Cell-free DNA analysis is becoming adopted for first line aneuploidy screening, however for most healthcare programs, cost and workflow complexity is limiting adoption of the test. We report a novel cost effective method, the Vanadis NIPT assay, designed for high precision digitally-enabled measurement of chromosomal aneuploidies in maternal plasma. Reducing NIPT assay complexity is achieved by using novel molecular probe technology that specifically label target chromosomes combined with a new readout format using a nanofilter to enrich single molecules for imaging and counting without DNA amplification, microarrays or sequencing. The primary objective of this study was to assess the Vanadis NIPT assay with respect to analytical precision and clinical feasibility. Analysis of reference DNA samples indicate that samples which are challenging to analyze with low fetal-fraction can be readily detected with a limit of detection determined at <2% fetal-fraction. In total of 286 clinical samples were analysed and 30 out of 30 pregnancies affected by trisomy 21 were classified correctly. This method has the potential to make cost effective NIPT more widely available with more women benefiting from superior detection and false positive rates.

Stress incontinence is the most prevalent form of female urinary incontinence and it affects approximately 5% of younger women to nearly 50% of elderly women. Women have traditionally been treated with pelvic floor muscle exercises alone or with the use of vaginal cones. A new treatment mode, vaginal balls, has been developed. The aim of this study was to compare pelvic floor muscle training with and without vaginal balls and to collect information on women's subjective feelings about the two training modes. The study was carried out as a prospective randomized clinical trial. Thirty-seven women aged 25-65 were assigned either to a pelvic floor muscle training program or to a training program using weighted vaginal balls for 4 months. Treatment outcomes were assessed by a pad-test with a standardized bladder volume, vaginal palpation, and by women's self-reported perceptions. The sense of coherence score was compared with the score for a normal population. Ninety-three percent of the women completed the study. Both training modes were effective in reducing urinary leakage: with vaginal balls (P < 0.0001) and without (P < 0.019); and increasing pelvic floor muscle strength: with vaginal balls (P < 0.0039) and without (P < 0.0002). However, the reduction of urinary leakage after four months of exercise in the training group with vaginal balls was significantly better (P < 0.03) than the results in the group training with pelvic floor muscle exercises alone. The study found the weighted vaginal balls to be a good alternative for training pelvic floor muscles in women with stress urinary incontinence.

Materials and Methods:Incontinent OAB patients, despite 4-weeks single-blind daily solifenacin 5 mg, were randomized 1:1:1 to double-blind, daily combination (mirabegron 50 mg/solifenacin 5 mg), solifenacin 5 or 10 mg for 12 weeks. Mirabegron dose was increased from 25 mg to 50 mg after week 4. Symptom Bother, health-related quality of life (HRQoL), and patient perception of bladder condition (PPBC) were assessed using respective OAB-q and PPBC questionnaires; responder rates were based on 50% reduction in daily incontinence, zero incontinence episodes and <8 micturitions/24 hours, and minimal important differences in OAB-q and PPBC.Results: Overall 2,174 patients, median age 59 years, were randomized to combination (n=727), solifenacin 5 mg (n=728) or 10 mg (n=719). Symptom Bother, total HRQoL and its subscales (Coping, Concern, and Social) and PPBC were significantly improved with combination vs solifenacin monotherapy (P<0.05). The odds of achieving clinically meaningful improvements in incontinence and micturition frequency, Symptom Bother, HRQoL and PPBC, was significantly higher with combination vs solifenacin monotherapy.The odds (95% CI) of becoming continent was 47% (OR 1.47; 1.17, 1.84; p=0.001) and 28% (OR 1.28; 1.02, 1.61; p=0.033) higher with combination vs solifenacin 5 and 10 mg, respectively. Conclusion:Significantly more patients on combination achieved clinically meaningful improvements in incontinence and micturition frequency, which were accompanied by similar improvements in PPBC, Symptom Bother and HRQoL. BESIDE Responder 3rd draft February 2016 4 Overactive bladder (OAB) is defined by symptoms of urinary urgency, usually accompanied by increased daytime frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection or other obvious pathology. 1,2 Urgency urinary incontinence affects approximately one third of all OAB cases. 3 Compared with continent ("dry") OAB patients, incontinent ("wet") OAB patients experience greatly diminished quality of life (QoL), reporting higher rates of depression, psychological and emotional distress, and social isolation. 4,5 The severity of urgency urinary incontinence is strongly correlated with reductions in QoL,6 suggesting that incontinent OAB patients who are refractory to treatment are likely to be extremely dissatisfied with their QoL. Daily activities are often severely disrupted, and incontinent patients are more likely to require assistance with daily activities, placing an additional financial burden on society. 7 OAB patients are more likely to seek treatment once symptoms affect health-related quality of life (HRQoL), 8 and to persist with treatment if HRQoL improves. 9 Objective efficacy assessments are essential in OAB trials. However, the greatest treatment benefit experienced by patients is likely to be related to improvements in QoL. It is, therefore, equally important to assess subjective, patient-reported outcomes (PROs) including HRQoL and perception of symptoms, and how these correlate wit...

ObjectiveTo evaluate clinical performance of a new automated cell‐free (cf)DNA assay in maternal plasma screening for trisomies 21, 18, and 13, and to determine fetal sex.MethodMaternal plasma samples from 1200 singleton pregnancies were analyzed with a new non–sequencing cfDNA method, which is based on imaging and counting specific chromosome targets. Reference outcomes were determined by either cytogenetic testing, of amniotic fluid or chorionic villi, or clinical examination of neonates.ResultsThe samples examined included 158 fetal aneuploidies. Sensitivity was 100% (112/112) for trisomy 21, 89% (32/36) for trisomy 18, and 100% (10/10) for trisomy 13. The respective specificities were 100%, 99.5%, and 99.9%. There were five first pass failures (0.4%), all in unaffected pregnancies. Sex classification was performed on 979 of the samples and 99.6% (975/979) provided a concordant result.ConclusionThe new automated cfDNA assay has high sensitivity and specificity for trisomies 21, 18, and 13 and accurate classification of fetal sex, while maintaining a low failure rate. The study demonstrated that cfDNA testing can be simplified and automated to reduce cost and thereby enabling wider population‐based screening.