Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Assessment of vestibulo-ocular function without measuring eye movements.

BACKGROUND: The vestibulo-ocular reflex (VOR) maintains stable gaze during head motion. Deficiencies lead to apparent world motion due to incomplete stabilization of eyes in space. VOR measurement requires specialized apparatus, trained operators, and significant setup time. NEW METHOD: We present a system (VON: vestibulo-ocular nulling) for rapid vestibulo-ocular assessment without measuring eye movements per se. VON uses a head-mounted motion sensor, laptop computer with user input control, and laser target whose position is controlled by the computer. As the head moves, the target is made to move in the same manner with a gain set by the subject. When the subject sets the gain so the target appears stationary in space, it is stationary on the retinas. One can determine from this gain the extent to which the eyes move in space when the head moves, which is the amount by which the VOR is deficient. From this the gain of the compensatory eye movements is derived. RESULTS: VON was compared with conventional video-based VOR measures. Both methods track expected changes in gain over 20min of adaptation to minifying spectacles. VON measures are more consistent across subjects, and pre-adaptation values are closer to compensatory. COMPARISON WITH EXISTING METHOD: VON is a rapid means to assess vestibulo-ocular performance. As a functional perceptual measure, it accounts for gaze-stabilizing contributions that are not apparent in the standard VOR, such as pursuit and perceptual tolerance. CONCLUSIONS: VON assesses functional VOR performance. Future implementations will make VOR assessment widely available to investigators and clinicians.

Biofeedback Signals for Robotic Rehabilitation: Assessment of Wrist Muscle Activation Patterns in Healthy Humans.

Electrophysiological recordings from human muscles can serve as control signals for robotic rehabilitation devices. Given that many diseases affecting the human sensorimotor system are associated with abnormal patterns of muscle activation, such biofeedback can optimize human-robot interaction and ultimately enhance motor recovery. To understand how mechanical constraints and forces imposed by a robot affect muscle synergies, we mapped the muscle activity of seven major arm muscles in healthy individuals performing goal-directed discrete wrist movements constrained by a wrist robot. We tested six movement directions and four force conditions typically experienced during robotic rehabilitation. We analyzed electromyographic (EMG) signals using a space-by-time decomposition and we identified a set of spatial and temporal modules that compactly described the EMG activity and were robust across subjects. For each trial, coefficients expressing the strength of each combination of modules and representing the underlying muscle recruitment, allowed for a highly reliable decoding of all experimental conditions. The decomposition provides compact representations of the observable muscle activation constrained by a robotic device. Results indicate that a low-dimensional control scheme incorporating EMG biofeedback could be an effective add-on for robotic rehabilitative protocols seeking to improve impaired motor function in humans.

Pelvic floor muscle training in treatment of female stress urinary incontinence, pelvic organ prolapse and sexual dysfunction.

OBJECTIVES: The objectives of the present review was to present and discuss evidence for pelvic floor muscle (PFM) training on female stress urinary incontinence (SUI), pelvic organ prolapse (POP) and sexual dysfunction. METHODS: This manuscript is based on conclusions and data presented in systematic reviews on PFM training for SUI, POP and sexual dysfunction. Cochrane reviews, the 4th International Consultation on Incontinence, the NICE guidelines and the Health Technology Assessment were used as data sources. In addition, a new search on Pubmed was done from 2008 to 2011. Only data from randomized controlled trials (RCTs) published in English language is presented and discussed. RESULTS: There is Level 1, Grade A evidence that PFM training is effective in treatment of SUI. Short-term cure rates assessed as <2 g of leakage on pad testing vary between 35 and 80%. To date there are 5 RCTs showing significant effect of PFM training on either POP stage, symptoms or PFM morphology. Supervised and more intensive training is more effective than unsupervised training. There are no adverse effects. There is a lack of RCTs addressing the effect of PFM training on sexual dysfunction. CONCLUSIONS: PFM training should be first line treatment for SUI and POP, but the training needs proper instruction and close follow-up to be effective. More high quality RCTs are warranted on PFM training to treat sexual dysfunction.

Dynamic assessment of baroreflex control of heart rate during induction of propofol anesthesia using a point process method.

In this article, we present a point process method to assess dynamic baroreflex sensitivity (BRS) by estimating the baroreflex gain as focal component of a simplified closed-loop model of the cardiovascular system. Specifically, an inverse Gaussian probability distribution is used to model the heartbeat interval, whereas the instantaneous mean is identified by linear and bilinear bivariate regressions on both the previous R-R intervals (RR) and blood pressure (BP) beat-to-beat measures. The instantaneous baroreflex gain is estimated as the feedback branch of the loop with a point-process filter, while the RR-->BP feedforward transfer function representing heart contractility and vasculature effects is simultaneously estimated by a recursive least-squares filter. These two closed-loop gains provide a direct assessment of baroreflex control of heart rate (HR). In addition, the dynamic coherence, cross bispectrum, and their power ratio can also be estimated. All statistical indices provide a valuable quantitative assessment of the interaction between heartbeat dynamics and hemodynamics. To illustrate the application, we have applied the proposed point process model to experimental recordings from 11 healthy subjects in order to monitor cardiovascular regulation under propofol anesthesia. We present quantitative results during transient periods, as well as statistical analyses on steady-state epochs before and after propofol administration. Our findings validate the ability of the algorithm to provide a reliable and fast-tracking assessment of BRS, and show a clear overall reduction in baroreflex gain from the baseline period to the start of propofol anesthesia, confirming that instantaneous evaluation of arterial baroreflex control of HR may yield important implications in clinical practice, particularly during anesthesia and in postoperative care.

Psychophysiological stress assessment using biofeedback.

In the last half century, research in biofeedback has shown the extent to which the human mind can influence the functioning of the autonomic nervous system, previously thought to be outside of conscious control. By letting people observe signals from their own bodies, biofeedback enables them to develop greater awareness of their physiological and psychological reactions, such as stress, and to learn to modify these reactions. Biofeedback practitioners can facilitate this process by assessing people s reactions to mildly stressful events and formulating a biofeedback-based treatment plan. During stress assessment the practitioner first records a baseline for physiological readings, and then presents the client with several mild stressors, such as a cognitive, physical and emotional stressor. Variety of stressors is presented in order to determine a person's stimulus-response specificity, or differences in each person's reaction to qualitatively different stimuli. This video will demonstrate the process of psychophysiological stress assessment using biofeedback and present general guidelines for treatment planning.

Synchronization of stochastic delayed neural networks with markovian switching and its application.

In this paper, the problem of adaptive synchronization for a class of stochastic neural networks (SNNs) which involve both mixed delays and Markovian jumping parameters is investigated. The mixed delays comprise the time-varying delays and distributed delays, both of which are mode-dependent. The stochastic perturbations are described in terms of Browian motion. By the adaptive feedback technique, several sufficient criteria have been proposed to ensure the synchronization of SNNs in mean square. Moreover, the proposed adaptive feedback scheme is applied to the secure communication. Finally, the corresponding simulation results are given to demonstrate the usefulness of the main results obtained.

Vulvodynia: a psychophysiological profile based on electromyographic assessment.

The objective of this study was to explore the relationship between psychological and physiological processes and how these interact in the case of vulvodynia. The study design consisted of a retrospective review of predominantly premenopausal women presenting with vulvodynia via analyses of questionnaires, psychometric tests, sexual history, surface electromyographic (sEMG) assessments, and clinical notes. Five hundred and twenty-nine patients with vulvodynia (mean age 27.7 years) were studied. The average age of symptom onset was 22.8 years and the average duration of symptoms was 5.0 years. Patients scored higher than the comparison group on global dimensions of the Symptom Checklist-90 Revised (SCL-90R), with anxiety and depression scores showing a significant but modest correlation with severity of pain. sEMG data confirmed an association with pelvic muscle dysfunction but there was no correlation with severity of vulvar pain. A negative correlation between sEMG readings and duration of pain was noted and may be due to progressive time-related quieting of electrical activity in muscle tissues, which is commonly associated with the development of a functional muscle contracture. In conclusion, it is important to view chronic pain syndromes like vulvodynia from a psychophysiological perspective which recognizes the potential contribution of psychological and physiological variables in the aetiology of chronic vulvar pain.

Use of medical technologies in rehabilitation medicine settings in Israel: results of the TECHNO-R 2005 survey.

BACKGROUND: With the development of computer technology and the high-tech electronic industry over the past 30 years, the technological age is flourishing. New technologies are continually being introduced, and questions regarding the economic viability of these technologies need to be addressed. OBJECTIVES: To identify the medical technologies currently in use in different rehabilitation medicine settings in Israel. METHODS: The TECHNO-R 2005 survey was conducted in two phases. Beginning in 2004, the first survey used a questionnaire with open questions relating to the different technologies in clinical use, including questions on their purpose, who operates the device (technician, physiotherapist, occupational therapist, physician, etc.), and a description of the treated patients. This questionnaire was sent to 31 rehabilitation medicine facilities in Israel. Due to difficulties in comprehension of the term "technology," a second revised standardized questionnaire with closed-ended questions specifying diverse technologies was introduced in 2005. The responder had to mark from a list of 15 different medical technologies which were in use in his or her facility, as well as their purpose, who operates the device, and a description of the treated patients. RESULTS: Transcutaneous electrical nerve stimulation, the TILT bed, continuous passive movement, and therapeutic ultrasound were the most widely used technologies in rehabilitation medicine facilities. Monitoring of the sitting position in the wheelchair, at the bottom of the list, was found to be the least used technology (with 15.4% occurrence). Most of the technologies are used primarily for treatment purposes and to a lesser degree for diagnosis and research. CONCLUSIONS: Our study poses a fundamental semantic and conceptual question regarding what kind of technologies are or should be part of the standard equipment of any accredited rehabilitation medicine facility for assessment, treatment and/or research. For this purpose, additional data are needed.

Neurofeedback in adolescents and adults with attention deficit hyperactivity disorder.

Neurofeedback is being utilized more commonly today in treating individuals who have attention deficit hyperactivity disorder (ADHD). Neurofeedback, which is based on theories that recognize the organic basis of ADHD, utilizes biofeedback to guide individuals to regulate their brain activity. Neurofeedback relies on research that has demonstrated that most individuals who have ADHD, as compared to matched peers, have excess slow wave activity and reduced fast wave activity. It provides immediate feedback to the individual about his or her brain wave activity in the form of a video game, whose action is influenced by the individual's meeting predetermined thresholds of brain activity. Over several sessions of using the video and auditory feedback, individuals reduce their slow wave activity and/or increase their fast wave activity. Individuals who complete a course of training sessions often show reduced primary ADHD symptoms. Research has shown that neurofeedback outcomes compare favorably to those of stimulant medication.

Biofeedback-based psychophysiological treatment in a primary care setting: an initial feasibility study.

We sought to determine whether an intervention labeled "biofeedback" could be implemented with patients who were diagnosed with "functional" disorders (Irritable Bowel Syndrome, Fibromyagia/Chronic Fatigue Syndrome, Myofascial Pain, Anxiety with somatic features, or Noncardiac Chest Pain), in a primary care setting, and whether cost savings through lowered utilization of medical services would be realized. Seventy patients were initially randomized into a treatment group or comparison group based on willingness to participate. Ultimately, 19 patients completed treatment and 30 were followed through usual treatment as a comparison. Treatment patients completed symptom diaries while working with a biofeedback therapist in the primary care facility. Both group's medical expenses were tracked for 6 months prior to and 6 months after the treatment time interval. Patients in the treatment group lowered symptom frequency and severity significantly. Medical costs were differentially reduced in this group such that all costs were $72 less in the treatment group and $9 in the comparison for the 6 months following the treatment time period. (p < .001). Unfortunately, a large group of assigned treatment patients did not start or complete treatment. These patients had high initial costs and went up even higher post. No comparable group could be found among the controls, limiting any inference regarding cost/benefit. Biofeedback based interventions for "functional" disorders can be easily integrated into primary care settings, can reduce symptoms, and may be able to reduce overall medical costs in this group of patients known as heavy utilizers.

A new procedure for assessment of proprioception.

A new method for the assessment of proprioception was developed and tested with 40 healthy subjects on two facial muscles (i.e., masseter and zygomatic muscles). The experiment was repeated after 3 1/2 months. In our study, proprioception was studied with respect to sensations arising from the muscle spindles and tendon organs. Therefore, myesthesia was investigated, which was assessed by the correspondence between a voluntary muscle contraction and its immediate replication. Good perception was defined by a small integral of differences, standardized by duration and intensity of the contraction, and its replication. Results show that this measure is independent of the characteristics of muscle activation. In concordance with our hypothesis, myesthesia was superior in a muscle richly supplied with muscle spindles and afferent fibers (i.e., masseter muscle), to that for a muscle less prepared for afferent information processing (i.e., zygomatus major).

Self-regulation and assessment approaches for vaso-occlusive pain management for pediatric sickle cell anemia patients.

An interdisciplinary program with the goal of teaching self-regulation and minimizing excessive narcotic use in the management of vaso-occlusive pain (V-O) in pediatric sickle cell anemia patients is described. A small group of patients do not respond well to any of our outpatients or inpatients medical regimens, leading us to suspect that psychological factors are influencing pain reports. We outline our multi-faceted assessment approach to evaluating such psychological factors, which includes a pain flow sheet, symptom check list, and a psychophysiologic profile. Published reports of self-regulation training including biofeedback, relaxation/imagery, and hypnosis have been associated with decreased pain symptoms, reduced number of emergency room and hospital visits for pain, decreased narcotic use, and increased school attendance. A case study of a nine-year-old patient with sickle cell disease is described before and after self-regulation training. Finally, other alternative approaches that avoid excessive narcotic use are discussed with some case reports.