RESUMEN
AIMS: Sacral neuromodulation (SNM) and Botulinum toxin A (BoNT-A) injections are well-known third-line treatment options in patients with refractory overactive bladder (OAB). Our aim is to evaluate the success rate of SNM in patients who received prior therapy with BoNT-A injections. METHODS: All patients with OAB symptoms referred for SNM between 2006 and 2019 were included. History taking and 3-day voiding diaries assessed the complaints and suitability for SNM. The success rate of SNM in patients who received prior BoNT-A was compared with BoNT-A naive patients. Success was defined as an improvement of 50% or greater in voiding diary parameters. Satisfaction was registered at their most recent visit. RESULTS: A total of 263 patients underwent SNM test stimulation, of which 75 (16 male/57 female) received prior BoNT-A and 188 (46 male/142 female) were BoNT-A naive. Success rate for SNM in BoNT-A naive patients was 72.9% and in BoNT-A patients 66.7% (p = 0.316). Success rate after ≤2 BoNT-A injections was 68.5%, compared to 61.1% after ≥3 injections (p > 0.05). Success rate in patients perceiving lack of efficacy of BoNT-A was 67.4% (p > 0.05), subjected to temporary CISC was 73.7% (p > 0.05) and with temporary effect of BoNT-A was 50% (p > 0.05). In 86% of BoNT-A patients the system was still activated and used to their satisfaction at their last follow-up visit (mean FU, 40.70 months). CONCLUSION: SNM in patients with refractory OAB who failed prior BoNT-A is an excellent approach. The number of injections nor reason of BoNT-A discontinuation have predictive value for success with SNM.
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Toxinas Botulínicas Tipo A/efectos adversos , Terapia por Estimulación Eléctrica , Vejiga Urinaria Hiperactiva , Femenino , Humanos , Masculino , Región Sacrococcígea , Sacro , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/tratamiento farmacológicoRESUMEN
Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspective of patients, healthcare professionals, and providers.
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Incontinencia Fecal/terapia , Invenciones , Prótesis e Implantes/normas , Sacro/fisiopatología , Terapias en Investigación/normas , Estimulación Eléctrica Transcutánea del Nervio/normas , Vejiga Urinaria Hiperactiva/terapia , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Guías como Asunto , Humanos , Masculino , Persona de Mediana Edad , Terapias en Investigación/instrumentación , Terapias en Investigación/métodos , Estimulación Eléctrica Transcutánea del Nervio/instrumentación , Estimulación Eléctrica Transcutánea del Nervio/métodosRESUMEN
INTRODUCTION: Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve. MATERIALS AND METHODS: A first-in-human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used. RESULTS: During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred. CONCLUSIONS: The results from this acute first-in-human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid-field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device.
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Terapia por Estimulación Eléctrica/instrumentación , Neuroestimuladores Implantables , Plexo Lumbosacro/fisiopatología , Vejiga Urinaria Hiperactiva/terapia , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sacro/fisiopatología , Nervios Espinales/fisiopatología , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/fisiopatología , Adulto JovenRESUMEN
INTRODUCTION: Detrusor underactivity (DU) is currently a topic that receives major attention within functional urology. Urologists are often confronted with men who present with voiding dysfunction without bladder outlet obstruction (BOO) or after desobstructive or neuromodulation treatment. Their impaired bladder emptying is suspected to be related to failure of detrusor contractile function. Earlier research indicated that patients with non-obstructive urinary retention (NOR), for example, detrusor underactivity (DU), have a lower success rate after sacral neuromodulation (SNM) compared to patients treated with SNM for storage dysfunction. However, predicting factors for treatment success in the NOR group have not yet been defined. METHODS AND EVIDENCE: The aim of this study was to assess whether the use of the new BOO-contractility (Maastricht-Hannover) nomogram can identify and predict SNM non-responders. Our results in 18 men showed that only 20% of patients below the 10th percentile, but 86% of men between the 10 and 25th percentiles of the nomogram can be treated successfully with SNM. All successfully treated patients voided without needing self- catheterisation. CONCLUSIONS: This pilot study showed for the first time that SNM treatment response in male patients with impaired bladder emptying can be predicted with the BOO-contractility (Maastricht-Hannover) nomogram. Men below the 10th percentile are likely to be treatment non-responders, whereas the majority of men above the 10th percentile are responders. Neurourol. Urodynam. 36:808-810, 2017. © 2016 Wiley Periodicals, Inc.
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Terapia por Estimulación Eléctrica/métodos , Obstrucción del Cuello de la Vejiga Urinaria/terapia , Retención Urinaria/terapia , Urodinámica/fisiología , Adulto , Humanos , Masculino , Persona de Mediana Edad , Contracción Muscular/fisiología , Proyectos Piloto , Resultado del Tratamiento , Obstrucción del Cuello de la Vejiga Urinaria/fisiopatología , Retención Urinaria/fisiopatologíaRESUMEN
AIMS: To investigate urologists' referral attitude for sacral neuromodulation (SNM) for treating refractory idiopathic overactive bladder syndrome (OAB) and to quantify the weight they attribute to clinical parameters to refrain from SNM referral. METHODS: We set up a vignette study using a discrete-choice design. The questionnaires were distributed at two national urological meetings. RESULTS: One hundred eight urologists completed the questionnaire. Three parameters were significantly associated with the decision to refrain from referral: absolute contraindications for SNM (anatomical low bladder compliance, current urinary tract infection, progressive neurological disease, urinary tumors) had the strongest association (0.78, 95% CI 0.58 to 0.97; P < 0.001), followed by cardiac pacemaker (0.24, 95% CI 0.08 to 0.39; P = 0.003), and diabetes mellitus (0.19, 95% CI 0.06 to 0.32; P = 0.006). On the other hand, urologists considered fecal incontinence as an important parameter for referral (-0.16, 95% CI -0.29 to -0.04; P = 0.011). Current medication with antimuscarinics and polyuria played no role in the decision. Results in a subgroup of 24 neuro-urologists/functional urologists were similar but non-critical parameters were not associated with the decision to refrain from SNM referral. CONCLUSIONS: Besides absolute contraindications, other non-critical parameters such as cardiac pacemaker or diabetes mellitus influence urologists' decision to refrain from referral for SNM. We believe that the use of decision tools will help urologists identifying patients benefiting from SNM and therefore we call for broad dissemination of such tools into clinical practice.
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Actitud del Personal de Salud , Terapia por Estimulación Eléctrica , Pautas de la Práctica en Medicina , Derivación y Consulta , Vejiga Urinaria Hiperactiva/terapia , Urología , Adulto , Contraindicaciones , Femenino , Humanos , Plexo Lumbosacro , Masculino , Encuestas y Cuestionarios , SíndromeRESUMEN
PURPOSE: We evaluated whether patients with overactive bladder and incontinence who discontinued intravesical botulinum toxin therapy can be successfully treated with sacral neuromodulation. MATERIALS AND METHODS: All patients who were referred to our center after discontinuation of botulinum toxin-A between 2005 and 2010 were included in this observational study. All patients underwent test stimulation with sacral neuromodulation and were evaluated with voiding diaries. Success was defined as more than 50% improvement in leakage episodes. Successful test stimulation was subsequently followed by a definitive implant. Patient satisfaction with sacral neuromodulation therapy was evaluated 1 year after the definitive implant. RESULTS: A total of 20 patients were included in the study. Of these patients 17 (85%) had discontinued botulinum toxin-A because of lack of efficacy and 3 had been treated successfully with botulinum toxin-A but requested a more permanent solution. The mean interval between the botulinum toxin-A and the sacral neuromodulation test stimulation was 23 months. In 14 patients (70%) the test stimulation was successful and they received a definitive implant. Of the 14 patients 5 even showed a decrease of greater than 90% in leakage episodes. One year after implantation 11 patients (79%) were satisfied with the sacral neuromodulation treatment. CONCLUSIONS: Despite the small sample size, this study indicates that patients who are dissatisfied with or in whom botulinum toxin-A treatment fails can respond successfully to sacral neuromodulation. The success rate of the test stimulation was comparable to that of patients who have never been treated with botulinum toxin-A. The 1-year satisfaction rate was comparable that of patients without a history of botulinum toxin-A treatment.
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Terapia por Estimulación Eléctrica , Vejiga Urinaria Hiperactiva/terapia , Incontinencia Urinaria/terapia , Adulto , Anciano , Anciano de 80 o más Años , Toxinas Botulínicas Tipo A/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fármacos Neuromusculares/uso terapéutico , Sacro , Vejiga Urinaria Hiperactiva/tratamiento farmacológicoRESUMEN
Neuromodulation is used as a treatment for overactive bladder syndrome, if conservative management is ineffective or only partially effective. Sacral neuromodulation is now a minimally invasive treatment as a result of improvements in surgical technique, and it has good long-term results. Nevertheless the risk of complications such as pain and decreasing effect is still present. Developments in alternative neuromodulation treatments, such as posterior tibial nerve stimulation, pudendal nerve stimulation and intravesical injection therapy with botulinum neurotoxin, have extended the role of neuromodulation. Intravesical injection therapy with botulinum toxin, along with sacral neuromodulation, has been included in the treatment algorithm of overactive bladder syndrome if this does not respond to conservative therapy. When choosing for a neuromodulation therapy, the side-effects and complications of the treatments should be considered alongside the specific patient situation and evidence for effectiveness and long-term effectiveness.
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Toxinas Botulínicas Tipo A/uso terapéutico , Terapia por Estimulación Eléctrica , Fármacos Neuromusculares/uso terapéutico , Vejiga Urinaria Hiperactiva/terapia , Administración Intravesical , Toxinas Botulínicas Tipo A/administración & dosificación , Terapia por Estimulación Eléctrica/efectos adversos , Humanos , Plexo Lumbosacro , Fármacos Neuromusculares/administración & dosificación , Síndrome , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/tratamiento farmacológicoRESUMEN
OBJECTIVES: To review the technique, indications, results and working mechanisms of sacral neuromodulation (SNM) for lower urinary tract dysfunction. METHODS: The available literature on SNM for lower urinary tract dysfunction was searched. Based on the information available in the literature and also based on personal experience, the urological indications, technique, mechanisms of action and results of SNM are presented and discussed. RESULTS: SNM for lower urinary tract dysfunction involves stimulation of the 3rd sacral nerve with an electrode implanted in the sacral foramen and connected to a pulse generator. The technique is accepted by the FDA since 1997. Currently, SNM for lower urinary tract dysfunction has been successfully used in about 26,000 patients with various forms of lower urinary tract dysfunction, including urgency, frequency and urgency incontinence as well as non-obstructive urinary retention. The actual procedure of SNM consists of a minimal invasive technique and is effective in about 70% of the patients who have been implanted with a permanent system. Also, in pelvic pain, interesting results have been described. SNM modulates the micturition reflexes at different levels in the central nervous system. CONCLUSIONS: Sacral neuromodulation is a safe and effective therapy for various forms of lower urinary tract dysfunction, including urgency, frequency and urgency incontinence as well as non-obstructive urinary retention. It should be the first choice after failure of maximal conservative therapy.
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Terapia por Estimulación Eléctrica/métodos , Síntomas del Sistema Urinario Inferior/terapia , Sacro/inervación , Enfermedades Urológicas/terapia , Femenino , Humanos , Plexo Lumbosacro/fisiología , Resultado del Tratamiento , Incontinencia Urinaria/terapia , Retención Urinaria/terapiaRESUMEN
UNLABELLED: What's known on the subject? and What does the study add? Sacral neuromodulation (SNM) is a well-established treatment for patients with chronic LUTS. The selection of eligible candidates could be improved by identifying factors that can predict a successful response. In the present study, we evaluated the role of various psychological and psychiatric factors in relation to SNM treatment. OBJECTIVE: ⢠To evaluate if psychological and psychiatric factors can predict the outcome of test stimulation or permanent treatment with sacral neuromodulation (SNM). PATIENTS AND METHODS: ⢠Between 2006 and 2009, patients with overactive bladder syndrome or non-obstructive urinary retention who were eligible for test stimulation were included. ⢠All patients completed the Amsterdam Biographic Questionnaire (ABQ), which measures the personality traits of the patient, and the Symptom Check-List-90-Revised (SCL-90-R), which is a screening instrument for neuroticism, and for current level of complaints. ⢠The results of the questionnaires were compared with the outcomes of test stimulation and permanent treatment. ⢠In addition to the questionnaires, we also included the psychiatric history as a potential predictive factor. RESULTS: ⢠On univariate analysis there was no relationship between the psychological characteristics and the outcome of test stimulation or the occurrence of adverse events (AEs) with permanent treatment. ⢠A history of psychiatric disease was not related to the outcome of test stimulation, but was shown to be a positive predictor for the occurrence of AEs with permanent SNM treatment. CONCLUSIONS: ⢠In the present study there was no evidence that psychological screening with the ABQ or SCL-90-R can predict the outcome of SNM treatment. ⢠Patients with a medical history of psychiatric disease appear to be more likely to encounter AEs with permanent SNM treatment.
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Terapia por Estimulación Eléctrica/psicología , Plexo Lumbosacro , Trastornos Mentales/complicaciones , Vejiga Urinaria Hiperactiva/terapia , Retención Urinaria/terapia , Adulto , Anciano , Enfermedad Crónica , Terapia por Estimulación Eléctrica/instrumentación , Terapia por Estimulación Eléctrica/métodos , Femenino , Humanos , Neuroestimuladores Implantables , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Encuestas y Cuestionarios , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/psicología , Retención Urinaria/psicologíaRESUMEN
INTRODUCTION: Sacral neuromodulation (SNM) of the lower urinary tract has proven to be safe and effective in patients with complaints of OAB syndrome who are not responding to conservative therapy. After 5 years of treatment the implanted system is still effective in 56-71% of patients. The loss of effect could be caused by adaptation of the nerve system to prolonged stimulation of the sacral nerves. MATERIALS AND METHODS: We set up a pilot intervention study. After a run-in period of 2 weeks patients were randomized into two groups: one group with on-demand neuromodulation (intervention group) and one group with continuous neuromodulation (control group). Patients in the intervention group were instructed to switch their INS off by default and to switch it on again when they felt recurrent symptoms, patients in the control group were asked to use their system as normally. RESULTS: After 2 weeks 10 out of 16 subjects reported a comparable symptom score during on-demand use of their neuromodulation system. Patients appreciated the comfort of being self-determent in the need for therapy. CONCLUSIONS: Possible benefits for patients could be: more autonomy, longer battery life of the implanted INS, decreasing the chance of adaptation by the nervous system.
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Terapia por Estimulación Eléctrica/métodos , Plexo Lumbosacro/fisiopatología , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria/inervación , Adaptación Fisiológica , Sistema Nervioso Autónomo/fisiopatología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Satisfacción del Paciente , Autonomía Personal , Proyectos Piloto , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Vejiga Urinaria/fisiopatología , Vejiga Urinaria Hiperactiva/fisiopatología , MicciónRESUMEN
PURPOSE: We evaluated the effect of pulse rate changes on the clinical response to and stimulation related pain symptoms of sacral neuromodulation treatment. MATERIALS AND METHODS: In this pilot study we evaluated the effect of 4 pulse rates, including 5.2, 10, 21 and 40 Hz, in patients with a suboptimal response to sacral neuromodulation. The effect of each frequency was evaluated during a 6-day test period. To avoid the carryover effect stimulation was discontinued for 24 hours between consecutive test periods. On the last 3 days of each test period a voiding diary and questionnaire were completed. Changes in the clinical response and pain symptoms were compared between the 4 pulse rates using multivariate analysis. RESULTS: Of the 50 patients included in the study 40 (80%) were female. Mean ± SD age was 55.5 ± 12.3 years. Of the patients 41 (82%) had overactive bladder symptoms and 9 (18%) were in chronic nonobstructive urinary retention. No significant difference was found in clinical outcome on the voiding diary and questionnaire between the pulse rates and none of the 4 rates was significantly related to sacral neuromodulation associated pain. However, individuals appeared to benefit from changing the pulse rate in terms of treatment efficacy and stimulation related pain. CONCLUSIONS: On the group level none of the 4 pulse rates appeared to have a significantly different effect on clinical outcome or sacral neuromodulation related pain. However, an individualized approach to optimize treatment efficacy by changing the pulse rate appears to be useful.
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Terapia por Estimulación Eléctrica/métodos , Plexo Lumbosacro/fisiología , Vejiga Urinaria Hiperactiva/terapia , Retención Urinaria/terapia , Análisis de Varianza , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Proyectos Piloto , Encuestas y Cuestionarios , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/fisiopatología , Retención Urinaria/fisiopatologíaRESUMEN
AIMS: To compare the patient's response rate to the Percutaneous Nerve Evaluation test (PNE) and the 1st stage tined-lead placement test (FSTLP) for sacral neuromodulation therapy (SNM). METHODS: Single center study on patients with refractory idiopathic overactive bladder syndrome (OAB) or non-obstructive urinary retention, screened with both PNE and FSTLP. Patients were followed prospectively and their response rate based on bladder diary after PNE was compared to that after FSTLP. More than 50% improvement in at least two relevant urinary symptoms was considered a positive response. A Wilcoxon paired test was done to compare the rates of the two screening options and logistic regression to determine possible associations. A follow-up was conducted to determine the long-term failure rate. RESULTS: One hundred patients were included (82 female, 69 OAB). The mean age was 55 years (SD 13). The positive response rate on PNE was 47%. FSTLP showed a 69% positive response rate, which was negatively related to age. The 22% gain in positive response was statistically significant (P < 0.001) and positively associated with female gender and younger age. All 69 patients with a positive response to FSTLP received SNM treatment. Failure rate after an average of 2 years was 2.9%. CONCLUSIONS: This study suggests that FSTLP may be a more sensitive screening method than PNE to identify patients eligible for SNM therapy, warranting randomized trials.
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Técnicas de Diagnóstico Neurológico , Terapia por Estimulación Eléctrica , Plexo Lumbosacro , Vejiga Urinaria Hiperactiva/diagnóstico , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria/inervación , Retención Urinaria/diagnóstico , Retención Urinaria/terapia , Adulto , Anciano , Distribución de Chi-Cuadrado , Terapia por Estimulación Eléctrica/efectos adversos , Terapia por Estimulación Eléctrica/instrumentación , Electrodos Implantados , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Países Bajos , Oportunidad Relativa , Selección de Paciente , Valor Predictivo de las Pruebas , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Sensación , Factores de Tiempo , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/fisiopatología , Retención Urinaria/fisiopatología , UrodinámicaRESUMEN
AIMS: To determine the effects on Quality of Life (QoL) of a Brindley procedure, which combines a sacral dorsal root rhizotomy to treat neurogenic detrusor overactivity with sacral anterior root stimulation to enable micturition, defecation, and penile erections in complete spinal cord injury (SCI) patients compared to a matched Control Group. METHODS: Cross-sectional study. The Qualiveen questionnaire, SF-36 questionnaire, and multiple choice questions about urinary continence and urinary tract infections were sent to 93 patients who had a Brindley stimulator implanted in the Netherlands and a matched Control Group of 70 complete SCI patients with neurogenic detrusor overactivity. Primary study outcomes were Specific Impact of Urinary Problems score and general QoL index of the Qualiveen. RESULTS: Response rates were 78% and 40% for patients with a Brindley stimulator and controls, respectively. Stimulators were still used for micturition in 46 (63%). These patients had a significant better Specific Impact of Urinary Problems score, general QoL index (Qualiveen), and continence rate, and less urinary tract infections compared to the Control Group. Patients also benefited of the rhizotomy with regard to QoL and continence rate if the stimulator was not used anymore. The subscales of the SF-36 had better scores for the patients who used their stimulator as compared to those who did not use the stimulator and compared to the Control Group. CONCLUSIONS: The Brindley stimulator for complete spinal cord injury patients improves Quality of Life, continence, and urinary tract infection rate compared to a matched Control Group.
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Calidad de Vida , Traumatismos de la Médula Espinal/complicaciones , Vejiga Urinaria Neurogénica/psicología , Vejiga Urinaria Neurogénica/terapia , Adulto , Anciano , Estudios Transversales , Terapia por Estimulación Eléctrica/métodos , Femenino , Humanos , Neuroestimuladores Implantables , Masculino , Persona de Mediana Edad , Rizotomía , Traumatismos de la Médula Espinal/psicología , Traumatismos de la Médula Espinal/cirugía , Encuestas y Cuestionarios , Resultado del Tratamiento , Vejiga Urinaria Neurogénica/etiología , Incontinencia Urinaria/etiología , Incontinencia Urinaria/psicología , Incontinencia Urinaria/terapiaRESUMEN
PURPOSE: We evaluated whether bilateral sacral nerve stimulation can be effective to restore treatment efficacy in patients in whom unilateral sacral neuromodulation fails. MATERIALS AND METHODS: Patients in whom unilateral sacral neuromodulation failed were included in analysis. The percutaneous nerve evaluation test was used to evaluate the effect of contralateral and bilateral stimulation. The stimulation electrode was placed in the contralateral S3 foramen and symptoms were self-recorded using a 3-day voiding diary. Clinical success was defined as more than 50% improvement in at least 1 relevant voiding diary parameter vs baseline. RESULTS: The 15 study patients underwent test stimulation with percutaneous nerve evaluation. In 3 patients lead migration was suspected and, thus, they were not included in analysis. Four of the remaining 12 patients had a successful response to percutaneous nerve evaluation, of whom 3 were eventually implanted with a contralateral lead. After 12 months of treatment 2 of the 3 patients had a successful outcome. CONCLUSIONS: In this pilot study only a select group of patients appeared to benefit from bilateral stimulation after unilateral therapy failure. Further investigation is needed to determine the predictive factors and cost-effectiveness of this treatment.
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Terapia por Estimulación Eléctrica , Vejiga Urinaria Hiperactiva/terapia , Adulto , Anciano , Femenino , Humanos , Plexo Lumbosacro , Masculino , Persona de Mediana Edad , Proyectos Piloto , Estudios ProspectivosRESUMEN
UNLABELLED: Study Type - Therapy (economic analysis). LEVEL OF EVIDENCE: 1b. OBJECTIVE: To assess and compare the costs and effects value of either starting with sacral neuromodulation (SNM) or botulinum toxin A (BTX) treatment in patients with refractory idiopathic overactive bladder from a societal perspective. MATERIALS AND METHODS: An economic model comparing SNM with BTX was developed. A clinical relevant effect (i.e. success) was defined as 50% or greater reduction in incontinence episodes or urgency frequency symptoms. Information on the clinical effectiveness of the two treatments and on the course of the disease with the two treatments were based primarily on published literature and, when required, on expert opinion. Both treatments were assumed to be performed under general anaesthesia and, for SNM treatment, first-stage tined lead test was used. All costs were based on national data from the year 2008. Analyses from the societal perspective were conducted for a 5-year duration. Costs were discounted at 4% and effects at 1.5%. In addition, different modelling scenarios were used to see determine any changes in the results obtained. RESULTS: Starting with SNM resulted in a higher quality adjusted life year (QALY) gain (difference of 0.23) and a higher cost (difference of 6428) compared to starting with BTX. The corresponding incremental cost-effectiveness ratio was 27,991/QALY. The probability of this ratio being cost effective (e.g. under 40,000/QALY) is 88%. SNM starts to be cost-effective after 4 years. SNM was not cost-effective in some other scenarios, such as when BTX was conducted under local anaesthesia or when peripheral nerve evaluation or bilateral testing was used for SNM. CONCLUSIONS: Starting with SNM, treatment is cost-effective after 5 years compared to BTX. However, in some scenarios, such as the use of local anaesthesia for BTX treatment and SNM peripheral nerve evaluation or bilateral test, SNM was not cost-effective.
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Toxinas Botulínicas Tipo A/economía , Terapia por Estimulación Eléctrica/economía , Plexo Lumbosacro , Neurotransmisores/economía , Vejiga Urinaria Hiperactiva/economía , Toxinas Botulínicas Tipo A/uso terapéutico , Enfermedad Crónica , Costo de Enfermedad , Análisis Costo-Beneficio , Terapia por Estimulación Eléctrica/métodos , Humanos , Neurotransmisores/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/terapiaRESUMEN
PURPOSE: We systematically assessed long-term satisfaction and patient experience with sacral nerve modulation therapy. MATERIALS AND METHODS: All patients who received sacral neuromodulation between 1990 and 2007 at our center and who still had the implant were included in the survey. All received a postal questionnaire regarding satisfaction and experiences with the system, such as side effects, complications, burden, impact on sexuality and defecation changes. RESULTS: Of the 275 questionnaires sent 207 were returned for a 75% response rate. The population was 83% female. Overall treatment was done for overactive bladder syndrome, nonobstructive urinary retention, combined overactive bladder and retention, and pelvic pain in 55%, 24%, 20% and 1% of patients, respectively. Overall satisfaction with sacral neuromodulation was high at 90%. No correlations were found between the satisfaction rate, and pretreatment age, gender, complaint type, sexual dysfunction or therapy duration. However, 56% of patients reported side effects, such as pain at the internal nerve stimulator site and due to stimulation. However, 89% of these patients did not seek further therapy. Of patients with additional defecation problems 47% experienced relief of complaints. CONCLUSIONS: This study shows a high satisfaction rate in patients with sacral neuromodulation. There was no relation between patient age, complaint type, therapy duration or side effects and the satisfaction rate. The number of side effects was limited but further analysis in prospective cohorts should identify patients who are likely to have side effects or stop sacral neuromodulation treatment.
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Terapia por Estimulación Eléctrica/métodos , Plexo Lumbosacro , Satisfacción del Paciente/estadística & datos numéricos , Encuestas y Cuestionarios , Trastornos Urinarios/terapia , Adolescente , Adulto , Factores de Edad , Anciano , Análisis de Varianza , Estudios de Cohortes , Electrodos Implantados , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Prótesis e Implantes , Calidad de Vida , Análisis de Regresión , Factores Sexuales , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/diagnóstico , Vejiga Urinaria Hiperactiva/terapia , Incontinencia Urinaria/diagnóstico , Incontinencia Urinaria/terapia , Retención Urinaria/diagnóstico , Retención Urinaria/terapia , Trastornos Urinarios/diagnóstico , Adulto JovenRESUMEN
Sacral neuromodulation has been developed to treat chronic lower urinary tract symptoms, resistant to classical conservative therapy. The suspected mechanisms of action include afferent stimulation of the central nervous system and modulation of activity at the level of the brain. Typical neuromodulation is indicated both in overactivity and in underactivity of the lower urinary tract. In the majority of patients, a unilateral electrode in a sacral foramen and connected to a pulse generator is sufficient to achieve significant clinical results also on long term. In recent years, other urological indications have been explored.
Asunto(s)
Terapia por Estimulación Eléctrica/métodos , Plexo Lumbosacro/fisiología , Raíces Nerviosas Espinales/fisiología , Sistema Urinario/fisiopatología , Trastornos Urinarios/terapia , Cistitis Intersticial/terapia , Humanos , Neuroestimuladores Implantables , Selección de Paciente , Dolor Pélvico/terapia , Sacro , Resultado del Tratamiento , Vejiga Urinaria Neurogénica/terapia , Sistema Urinario/inervación , Trastornos Urinarios/fisiopatologíaRESUMEN
PURPOSE: We present long-term followup data on the outcome of sacral neuromodulation using the tined lead procedure. MATERIALS AND METHODS: We conducted a single center study including all patients who received an implantable neurostimulator between 2002 and 2005 using the tined lead technique. Treatment efficacy was evaluated by comparing the data of a 3-day voiding diary filled out in May 2009 to the data before the onset of sacral neuromodulation treatment (baseline). Clinical success was defined as more than 50% improvement in at least 1 of the relevant voiding diary parameters. RESULTS: A total of 64 patients underwent implantation with an implantable neurostimulator using the tined lead procedure. Mean followup was 53 months (range 35 to 77). Five patients died of causes unrelated to sacral neuromodulation and they were not included in analysis. The implantable neurostimulator was removed from 7 patients and 3 stopped using the neurostimulator. Voiding diary analysis showed that 38 of 59 patients (64%) were successfully treated. There were 21 patients (33%) who underwent a surgical revision due to an adverse event and 1 (1.6%) who underwent lead revision because of suspected lead migration. CONCLUSIONS: Sacral neuromodulation with the tined lead procedure is a safe and effective treatment for patients with overactive bladder symptoms or urinary retention.
Asunto(s)
Terapia por Estimulación Eléctrica/métodos , Vejiga Urinaria Hiperactiva/terapia , Incontinencia Urinaria/terapia , Retención Urinaria/terapia , Adulto , Anciano , Femenino , Estudios de Seguimiento , Humanos , Plexo Lumbosacro , Masculino , Persona de Mediana Edad , Factores de Tiempo , Adulto JovenRESUMEN
OBJECTIVES: The aim of this review is to evaluate the place of transurethral resection of the prostate (TURP) in patients with elevated and/or rising prostate specific antigen (PSA). The role of TURP in these patients is assessed in symptomatic as well as in asymptomatic patients. METHODS: Current literature (1987-2009) was reviewed with regard to this specific population. This research was performed using the Medline online search tools. RESULTS: Initially, possible therapeutic strategies other than TURP could be used in patients with elevated and/or rising PSA values and no sign of proven prostate cancer. Consequently, the value of TURP in patients with elevated and/or rising PSA and no proven prostate cancer is discussed. In this setting, TURP can be executed with or without concomitant prostate biopsies. Furthermore, TURP can be proposed to patients with and without lower urinary tract symptoms. CONCLUSIONS: In this review, we evaluated the role of TURP in patients with elevated and/or rising PSA values and no proven prostate cancer. We believe TURP has a place in this particular population even in patients without lower urinary tract symptoms. This strategy is well founded on solid ground after an extensive review of the available literature. In most cases, a TURP will result in a normalization of PSA as well as a symptomatic benefit. Additionally, this procedure will allow histological evaluation which might show a possible life threatening prostate cancer in some patients.
Asunto(s)
Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/cirugía , Resección Transuretral de la Próstata , Humanos , MasculinoRESUMEN
The overactive bladder syndrome (OAB) negatively affects the daily life of many people. Conservative treatments, such as antimuscarinics, do not always lead to sufficient improvement of the complaints and/or are often associated with considerable side effects resulting in treatment failure. In the case of failure or intolerable side effects, sacral neuromodulation (SNM) and botulinum toxin are minimally invasive and reversible alternatives. Currently, of these alternatives only SNM with InterStimTM therapy has FDA approval for use in OAB patients. This review attempts to provide an update on the current position of SNM and botulinum toxin in the second-line management of adults with idiopathic OAB, based on the available clinical evidence concerning the efficacy and safety.