[Effectiveness of influenza vaccine in the Netherlands: predominant circulating virus type and vaccine match are important conditions]. / Effectiviteit van influenzavaccinatie in Nederland.

OBJECTIVE: To investigate the relationship between circulating influenza virus A types and subtypes and influenza B lineages, their match with the vaccine and the effectiveness of the influenza vaccine (IVE). DESIGN: Test negative case control study. METHOD: We used data from the Dutch Sentinel Practices of the Netherlands Institute for Health Services Research (NIVEL) Primary Care Database. Participating general practitioners took nose and throat swabs for viral studies from patients with influenza-like illness or another acute respiratory infection. Cases were those patients whose samples were positive for an influenza virus and controls were those whose samples were negative for influenza virus. We determined the IVE of 11 influenza seasons 2003/2004 to 2013/2014, for all seasons together and stratified by influenza virus type and to vaccine match or mismatch. RESULTS: Over all seasons, the IVE was 29% (95% CI:11-43). In seven of the 11 seasons there was a mismatch between vaccine and circulating virus type. The IVE was 40% (95% CI: 18-56) for those seasons in which there was a vaccine match, and 20% (95% CI: - 5-38) for seasons with a mismatch. When the influenza A/H3N2 virus was dominant, the IVE was 38% (95% CI: 14-55). The IVE against the influenza virus A/H1N1, A/H1N1/pdm09 and against both influenza B lineages was 77% (95% CI: 37-92), 47% (95% CI: 22-64) and 64% (95% CI: 50-74), respectively. CONCLUSION: The IVE was particularly low when there was a mismatch between the vaccine and the circulating virus type and when A/H3N2 was the dominant influenza subtype.

WITHDRAWN: Pelvic floor muscle training for urinary incontinence in women.

BACKGROUND: Pelvic floor muscle training is the most commonly recommended physical therapy treatment for women with stress leakage of urine. It is also used in the treatment of women with mixed incontinence, and less commonly for urge incontinence. Adjuncts, such as biofeedback or electrical stimulation, are also commonly used with pelvic floor muscle training. The content of pelvic floor muscle training programmes is highly variable. OBJECTIVES: To determine the effects of pelvic floor muscle training for women with symptoms or urodynamic diagnoses of stress, urge and mixed incontinence, in comparison to no treatment or other treatment options. SEARCH STRATEGY: Search strategy: We searched the Cochrane Incontinence Group trials register (May 2000), Medline (1980 to 1998), Embase (1980 to 1998), the database of the Dutch National Institute of Allied Health Professions (to 1998), the database of the Cochrane Rehabilitation and Related Therapies Field (to 1998), Physiotherapy Index (to 1998) and the reference lists of relevant articles. We handsearched the proceedings of the International Continence Society (1980 to 2000). We contacted investigators in the field to locate studies. Date of the most recent searches: May 2000. SELECTION CRITERIA: Randomised trials in women with symptoms or urodynamic diagnoses of stress, urge or mixed incontinence that included pelvic floor muscle training in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data were extracted by the lead reviewer onto a standard form and cross checked by another. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. Sensitivity analysis on the basis of diagnosis was planned and undertaken where appropriate. MAIN RESULTS: Forty-three trials met the inclusion criteria. The primary or only reference for 15 of these was a conference abstract. The pelvic floor muscle training programs, and comparison interventions, varied markedly. Outcome measures differed between trials, and methods of data reporting varied, making the data difficult to combine. Many of the trials were small. Allocation concealment was adequate in five trials, and nine trials used assessors masked to group allocation. Thirteen trials reported that there were no losses to follow up, seven trials had dropout rates of less than 10%, but in the remaining trials the proportion of dropouts ranged from 12% to 41%. Pelvic floor muscle training was better than no treatment or placebo treatments for women with stress or mixed incontinence. 'Intensive' appeared to be better than 'standard' pelvic floor muscle training. PFMT may be more effective than some types of electrical stimulation but there were problems in combining the data from these trials. There is insufficient evidence to determine if pelvic floor muscle training is better or worse than other treatments. The effect of adding pelvic floor muscle training to other treatments (e.g. electrical stimulation, behavioural training) is not clear due to the limited amount of evidence available. Evidence of the effect of adding other adjunctive treatments to PFMT (e.g. vaginal cones, intravaginal resistance) is equally limited. The effectiveness of biofeedback assisted PFMT is not clear, but on the basis of the evidence available there did not appear to be any benefit over PFMT alone at post treatment assessment.Long-term outcomes of pelvic floor muscle training are unclear. Side effects of pelvic floor muscle training were uncommon and reversible. A number of the formal comparisons should be viewed with caution due to statistical heterogeneity, lack of statistical independence, and the possibility of spurious confidence intervals in some instances. AUTHORS' CONCLUSIONS: Pelvic floor muscle training appeared to be an effective treatment for adult women with stress or mixed incontinence. Pelvic floor muscle training was better than no treatment or placebo treatments. The limitations of the evidence available mean that is difficult to judge if pelvic floor muscle training was better or worse than other treatments. Most trials to date have studied the effect of treatment in younger, premenopausal women. The role of pelvic floor muscle training for women with urge incontinence alone remains unclear. Many of the trials were small with poor reporting of allocation concealment and masking of outcome assessors. In addition there was a lack of consistency in the choice and reporting of outcome measures that made data difficult to combine. Methodological problems limit the confidence that can be placed in the findings of the review. Further, large, high quality trials are necessary.

Prevalence of delayed gastric emptying in diabetic patients and relationship to dyspeptic symptoms: a prospective study in unselected diabetic patients.

OBJECTIVE: Data on the prevalence of abnormal gastric emptying in diabetic patients are still lacking. The relation between gastric emptying and dyspeptic symptoms assessed during gastric emptying measurement has not yet been investigated. The aim was to investigate the prevalence of delayed gastric emptying in a large cohort of unselected diabetic patients and to investigate the relation between gastric emptying and gastrointestinal sensations experienced in the 2 weeks before and during the test meal, prospectively. RESEARCH DESIGN AND METHODS: Gastric emptying was evaluated in 186 patients (106 with type 1 diabetes, mean duration of diabetes 11.6 +/- 11.3 years) using 100 mg (13)C-enriched octanoic acid added to a solid meal. RESULTS: Gastric emptying was significantly slower in the diabetic subjects than in the healthy volunteers (T(50): 99.5 +/- 35.4 vs. 76.8 +/- 21.4 min, P < 0.003; Ret(120 min): 30.6 +/- 17.2 vs. 20.4 +/- 9.7%, P < 0.006). Delayed gastric emptying was observed in 51 (28%) diabetic subjects. The sensations experienced in the 2 weeks before the test were weakly correlated with the sensation scored during the gastric emptying test. Sensations assessed during the gastric emptying test did predict gastric emptying to some extent (r = 0.46, P < 0.0001), whereas sensations experienced in the previous 2 weeks did not. CONCLUSIONS: This prospective study shows that delayed gastric emptying can be observed in 28% of unselected patients with diabetes. Upper gastrointestinal sensations scored during the gastric emptying tests do predict the rate of gastric emptying to some extent and sensation experienced during daily life does not.

Pelvic floor muscle training for urinary incontinence in women.

BACKGROUND: Pelvic floor muscle training is the most commonly recommended physical therapy treatment for women with stress leakage of urine. It is also used in the treatment of women with mixed incontinence, and less commonly for urge incontinence. Adjuncts, such as biofeedback or electrical stimulation, are also commonly used with pelvic floor muscle training. The content of pelvic floor muscle training programmes is highly variable. OBJECTIVES: To determine the effects of pelvic floor muscle training for women with symptoms or urodynamic diagnoses of stress, urge and mixed incontinence, in comparison to no treatment or other treatment options. SEARCH STRATEGY: Search strategy: We searched the Cochrane Incontinence Group trials register (May 2000), Medline (1980 to 1998), Embase (1980 to 1998), the database of the Dutch National Institute of Allied Health Professions (to 1998), the database of the Cochrane Rehabilitation and Related Therapies Field (to 1998), Physiotherapy Index (to 1998) and the reference lists of relevant articles. We handsearched the proceedings of the International Continence Society (1980 to 2000). We contacted investigators in the field to locate studies. Date of the most recent searches: May 2000. SELECTION CRITERIA: Randomised trials in women with symptoms or urodynamic diagnoses of stress, urge or mixed incontinence that included pelvic floor muscle training in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data were extracted by the lead reviewer onto a standard form and cross checked by another. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. Sensitivity analysis on the basis of diagnosis was planned and undertaken where appropriate. MAIN RESULTS: Forty-three trials met the inclusion criteria. The primary or only reference for 15 of these was a conference abstract. The pelvic floor muscle training programs, and comparison interventions, varied markedly. Outcome measures differed between trials, and methods of data reporting varied, making the data difficult to combine. Many of the trials were small. Allocation concealment was adequate in five trials, and nine trials used assessors masked to group allocation. Thirteen trials reported that there were no losses to follow up, seven trials had dropout rates of less than 10%, but in the remaining trials the proportion of dropouts ranged from 12% to 41%. Pelvic floor muscle training was better than no treatment or placebo treatments for women with stress or mixed incontinence. 'Intensive' appeared to be better than 'standard' pelvic floor muscle training. PFMT may be more effective than some types of electrical stimulation but there were problems in combining the data from these trials. There is insufficient evidence to determine if pelvic floor muscle training is better or worse than other treatments. The effect of adding pelvic floor muscle training to other treatments (e.g. electrical stimulation, behavioural training) is not clear due to the limited amount of evidence available. Evidence of the effect of adding other adjunctive treatments to PFMT (e.g. vaginal cones, intravaginal resistance) is equally limited. The effectiveness of biofeedback assisted PFMT is not clear, but on the basis of the evidence available there did not appear to be any benefit over PFMT alone at post treatment assessment. Long-term outcomes of pelvic floor muscle training are unclear. Side effects of pelvic floor muscle training were uncommon and reversible. A number of the formal comparisons should be viewed with caution due to statistical heterogeneity, lack of statistical independence, and the possibility of spurious confidence intervals in some instances. REVIEWER'S CONCLUSIONS: Pelvic floor muscle training appeared to be an effective treatment for adult women with stress or mixed incontinence. Pelvic floor muscle training was better than no treatment or placebo treatments. The limitations of the evidence available mean that is difficult to judge if pelvic floor muscle training was better or worse than other treatments. Most trials to date have studied the effect of treatment in younger, premenopausal women. The role of pelvic floor muscle training for women with urge incontinence alone remains unclear. Many of the trials were small with poor reporting of allocation concealment and masking of outcome assessors. In addition there was a lack of consistency in the choice and reporting of outcome measures that made data difficult to combine. Methodological problems limit the confidence that can be placed in the findings of the review. Further, large, high quality trials are necessary.

Conservative treatment of urge urinary incontinence in women: a systematic review of randomized clinical trials.

OBJECTIVE: To assess the efficacy of physical therapies for first-line use in the treatment of urge urinary incontinence (UUI) in women, using a systematic review of randomized clinical trials (RCTs). MATERIALS AND METHODS: A computer-aided and manual search was carried out for RCTs published between 1980 and 1999 investigating the treatment of UUI defined by the keywords 'physical therapies', e.g. bladder (re)training (including 'behavioural' treatment), pelvic floor muscle (PFM) exercises, with or without biofeedback and/or electrical stimulation. The methodological quality of the included trials was assessed using methodological criteria, based on generally accepted principles of interventional research. RESULTS: Fifteen RCTs were identified; the methodological quality of the studies was moderate, with a median (range) score of 6 (3-8.5) (maximum possible 10). Eight RCTs were considered of sufficient quality, i.e. an internal validity score of >/= 5.5 points on a scale of 0-10, and were included in a further analysis. Based on levels-of-evidence criteria, there is weak evidence to suggest that bladder (re)training is more effective than no treatment (controls), and that bladder (re)training is better than drug therapy. Stimulation types and parameters in the studies of electrical stimulation were heterogeneous. There is insufficient evidence that electrical stimulation is more effective than sham electrical simulation. To date there are too few studies to evaluate effects of PFM exercise with or without biofeedback, and of toilet training for women with UUI. CONCLUSION: Although almost all studies included reported positive results in favour of physical therapies for the treatment of UUI, more research of high methodological quality is required to evaluate the effects of each method in the range of physical therapies.

Validity of a non-invasive determination of the isovolumetric bladder pressure during voiding in men with LUTS.

Invasive pressure flow analysis is the gold standard for discriminating between hypocontractile bladder muscle function and infravesical obstruction in male patients with lower urinary tract symptoms. Here a non-invasive method to determine the isovolumetric bladder pressure to judge contractility is presented. This is based on interruption of urine flow by sudden occlusion of a specially fixed condom catheter. The pressure inside the condom is recorded and used to estimate the isovolumetric bladder pressure. Combined with, for example, home uroflowmetry, this non-invasive method may overcome some of the disadvantages (e.g., invasiveness, cost) of the conventional pressure flow test. To determine the isovolumetric bladder pressure reliably with this non-invasive method, two constraints have to be met. First, the bladder neck and urethra have to remain open after occlusion of the condom catheter. This was tested combining the non-invasive test with radiography in five patients. Second, a steady state has to be reached, i.e., the flow in the urethra, due to the elastic properties of the biological and the condom systems, should come to a stop when the bladder pressure and the condom pressure equilibrate. This was investigated by comparing the non-invasively recorded condom pressure with the simultaneously invasively recorded intravesical pressure in 52 patients. In these patients, three different methods of condom fixation were evaluated. The results show that the bladder neck and urethra remain open during the test. However, a steady state is often not reached. In more than 80% of the cases with the best condom fixation, the bladder pressure has not stabilized, although the condom pressure reached a plateau. Therefore, this method of sudden occlusion is not yet clinically applicable for determining the isovolumetric bladder pressure. Neurourol. Urodynam. 18:477-486, 1999.

A non-invasive method for bladder electromyography in humans.

No convincing correlation of bladder EMG in humans to simultaneously measured intravesical pressure has been reported in the literature. In most studies on bladder EMG the electrodes contact the bladder wall itself. This causes problems in the discrimination between very small extracellular signals, reflecting actual membrane potential changes of bladder muscle cells, and large electro-mechanical artefact caused by electrode movement as the tissue contracts. Aim of this study is to investigate whether bladder EMG can be performed non-invasively with Ag-AgCl surface electrodes that are placed on the abdominal skin of healthy volunteers. Bipolar electrode signals are obtained in a diagonal, vertical and horizontal direction of the abdominal electrodes. A conventional urodynamic investigation is performed according to International Continence Society standards simultaneously with bladder EMG. This new method shows that voiding is accompanied by a slow voltage change in bipolar electrode signals. The contribution of abdominal and other striated muscle activity to the bipolar electrode signals can clearly be distinguished from the slow voltage changes related to voiding. Free flowmetry shows that the electrical activity picked up by the abdominal electrodes is related to bladder emptying. In pressure/flow studies a relation between the electrical activity and the detrusor pressure is found. The present results suggest that the slow voltage changes found during bladder contraction are caused by summed membrane potential changes of bladder muscle cells, but this concept needs further testing. Also, validation for clinical use remains to be established.

Conservative treatment of stress urinary incontinence in women: a systematic review of randomized clinical trials.

OBJECTIVE: To assess the efficacy of physical therapies for first-line use in the treatment and prevention of stress urinary incontinence (SUI) in women, using a systematic review of randomized clinical trials (RCTs). MATERIALS AND METHODS: A computer-aided and manual search for published RCTs investigating treatment and prevention of SUI using physical therapies, e.g. pelvic floor muscle (PFM) exercises, with or without other treatment modalities, were carried out. The methodological quality of the included trials was assessed using criteria based on generally accepted principles of interventional research. RESULTS: Twenty-four RCTs (22 treatment and two prevention) were identified; the methodological quality of the studies included was moderate and 11 RCTs were of sufficient quality to be included in further analysis. Based on levels-of-evidence criteria, there is strong evidence to suggest that PFM exercises are effective in reducing the symptoms of SUI. There is limited evidence for the efficacy of high-intensity vs a low-intensity regimen of PFM exercises. Despite significant effects of biofeedback after testing as an adjunct to PFM exercises, there is no evidence that PFM exercises with biofeedback are more effective than PFM exercises alone. There is little consistency (of stimulation types and parameters) in the studies of electrical stimulation, but when the results are combined there is strong evidence to suggest that electrostimulation is superior to sham electrostimulation, and limited evidence that there is no difference between electrostimulation and other physical therapies. In the prevention of SUI the efficacy of PFM exercises, with or without other adjuncts, is uncertain.

Long-term ambulatory monitoring of urine leakage in the elderly: an evaluation of the validity and clinical applicability of thermistor signalling.

This study evaluated the validity and applicability of a low-cost Urine Leakage Recording Device (ULRD) in a geriatric setting. The ULRD consisted of a thermistor, connected to a portable, digital datalogger. The thermistor was positioned on a commercially available adult diaper. Five healthy females were instructed to void urine in seven behavioural conditions comprising general motor activity patterns of the average, psychogeriatric elderly in-patient. Voids were verbally indicated by the subjects and concomitantly recorded by the ULRD and the observer. After comparing the ULRD records--scored by three independent assessors--with the subjects' reports, on average (SD) 5.3 (0.6) of a total of 10 voids were classified correctly, whereas 9.3 (1.3) false positive events were indicated. None of the subjects reported any inconvenience as a result of the recording procedure. Although the ULRD is easily applicable, we conclude that it seems to be of little value in its present form as a method for long-term ambulatory monitoring of urine leakage.

Detrusor activity index: quantification of detrusor overactivity by ambulatory monitoring.

PURPOSE: Ambulatory urodynamic monitoring has been developed and evaluated during the last decade, and its appreciation is growing rapidly. We investigated the usefulness of this technique to quantify detrusor activity, and developed a parameter to quantify the grade of detrusor overactivity. MATERIALS AND METHODS: We investigated 167 female patients with lower urinary tract symptoms and 61 asymptomatic volunteers. Detrusor behavior was classified according to the medical history findings and independently based on urodynamic investigation. The possible categories were termed overactive or not overactive. Subjects who were classified consistently formed the 2 reference groups, which were used in the statistical analysis of logistic regression. RESULTS: By logistic regression a scoring rule was developed. The individual score (detrusor activity index 0 to 1) is a measure of detrusor activity during the filling phase. At a cutoff point of 0.41 the sensitivity equaled specificity of 85% in our patient and volunteer groups. CONCLUSIONS: The scoring rule can be applied clinically as a test to detect and quantify detrusor overactivity in patients with urinary incontinence.

A method for the electromyographic mapping of the detrusor smooth muscle.

Various methods for detrusor EMG in the living mammal have been described in the literature. These methods do insufficiently take into account signal components that are caused by movement between the electrodes and the bladder wall. Reliable detrusor EMG has not been achieved yet. This study investigates the feasibility of a new experimental set-up, in which the electrical activity of the detrusor smooth muscle can be examined. In six rabbits, after cervical dislocation, laparotomy and after excision of the heart, electrical signals of the detrusor muscle are measured with 240 electrodes. The electrodes are positioned on the serosal surface of the filled and isovolumetric bladder. During the recordings, no bladder contractions are deliberately evoked by any stimulus. Consistent results in all six animals show a repetitive spike pattern on multiple electrodes with a repetition frequency of 1.2 Hz. Spikes are triphasic and have a mean duration of 0.47 s (STD = 0.15 s, n = 40) and a mean amplitude of 0.29 mV (STD = 0.07 mV, n = 40). On adjacent electrodes a time shift between the spikes is found, suggesting the propagation of electrical activity across the detrusor surface. The maximum conduction velocity of an arbitrary spike front in the direction of propagation is approximately 30 mm/s. In two animals slow waves are found on the edge of the highpass filter setting. Extensive control experiments are executed to validate the set-up and to interpret the data obtained by the animal experiments. The bladder is still able to contract thirty minutes post mortem. The heart, as a distant signal source, generates a signal that is present on all electrodes and shows no detectable time shift from one electrode to any other. Motion imposed on the electrodes relative to the bladder wall does not reproduce the slow waves and spikes found in the animal experiments. The control experiments support that the results of the animal experiments show electrical activity originating from the detrusor muscle itself. With the experimental set-up described in this paper, nearly artefact free detrusor EMG can be recorded. An electromyographic map of a considerable detrusor smooth muscle area can be obtained.

Ambulatory urodynamics: extramural testing of the lower and upper urinary tract by Holter monitoring of cystometrogram, uroflowmetry, and renal pelvic pressures.

This article elucidates the clinical applicability and state of the art of ambulatory urodynamics. Ambulatory urodynamics have evolved into practical investigations like EAC, HFM, and EAC combined with renal pelvimetry. EAC has been shown to be the method of preference if detrusor overactivity is involved. Conventional filling cystometry has proved to be an unreliable way to exclude detrusor instability. De novo instability after suspension surgery often indicates that an existing detrusor overactivity was not identified preoperatively. EAC including flowmetry has shown considerable variance in obstructive and contractility parameters in males with LUTS indicative for BPH. This raises doubt whether the clinical flow analysis is the suitable "gold standard" as advocated by the ICS. For a real break through of EAC, less complex automatic analysis is necessary. HFM is a newer method within the range of ambulatory urodynamic tests. It has not yet been completely evaluated. But, because the technique is analogous to the office flowmetry, noninvasive and very well accepted by the patients, it is expected to be widely used. This expectation is strengthened by the fact that HFM seems to show individual therapeutic efficacy of drugs, such as alpha-blockers. As a research tool to evaluate efficacy, it is far more powerful than conventional methods because of the reduction of within-patient standard deviation to about 10%. Finally, EAC combined with pelvimetry offers a promising method for the clinical evaluation of a combined dysfunction of upper and lower urinary tract.

Efficacy of biofeedback, when included with pelvic floor muscle exercise treatment, for genuine stress incontinence.

UNLABELLED: We performed a randomized clinical trial on the efficacy of physical therapy on genuine stress incontinence. STUDY OBJECTIVE: "Is a physical therapeutical training program (pelvic floor muscle training) combined with biofeedback, more effective than the same program without biofeedback in patients with mild or moderate stress incontinence?" Forty-four patients were referred by a general practitioner or a urologist. After informed consent, 40 patients were randomized in an exercises and biofeedback group (BF), or treated with exercises exclusively (pelvic floor muscle training = PFMT). After a diagnostic phase of 1 week every patient received twelve treatment sessions, three times weekly. The primary measure of effect, the quantity of involuntary urine loss, was measured with the 48 hours PAD test (Inco-test Mölnlycke). Before every treatment session the Symptoms questionnaire was filed out by the patient and the Patient dairy was controlled. The data of the trial were analysed according to the principal of intention to treat. During the trial there was 100% compliance. There were no drop-outs. Both treatment modalities appeared to be effective. After twelve treatment sessions there was a mean improvement of +/- 55% (P = 0.00) in both treatment groups, measured by the primary measure of effect. In the group with BF this improvement was already realized after six treatment sessions (P = 0.01). Yet, the difference between BF and PFMT faded to reach significance at six treatment sessions (P = 0.08). Although differences in treatment effects between both groups were not significant, our findings suggest that adding biofeedback to pelvic floor muscle exercises might be more effective than pelvic floor muscle exercises alone after six treatments.

Ambulatory urodynamics.

Ambulatory monitoring of lower and upper urinary tract continues to develop. The addition of electronic urine-loss measurements to indicate the exact time-related loss is an important new feature. In the near future, quantitative urine-loss measurements will become available. The additional possibility of plugging in a flowmeter completes the technique with respect to pressure-flow analysis. At present, however, ambulatory urodynamics is still confined to specialized urodynamic centers. Ambulatory urodynamic monitoring has shown that de-novo detrusor instability after a suspension operation is frequently missed as a preoperative diagnosis of detrusor overactivity. The first steps are being taken toward giving a quantitative analysis of detrusor activity during the filling phase. This justifies a more widespread use of this ambulatory monitoring.