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BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.
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Incontinencia Urinaria de Urgencia , Humanos , Femenino , Persona de Mediana Edad , Estudios Prospectivos , Incontinencia Urinaria de Urgencia/terapia , Incontinencia Urinaria de Urgencia/fisiopatología , Incontinencia Urinaria de Urgencia/diagnóstico , Anciano , Resultado del Tratamiento , Terapia por Estimulación Eléctrica/efectos adversos , Terapia por Estimulación Eléctrica/instrumentación , Adulto , Neuroestimuladores Implantables/efectos adversos , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria Hiperactiva/fisiopatología , Vejiga Urinaria Hiperactiva/diagnóstico , Nervio Tibial/fisiopatologíaRESUMEN
PURPOSE: The aim of this study was to demonstrate features predictive of treatment response for patient-tailored overactive bladder (OAB) intervention with an implantable tibial neurostimulator using patient and technical prediction factors. MATERIALS AND METHODS: This study was designed as a follow-up study based on parameter settings and patients' preferences during the pilot and extended study of the implantable tibial nerve stimulator (RENOVA™ iStim system). For this study, we compared all treatment parameters (stimulation amplitude, frequency, and pulse width) and usage data (duration of treatment) during the different follow-up visits. RESULTS: We obtained usage data from a total of 32 patients who were implanted with the system between February and September 2015. Age, sex, body mass index (BMI) and previous experience with percutaneous tibial nerve stimulation (PTNS) treatment were considered as possible prediction factors for treatment success. However, only BMI was considered a statistically significant prediction factor (p = 0.042). A statistically significant increase in mean treatment level was seen in the responder group during the 3 month follow-up visit (mean: 6.7 mA, SD 0.416) as compared with the initial system activation visit (mean: 5.8 mA, SD 0.400) (p = 0.049). No other visits demonstrated statistically significant changes in both groups (responders and nonresponders) during the defined timepoints. CONCLUSION: This data underscores the need to use patient-tailored OAB treatment. BMI was found to be a negative predictive factor for treatment success. However, it was not possible to develop a specific responder model. A model predicting response to treatment could be useful for implementing shared decision making.
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Estimulación Eléctrica Transcutánea del Nervio , Vejiga Urinaria Hiperactiva , Estudios de Seguimiento , Humanos , Prioridad del Paciente , Nervio Tibial , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/terapiaRESUMEN
Stress urinary incontinence (SUI) is a common and burdensome condition. Because of the large knowledge gap around the molecular processes involved in its pathophysiology, the aim of this review was to provide a systematic overview of genetic variants, gene and protein expression changes related to SUI in human and animal studies. On 5 January 2021, a systematic search was performed in Pubmed, Embase, Web of Science, and the Cochrane library. The screening process and quality assessment were performed in duplicate, using predefined inclusion criteria and different quality assessment tools for human and animal studies respectively. The extracted data were grouped in themes per outcome measure, according to their functions in cellular processes, and synthesized in a narrative review. Finally, 107 studies were included, of which 35 used animal models (rats and mice). Resulting from the most examined processes, the evidence suggests that SUI is associated with altered extracellular matrix metabolism, estrogen receptors, oxidative stress, apoptosis, inflammation, neurodegenerative processes, and muscle cell differentiation and contractility. Due to heterogeneity in the studies (e.g., in examined tissues), the precise contribution of the associated genes and proteins in relation to SUI pathophysiology remained unclear. Future research should focus on possible contributors to these alterations.
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Incontinencia Urinaria de Esfuerzo , Animales , Humanos , Ratones , Ratas , Incontinencia Urinaria de Esfuerzo/genéticaRESUMEN
PURPOSE OF REVIEW: This review is timely and relevant because many patients live many years with urinary diversions. Knowledge about the long term outcome with respect to function and complications are important for patient counseling and for the manner to follow-up patients. This study was performed to investigate the functioning of urinary diversions constructed > 25 years earlier. RECENT FINDINGS: Most studies have a relatively shorter follow-up, mainly focussing on short term postoperative complications. Focussing on the long term, urinary tract infections (UTI) including pyelonephritis are common. Mild kidney function deterioration is described. SUMMARY: Retrospective study (2018-2019); 43 patients with regular follow-up at the Radboud University Medical Centre Nijmegen the Netherlands. Ileal conduit (nâ=â19) and ureterosigmoidostomy (nâ=â11) are the most common diversion types for reasons such as: bladder exstrophy (nâ=â15), urinary incontinence (nâ=â9) and malignancy (nâ=â8). This series with a median follow-up of 40âyears, shows it is possible to live and cope with a urinary diversion for a very long time. Ureterosigmoidostomies give relatively good results. Ileal conduits are functioning properly with acceptable complication rates. 95% suffers from chronic UTI's. Kidney function deterioration was mild. Diversions for benign reasons have more complex complications compared to diversion constructed for malignant reasons. VIDEO ABSTRACT: http://links.lww.com/COU/A32.
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Extrofia de la Vejiga , Derivación Urinaria , Incontinencia Urinaria , Humanos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Derivación Urinaria/efectos adversosRESUMEN
INTRODUCTION: The aim of this study is to determine the outcome of surgically treated vesico-vaginal fistulae (VVaFs) using a transvaginal approach with a Latzko technique. METHODS: A retrospective chart study was conducted at the Department of Urology, Radboud University Medical Centre. Surgical approaches to repair VVaF, from 2014 to September 2020, were selected. Patients who underwent a transvaginal approach were included. The primary objective was fistula closure. Secondary objectives were predictive factors for the outcome of the surgical procedure, for example, patient characteristics, leakage on cystography 2 weeks postoperative, and surgery time. RESULTS: Thirty-one patients had surgery for VVaF. Twenty-five procedures (81%) were performed transvaginally. Thirteen of these (52%) had successful transvaginal closure after the first attempt. Seven out of 12 had their second attempt at the time of analysis, of which 4 (57%) were successfully closed thereafter. After either 1 or 2 attempts with the transvaginal approach, 17 (68%) of the VVaFs were successfully closed, but 79% if patients who did not yet had a second attempt were taken into account with the current success extrapolated. Only few minor complications were observed. CONCLUSION: Transvaginal closure of VVaFs with a Latzko technique is successful in about 79% in either 1 or 2 attempts, with few minor complications. A second attempt in closing the fistula with a transvaginal approach is useful, and a previous transvaginal attempt is not a contraindication for a second transvaginal attempt in closing the VVaF surgically.
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Procedimientos Quirúrgicos Urológicos , Fístula Vesicovaginal/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias/etiología , Recurrencia , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Procedimientos Quirúrgicos Urológicos/efectos adversos , Fístula Vesicovaginal/diagnósticoRESUMEN
INTRODUCTION: The quality of urodynamic measurements in clinical practice has been debated as a matter of concern. It is considered plausible that this has a direct bearing on patient care and the perceived value of urodynamic testing. METHODS: This is a report of the proceedings of the Think Tank: "Is the value of urodynamics undermined by poor technique?" from the Annual International Consultation on Incontinence-Research Society, which took place in June 2018 in Bristol, UK. The Think Tank discussed the evidence for deficiencies in urodynamic test quality and considered the implications of improvements for clinical diagnosis and practice. RESULTS: There is evidence that technique affects urodynamic quality, and that urodynamic practice is variable. Factors such as team skill set, technologies used, and training received will also affect the quality of urodynamic service. Questions exist regarding the influence of technique on the utility and perceived value of urodynamics. CONCLUSIONS: We suggest research questions that will provide the necessary evidence on the link between technique, reporting, and outcome, and clarify the role of good practice in the utility of urodynamic testing.
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Competencia Clínica , Técnicas de Diagnóstico Urológico , Urodinámica/fisiología , Enfermedades Urológicas/diagnóstico , Humanos , Enfermedades Urológicas/fisiopatologíaRESUMEN
PURPOSE: This study was designed to investigate the safety and performance of a new implantable system for tibial nerve stimulation for overactive bladder symptoms. MATERIALS AND METHODS: A battery-free stimulation device for tibial nerve stimulation (BlueWind Medical, Herzliya, Israel) was implanted in 15 patients. Safety and efficacy assessments were done at 3 months after activation with a 3-day bladder diary, a 24-hour pad test and 2 quality of life questionnaires. RESULTS: Two males and 13 females were enrolled in the study. Mean age was 54 years (range 19 to 72). Five of 15 patients were previously treated with percutaneous tibial nerve stimulation and 12 experienced urgency urinary incontinence. Median operative time was 34 minutes. At 3 months of followup a significant change was seen in 24-hour frequency from a mean ± SD of 11.8 ± 3.5 to 8.1 ± 2.0 times per day (p = 0.002), the number of severe urinary urgency episodes from 6.5 ± 5.1 to 2.0 ± 2.1 times per day (p = 0.002), the number of severe incontinence episodes from 2.8 ± 5.2 to 0.3 ± 0.4 episodes per day (p = 0.017), urinary loss per day from 243 ± 388 to 39 ± 55 gm (p = 0.038) and improvement in quality of life. After implantation, 3 patients received prolonged antibiotic treatment and 3 received pain medication for 1 week. In 1 patient the device was explanted due to pain and swelling suspicious for infection, although tissue cultures did not reveal a bacterial infection. CONCLUSIONS: This novel posterior tibial nerve stimulator is safe and easy to implant with good clinical results.
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Electrodos Implantados , Nervio Tibial , Estimulación Eléctrica Transcutánea del Nervio/instrumentación , Vejiga Urinaria Hiperactiva/terapia , Adulto , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tempo Operativo , Calidad de Vida , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Glomerular filtration rate (GFR) is accepted as the best indicator of kidney function and is commonly estimated from serum creatinine (SCr)-based equations. Separate equations have been developed for children (Schwartz equation), younger and middle-age adults [Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation] and older adults [Berlin Initiative Study 1 (BIS1) equation], and these equations lack continuity with ageing. We developed and validated an equation for estimating the glomerular filtration rate that can be used across the full age spectrum (FAS). METHODS: The new FAS equation is based on normalized serum creatinine (SCr/Q), where Q is the median SCr from healthy populations to account for age and sex. Coefficients for the equation are mathematically obtained by requiring continuity during the paediatric-adult and adult-elderly transition. Research studies containing a total of 6870 healthy and kidney-diseased white individuals, including 735 children, <18 years of age, 4371 adults, between 18 and 70 years of age, and 1764 older adults, ≥70 years of age with measured GFR (inulin, iohexol and iothalamate clearance) and isotope dilution mass spectrometry-equivalent SCr, were used for the validation. Bias, precision and accuracy (P30) were evaluated. RESULTS: The FAS equation was less biased [-1.7 (95% CI -3.4, -0.2) versus 6.0 (4.5, 7.5)] and more accurate [87.5% (85.1, 89.9) versus 83.8% (81.1, 86.5)] than the Schwartz equation for children and adolescents; less biased [5.0 (4.5, 5.5) versus 6.3 (5.9, 6.8)] and as accurate [81.6% (80.4, 82.7) versus 81.9% (80.7, 83.0)] as the CKD-EPI equation for young and middle-age adults; and less biased [-1.1 (-1.6, -0.6) versus 5.6 (5.1, 6.2)] and more accurate [86.1% (84.4, 87.7) versus 81.8% (79.7, 84.0)] than CKD-EPI for older adults. CONCLUSIONS: The FAS equation has improved validity and continuity across the full age-spectrum and overcomes the problem of implausible eGFR changes in patients which would otherwise occur when switching between more age-specific equations.
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Biomarcadores/análisis , Tasa de Filtración Glomerular , Riñón/fisiopatología , Modelos Teóricos , Insuficiencia Renal Crónica/diagnóstico , Adolescente , Adulto , Factores de Edad , Anciano , Niño , Preescolar , Estudios de Cohortes , Femenino , Humanos , Lactante , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , Insuficiencia Renal Crónica/metabolismo , Adulto JovenRESUMEN
BACKGROUND: As a cornerstone of quality management in the laboratory, External Quality Assessment (EQA) schemes are used to assess laboratory and analytical method performance. The characteristic function is used to describe the relation between the target concentration and the EQA standard deviation, which is an essential part of the evaluation process. The characteristic function is also used to compare the variability of different analytical methods. METHODS: We fitted the characteristic function to data from the Belgian External Quality Assessment program for serum ethanol. Data included results from headspace gas chromatography and the enzymatic methods of Abbott, Roche, Siemens, and Ortho-Clinical Diagnostics. We estimated the characteristic function with weighted nonlinear regression. By introducing dummy variables, we rewrote the original formula of the characteristic function to assess statistical inference for comparing the variability of the different analytical methods. RESULTS: The characteristic function fitted the data precisely. Comparison between methods showed that there was little difference between the estimated variability for low concentrations, and that the increase in SD with increasing target concentration was slower for Abbott and Roche than for the other methods. CONCLUSIONS: The characteristic function can successfully be introduced in clinical schemes, although its applicability to fit the data should always be assessed. Because of its easy parameterization, it can be used to assess differences in performance between analytical methods and to assess laboratory performance. The characteristic function also offers an alternative framework for coefficients of variation to describe variability of analytical methods.
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Análisis Químico de la Sangre/métodos , Análisis Químico de la Sangre/normas , Etanol/sangre , Control de Calidad , Análisis de Regresión , Cromatografía de Gases/normas , Humanos , Laboratorios/normasRESUMEN
BACKGROUND: The first aim of the study was to investigate the accuracy and intra-laboratory variation of serum creatinine measurements in clinical laboratories in Flanders. The second purpose was to check the effect of this variation in serum creatinine concentration results on the calculated estimated glomerular filtration rate (eGFR) and the impact on classification of patients into a chronic kidney disease (CKD) stage. METHODS: 26 routine instruments were included, representing 13 different types of analyzers from 6 manufacturers and covering all current methodologies (Jaffe, compensated Jaffe, enzymatic liquid and dry chemistry methods). Target values of five serum pools (creatinine concentrations ranging from 35 to 934 µmol/L) were assigned by the gold standard method (ID-GC/MS). RESULTS: Intra-run CV (%) (n = 5) and bias (%) from the target values were higher for low creatinine concentrations. Especially Jaffe and enzymatic dry chemistry methods showed a higher error. The calculated eGFR values corresponding with the reported creatinine concentration ranges resulted in a different CKD classification in 47% of cases. CONCLUSIONS: Although most creatinine assays claim to be traceable to the gold standard (ID-GC/MS), large inter-assay differences still exist. The inaccuracy in the lower concentration range is of particular concern and may lead to clinical misinterpretation when the creatinine-based eGFR of the patient is used for CKD staging. Further research to improve harmonization between methods is required.
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Creatinina/sangre , Espectrometría de Masas/métodos , Insuficiencia Renal Crónica/sangre , Adulto , Anciano , Niño , Pruebas Diagnósticas de Rutina , Femenino , Tasa de Filtración Glomerular/fisiología , Humanos , Laboratorios , Masculino , Control de Calidad , Estándares de Referencia , Insuficiencia Renal Crónica/diagnóstico , MuestreoRESUMEN
BACKGROUND: A new estimated glomerular filtration rate (eGFR) equation, designed for isotope dilution mass spectrometry-standardized serum creatinine (Scr), is presented for use in children, adolescent boys and girls and young adults. METHODS: The new equation, eGFR = 107.3/(Scr/Q), is based on the concept of normalized Scr: Q is the normalization value and is considered as the Scr concentration for the average healthy child, adolescent or young adult of a specific height (L) and is modeled as a height-dependent polynomial of the fourth degree. RESULTS: The well-known Schwartz equation [eGFR = kL/Scr, k = 0.413 (Schwartz) or k = 0.373 (Schwartz-Lyon)] for children between 1 and 14 years can be seen as a special case of the new equation for which the Q-polynomial is simplified to a linear equation: Q = 0.0035 × L (cm). The new eGFR equation has been validated in a data set of n = 750 children, adolescents and young adults aged 10-25, against the true GFR (inulin method), and outperforms the selected (but most used) creatinine-based eGFR equations for children, mainly in the healthy GFR region. CONCLUSIONS: The new Q(height)-eGFR equation serves as an excellent screening tool for kidney disease in 1-25-year-old children, adolescents and young adults.
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Biomarcadores/sangre , Creatinina/sangre , Tasa de Filtración Glomerular , Enfermedades Renales/diagnóstico , Modelos Teóricos , Adolescente , Adulto , Algoritmos , Niño , Preescolar , Femenino , Humanos , Lactante , Enfermedades Renales/sangre , Masculino , Espectrometría de Masa por Láser de Matriz Asistida de Ionización Desorción , Adulto JovenRESUMEN
BACKGROUND: A creatinine clearance (CrCl) is still often requested to estimate the glomerular filtration rate (GFR) in clinical practice. However, the diversity of serum and urine creatinine (Scr, Ucr) assays leads to different CrCl-results which are here compared with each other and with the CKD-EPI eGFR-formula. METHODS: We collected information on urine volume, Ucr and Scr using Roche's enzymatic (E), compensated Jaffe (CJ) and Jaffe (J) assay for 589 patients. To allow comparison with the CKD-EPI prediction results, CrCl was normalized for body surface area. RESULTS: Differences between CrCl-E and CrCl-CJ are rather small as opposed to the large differences with CrCl-J. However, two compensating errors in the CrCl-J calculation result in a closer agreement with CKD-EPI eGFR, than between CrCl-CJ or CrCl-E and CKD-EPI eGFR. The explained variance R(2) in all three cases is smaller than 0.66, demonstrating the very large scatter of the data around the regression line. CONCLUSIONS: CrCl determination is very assay-dependent. Although many clinical labs have switched to ID-GC/MS-standardized assays (E and CJ) for the determination of Scr and Ucr to improve analytical accuracy, the increased deviation of the normalized CrCl from the CKD-EPI prediction illustrates that the use of CrCl remains questionable for clinical practice. When a CrCl is requested, we would even recommend clinical labs who work with compensated Jaffe assays not to compensate the Scr-J value.
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Creatinina/sangre , Creatinina/orina , Adolescente , Adulto , Anciano , Biomarcadores/sangre , Biomarcadores/orina , Femenino , Tasa de Filtración Glomerular , Humanos , Riñón/fisiopatología , Masculino , Persona de Mediana Edad , Insuficiencia Renal/sangre , Insuficiencia Renal/diagnóstico , Insuficiencia Renal/orina , Reproducibilidad de los Resultados , Adulto JovenRESUMEN
BACKGROUND: Quality of life (QoL)-based outcomes are hardly incorporated into interstitial cystitis/bladder pain syndrome (IC/BPS) guidelines, because studies are limited and outdated. Therefore, guidelines might not reflect the current clinical situation accurately. Secondly, guidelines suggest using a multimodal approach for BPS/IC management, but data on the patient-perceived efficacy of these therapies are limited. The aim of this study is to investigate the perception of IC/BPS patients of their QoL, to determine which treatments they have received, and to examine how they evaluate the efficacy of these various (alternative) therapies. METHODS: A quantitative retrospective database evaluation was performed, with data from an existing IC/BPS patient survey (n = 217) that was conducted in 2021. This survey contained QoL data based on validated questionnaires such as EQ-5D 5L. RESULTS: The QoL of patients is affected significantly by IC/BPS. This is evident from the various affected domains on the EQ-5D 5L. The symptom severity was negatively affected by a delay in diagnosis, and there were clear differences in QoL domains between females and males. Secondly, coagulation therapy and intravesical glycosaminoglycan (GAG) therapy were most appreciated by patients. Other (alternative) treatments were commonly utilized, although some had doubtful results and high discontinuation rates. CONCLUSION: QoL is considerably impaired in IC/BPS patients. The diverse responses and adherence to various treatments warrant a personalized approach (phenotype-oriented therapy). To achieve QoL improvement, it is important to incorporate the patient's perspective in treatment guidelines.
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BACKGROUND AND OBJECTIVE: The European, prospective, multicenter SATURN registry was developed to analyze surgical devices for male stress urinary incontinence. The primary objective is the cure rate during follow-up. METHODS: Efficacy, complications, patient-reported outcomes, and prognostic factors are being analyzed at various intervals during 10-yr follow-up. The results at 1-yr follow-up are presented here. KEY FINDINGS AND LIMITATIONS: The cohort included 1046 patients (mean age 70 yr) from 28 centers in nine countries. The main cause of incontinence was radical prostatectomy (83.5%), followed by radiotherapy (4.5%), endourological procedures (9.7%), neurogenic conditions (1.0%), and trauma (0.2%). Some 19.5% of the patients underwent at least one incontinence procedure before registry inclusion. A baseline pad test was performed in 64% of the patients (mean 525 g, range 3.5-3600), urodynamics in 66%, and cystoscopy in 80%. The main implants used were AMS800 (n = 684) and Advance (n = 210) devices, followed by Atoms (n = 63) Victo/Plus (n = 33), ProACT (n = 30), and others (n = 24). A total of 896 patients had 1-yr follow-up data, of whom 164 completed a 1-yr pad test. Self-reported complete incontinence rates at baseline by device were as follows: Advance, 17%; other slings, 33%; ProACT, 0%; AMS800, 49%; other sphincter prosthesis, 100%; and overall group, 44%. The corresponding 1-yr self-reported continence rates were 73%, 37%, 50%, 76%, 11%, and 68%. Some 32% of the patients were still incontinent. Overall, 132 patients had at least one revision. Among the 110 patients with an artificial urinary sphincter (AUS), 122 revisions were performed, while there were 29 revisions for the 22 patients with a sling or ProACT device. International Consultation on Incontinence Questionnaire Short Form and EuroQol 5-dimensions 5-levels scores improved with all devices. CONCLUSIONS AND CLINICAL IMPLICATIONS: AUS implants are used in cases with more severe incontinence and are associated with better outcomes but more revisions than the alternatives. Patients report that every improvement is important. Choices for procedures should be made on the basis of these considerations. PATIENT SUMMARY: We collected data from 29 urology departments in Europe on surgical treatments for patients who suffer from incontinence during exercise, sneezing, and coughing. Results after 1 year show that an artificial urinary sphincter has the best outcomes overall and for patients with heavy urine loss. However, this surgery also requires more revisions. Patients report that every improvement in continence is important to them.
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INTRODUCTION: Obtaining level 1 evidence on efficacy of glycosaminoglycan (GAG) therapy is difficult, due to low incidence of bladder pain syndrome/interstitial cystitis (BPS/IC) and heterogeneous symptoms experienced by patients with BPS/IC. Currently, because of a lack of high-grade evidence, the recommendation for applying GAG therapy in most guidelines is 'low grade'. An aggregated N-of-1 trial is a multicrossover design that yields similar level 1 evidence as a traditional randomised controlled trial (RCT), while requiring far less patients. The goal of this study is to investigate the efficacy of intravesical GAG therapy (Ialuril) for patients with BPS/IC with Hunner lesions using a dual RCT and aggregated N-of-1 trial design to obtain level 1 evidence. METHODS AND ANALYSIS: The GETSBI study is a double-blind multidesign multicentre randomised placebo-controlled study to assess the short-term and long-term efficacy of hyaluronic acid (1.6%) + chondroitin sulfate (2%) therapy (Ialuril Prefill, IBSA, Goodlife) in patients with symptomatic BPS/IC with Hunner lesions. It starts as a standard RCT (n=80), but continues as an aggregated N-of-1 trial. There are three parallel arms, receiving blinded treatment for three periods (1 x/week for 6 weeks, ratio placebo to intervention in periods of 2:1). Followed by an open prospective part for the long-term efficacy. The primary study outcome is the maximum bladder pain experienced in the last 3 days measured using the visual analogue pain scale (0-10).This study is a collaboration with the Dutch government and will deliver evidence for the decision to reimburse the therapy. Furthermore, this multidesign study will allow us to compare the two main methods to evaluate applicability for future study designs for BPS/IC research. ETHICS AND DISSEMINATION: Ethical approval was given by METC Oost-Nederland, file number: 2020-7265, NL-number: NL76290.091.20. Findings from this study will be disseminated via publication, reports and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier (NCT number): NCT05518864.
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Cistitis Intersticial , Humanos , Cistitis Intersticial/tratamiento farmacológico , Glicosaminoglicanos/uso terapéutico , Administración Intravesical , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: Interstitial cystitis/bladder pain syndrome (IC/BPS) patients are more susceptible to urinary tract infections (UTIs), likely worsening pre-existing symptoms. However, this receives limited attention in guidelines. This study aimed to explore the burden of UTIs on IC/BPS patients' quality of life and their healthcare. METHODS: Two quantitative retrospective database studies were conducted in cystoscopically proven IC/BPS patients: one compiled existing patient survey data (n = 217) from July 2021 to examine physical and emotional UTI burden, and the other used a patient file database (n = 100) from January 2020 to May 2022, focusing on UTI prevalence, healthcare use, urine cultures and antibiotic resistance. RESULTS: A delay in diagnosis was seen in 70% of patients, due to doctors confusing IC/BPS symptoms with UTIs. The UTI prevalence was over 50%; these patients also report anxiety for new UTIs (70%) and worsening of IC/BPS symptoms (60%). Additionally, for UTI+ patients, healthcare consumption was significantly increased in both studies. Antibiotic resistance (80% of cultures) and prophylactic antibiotic use were common. CONCLUSIONS: These findings highlight the burden of UTIs on quality of life in IC/BPS patients and the healthcare system. These results emphasize the need for improved UTI guidelines concerning diagnosis, management and prevention for IC/BPS patients to improve quality of life and care.
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Surgery for male incontinence with artificial urinary sphincters and slings (SATURN) is a prospective, multicentre registry (observational cohort) for male stress urinary incontinence surgery to collect prospective data from multiple European centres and surgeons, to evaluate the short- and long-term success and the impact on quality of life.
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BACKGROUND: The chronic kidney disease (CKD) classification system for children is similar to the CKD classification system for adults, using estimated glomerular filtration rate (eGFR) combined with fixed cut-off values of 60, 30, and 15 ml/min/1.73 m(2) for CKD stages III, IV, and V, respectively. To estimate GFR in children, eGFR-equations are used that require serum creatinine (Scr), but also height information, which is normally not available in clinical laboratory databases. METHODS: This retrospective study is based on data from two different databases, one that has previously been used to develop the Flanders Metadata equation for children and one database including 353 children who underwent (51)Cr-EDTA GFR, serum creatinine, height, and weight measurements. RESULTS: A height-independent eGFR equation based on the concept of a population-normalized Scr, presented before for adults, is extended to children: eGFR = 107.3/(Scr/Q), with Q the median Scr for healthy children of a particular age. This equation is validated against direct measurements of GFR, and against the updated Schwartz and Flanders Metadata equation. CONCLUSIONS: The new simple height-independent equation performs very well and should make (mass) screening of kidney function in children easier.
Asunto(s)
Estatura , Tasa de Filtración Glomerular , Enfermedades Renales/diagnóstico , Riñón/fisiopatología , Modelos Biológicos , Adolescente , Adulto , Distribución por Edad , Factores de Edad , Anciano , Bélgica , Biomarcadores/sangre , Peso Corporal , Niño , Preescolar , Radioisótopos de Cromo , Enfermedad Crónica , Creatinina/sangre , Ácido Edético , Femenino , Humanos , Lactante , Riñón/metabolismo , Enfermedades Renales/sangre , Enfermedades Renales/fisiopatología , Modelos Lineales , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Estudios Retrospectivos , Adulto JovenRESUMEN
This study evaluates the outcome of trials to stimulate the dorsal genital nerve (DGN) in patients with lower urinary tract dysfunction. The aim of most studies was to suppress detrusor overactivity in patients with overactive bladder (OAB) syndrome by DGN stimulation. A literature search was performed using Pub Med, Web of Science, and Scopus databases (1980 to April 2012) for clinical trials of DGN stimulation in patients with detrusor overactivity. Seventeen studies were found in the literature. In the studies, different patterns of DGN stimulation were applied. The patterns were either continuous, conditional, or semi-conditional; on an acute or on a chronic basis. DGN stimulation lead to improvement of bladder capacity and reduction in urgency and/or incontinence episodes in many patients. The outcomes of conditional stimulation were comparable to continuous stimulation with respect to improvement of bladder capacity. The publications give evidence that DGN stimulation increases bladder capacity and suppresses involuntary detrusor contractions. Implantable DGN stimulation electrodes can open the way for more prolonged studies in larger patient groups to assess the effectiveness of chronic DGN stimulation in patients with OAB syndrome. Chronic DGN stimulation seems to be of value in the management of OAB syndrome.