of alpha-blockers for the treatment of NLUTD in patients with MS. RESULTS: After screening of 7'015 abstracts, three studies enrolling a total of 50 patients were included: one randomized, placebo-controlled, single-blind trial and two prospective cohort studies. Alpha-blocker treatment was successful in 50% to 96% of the patients. Pooling data from the three included studies, the relative risk for successful alpha-blocker treatment was 3.89 (95% confidence interval 2.7-7.0). The general safety profile of alpha-blockers was favorable with 8% of the patients reporting adverse events. CONCLUSIONS: Alpha-blockers may be effective and safe for treating NLUTD in female and male patients with MS but the studies were small and the overall quality of evidence was low. To make definitive conclusions, well designed randomized controlled trials are highly warranted.

Diagnostic value of immunoassays for heparin-induced thrombocytopenia: a systematic review and meta-analysis.

Immunoassays are essential in the workup of patients with suspected heparin-induced thrombocytopenia. However, the diagnostic accuracy is uncertain with regard to different classes of assays, antibody specificities, thresholds, test variations, and manufacturers. We aimed to assess diagnostic accuracy measures of available immunoassays and to explore sources of heterogeneity. We performed comprehensive literature searches and applied strict inclusion criteria. Finally, 49 publications comprising 128 test evaluations in 15 199 patients were included in the analysis. Methodological quality according to the revised tool for quality assessment of diagnostic accuracy studies was moderate. Diagnostic accuracy measures were calculated with the unified model (comprising a bivariate random-effects model and a hierarchical summary receiver operating characteristics model). Important differences were observed between classes of immunoassays, type of antibody specificity, thresholds, application of confirmation step, and manufacturers. Combination of high sensitivity (>95%) and high specificity (>90%) was found in 5 tests only: polyspecific enzyme-linked immunosorbent assay (ELISA) with intermediate threshold (Genetic Testing Institute, Asserachrom), particle gel immunoassay, lateral flow immunoassay, polyspecific chemiluminescent immunoassay (CLIA) with a high threshold, and immunoglobulin G (IgG)-specific CLIA with low threshold. Borderline results (sensitivity, 99.6%; specificity, 89.9%) were observed for IgG-specific Genetic Testing Institute-ELISA with low threshold. Diagnostic accuracy appears to be inadequate in tests with high thresholds (ELISA; IgG-specific CLIA), combination of IgG specificity and intermediate thresholds (ELISA, CLIA), high-dose heparin confirmation step (ELISA), and particle immunofiltration assay. When making treatment decisions, clinicians should be a aware of diagnostic characteristics of the tests used and it is recommended they estimate posttest probabilities according to likelihood ratios as well as pretest probabilities using clinical scoring tools.

Prediction of bladder outcomes after ischemic spinal cord injury: A longitudinal cohort study from the European multicenter study about spinal cord injury.

OBJECTIVE: The recovery of bladder function after spinal cord injury (SCI) is of major importance for patients and caregivers. We recently developed prediction models of bladder outcomes (defined as the capacity of storing the urine and emptying completely the bladder) 1 year after a SCI of traumatic etiology and investigated if these models would also be applicable to patients with ischemic SCI. PATIENTS AND METHODS: From the European multicenter study about spinal cord injury (EMSCI), we extracted data of all ischemic SCI patients with available neurological and functional data (according to the International Standards for Neurological Classification of Spinal Cord Injury, ISNCSCI, and Spinal Cord Independence Measure, SCIM) within 40 days and bladder outcomes 1 year after ischemia. The model relies on three predictors: strength of the legs, the presence of sensation in the S3 dermatome, and the part of the SCIM assessing breathing and bladder and bowel control. A simplified model relying on leg strength only was also tested. Bladder outcomes were evaluated according to the score of item six of SCIM. RESULTS: In total 85 patients (56 males (66%), mean age 55 years) were included. Twenty-three patients (27%) showed complete bladder function recovery one year after ischemia. Both models showed a very good predictive power: the area under the receiver operating characteristics curve (aROC) of the two models was 0.825 and 0.822, respectively. CONCLUSIONS: Comparable to acute traumatic SCI, also in ischemic SCI the outcome of full bladder function recovery can be predicted by clinical scores, and prediction models of bladder outcomes may be applicable in clinical trials.

Intravesical vanilloids for treating neurogenic lower urinary tract dysfunction in patients with multiple sclerosis: A systematic review and meta-analysis. A report from the Neuro-Urology Promotion Committee of the International Continence Society (ICS).

AIMS: To systematically assess all available evidence on efficacy and safety of vanilloids for treating neurogenic lower urinary tract dysfunction (NLUTD) in patients with multiple sclerosis (MS). METHODS: This systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies were identified by electronic search of Cochrane register, Embase, Medline, Scopus, (last search January 8, 2016). RESULTS: After screening of 7848 abstracts, 4 randomized controlled trials (RCTs) and 3 prospective cohort studies were included. Pooled data from three RCTs evaluating intravesical capsaicin showed the standardized mean difference to be -2.16 (95% confidence interval [CI] -2.87 to -1.45) in incontinence episodes per 24 h and -0.54 (95%CI -1.03 to -0.05) in voids per 24 h. There was no statistically significant effect on maximum cystometric capacity and maximum storage detrusor pressure. Overall, adverse events were reported by >50% of the patients, most commonly were pelvic pain, facial flush, worsening of incontinence, autonomic dysreflexia, urinary tract infection and haematuria. Risk of bias and confounding was relevant in both RCTs and non-RCTs. CONCLUSIONS: Preliminary data suggest that intravesical vanilloids might be effective for treating NLUTD in patients with MS. However, the safety profile seems unfavorable, the overall quality of evidence is low and no licensed substance is currently available warranting well-designed, adequately sampled and properly powered RCTs.

Catheterization for treating neurogenic lower urinary tract dysfunction in patients with multiple sclerosis: A systematic review. A report from the Neuro-Urology Promotion Committee of the International Continence Society (ICS).

AIM: To systematically assess all available evidence on efficacy and safety of catheterization for treating neurogenic lower urinary tract dysfunction (NLUTD) in patients with multiple sclerosis (MS). METHODS: This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies were identified by electronic search of Embase, Medline, Scopus, Cochrane register (last search March 3, 2018) and by screening of reference lists and reviews. RESULTS: After screening 7'015 articles, we included four studies (one prospective and two retrospective cohort studies, one retrospective cross-sectional study), in which a total of 445 patients were enrolled. No randomized controlled trial was available. Catheterization substantially increased quality of life, post void residual, and incontinence episodes in all included studies. Pooling of data for meta-analysis was not possible due to the heterogeneity of reported outcomes. Adverse events were reported in two studies only. Risk of bias and confounding was intermediate. CONCLUSIONS: Preliminary data suggests beneficial effects of catheterization on the urological outcome in patients with MS. However, although intermittent and indwelling catheterization is used frequently in daily clinical practice in the MS population, the evidence base is very limited and well-designed, properly sampled, and powered studies are urgently needed.

The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation.

BACKGROUND: No official German translation exists for the 50-item Expanded Prostate Cancer Index Composite (EPIC), and no minimal important difference (MID) has been established yet. The aim of the study was to translate and validate a German version of the EPIC with cultural adaptation to the different German speaking countries and to establish the MID. METHODS: We translated and culturally adapted the EPIC into German. For validation, we included a consecutive subsample of 92 patients with localized prostate cancer undergoing radical prostatectomy who participated the Prostate Cancer Outcomes Cohort. Baseline and follow-up assessments took place before and six weeks after prostatectomy in 2010 and 2011. We assessed the EPIC, EORTC QLQ-PR25, Feeling Thermometer, SF-36 and a global rating of health state change variable. We calculated the internal consistency, test-retest reliability, construct validity, responsiveness and MID. RESULTS: For most EPIC domains and subscales, our a priori defined criteria for reliability were fulfilled (construct reliability: Cronbach's alpha 0.7-0.9; test-retest reliability: intraclass-correlation coefficient ≥ 0.7). Cross-sectional and longitudinal correlations between EPIC and EORTC QLQ-PR25 domains ranged from 0.14-0.79, and 0.06-0.5 and 0.08-0.72 for Feeling Thermometer and SF-36, respectively. We established MID values of 10, 4, 12, and 6 for the urinary, bowel, sexual and hormonal domain. CONCLUSION: The German version of the EPIC is reliable, responsive and valid to measure HRQL in prostate cancer patients and is now available in German language. With the suggested MID we provide interpretation to what extent changes in HRQL are clinically relevant for patients. Hence, study results are of interest beyond German speaking countries.