RESUMO
BACKGROUND: Neurogenic detrusor overactivity incontinence (NDOI) is often inadequately managed with oral therapy. OBJECTIVE: To assess efficacy and safety of abobotulinumtoxinA (aboBoNT-A; Dysport®; Ipsen Ltd.) according to etiology of NDOI. DESIGN, SETTING, AND PARTICIPANTS: Two phase III, randomized, double-blind studies (CONTENT1 [NCT02660138] conducted in Asia, Europe and North America; CONTENT2 [NCT02660359] conducted in the Americas, Asia, Europe and Oceania) both included patients with spinal cord injury (SCI) or multiple sclerosis (MS), with inadequately managed NDOI, regularly performing clean intermittent catheterization (CIC). INTERVENTION: Patients in CONTENT1 and CONTENT2 received aboBoNT-A injections 600 U (n = 162)/800 U (n = 161), or placebo (n = 162) into the detrusor muscle. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary endpoint: mean change from baseline in number of NDOI episodes/week at Week 6. Secondary endpoints: proportion of patients with no NDOI episodes; incontinence-related quality of life (I-QoL); urodynamic parameters; and time-to-retreatment. Safety was also assessed. Statistical analyses were conducted for pooled populations by etiology (aboBoNT-A doses vs. placebo). RESULTS AND LIMITATIONS: Of 485 randomized patients, 341 (70%) and 144 (30%) had SCI and MS etiologies, respectively. A significant reduction was observed in mean NDOI episodes/week at Week 6 with both aboBoNT-A doses versus placebo in the SCI (all p < 0.001) and MS (all p < 0.01) groups, as well as significant improvements in I-QoL and urodynamic parameters. Median time-to-retreatment was longer in patients with MS (48-62 weeks across doses) than those with SCI (39-44 weeks). Safety data were similar between etiologies. Urinary tract infection was the most frequent adverse event; similar numbers were reported across treatment groups. CONCLUSIONS: AboBoNT-A was well tolerated and significantly improved continence and bladder function, and QoL, in patients with SCI or MS with NDOI performing regular CIC. PATIENT SUMMARY: AboBoNT-A injections improved QoL, symptoms, and bladder function in patients with SCI or MS with bladder muscle overactivity that causes incontinence.
Assuntos
Toxinas Botulínicas Tipo A , Esclerose Múltipla , Fármacos Neuromusculares , Traumatismos da Medula Espinal , Bexiga Urinaria Neurogênica , Bexiga Urinária Hiperativa , Incontinência Urinária , Humanos , Toxinas Botulínicas Tipo A/efeitos adversos , Esclerose Múltipla/complicações , Esclerose Múltipla/tratamento farmacológico , Fármacos Neuromusculares/uso terapêutico , Qualidade de Vida , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/tratamento farmacológico , Resultado do Tratamento , Bexiga Urinaria Neurogênica/tratamento farmacológico , Bexiga Urinaria Neurogênica/etiologia , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária Hiperativa/etiologia , Incontinência Urinária/etiologia , Incontinência Urinária/complicaçõesRESUMO
AIMS: Sacral neuromodulation (SNM) is an accepted therapy for a variety of conditions. However, despite over 20 years of experience, it remains a specialized procedure with a number of subtleties. Here we present the recommendations issued from the International Continence Society (ICS) SNM Consensus Panel. METHODS: Under the auspices of the ICS, eight urologists, three colorectal surgeons and two urogynecologists, covering a wide breadth of geographic and specialty interest representation, met in January 2017 to discuss best practices for neuromodulation. Suggestions for statements were submitted in advance and specific topics were assigned to committee members, who prepared and presented supporting data to the group, at which time each topic was discussed in depth. Best practice statements were formulated based on available data. This document was then circulated to multiple external reviewers after which final edits were made and approved by the group. RESULTS: The present recommendations, based on the most relevant data available in the literature, as well as expert opinion, address a variety of specific and at times problematic issues associated with SNM. These include the use of SNM for a variety of underlying conditions, need for pre-procedural testing, use of staged versus single-stage procedures, screening for success during the trial phase, ideal anesthesia, device implantation, post-procedural management, trouble-shooting loss of device function, and future directions for research. CONCLUSIONS: These guidelines undoubtedly constitute a reference document, which will help urologists, gynecologists, and colorectal surgeons optimize their use of SNM for refractory urinary urgency and frequency, UUI, NOR, and FI.
Assuntos
Terapia por Estimulação Elétrica , Sacro , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária/terapia , Retenção Urinária/terapia , Consenso , HumanosRESUMO
AIMS: To evaluate the efficacy and complications of extradural sacral anterior root stimulation (SARS) implantation in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI). MATERIALS AND METHODS: A retrospective study was conducted between 2009 and 2013, on consecutive patients with NDO associated with SCI that underwent SARS implantation. We evaluated those factors related to clinical symptoms such as urinary infection rate, erections, and episodes of autonomic dysreflexia. Data from cystometric bladder capacity (CBC) and post-void residual (PVR) volume were also analyzed. RESULTS: Of the 104 patients included in the study, 95 (91%) patients were men with a mean (standard deviation) (SD) age of 38 (10) years. Mean (SD) time between the onset of SCI and the SARS was 78.2 (59.0) months. At baseline, 95 (91%) patients had urinary infections as compared with 16 (15%) after treatment, P < 0.001. The percentage of patients that had urinary incontinence was significantly higher at baseline than that observed after SARS, 100% versus 14%, respectively, P < 0.001. Similar results were obtained regarding dysreflexia, P < 0.001. After SARS, the mean (SD) bladder capacity was 362 (108) ml and 98 (94%) patients had a bladder capacity greater than 400 ml. As regard to the adverse effects, six patients (6%) required a suburethral mesh implant and two (2%) patients had an infection, 4 and 5 months after SARS, respectively. CONCLUSIONS: Extradural implantation of SARS seems to be an effective and safe procedure in patients with spinal cord injury and neurogenic detrusor overactivity. Neurourol. Urodynam. 35:970-974, 2016. © 2015 Wiley Periodicals, Inc.
Assuntos
Terapia por Estimulação Elétrica/métodos , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/terapia , Raízes Nervosas Espinhais , Bexiga Urinária Hiperativa/etiologia , Bexiga Urinária Hiperativa/terapia , Adulto , Terapia por Estimulação Elétrica/efeitos adversos , Eletrodos Implantados , Feminino , Humanos , Laminectomia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Rizotomia , Região Sacrococcígea , Resultado do Tratamento , Bexiga Urinária/patologia , Incontinência Urinária/etiologia , Incontinência Urinária/terapiaRESUMO
Resumen ANTECEDENTES: El síndrome de Fowler es poco común, con predominio en mujeres jóvenes; se caracteriza por una actividad anormal, con contracciones repetidas en el esfínter uretral externo, en ausencia de enfermedad neurológica. CASO CLÍNICO: Paciente de 51 años, acudió a consulta por prolapso de órganos pélvicos con sensación de masa en la vagina y dificultad para orinar. En la videourodinamia se apreció una onda intermitente, con hipoactividad del detrusor y micción no coordinada, sin incontinencia, hallazgos característicos del síndrome de Fowler. Se le indicó terapia de aprendizaje de relajación del esfínter para coordinar la micción, posteriormente neuromodulación sacra. Durante el seguimiento se observó mejor coordinación y satisfacción después de orinar. CONCLUSIONES: La micción es un proceso complejo, que implica la integridad de la vía urinaria inferior y adecuado sinergismo con el sistema nervioso central, autónomo y somático. La falla en alguna de estas estructuras podría ocasionar un patrón miccional obstructivo.
Abstract BACKGROUND: Fowler's syndrome is a rare phenomenon mainly in young women in reproductive age with abnormal, repeated contractions in the external urethral sphincter without a neurological disease. CLINICAL CASE: 51-year-old woman with pelvic organ prolapse, symptoms of vaginal bulge and difficult micturition. A videourodynamic study was done showing intermittent waveform, detrusor hypoactivity and uncoordinated micturition without incontinence, suggestive of Fowler's syndrome. The patient underwent therapy for sphincter relaxation and sacral neuromodulation with good response. In the follow up with clinical improvement, referring being satisfied after micturition. CONCLUSIONS: Micturition is a complex process that needs integrity of the lower urinary tract and synergy between this and the central nervous system, autonomous and somatic. Failure in any of these structures can result in an obstructive pattern.