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BACKGROUND: Persons with multiple sclerosis (pwMS) frequently suffer from bladder problems that are not identified and managed optimally, reducing quality of life and increasing risk of health consequences. OBJECTIVE: This study aimed to investigate associations between bladder problems and well-being of pwMS. METHODS: The study included 1872 pwMS from France, Germany, Italy, and the UK self-reporting on demographics, MS status, bladder problems and management, and well-being. Logistic regression analyses were performed to investigate associations with self-reported well-being. RESULTS: Population mean age was 51 years and 79 % were women. Among pwMS, 55 % reported bladder problems indicating overactive bladder (OAB), and 40 % reported self-experienced urinary retention. Self-management of bladder problems was reported by 32 %, 33 % were yet to have problem resolution, and 45 % reported a wish to receive bladder management help. Additionally, 35 % of pwMS reported that bladder problem onset preceded awareness of a link to MS. OAB, problem self-management, and urinary complications were significantly associated with lower well-being. CONCLUSION: Bladder problems affect pwMS across disease subtypes and many attempt self-management. Consequently, pwMS with bladder problems are more likely to experience lower well-being, suggesting an unmet need. Raising awareness of the link between bladder problems and well-being could benefit pwMS living with bladder problems.
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Esclerosis Múltiple , Humanos , Femenino , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/epidemiología , Persona de Mediana Edad , Masculino , Estudios Transversales , Adulto , Vejiga Urinaria Hiperactiva/etiología , Calidad de Vida , Automanejo , Anciano , Retención Urinaria/etiología , Europa (Continente)RESUMEN
BACKGROUND AND OBJECTIVE: Most patients with neurourological disorders require lifelong medical care. The European Association of Urology (EAU) regularly updates guidelines for diagnosis and treatment of these patients. The objective of this review is to provide a summary of the 2024 updated EAU guidelines on neurourology. METHODS: A structured literature review covering the timeframe 2021-2023 was conducted for the guideline update. A level of evidence and a strength rating were assigned for each recommendation on the basis of the literature data. KEY FINDINGS AND LIMITATIONS: Neurological conditions significantly affect urinary, sexual, and bowel function, and lifelong management is required for neurourological patients to maintain their quality of life and prevent urinary tract deterioration. Early diagnosis and effective treatment are key, and comprehensive clinical assessments, including urodynamics, are crucial. Management should be customised to individual needs and should involve a multidisciplinary approach and address sexuality and fertility. Lifelong monitoring and follow-up highlight the importance of continuous care for neurourological patients. CONCLUSIONS AND CLINICAL IMPLICATIONS: The 2024 EAU guidelines on neurourology provide an up-to-date overview of available evidence on diagnosis, treatment, and follow-up for neurourological patients. PATIENT SUMMARY: Neurological disorders very frequently affect the lower urinary tract and sexual and bowel function and patients need lifelong management. We summarise the updated European Association of Urology guidelines on neurourology to provide patients and caregivers with the latest insights for optimal health care support.
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Guías de Práctica Clínica como Asunto , Urología , Humanos , Urología/normas , Europa (Continente) , Enfermedades Urológicas/terapia , Enfermedades Urológicas/diagnóstico , Sociedades Médicas , Enfermedades del Sistema Nervioso/terapia , Enfermedades del Sistema Nervioso/diagnósticoRESUMEN
BACKGROUND: Lower urinary tract dysfunction impacts quality of life of people with MS; often, symptoms are 'lived with' or deprioritised by healthcare providers (HCPs). Consequently, patients must be given the skills they need to become confident in managing their illness and enhance their involvement in the process. OBJECTIVE: To develop and validate a self-assessment tool to help people with MS become more aware of their bladder symptoms and prompt contact with their HCP to facilitate timely management and specialist referral, if required. METHODS: The 'MS bladder check tool' was developed by a multidisciplinary panel of specialist advisors. Consensus meetings and pilot testing were conducted to design and evolve the tool into a series of nine questions, using population-appropriate language, and covering all aspects of bladder dysfunction in MS. The tool was then validated by an international, multidisciplinary team of experts. RESULTS: Validity was rated 'excellent' for all questions indicating that the MS bladder check tool is an appropriate method of highlighting bladder problems in people with MS. CONCLUSION: The MS bladder check tool is simple, easy-to-use, and empowers patients to take charge of their urinary tract health, aiming to improve the management of MS and, ultimately, patient quality of life.
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Esclerosis Múltiple , Vejiga Urinaria , Humanos , Calidad de Vida , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/terapia , Consenso , Personal de SaludRESUMEN
OBJECTIVES: In this study, we aimed to investigate whether peroneal electrical Transcutaneous Neuromodulation invented for overactive bladder (OAB) treatment elicits activation in brain regions involved in neural regulation of the lower urinary tract. MATERIALS AND METHODS: Among 22 enrolled healthy female volunteers, 13 were eligible for the final analysis. Functional magnetic resonance imaging (fMRI) (Siemens VIDA 3T; Erlangen, Germany) was used to compare the brain region activation elicited by peroneal electrical Transcutaneous Neuromodulation with the activation elicited by sham stimulation. Each subject underwent brain fMRI recording during eight 30-second periods of rest, alternating with 30-second periods of passive feet movement using the sham device, mimicking the motor response to peroneal nerve stimulation. Subsequently, fMRI recording was performed during the analogic "off-on" stimulation paradigm using peroneal electrical transcutaneous neuromodulation. Magnetic resonance imaging data acquired during both paradigms were compared using individual and group statistics. RESULTS: During both peroneal electrical Transcutaneous Neuromodulation and sham feet movements, we observed activation of the primary motor cortex and supplementary motor area, corresponding to the cortical projection of lower limb movement. During peroneal electrical Transcutaneous Neuromodulation, we observed significant activations in the brain stem, cerebellum, cingulate gyrus, putamen, operculum, and anterior insula, which were not observed during the sham feet movement. CONCLUSIONS: Our study provides evidence that peroneal electrical Transcutaneous Neuromodulation elicits activation of brain structures that have been previously implicated in the perception of bladder fullness and that play a role in the ability to cope with urinary urgency. Our data suggest that neuromodulation at the level of supraspinal control of the lower urinary tract may contribute to the treatment effect of peroneal electrical Transcutaneous Neuromodulation in patients with OAB.
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Estimulación Eléctrica Transcutánea del Nervio , Vejiga Urinaria Hiperactiva , Humanos , Femenino , Vejiga Urinaria Hiperactiva/diagnóstico por imagen , Vejiga Urinaria Hiperactiva/terapia , Estimulación Eléctrica Transcutánea del Nervio/métodos , Vejiga Urinaria , Encéfalo/fisiología , Imagen por Resonancia Magnética/métodosRESUMEN
Objectives: Our aim was to evaluate trends and regional differences in the use of indwelling and intermittent urinary catheters in the community setting in the Netherlands from 2012 to 2021. Design and methods: For this population-based cohort study, data on catheter use was collected from the Drug and Medical Devices Information System of the National Healthcare Institute of the Netherlands. This database contains information on the Dutch insured population, which was 100% of the total population in 2018. Users were divided into 12 provinces according to the Nomenclature of Territorial Units for Statistics codes. The number of catheter users was adjusted for the total population of the provinces by sex and age, and was expressed by users per 100,000 people. Negative binomial regression (NBR) was used to test for differences in clean intermittent catheter (CIC) and indwelling catheter (IDC) users across Dutch provinces. Results: Between 2012 and 2021, IDC users increased by 44.6% from 41,619 to 60,172, and CIC users increased by 27.3% from 34,204 to 43,528. The greatest increases were mainly observed among IDC users over 85 years old and male CIC users over 65 years old. NBR showed significant differences for IDC and CIC users between the 12 provinces. CIC incidence was higher in Drenthe and Groningen (Northern Netherlands) compared to Zuid-Holland (Southern Netherlands). IDC incidence was higher in seven provinces dispersed throughout the Netherlands compared to Noord-Holland. Conclusion: CIC and IDC users have continued to increase in recent years; this was especially observed among older men. In addition, there were regional differences in the number of CIC and IDC users; CIC was more prominent in the northern region of the Netherlands, and IDC varied between multiple provinces. Practice variation in urinary catheterization may result from patient population differences or healthcare provider preferences and their alignment with guidelines.
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Against the background of the climate crisis, there is an urgent need to include environmental sustainability recommendations in clinical practice guidelines. We highlight five domains for which suitable recommendations could help in mitigating the environmental impact of urology practice. PATIENT SUMMARY: Climate change is an urgent issue that requires global action. Guidelines published by urological societies should include recommendations for minimizing the impact of urology practice on the environment.
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Urología , Humanos , Prescripciones , Sociedades MédicasRESUMEN
PURPOSE: The global prevalence of overactive bladder (OAB) is estimated at 11.8%. Despite existing treatment options such as sacral neuromodulation, a substantial number of patients remain untreated. One potential alternative is noninvasive transcutaneous electrical stimulation. This form of stimulation does not necessitate the implantation of an electrode, thereby eliminating the need for highly skilled surgeons, expensive implantable devices, or regular hospital visits. We hypothesized that alternative neural pathways can impact bladder contraction. METHODS: In this pilot study, we conducted transcutaneous electrical stimulation of the abdominal wall (T6-L1), the ear (vagus nerve), and the ankle (tibial nerve) of 3 anesthetized female Sprague-Dawley rats. Stimulation was administered within a range of 20 Hz to 20 kHz, and its impact on intravesical pressure was measured. We focused on 3 primary outcomes related to intravesical pressure: (1) the pressure change from the onset of a contraction to its peak, (2) the average duration of contraction, and (3) the number of contractions within a specified timeframe. These measurements were taken while the bladder was filled with either saline or acetic acid (serving as a model for OAB). RESULTS: Transcutaneous stimulation of the abdominal wall, ear, and ankle at a frequency of 20 Hz decreased the number of bladder contractions during infusion with acetic acid. As revealed by a comparison of various stimulation frequencies of the tibial nerve during bladder infusion with acetic acid, the duration of contraction was significantly shorter during stimulation at 1 kHz and 3 kHz relative to stimulation at 20 Hz (P = 0.025 and P = 0.044, respectively). CONCLUSION: The application of transcutaneous electrical stimulation to the abdominal wall, ear, and tibial nerve could provide less invasive and more cost-effective treatment options for OAB relative to percutaneous tibial nerve stimulation and sacral neuromodulation. A follow-up study involving a larger sample size is recommended.
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Background: The diagnosis of a clinically significant catheter-associated urinary tract infection (CAUTI) in patients performing clean intermittent catheterization (CIC) or with an indwelling catheter (IC) can be challenging. Objective: To get an insight into the variation of the used definition, diagnosis and management of CAUTIs by relevant healthcare workers in the Netherlands. Design: An online clinical scenario-based survey. Methods: The survey was built in Limesurvey and distributed to healthcare workers from randomly selected urology departments, rehabilitation departments/centres and general practice offices between January and May 2022. Questions regarding their field of experience, management strategies, used guidelines and two hypothetical cases with clinical scenarios of a possible CAUTI were included. Results: A total of 172 individuals participated, of which 112 completed the survey. In all, 32 individuals who completed the survey partially were also included. Participants consisted of 68 [44 urologists, 22 rehabilitation doctors (RDs) and 2 general practitioners (GPs)] doctors, 60 nurses (46 from the urology department and 14 from rehabilitation centres/departments) and 16 medical assistants (13 from urology department and 3 from GP offices). The majority consulted patients with an IC or on CIC on a daily/weekly or monthly basis. In all, 35 urologists (79.5%), 9 RDs (40.9%), 21 (45.7%) nurses in the urology department and 6 (42.9%) nurses from a rehabilitation department/centre indicated bladder irrigation as a treatment option for prevention/treatment of CAUTIs, treatment of symptoms or treatment of blockage of the catheter. In the clinical scenarios presented, treatment discrepancies were seen between subspecialties and healthcare workers. Various guidelines were named for the definition of CAUTIs. Conclusion: A considerable variation in diagnoses and management of CAUTIs between the healthcare workers involved was seen. Uniformity in diagnosing and managing CAUTIs, to prevent overtreatment and possible resistance to antibiotics, is advised. Suitable multidisciplinary guidelines are preferred.
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INTRODUCTION: Neurogenic lower urinary tract dysfunction (NLUTD) in children can cause renal failure and urinary incontinence if not treated sufficiently. Antimuscarinics (AM) and intradetrusor botulinum toxin injections (BoNT-A) with clean intermittent catheterization (CIC) are widely used treatment options for children with NLUTD. However, a considerable number will become refractory to these treatment options. This study aimed to evaluate the efficacy and long-term outcomes of mirabegron in children with NLUTD as an add-on and as a stand-alone treatment. MATERIAL AND METHODS: Patients under 18 years of age with NLUTD who were refractory to AM and/or BoNT-A and were treated with mirabegron 50 mg were retrospectively studied. Mirabegron was either used as monotherapy or in addition to AM and/or BoNT-A. Video-urodynamic studies (VUDSs) were performed before and after treatment with mirabegron. Changes in video-urodynamic parameters, the need for other NLUTD therapy during follow-up, patient-reported side effects, and urinary incontinence were outcomes of interest. RESULTS: A total of 34 patients with NLUTD were included. All patients were on CIC and the median age was 13.1 years (IQR 15.9-10.3). Median follow-up was 31.4 months (IQR 57.4-11.4). Bladder compliance improved by 89.9%, from 14.9 to 28.3 ml/cm H2O (p-value<0.001). Maximum cystometric capacity, end-filling detrusor pressure, volume at first detrusor overactivity, vesicoureteral reflux, and urinary incontinence significantly improved after mirabegron. The add-on therapy group showed more significant improvements in video-urodynamic outcomes compared to the monotherapy group. The median time of requiring other NLUTD therapy was 25.5 months (IQR 39.8-14.8). None of the included patients reported side effects. CONCLUSIONS: Mirabegron is an effective treatment for children with therapy-refractory NLUTD with an average efficacy of 2 years after which additional therapy is required. Despite the retrospective character of this study, our results confirm the beneficial effect of mirabegron in children with therapy-refractory NLUTD, in particular when mirabegron is used as add-on therapy in those with low-compliance bladders.
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Toxinas Botulínicas Tipo A , Vejiga Urinaria Neurogénica , Vejiga Urinaria Hiperactiva , Incontinencia Urinaria , Humanos , Niño , Adolescente , Vejiga Urinaria , Estudios Retrospectivos , Vejiga Urinaria Neurogénica/etiología , Incontinencia Urinaria/etiología , Incontinencia Urinaria/complicaciones , Resultado del Tratamiento , Antagonistas Muscarínicos/uso terapéutico , UrodinámicaRESUMEN
OBJECTIVES: To compare brain responses to peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) and transcutaneous tibial nerve stimulation (TTNS), two methods for treating overactive bladder (OAB), using functional magnetic resonance imaging (fMRI). The present study was not designed to compare their clinical efficacy. MATERIALS AND METHODS: This study included 32 healthy adult female volunteers (average age 38.3 years (range 22-73)). Brain MRI using 3 T scanner was performed during three 8-min blocks of alternating sequences. During each 8-min block, the protocol alternated between sham stimulation (30 s) and rest (30 s) for 8 repeats; then peroneal eTNM® stimulation (30 s) and rest (30 s) for 8 repeats; then, TTNS stimulation (30 s) and rest (30 s) for 8 repeats. Statistical analysis was performed at the individual level with a threshold of p = 0.05, family-wise error (FWE)-corrected. The resulting individual statistical maps were analyzed in group statistics using a one-sample t-test, p = 0.05 threshold, false discovery rate (FDR)-corrected. RESULTS: During peroneal eTNM®, TTNS, and sham stimulations, we recorded activation in the brainstem, bilateral posterior insula, bilateral precentral gyrus, bilateral postcentral gyrus, left transverse temporal gyrus, and right supramarginal gyrus. During both peroneal eTNM® and TTNS stimulations, but not sham stimulations, we recorded activation in the left cerebellum, right transverse temporal gyrus, right middle frontal gyrus, and right inferior frontal gyrus. Exclusively during peroneal eTNM® stimulation, we observed activation in the right cerebellum, right thalamus, bilateral basal ganglia, bilateral cingulate gyrus, right anterior insula, right central operculum, bilateral supplementary motor cortex, bilateral superior temporal gyrus, and left inferior frontal gyrus. CONCLUSIONS: Peroneal eTNM®, but not TTNS, induces the activation of brain structures that were previously implicated in neural control of the of bladder filling and play an important role in the ability to cope with urgency. The therapeutic effect of peroneal eTNM® could be exerted, at least in part, at the supraspinal level of neural control.
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Estimulación Eléctrica Transcutánea del Nervio , Vejiga Urinaria Hiperactiva , Adulto , Humanos , Femenino , Adulto Joven , Persona de Mediana Edad , Anciano , Vejiga Urinaria Hiperactiva/diagnóstico por imagen , Vejiga Urinaria Hiperactiva/terapia , Estimulación Eléctrica Transcutánea del Nervio/métodos , Vejiga Urinaria , Encéfalo/diagnóstico por imagen , Encéfalo/fisiología , Imagen por Resonancia Magnética , Nervio TibialRESUMEN
PURPOSE: The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in patients with overactive bladder (OAB). METHODS: This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM®. The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3 months. The patient's request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM®. The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12 months after initial course of peroneal eTNM®. Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation. RESULTS: The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM® was 76%, 76%, 62% and 48% at 3, 6, 9 and 12 months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017). CONCLUSION: The treatment effect achieved during the initial phase of peroneal eTNM® persists for at least 12 months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.
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Terapia por Estimulación Eléctrica , Estimulación Eléctrica Transcutánea del Nervio , Vejiga Urinaria Hiperactiva , Humanos , Femenino , Vejiga Urinaria Hiperactiva/terapia , Estudios de Seguimiento , Estudios Prospectivos , Resultado del TratamientoRESUMEN
Neurogenic lower urinary tract dysfunction (NLUTD), the abnormal function of the lower urinary tract in the context of neurological pathology, has been the subject of multiple efforts worldwide for the development of clinical practice guidelines. These guidelines are based on the same body of evidence, and are therefore subject to the same gaps. For example, sexual and bowel dysfunction in the context of NLUTD, optimal renal function assessment in those who are non-ambulatory or with low muscle mass, optimal upper tract surveillance timing, and modification of diagnostic and treatment modalities for low-resource nations and communities are inadequately addressed. In addition, many aspects of the conclusions and final recommendations of the guidelines are similar. This duplicative work represents a large expenditure of time and effort, which we believe could be focused instead on evidence gaps. Here, we call for a global unified approach to create a single, resource-independent, comprehensive guidance on NLUTD, neurogenic sexual, and neurogenic bowel dysfunction. Targeted research addressing the evidence gaps should be called for and pursued. This will allow for focus to shift to filling the gaps in the evidence for future guidelines.
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Androgens and their receptors are present throughout the body. Various structures such as muscles, genitals, and prostate express androgen receptors. The central nervous system also expresses androgen receptors. Androgens cross the blood-brain barrier to reach these central areas. In the central nervous system, androgens are involved in multiple functions. The current study investigated in which forebrain areas androgens are expressed in the male cat. Androgen receptor immunoreactive (AR-IR) nuclei were plotted and the results were quantified with a Heidelberg Topaz II + scanner and Linocolor 5.0 software. The density and intensity of the labeled cells were the main outcomes of interest. The analysis revealed a dense distribution of AR-IR nuclei in the preoptic area, periventricular complex of the hypothalamus, posterior hypothalamic area, ventromedial hypothalamic, parvocellular hypothalamic, infundibular, and supramammillary nucleus. Numerous AR-IR cells were also observed in the dorsal division of the anterior olfactory nucleus, lateral septal nucleus, medial and lateral divisions of the bed nucleus of the stria terminalis, lateral olfactory tract nucleus, anterior amygdaloid area, and the central and medial amygdaloid nuclei. AR-IR nuclei were predominantly observed in areas involved in autonomic and neuroendocrinergic responses which are important for many physiological processes and behaviors.
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Receptores Androgénicos , Telencéfalo , Animales , Masculino , Andrógenos , Hipotálamo , Receptores Androgénicos/metabolismo , Telencéfalo/metabolismo , GatosRESUMEN
OBJECTIVES: The aims of this study were to 1) determine the success rate of the tined lead test phase in patients with nonobstructive urinary retention (NOUR), 2) determine predictive factors of a successful test phase in patients with NOUR, and 3) determine long-term treatment efficacy and satisfaction in patients with NOUR. MATERIALS AND METHODS: The first part was a multicenter retrospective study at two centers in The Netherlands. Patients with NOUR received a four-week tined lead test phase. Success was defined as a ≥50% reduction of clean intermittent catheterization frequency or postvoid residual. We analyzed possible predictors of success with multivariable logistic regression. Second, all patients received a questionnaire to assess efficacy, perceived health (Patient Global Impression of Improvement), and treatment satisfaction. RESULTS: This study included 215 consecutive patients (82 men and 133 women) who underwent a tined lead test phase for the treatment of NOUR. The success rate in women was significantly higher than in men, respectively 62% (83/133) and 22% (18/82, p < 0.001). In women, age per ten years (odds ratio [OR] 0.74, 95% CI: 0.59-0.93) and a history of psychiatric illness (OR 3.92, 95% CI: 1.51-10.2), including posttraumatic stress disorder (PTSD), significantly predicted first stage sacral neuromodulation (SNM) success. In men, age per ten years (OR 0.43, 95% CI: 0.25-0.72) and previous transurethral resection of the prostate and/or bladder neck incision (OR 7.71, 95% CI: 1.43-41.5) were significant predictors of success. Conversely, inability to void during a urodynamic study (for women, OR 0.79, 95% CI: 0.35-1.78; for men, OR 3.06, 95% CI: 0.83-11.3) was not predictive of success. Of the patients with a successful first stage, 75% (76/101) responded to the questionnaire at a median follow-up of three years. Of these patients, 87% (66/76) continued to use their SNM system, and 92% (70/76) would recommend SNM to other patients. CONCLUSIONS: A history of psychiatric illness, including PTSD, in women with NOUR increased the odds of first stage SNM success 3.92 times. A previous transurethral resection of the prostate and/or bladder neck incision in men increased the odds of success 7.71 times. In addition, a ten-year age increase was associated with an OR of 0.43 in men and 0.74 in women, indicating a 2.3- and 1.3-times decreased odds of success, respectively.
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Terapia por Estimulación Eléctrica , Resección Transuretral de la Próstata , Vejiga Urinaria Hiperactiva , Retención Urinaria , Masculino , Humanos , Femenino , Niño , Retención Urinaria/etiología , Retención Urinaria/terapia , Estudios Retrospectivos , Resultado del Tratamiento , Terapia por Estimulación Eléctrica/efectos adversos , Vejiga Urinaria Hiperactiva/terapiaRESUMEN
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.
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Succinato de Solifenacina , Vejiga Urinaria Hiperactiva , Humanos , Femenino , Succinato de Solifenacina/uso terapéutico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Calidad de Vida , Estudios Prospectivos , Resultado del Tratamiento , Antagonistas MuscarínicosRESUMEN
The first two objectives were to establish which stimulation parameters of kilohertz frequency alternating current (KHFAC) neuromodulation influence the effectiveness of pudendal nerve block and its safety. The third aim was to determine whether KHFAC neuromodulation of the pudendal nerve can relax the pelvic musculature, including the anal sphincter. Simulation experiments were conducted to establish which parameters can be adjusted to improve the effectiveness and safety of the nerve block. The outcome measures were block threshold (measure of effectiveness) and block threshold charge per phase (measure of safety). In vivo, the pudendal nerves in 11 male and 2 female anesthetized Sprague Dawley rats were stimulated in the range of 10 Hz to 40 kHz, and the effect on anal pressure was measured. The simulations showed that block threshold and block threshold charge per phase depend on waveform, interphase delay, electrode-to-axon distance, interpolar distance, and electrode array orientation. In vivo, the average anal pressure during unilateral KHFAC stimulation was significantly lower than the average peak anal pressure during low-frequency stimulation (p < 0.001). Stimulation with 20 kHz and 40 kHz (square wave, 10 V amplitude, 50% duty cycle, no interphase delay) induced the largest anal pressure decrease during both unilateral and bilateral stimulation. However, no statistically significant differences were detected between the different frequencies. This study showed that waveform, interphase delay and the alignment of the electrode along the nerve affect the effectiveness and safety of KHFAC stimulation. Additionally, we showed that KHFAC neuromodulation of the pudendal nerves with an electrode array effectively reduces anal pressure in rats.
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Bloqueo Nervioso , Nervio Pudendo , Canal Anal/inervación , Animales , Axones , Femenino , Masculino , Ratas , Ratas Sprague-DawleyRESUMEN
Background: Neurogenic bowel dysfunction (NBD), like fecal incontinence and constipation, is a common symptom of disease in patients with multiple sclerosis (MS). The NBD score is a validated symptom-based questionnaire consisting of 10 multiple-choice questions. The aim of this study was to validate the Dutch version of the NBD score in patients with MS, creating an objective measuring tool of bowel dysfunction. Methods: Translation and validation of the NBD score was performed according to standardized guidelines. Adult patients with MS visiting a urology department completed a set of questionnaires (test): the NBD score, the Fecal Incontinence Quality of Life scale (FIQL), the Fecal Incontinence Severity Index (FISI), and the EQ-5D 3-Level questionnaire (EQ-5D-3L). After 1 to 2 weeks, the questionnaires were completed again (retest). A control group recruited at a general practitioner's practice completed the questionnaires once. Data were analyzed for measurement properties. Results: Sixty-one patients and 50 controls were included. Content validity was adequate, internal consistency was moderate (Cronbach α = 0.57 and 0.41), and reproducibility was excellent (interclass correlation coefficient = 0.78). Criterion validity was confirmed; the NBD score correlated moderately/strongly with the FIQL, FISI, and EQ-5D-3L. The NBD scores in the patient group were significantly higher than those in the control group, demonstrating good construct validity. Conclusions: The Dutch version of the NBD score showed moderate to good validity and good reliability for assessment of NBD in patients with MS.
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Background: Urinary incontinence is a prevalent form of pelvic floor dysfunction, with a non-negligible impact on a patient's quality of life. There are several treatment options, varying from conservative to invasive. The aim of this study is to predict treatment outcomes of pure or predominant urge urinary incontinence (UUI) in women to support shared decision-making and manage patient expectations. Methods: Data on patient characteristics, disease history, and investigations of 512 consecutive women treated for UUI in three hospitals in the Netherlands were retrospectively collected. The predicted outcome was the short-term subjective continence outcome, defined as patient-reported continence 3 months after treatment categorized as cure (no urinary leakage), improvement (any degree of improvement of urinary leakage), and failure (no improvement or worsening of urinary leakage). Multivariable ordinal regression with backward stepwise selection was performed to analyze association between outcome and patient's characteristics. Interactions between patient characteristics and treatment were added to estimate individual treatment benefit. Discriminative ability was assessed with the ordinal c-statistic. Results: Conservative treatment was applied in 12% of the patients, pharmacological in 62%, and invasive in 26%. Subjective continence outcome was cure, improvement, and failure in 20%, 49%, and 31%, respectively. Number of incontinence episodes per day, voiding frequency during the day, subjective quantity of UI, coexistence of stress urinary incontinence (SUI), night incontinence, and bladder capacity and the interactions between these variables were included in the model. After internal validation, the ordinal c-statistic was 0.699. Conclusions: Six variables were of value to predict pure or predominant UUI treatment outcome in women. Further development into a comprehensive set of models for the use in various pelvic floor disorders and treatments is recommended to optimize individualized care. This model requires external validation before implementation in clinical practice.
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INTRODUCTION: Chronic urinary retention is a common lower urinary tract disorder, mostly neurogenic or idiopathic in origin. The preferred treatment is clean intermittent urinary self-catheterisation (CISC) four to six times a day. In most European countries, virtually all patients use single use catheters, which is in contrast to several countries where the use of reusable catheters is more common. The available literature on the use of reusable catheters is conflicting and until now, no randomised controlled trial with sufficient power has been performed to investigate if reusable catheters for CISC is as safe as single use catheters. METHODS AND ANALYSIS: We described this protocol for a prospective, randomised controlled non-inferiority trial to investigate if the use of reusable catheters is as safe as single use catheters for CISC patients, measured by symptomatic urinary tract infections (sUTIs). Secondary objectives are adverse events due to a sUTI, urethral damage, stone formation, quality of life and patient satisfaction. A cost-effectiveness analysis will also be performed. 456 Participants will be randomised into two groups stratified for age, gender, menopausal status and (non-)neurogenic underlying disorder. The intervention group will replace the reusable catheter set every 2 weeks for a new set and replace the cleaning solution every 24 hours. The control group continues to use its own catheters. The primary outcome (amount of sUTIs from baseline to 1 year) will be tested for non-inferiority. Categorical outcome measures will be analysed using χ2 tests and quantitative outcome variables by t-tests or Mann-Whitney U tests. Two-sided p values will be calculated. ETHICS AND DISSEMINATION: This protocol was reviewed and approved by the Medical Ethics Committee of the Erasmus MC (MEC 2019-0134) and will be performed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for non-inferiority trials. The results of this randomised controlled non-inferiority trial will be published in a peer-reviewed journal and will be publicly available. TRIAL REGISTRATION NUMBER: NL8296.
Asunto(s)
Cateterismo , Retención Urinaria , Cateterismo/efectos adversos , Cateterismo/métodos , Humanos , Estudios Multicéntricos como Asunto , Estudios Prospectivos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Retención Urinaria/terapia , Infecciones Urinarias/etiologíaRESUMEN
STUDY DESIGN: This is a prospective validation study. OBJECTIVES: The neurogenic bowel dysfunction (NBD) score is a widely used symptom-based questionnaire evaluating bowel dysfunction and its impact on quality of life (QoL) in spinal cord-injured patients. This study aimed to translate and validate a Dutch-language NBD score in patients with SCI. SETTING: Patients with SCI visiting the urology department or general practitioner (GP) in Rotterdam, the Netherlands. METHODS: Standardized guidelines were followed for the translation and validation process of the NBD score. Adult patients with SCI visiting our urology department were asked to participate by filling in a set of questionnaires: the NBD score, the Fecal Incontinence Quality of Life scale (FIQL), the Fecal Incontinence Severity Index (FISI), and the European Quality of life 5-Dimension 3-Level questionnaire (EQ-5D-3L) at baseline and 1-2 weeks afterward. A control group recruited at a GP office completed the questionnaires once. The following measurement properties were evaluated: content validity, internal consistency, reproducibility, criterion-, and construct validity. RESULTS: Fifty-eight patients and 50 references were included. Content validity was adequate, internal consistency was moderate (Cronbach's alpha 0.56 and 0.30) and reproducibility was adequate (ICC 0.87). Criterion validity was confirmed; NBD score correlated significantly with the FIQL, FISI, and EQ-5D-3L. NBD scores in the patient group were significantly higher than in references, demonstrating good construct validity. CONCLUSIONS: The Dutch-language version of the NBD score showed moderate to good measurement properties, and therefore is a reliable tool to measure bowel dysfunction in patients with SCI. We recommend standardized usage of this questionnaire for clinical evaluation and research purposes.