Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naïve Patients With Overactive Bladder.

PURPOSE: We investigated the safety and efficacy of peroneal electrical transcutaneous neuromodulation using the URIS neuromodulation system in a home-based setting in comparison with standard treatment using solifenacin in treatment-naïve female patients with overactive bladder. MATERIALS AND METHODS: A total of 120 patients were screened, of whom 77 were randomized in a 2:1 ratio to 12 weeks of treatment with daily peroneal electrical transcutaneous neuromodulation or solifenacin 5 mg. The primary endpoint was safety; efficacy assessments included proportion of responders, defined as subjects with ≥50% reduction in bladder diary-derived variables; Overactive Bladder-Validated 8-question Screener, and European Quality of Life-5 Dimensions questionnaire; and treatment satisfaction after 12 weeks of therapy. RESULTS: Seventy-one out of 77 randomized patients completed the study. In the peroneal electrical transcutaneous neuromodulation group 6/51 (12%) patients reported a treatment-related adverse event vs 12/25 (48%) in the solifenacin group (P < .001). No clinically significant changes were observed in any other safety endpoint. The proportions of responders in the peroneal electrical transcutaneous neuromodulation group vs the solifenacin group were 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale grade 3 urgency episodes, 87% vs 75% with respect to grade 3+4 urgency episodes, and 90% vs 94% with respect to urgency incontinence episodes. In post hoc analyses we observed significant improvement over time in multiple efficacy variables in both treatment arms. CONCLUSIONS: Peroneal electrical transcutaneous neuromodulation is a safe and effective method for overactive bladder treatment associated with a significantly lower incidence of treatment-related adverse events compared to solifenacin and a considerably better benefit-risk profile.

Peroneal electrical transcutaneous neuromodulation in the home treatment of the refractory overactive bladder.

INTRODUCTION AND HYPOTHESIS: The aim of this prospective, open-label, multicenter, noncomparative study was to evaluate the efficacy and safety of peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) using the URIS® neuromodulation system as a home treatment for refractory overactive bladder (OAB). METHODS: The patients were treated with daily peroneal eTNM® for 30 min over a 6-week period. The primary endpoint was defined as the proportion of responders, i.e., participants with ≥ 50% reduction in the average daily sum of severe urgency episodes (defined as "I could not postpone voiding but had to rush to the toilet in order not to wet myself") and urgency incontinence episodes. In addition, bladder diary variables, symptom severity (OAB V8 questionnaire), treatment satisfaction (visual analog scale), and pain perception (visual analog scale) were evaluated at baseline (BL), at week 4 (W4), and at the end of treatment (EoT). Safety evaluations included monitoring of the incidence and severity of adverse events (AEs). Changes in time were analyzed using the nonparametric one-way ANOVA Friedman test for categorical variables and the Wilcoxon rank-sum test for the noncategorical variables. RESULTS: In total, 40 subjects were screened and 29 were included in the full analysis set. The proportion of responders was 86% at W4 and 79% at EoT. There was a significant reduction in frequency (p<0.001), number of severe urgency episodes (p< 0.001), number of urgency incontinence episodes (p=0.001), and number of nocturia episodes (p=0.002). There was a significant improvement in the OAB V8 score and treatment satisfaction (both p<0.001). Two mild treatment-related AEs were recorded. Both patients recovered without sequelae and completed the study. CONCLUSIONS: Peroneal eTNM® proved to be a highly effective and safe method for the home treatment of OAB, providing a therapeutic response in approximately 80% of patients.

Sensory Barrage Stimulation in the Treatment of Elbow Spasticity: A Crossover Double Blind Randomized Pilot Trial.

OBJECTIVE: To assess the feasibility of using a novel form of multichannel electrical stimulation, termed Sensory Barrage Stimulation (SBS) for the treatment of spasticity affecting the elbow flexor muscles and to compare this with conventional single-channel TENS stimulation. MATERIALS AND METHODS: Altogether ten participants with spasticity of the flexor muscles of the elbow of Grade 2 or above on the Modified Ashworth Scale (MAS) were recruited to this crossover double blind randomized trial. The participants received two intervention sessions (SBS and TENS), one week apart in a randomized order. Both interventions were applied over the triceps brachii on the affected arm for a duration of 60 minutes. Spasticity was measured using the MAS. Secondary outcome measures were self-reported change in spasticity, measured on a visual analog scale (VAS, 0-100), and therapist-rated strength of elbow extension and strength of elbow flexion. Measurements were taken immediately before each intervention was applied, immediately after the intervention, and one hour after the intervention. RESULTS: Immediately after stimulation spasticity showed a significant reduction for both TENS and SBS groups assessed by MAS -0.9 ± 0.2 vs. -1.1 ± 0.2 and by VAS -15 ± 3 vs. -31 ± 8. For SBS this improvement in MAS was still present at one hour after the stimulation, but not for TENS. Altogether seven SBS responders and four TENS responders were identified. CONCLUSIONS: This study demonstrates the feasibility and practicality of applying the new concept of SBS. Promising results indicate it causes a reduction in spasticity.

Peroneal Electric Transcutaneous NeuroModulation (eTNM®): A Novel Method for the Treatment of the Overactive Bladder.

Overactive bladder syndrome (OAB) is a prevalent medical problem with a significant impact on the quality of life of the affected individuals. Pharmacotherapy is considered the main treatment method, although it is discontinued in a significant proportion of patients due to inefficacy or associated side effects. If pharmacotherapy fails, patients can undergo peripheral neuromodulation of the somatic nerves of the lower limb or sacral neuromodulation; however, neither of these represents an ideal therapeutic tool. The Peroneal electric Transcutaneous NeuroModulation (Peroneal eTNM®), based on the selective stimulation of the peroneal nerve, is the new fully noninvasive neuromodulation method intended to treat OAB. The URIS® neuromodulation system, engineered to provide Peroneal eTNM®, consists of the URIS® device, URIS® active electrodes, and the biofeedback foot sensor (BFS). The unique design of the URIS® device and URIS® active electrodes allows for the use of a low voltage and current during neuromodulation, which significantly reduces the unpleasant sensations. The BFS allows for precise localization of the active electrodes and for continuous adjustment of the voltage and frequency to achieve the optimal therapeutic effect. The URIS® system adopts several principles of telemedicine, which makes it compatible with the US Food and Drug Administration (FDA) and European Union (EU) regulations for home-based use. This article describes both the Peroneal eTNM® method and the URIS® neuromodulation system, including its technical specifications and data from laboratory testing. Preclinical and early clinical data demonstrate the feasibility of this new method for noninvasive OAB treatment and possible implications for clinical practice.

Intrastromal Lenticule Rotation for the Treatment of High Astigmatism.

PURPOSE: To describe the first clinical case using intrastromal lenticule rotation to surgically correct high astigmatism in an amblyopic eye. METHODS: A 31-year-old woman with mixed astigmatism of +2.00 -5.00 × 10° (spherical equivalent -0.50 diopters [D]) in her left eye, uncorrected distance visual acuity (UDVA) of 0.8 logMAR, and corrected distance visual acuity (CDVA) of 0.7 logMAR underwent refractive lenticule rotation surgery. RESULTS: Postoperative refractive astigmatism changed to 0.00 D cylinder. There was a postoperative myopic shift and her spherical equivalent refraction was -4.00 D at 1 week, -3.75 D at 1 month, and -3.25 D at 3 and 6 months. The patient noted a slight improvement in UDVA and a significant improvement in her uncorrected near visual acuity from Jaeger 13 (> 1.0 logMAR) to Jaeger 5 (0.3 logMAR) at 1 and 3 months and subsequently to Jaeger 2 (0.1 logMAR). CONCLUSIONS: To the best of the authors' knowledge, this is the first clinical case of astigmatism correction using small incision lenticule extraction lenticule rotation. This case of an amblyopic eye demonstrates that the procedure is capable of correcting both corneal and refractive astigmatism, and the short-term result seems stable. [J Refract Surg. 2020;36(6):415-418.].

Posterior chamber phakic intraocular lens for the correction of presbyopia in highly myopic patients.

PURPOSE: To report the initial experience with a new presbyopic phakic intraocular lens (pIOL) in the correction of high myopia and presbyopia. SETTING: Gemini Eye Clinic, Zlin, Czech Republic. DESIGN: Prospective cohort study. METHODS: Presbyopic eyes with moderate to high myopia were implanted with a presbyopic posterior chamber pIOL (IPCL). The visual acuities at near and distance, endothelial cell density, and ocular condition were examined 1 week, 3 months, 1 year and 2 years postoperatively. RESULTS: The mean uncorrected distance visual acuity improved significantly from 1.25 logarithm of the minimum angle of resolution (logMAR) (1.15 to 1.35 95% confidence interval [CI]) to 0.11 logMAR (95% CI, 0.03 to 0.17) (P < .0001). No eye lost 1 or more lines of corrected distance visual acuity. The mean distance refraction improved significantly from -6.9 diopters (D) (range -8.6 to -5.3 D) preoperatively to -0.35 D (range -0.55 to -0.15 D, P < .0001) with less than -0.5 D residual refraction in 11 of 17 eyes. Fifteen of 17 eyes had improved uncorrected near visual acuity to J1 (Jaeger chart) at the 2-year follow-up. The near addition at the 2-year follow-up decreased from preoperatively +1.26 D (range 0.19 to 2.34 D) to +0.39 D (range 0.18 to 0.60 D). The mean endothelial cell density was reduced from 2552 cells/mm (range 2421 to 2682 cells/mm) to 2299 cells/mm (range 2108 to 2490 cells/mm) after 2 years. All patients were subjectively satisfied with the outcomes. CONCLUSIONS: The new pIOL provided good visual outcomes in near and far distances in an initial case series of patients.

Photorefractive intrastromal crosslinking for correction of hyperopia: 12-month results.

PURPOSE: To evaluate the efficacy of epithelium-on photorefractive intrastromal crosslinking (PiXL), a noninvasive procedure to reduce refractive error in patients with low hyperopia. SETTING: Gemini Eye Clinic, Zlin, Czech Republic. DESIGN: Prospective single-center study. METHODS: Twenty-two low hyperopic eyes were enrolled and underwent PiXL treatment according to a standardized treatment protocol. Visual acuity, subjective distance refraction, keratometry, topography, pachymetry, subjective discomfort, and endothelial cell density (ECD) were recorded during 12-month follow-up. RESULTS: In 22 eyes, the median manifest refraction decreased significantly (P < .0001) from +0.75 diopters (D) (interquartile range [IQR], +0.63 to +1.06 D), median and IQR) diopters (D) preoperatively to +0.25 D (IQR, 0.0 to +0.50 D) at 12-month follow-up and remained stable. Seventy-seven percent of eyes achieved refraction within ± 0.50 D of emmetropia by 1 month postoperatively and was stable through 12-month follow-up. ECD was stable and did not show significant changes. There was low incidence of postoperative pain and dry eye. CONCLUSIONS: PiXL is a promising alternative to conventional laser refractive surgeries for low hyperopia. Further studies are warranted to optimize treatment parameters for a wider range of refractive errors and to evaluate the potential to improve precision.

Improving clinical refractive results of cataract surgery by machine learning.

AIM: To evaluate the potential of the Support Vector Machine Regression model (SVM-RM) and Multilayer Neural Network Ensemble model (MLNN-EM) to improve the intraocular lens (IOL) power calculation for clinical workflow. BACKGROUND: Current IOL power calculation methods are limited in their accuracy with the possibility of decreased accuracy especially in eyes with an unusual ocular dimension. In case of an improperly calculated power of the IOL in cataract or refractive lens replacement surgery there is a risk of re-operation or further refractive correction. This may create potential complications and discomfort for the patient. METHODS: A dataset containing information about 2,194 eyes was obtained using data mining process from the Electronic Health Record (EHR) system database of the Gemini Eye Clinic. The dataset was optimized and split into the selection set (used in the design for models and training), and the verification set (used in the evaluation). The set of mean prediction errors (PEs) and the distribution of predicted refractive errors were evaluated for both models and clinical results (CR). RESULTS: Both models performed significantly better for the majority of the evaluated parameters compared with the CR. There was no significant difference between both evaluated models. In the ±0.50 D PE category both SVM-RM and MLNN-EM were slightly better than the Barrett Universal II formula, which is often presented as the most accurate calculation formula. CONCLUSION: In comparison to the current clinical method, both SVM-RM and MLNN-EM have achieved significantly better results in IOL calculations and therefore have a strong potential to improve clinical cataract refractive outcomes.

Reducing the sensation of electrical stimulation with dry electrodes by using an array of constant current sources.

Hydrogel electrodes are commonly used for functional and other electrical stimulation applications since the hydrogel layer has been shown to considerably reduce the perception of stimulation compared to dry electrodes. However, these hydrogel electrodes must be changed regularly as they dry out or become contaminated with skin cells and sweat products, thus losing their adhesiveness and resistive properties. Dry electrodes are longer lasting but are more uncomfortable due to unequal current distribution (current hogging). We hypothesise that if current through a dry electrode is equally shared amongst an array of small sub-electrodes, current hogging and thus the sensitivity perceived due to stimulation will be reduced. We constructed an 8 × 8 array of millimetre sized dry electrodes that could either be activated as individual current sources, or together as one large source. A study was performed with 13 participants to investigate the differences in sensation between the two modes of operation. The results showed that 12 out of 13 participants found the new (distributed-constant-current) approach allowed higher stimulation for the same sensation. The differences in sensation between single and multiple sources became larger with higher intensity levels.

Non-invasive transcutaneous electrical stimulation in the treatment of overactive bladder.

We reviewed the literature on transcutaneous electrical nerve stimulation (TENS) used as a therapy for overactive bladder (OAB) symptoms, with a particular focus on: stimulation site, stimuli parameters, neural structures thought to be targeted, and the clinical and urodynamic outcomes achieved. The majority of studies used sacral or tibial nerve stimulation. The literature suggests that, whilst TENS therapy may have neuromodulation effects, patient are unlikely to benefit to a significant extent from a single application of TENS and indeed clear benefits from acute studies have not been reported. In long-term studies there were differences in the descriptions of stimulation intensity, strategy of the therapy, and positioning of the electrodes, as well as in the various symptoms and pathology of the patients. Additionally, most studies were uncontrolled and hence did not evaluate the placebo effect. Little is known about the underlying mechanism by which these therapies work and therefore exactly which structures need to be stimulated, and with what parameters. There is promising evidence for the efficacy of a transcutaneous stimulation approach, but adequate standardisation of stimulation criteria and outcome measures will be necessary to define the best way to administer this therapy and document its efficacy.

Recent developments in technology for the assessment and management of incontinence.

Urinary incontinence, the leakage of urine, is a common condition, which can have a significant impact on a patient's quality-of-life. Incontinence may arise as a consequence of a weakness of the urinary sphincter or bladder dysfunction, usually over-activity. Incontinence therapies occupy a large proportion of the healthcare budget. As no single device to manage incontinence is appropriate for all situations, a diverse range of products are available on the market and the development of improved products based on fundamental designs has been slow. This review highlights some of the key issues of continence care and describes the current technology and recent developments involved in the diagnosis, assessment and treatment of incontinence, along with the strengths and limitations of these methods. These issues are imperative to address if improved technology is to be developed.