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2.
Neurourol Urodyn ; 41(1): 211-219, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34529869

RESUMEN

OBJECTIVES: To determine the outcome of combined transobturator tape sling (TOT) and low dose intradetrusor injection of Abobotulinumtoxin-A (Abobot-A, Dysport®) in women with mixed urinary incontinence (MUI). METHODS: This randomized, active comparator-controlled, parallel-group, two-part clinical trial was conducted on women who had positive Valsalva leak point pressure (VLPP) + detrusor overactivity (DO), cough-associated DO. In Part 1, 20 women with MUI who had a failure of medical and behavioral therapies to cure MUI, randomized in two groups receiving TOT surgery alone, or in combination with Dysport® injection (n = 10 in each group), and then Part 2 was initiated as a prospective open-label on 40 more patients. We performed cystoscopy and injected 300 U of Dysport®in 20-30 intradetrusor injection sites in each patient. RESULTS: The patient's symptoms in both groups decreased significantly after treatment. The symptoms were improved significantly in the combination therapy group according to the International Consultation on Incontinence Questionnaire-overactive bladder (ICIQ-OAB) questionnaire (p < .001), and International Consultation on Incontinence Questionnaire-urinary Incontinence-short form (ICIQ-UI-SF) (p = .041) in comparing with the TOT group. In Part 2, the mean score was 17.10 (4.75) for ICIQ-UI-SF and 9.22 (2.89) for ICIQ-OAB before the treatment. Twelve weeks after the intervention, the median (interquartile range: IQR) of ICIQ-OAB symptoms (2.0 [3.0]; p < .001) and ICIQ-UI-SF decreased, too (1. 0 [2.0]; p < .001). Considering improvement using Patient Global Impression of Improvement scale, 46 (92.0%) stated that they had significant subjective improvement of their symptoms. CONCLUSIONS: Combination therapy was accompanied with a promising effect in the patients with MUI according to the results of standardized questionnaires. However, further studies with controlled arms are recommended.


Asunto(s)
Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo , Incontinencia Urinaria , Femenino , Humanos , Estudios Prospectivos , Encuestas y Cuestionarios , Resultado del Tratamiento , Incontinencia Urinaria/complicaciones , Incontinencia Urinaria/tratamiento farmacológico , Incontinencia Urinaria de Esfuerzo/cirugía
3.
J Sex Med ; 19(1): 83-89, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34937674

RESUMEN

BACKGROUND: Some evidence suggests that intracavernosal botulinum toxin A (BTX-A IC) injections administered in addition to phosphodiesterase type 5 inhibitors (PDE5-Is) or prostaglandin E1 intracavernosal injections (PGE1 ICI) could effectively treat erectile dysfunction (ED) in non-responders, or insufficient responders to these pharmacologic treatments. AIM: To determine the long-term effectiveness and safety of combined treatment involving a single injection of BTX-A IC as an add on therapy to PDE5-Is or PGE1-ICI for the treatment of ED of different etiologies. METHODS: A retrospective, uncontrolled, single center study was conducted. Data from 123 consecutive patients with ED who were insufficient responders to PDE5-Is or PGE1-ICI and who received onabotulinumtoxinA 100 U, abobotulinumtoxinA 250 U or 500 U IC as an add on to their current pharmacologic treatment were analyzed. All analyses were exploratory. Qualitative data were compared using the Fisher's exact test. Univariate and multivariate analysis were performed using logistic regression with Odds Ratios (OR). Only variables with P < .05 in the univariate analysis were selected for multivariate analysis. RESULTS: The minimally clinically important difference (relative to baseline severity of ED) in the International Index of Erectile Function-Erectile function domain (IIEF-EF) score was achieved in 50% of patients at 34 (27-42) days and in 41% at 5.9 (3.9 - 8.1) months following BTX-A IC in combination with PDE5-Is or PGE1 ICI. The severity of ED influenced response to BTX-A IC according to the multivariate analysis (OR = 0.3, IC(95%]) = (0.16 - 0.56). Neither being post prostatectomy nor the type of BTX-A affected the response. Effectiveness tended to decrease more over time with abobotulinumtoxinA 250 U than 500 U. The only side-effects were mild penile pain on injection (n = 1) and mild penile pain for 3 days following injection (n = 1); no systemic effects were reported. CLINICAL IMPLICATIONS: BTX-A IC (all types) administered as an add on to registered pharmacologic treatments improved erectile function for at least 6 months in 41% of patients with ED of varying etiologies, and was safe. STRENGTHS & LIMITATIONS: A relatively large cohort of patients with ED was included, with a long follow-up period, however the study was retrospective, and uncontrolled. CONCLUSION: This study provides preliminary evidence that BTX-A IC administered as an add-on therapy for ED that is insufficiently responsive to standard therapy is effective for at least 6 months, and is safe. Randomized clinical trials are now needed to fully confirm these results. Giuliano F, Joussain C, Denys P, Long Term Effectiveness and Safety of Intracavernosal Botulinum Toxin A as an Add-on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 Injections for Erectile Dysfunction. J Sex Med 2022;19:83-89.


Asunto(s)
Toxinas Botulínicas Tipo A , Disfunción Eréctil , Alprostadil/efectos adversos , Toxinas Botulínicas Tipo A/efectos adversos , Disfunción Eréctil/etiología , Humanos , Masculino , Erección Peniana , Estudios Retrospectivos , Resultado del Tratamiento
4.
Artículo en Ruso | MEDLINE | ID: mdl-34932284

RESUMEN

OBJECTIVE: To assess the longitudinal attainment of patient-centred and function related goals after integrated spasticity management including repeated cycles of botulinum toxin A type A (BoNT-A) injections in real life settings over a period of 2 years. The article presents analysis of the results within the subpopulation of patients from Russia. MATERIAL AND METHODS: This international, multicentre, observational, prospective, longitudinal cohort study (registered at clinicaltrials.gov as NCT02454803) included patients ≥18 years old with upper-limb spasticity of any aetiology in whom a decision had already been made to inject any BoNT-A formulation commercially available in the Russi. The treatment outcomes were evaluated using the Upper Limb Spasticity Index, which combines the patient-centred Goal Attainment Scaling (GAS) with a set of targeted standardised measures to assess the neurological impairment. The extent of functional impairment was assessed using the DAS. RESULTS: 168 Russian patients from 7 sites with a mean age of 49.8 years participated in the study. The Russian subpopulation had some differences from the overall study population in baseline characteristics of patients and injection practices of BoNT-A treatment. During the study period, the majority of Russian patients received AboBoNT-A (Dysport) injections - 142 (85%) patients at cycle 1, while OnaBoNT-A (Botox) was used in 14 (8%) patients, and IncoBoNT-A (Xeomin) - in 12 (7%) patients. Higher doses of AboBoNT-A were observed compared to the overall population, mean doses of AboBoNT-A between cycles 1 and 4 were 909-934 U in the Russian patients and 814-859 U in the overall population. In general, patients of the Russian subpopulation successfully achieved their treatment goals. The mean cumulated GAS T-score over the study was 51.1±3.0, marginally exceeding the same parameter in the overall population (49.5±5.9). Across the 6 goal domains, cumulated GAS T-scores in Russian subpopulation were highest for the goals related to passive function and pain relief, with mean scores of 51.8±4.2 and 51.6±4.8, respectively. In the overall population cumulated GAS T-scores were highest for involuntary movements (mean 50.5±5.6) and pain relief (mean 50.4±6.2). The lowest GAS T-scores were for the treatment goals related to active function in both Russian subpopulation and overall population, the mean scores were 48.3±5.5 and 46.6±7.4 respectively. The study results also showed significant improvement in in terms of reduction of muscle tone according to MAS (Modified Ashworth Scale) and the extent of functional impairment according to DAS (Disability Assessment Scale). CONCLUSIONS: The results of this subgroup analysis on patients from Russia showed high effectiveness of repeated cycles of BoNT-A injections as part of the integrated upper limb spasticity management conducted in real life settings, both in terms of reduction of muscle tone and correction of functional impairment, which contributes to the successful achievement of the treatment goals. The right choice of individual patient-centred treatment goals and methods for assessing their achievement are important components of the treatment and rehabilitation process for patients with spastic paresis of the upper limb.


Asunto(s)
Toxinas Botulínicas Tipo A , Espasticidad Muscular , Fármacos Neuromusculares , Toxinas Botulínicas Tipo A/uso terapéutico , Objetivos , Humanos , Estudios Longitudinales , Persona de Mediana Edad , Espasticidad Muscular/tratamiento farmacológico , Fármacos Neuromusculares/uso terapéutico , Estudios Prospectivos , Federación de Rusia , Resultado del Tratamiento , Extremidad Superior
5.
Toxins (Basel) ; 12(11)2020 10 31.
Artículo en Inglés | MEDLINE | ID: mdl-33142833

RESUMEN

Sialorrhea, or excessive saliva beyond the margin of the lip, is a common problem in many neurological diseases. Previously, sialorrhea has been underrecognized in Parkinson's disease (PD) patients. Despite this, many patients rank sialorrhea as one of the most debilitating complaints of Parkinson's disease. Previous treatment for sialorrhea has been suboptimal and has been plagued by significant side effects that are bothersome and can be dangerous in patients with a concurrent neurodegenerative disease. This review sought to review the anatomy, function, and etiology of sialorrhea in PD. It then sought to examine the evidence for the different treatments of sialorrhea in PD, and further examined newer evidence for safety and efficacy in minimally invasive treatment such as botulinum toxin.


Asunto(s)
Enfermedad de Parkinson/complicaciones , Glándulas Salivales/fisiopatología , Salivación , Sialorrea/etiología , Inhibidores de la Liberación de Acetilcolina/uso terapéutico , Animales , Toxinas Botulínicas Tipo A/uso terapéutico , Humanos , Enfermedad de Parkinson/diagnóstico , Enfermedad de Parkinson/fisiopatología , Glándulas Salivales/efectos de los fármacos , Salivación/efectos de los fármacos , Sialorrea/diagnóstico , Sialorrea/tratamiento farmacológico , Sialorrea/fisiopatología , Resultado del Tratamiento
6.
Toxins (Basel) ; 12(2)2020 01 23.
Artículo en Inglés | MEDLINE | ID: mdl-31979238

RESUMEN

In contrast to the prevailing arguments presented in the current review, the incidence of neutralising antibody (NAb) formation is not a significant issue for any of the present type A therapeutic botulinum neurotoxin (BoNT) products. Furthermore, clinical non-responsiveness is poorly correlated with the presence of NAbs. The overriding evidence supports the view that the rate of NAb formation is low, does not differ significantly between the different type A BoNT products and that it is not the major factor in clinical response. BoNT products are highly effective and important therapies for the treatment of a variety of neurological and non-neurological conditions.


Asunto(s)
Toxinas Botulínicas Tipo A , Anticuerpos Neutralizantes , Neurotoxinas
7.
Toxins (Basel) ; 11(9)2019 08 30.
Artículo en Inglés | MEDLINE | ID: mdl-31480323

RESUMEN

Botulinum neurotoxin A (BoNT/A) appears to be one of the best intravesical treatments for interstitial cystitis/bladder painful syndrome (IC/BPS). We aimed to point out what the evidence is regarding the effects of BoNT/A intravesically injected in patients with IC/BPS. We performed a systematic review of all randomized controlled trials (RCTs) assessing BoNT/A for IC/BPS by using Medline, EMBASE, CINAHL, CENTRAL and MetaRegister of Controlled Trials. Standardized mean differences (SMD) were extracted from the available trials and combined in a meta-analysis applying a random effect model, including heterogeneity of effects. Twelve trials were identified. Significant benefits from BoNT/A injections were detected in: Interstitial Cystitis Symptom Index and Problem Index (ICSI, ICPI) (small to medium effect size: SMD = -0.302; p = 0.007 and -0.430, p = 0.004, respectively); Visual Analog Scale (VAS) for pain and day-time urinary frequency (medium effect size: SMD = -0.576, p < 0.0001 and -0.546, p = 0.013, respectively). A great effect size was detected for post-void residual volume (PVR, SMD = 0.728; p =0.002) although no clinically relevant in most cases. Great heterogeneity was observed in treatments' methodologies and symptoms assessment. Overall, BoNT/A intravesical injections significantly improve some of the most relevant symptoms affecting IC/BPS patients.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Cistitis Intersticial/tratamiento farmacológico , Dolor/tratamiento farmacológico , Administración Intravesical , Animales , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto
8.
Ther Clin Risk Manag ; 12: 147-54, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-26917963

RESUMEN

INTRODUCTION: Botulinum toxin (BoNT) is the treatment of choice for many neurologic movement disorders, including blepharospasm, hemifacial spasm, and cervical dystonia. There are two serotypes approved for use by the US Food and Drug Administration: three brands of serotype A and one of serotype B. Many attempts have been made at establishing dose conversion ratios between brands and serotypes. This review focuses on the existing data comparing different formulations of the same BoNT serotypes as well as that comparing different serotypes with one another. We focus on existing data regarding switching from one formulation or serotype to another and will also discuss the issue of immunogenicity of BoNT. With this information as a foundation, recommendations on safety of switching agents are addressed. METHOD: Literature review searching PubMed and Google Scholar using the search terms "switching botox", "dosing equivalency in botox", and "comparing botox". RESULTS/CONCLUSION: Overall, there are many studies that demonstrate the efficacy and safety of each of the brands of BoNTs used in clinical practice. However, determination of dosing equivalencies among these brands and serotypes is complex with inconsistencies among the studies. When switching from one brand to another, the clinician should be aware of these issues, and not make the assumption that such ratios exist. Tailoring the dosage of each brand of BoNT to the clinical situation is the most prudent treatment strategy rather than focusing closely on conversion factors and concerns for immunogenicity.

9.
Rev. chil. neuro-psiquiatr ; 51(2): 115-125, abr. 2013. ilus, tab
Artículo en Español | LILACS | ID: lil-682330

RESUMEN

Botulinum neurotoxin is widely used to treat a variety of movement disorders, especially dystonia and spasticity. There botúlica different preparations of botulinum type A, that because biologics are difficult to compare. AbobotulinumtoxinA (Dysport ®) has recently been introduced in Chile for treating dystonia and spasticity. The aim of this paper is to provide a review by experts on the existing evidence and propose a practical guide to the use of the drug. Methods and Results: A group of Chilean experts met on 6 and 7 July 2012 to review AbobotulinumtoxinA doses along with injection protocols for dystonia, spasticity and other movement disorders. We worked in two groups, one composed of neurologists who reviewed the on dystonias and other by physiatrists who reviewed the indications for spasticity. Conclusions: Finally, there is a proposal in terms of dose, injection points and recommendations for dystonia and spasticity...


La neurotoxina botulínica es ampliamente usada para tratar una variedad de trastornos del movimiento, especialmente la distonía y la espasticidad. Existen diferentes preparados de toxina botúlica tipo A, que por ser productos biológicos resultan difícilmente comparables. La abobotulinumtoxinA (Dysport®) ha sido introducida en Chile recientemente para el tratamiento de la distonía y la espasticidad. El objetivo de este trabajo es entregar una revisión hecha por expertos sobre la evidencia existente y plantear una guía práctica para el uso del medicamento. Métodos y Resultados: Un grupo de expertos chilenos se reunieron el 6 y 7 julio de 2012 para revisar las dosis abobotulinumtoxin A, junto con los protocolos de inyección para la distonía, la espasticidad y otros trastornos del movimiento. Se trabajó en dos grupos, uno compuesto por neurólogos que revisaron las indicaciones en distonías y otro por fisiatras que revisaron las indicaciones para espasticidad. Conclusiones: Finalmente, se realiza una propuesta en cuanto a dosis, puntos a inyectar y recomendaciones para la distonia y espasticidad...


Asunto(s)
Humanos , Distonía/tratamiento farmacológico , Espasticidad Muscular/tratamiento farmacológico , Fármacos Neuromusculares/administración & dosificación , Toxinas Botulínicas Tipo A/administración & dosificación , Chile , Consenso , Medicina Basada en la Evidencia , Fármacos Neuromusculares/efectos adversos , Guías de Práctica Clínica como Asunto , Toxinas Botulínicas Tipo A/efectos adversos
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