Noninvasive Wireless Sensor PFMT Device for Pelvic Floor Muscle Training

[[abstract]]Urinary incontinence is a common problem among adults. Studies have shown up to 70% improvement in stress incontinence symptoms following appropriately performed pelvic floor exercise. This improvement is evident across all age groups. In this study, we cooperated with a doctor of the Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taiwan. We developed a noninvasive device with the purpose of helping patients commence and perform pelvic floor muscle training (PFMT). This device consists of a PFMT device, an Arduino control board, a force sensor, a Bluetooth device, and an SD card. The objectives of this study are to train patients to inhibit detrusor contraction voluntarily and to contract periurethral muscles selectively. The system records and analyzes sensor data and provides voice prompts during PFMT exercise for patients at hospitals or their homes. Meanwhile, it tracks patients’ PFMT exercise at home, and doctors can contact patients for additional visitation(s) if necessary.[[incitationindex]]SCI[[booktype]]紙

On the Relationship between Pubovisceral Muscle Tears and Urethral Closure Pressure in Women Following Vaginal Birth

Little is known about the implications of pubovisceral muscle tear on urethral closure pressure – the focus of this dissertation. The literature on interventions for stress urinary incontinence has focused almost exclusively on pubovisceral muscle strengthening with repetitive exercise for life, but to date reports on “strength change” and on “leakage reduction” fail to convincingly relate these two outcomes, and essentially none of the studies reported take into account pubovisceral muscle tear, which renders the muscle incapable of response to volitional contraction effort. These major limitations in the literature are largely due to a long struggle to find adequate valid, cost effective, acceptable, accessible, reliable measures for the constructs of pubovisceral muscle. Recent major advances have been made in the field of pubovisceral muscle measurement, but come with a history (70+ years) of measurement difficulties that have caused fixed ideas and misunderstandings. This dissertation advances our understanding of measures of pubovisceral muscle structure (tears at the enthesis) and pubovisceral muscle function (loss of capacity for strength), suggests gold standard measures, advances the possibility of cost-effective clinical screening exams, and then for the first time examines in a sample of postpartum women known to have had obstetric high-risk factors at delivery the relationship of pubovisceral muscle tear to urethral closure pressure. The dissertation has three purposes: 1) reviewing past and current measures for assessing pubovisceral muscle strength and pubovisceral muscle tear; 2) estimating the odds of pubovisceral muscle tear (with gold standard magnetic resonance imaging) from clinical examination identifying using index finger palpatory assessment; and 3) determining predictive value of pubovisceral muscle tear on urethral closure pressure both at rest and during volitional effort of pelvic muscle contraction. The findings from the research suggest that there are gold standard measures (MRI and one-billed speculum) that are unsurpassed in meeting criteria of precise, valid, acceptable to women, but with some not broadly accessible in part due to prohibitive cost factors and lack of technology transfer from the research arena to the public. Quantified standing stress paper towel test and sagittal dynamic ultrasound for estimating pubovisceral muscle function in women with stress incontinence are suggested for adoption widely in the clinical setting, where currently implementation is nearly non-existent. The findings also suggest, for either scientific or clinical purposes, to avoid commonly used intravaginal instrument devices known to produce measures contaminated by intraabdominal pressure, making it impossible to isolate the pubovisceral muscle activities from non-pubovisceral muscle activity occurring simultaneously. The findings further suggest that index finger palpatory assessment can be used to initially identify pubovisceral muscle tear. Finally, the findings demonstrate the strong influence of the pubovisceral muscle tear (unstandardized coefficient = - 21.1; p=.001) on reducing a woman’s ability to volitionally optimize urethral closure pressure at the moment of intraabdominal pressure rise (as in cough), to prevent stress-type incontinence. These findings establish the foundation for future prospective research on estimation of pubovisceral muscle status in parous women who have vaginal birth and have risk factors for pubovisceral muscle tear, as well as identifying the role of volitional urethral closure pressure for future prevention and intervention studies on stress incontinence. This dissertation provides crucial data to inform the field focusing on testing pubovisceral muscle tear and the tear’ influences on the urethra, as well as the prevention and intervention for stress urinary incontinence.PHDNursingUniversity of Michigan, Horace H. Rackham School of Graduate Studieshttps://deepblue.lib.umich.edu/bitstream/2027.42/143908/1/shying_1.pd

Rethinking the artificial urinary sphincter : from current knowledge to the development of a new smart device

Background: Urinary incontinence (UI) plagues millions of women and men worldwide, leading to social stigma, low self-esteem, poor quality of life, and affects their loved ones. In women, frequent causes include childbirth, and in men prostate surgery for benign or malignant disease. In both genders congenital anomalies, neurological diseases, pelvic surgery, and radiation therapy are incriminating factors. Many patients struggle daily with pads and/or diapers, often unaware of the existence of a surgical cure. Since the seventies, the AMS 800Ô (Boston Scientific - Marlborough, Massachusetts, USA) artificial urinary sphincter (AUS) has been the reference to treat severe male stress UI (SUI) secondary to intrinsic sphincter deficiency (ISD). In women, it constitutes a second-line option, the mid-urethral sling (MUS) being recommended as first-line surgical therapy in moderate to severe cases. However, although efficient, it has several drawbacks, namely poor ergonomics, untailored status to patients’ physical activities, high revision and explantation rates. Aims: To solve the above issues, a novel electronic AUS was incepted in France in 2007. This thesis tells the modern developmental journey of this device for severe SUI treatment. The objective is three- fold: to conduct a review of the current AMSÔ in both genders to identify potential literature gaps to identify and analyze data resulting from bench tests and clinical studies, and to conduct pre-clinical feasibility, performance and safety studies on human cadavers and animals prior to FIM studies. The 6 constituent papers present the results of the process rethinking the current AMS 800Ô known today, from State of the Art (papers I-III) to the design stages (paper IV) and subsequent pre-clinical implantation phases (papers V and VI) prior to the First in Man study, which eventually leads to the obtention of CE marking. Material, Methods, and Results: In Paper I, a systematic literature review of AMS 800Ô implantation in women with non-neurogenic severe SUI, non-extant to date, was performed. The 12 articles included showed a very low level of evidence, result heterogeneity in performance and safety outcomes and highlighted the need for post- market studies. Paper II addressed the absence of standardized continence outcome measurement tool, essential to homogenize functional reported outcomes data, but also crucial for defining the primary outcomes of the FIM study. We retrospectively assessed the 24- hour pad weight test in 180 men treated with primary AUS for PPUI. Secondarily, its correlation to quality-of-life was analyzed. Thirdly (Paper III), we retrospectively evaluated long-term continence and safety results of transscrotal versus transperineal (TP) primary AUS implantation in 183 men with PPUI in a single center. No statistical difference in performance outcomes was seen; however, the TP technique appeared to present worse long-term safety results. In Paper IV, we dimensioned the novel AUS by prospectively measuring the exact in vivo volume taken by the AMS 800Ô occlusive cuff after its pressurization at implantation. We found that the larger the cuff, the greater the accommodated volume, which did not surpass 1 cc. Therefore, the final prototype could be designed, an essential developmental milestone. In paper V the usability and performance of the novel AUS was established, in accordance with current FDA and European regulations on AIMDs in development. The device’s usability and performance were shown in 8 anatomical subjects, using randomly obtained urodynamic maximum urethral closure pressure ranges, equivalent to those of the AMS 800Ô. In Paper VI, we ascertained the novel device’s feasibility of implantation and histopathological safety in an animal pilot study using two wether models. The study showed the suitability of the models, the device’s ease of implantation and the absence of peri-or postoperative, and histopathological adverse events. We could therefore safely consider a Pivot study. Conclusion: Developing a novel AUS is a lengthy, expensive, and regulatory challenging process. In the ‘State of the Art’, essential to assess the ‘Gold standard’, we identified three literature gaps relevant for the risk analysis and evaluated similar competing devices. We showed a fine example of the application of ‘in vivo’ clinical study to the design of the smart AUS device. These initiated the required pre- clinical studies prior to FIM trials, demonstrating device feasibility, performance, and safety. the importance of post-market studies was also highlighted, and we strive to soon deliver a safe and efficient electronic device, tailored to the patient’s needs, whilst abiding to current regulations

Muscle activation patterns in shoulder impingement patients

Introduction: Shoulder impingement is one of the most common presentations of shoulder joint problems 1. It appears to be caused by a reduction in the sub-acromial space as the humerus abducts between 60o -120o – the 'painful arc'. Structures between the humeral head and the acromion are thus pinched causing pain and further pathology 2. Shoulder muscle activity can influence this joint space but it is unclear whether this is a cause or effect in impingement patients. This study aimed to observe muscle activation patterns in normal and impingement shoulder patients and determine if there were any significant differences. Method: 19 adult subjects were asked to perform shoulder abduction in their symptomatic arm and non-symptomatic. 10 of these subjects (age 47.9 ± 11.2) were screened for shoulder impingement, and 9 subjects (age 38.9 ± 14.3) had no history of shoulder pathology. Surface EMG was used to collect data for 6 shoulder muscles (Upper, middle and lower trapezius, serratus anterior, infraspinatus, middle deltoids) which was then filtered and fully rectified. Subjects performed 3 smooth unilateral abduction movements at a cadence of 16 beats of a metronome set at 60bpm, and the mean of their results was recorded. T-tests were used to indicate any statistical significance in the data sets. Significance was set at P<0.05. Results: There was a significant difference in muscle activation with serratus anterior in particular showing a very low level of activation throughout the range when compared to normal shoulder activation patterns (<30%). Middle deltoid recruitment was significantly reduced between 60-90o in the impingement group (30:58%).Trends were noted in other muscles with upper trapezius and infraspinatus activating more rapidly and erratically (63:25%; 60:27% respectively), and lower trapezius with less recruitment (13:30%) in the patient group, although these did not quite reach significance. Conclusion: There appears to be some interesting alterations in muscle recruitment patterns in impingement shoulder patients when compared against their own unaffected shoulders and the control group. In particular changes in scapula control (serratus anterior and trapezius) and lateral rotation (infraspinatus), which have direct influence on the sub-acromial space, should be noted. It is still not clear whether these alterations are causative or reactionary, but this finding gives a clear indication to the importance of addressing muscle reeducation as part of a rehabilitation programme in shoulder impingement patients